Institute of Good Manufacturing Practices India

Clinical Research Newsletter


Protagonist documents positive outcomes from phase 2b FRONTIER 1 trial of JNJ-2113 to moderate-to-severe plaque psoriasis

Protagonist Therapeutics, Inc. (Protagonist) has reported positive topline results from the phase 2b FRONTIER 1 clinical trial of JNJ-2113, an oral IL-23R antagonist, i


Boehringer Ingelheim demonstrates positive outcomes from the EFFISAYIL 2 trial of spesolimab for GPP flares at the World Congress of Dermatology

During the 25th World Congress of Dermatology (WCD), Boehringer Ingelheim presented groundbreaking findings from their EFFISAYIL 2 trial, demonstrating that spesolimab


AstraZeneca, Daiichi Sankyo’s TROPION-Lung01 phase III trial of datopotamab deruxtecan satisfies dual primary endpoint of PFS in patients with advanced NSCLC

Positive results from the TROPION-Lung01 phase III trial showed datopotamab deruxtecan (Dato-DXd) significantly improved progression-free survival (PFS) compared to doc


SK bioscience, Sanofi, reports positive outcomes from the phase II trial of the 21-valent pneumococcal conjugate vaccine candidate

SK bioscience and Sanofi's vaccine candidate, GBP410, showed positive results in infant phase II trials. The 21-valent pneumococcal conjugate vaccine combines proteins


Sanofi reports STREAM-AD phase 2b trial of amlitelimab in adults with moderate-to-severe atopic dermatitis satisfies the primary endpoint

The phase 2b study, known as STREAM-AD, met its primary endpoint by evaluating amlitelimab's efficacy in adults with moderate-to-severe atopic dermatitis unresponsive t


Curasight reports positive outcomes in uPAR-PET/MR phase II study in brain cancer

Curasight A/S reports positive results from an investigator-initiated phase II study using uPAR-PET (uTRACE) in primary brain cancer. The trial assessed 68Ga-NOTA-AE105


Bayer and BlueRock report positive outcomes from a phase I trial of bemdaneprocel to treat Parkinson's disease

Bayer AG and BlueRock Therapeutics LP announced positive top-line results from a phase I clinical trial of bemdaneprocel (BRT-DA01), an investigational cell therapy for


Aldeyra Therapeutics reports phase 3 INVIGORATE-2 trial of reproxalap to treat allergic conjunctivitis fulfils primary and secondary endpoints

Aldeyra Therapeutics, Inc. (Aldeyra) announced positive results from the phase 3 INVIGORATE-2 trial of reproxalap, an investigational drug for allergic conjunctivitis.


AbbVie and Genmab report positive outcomes from phase 1/2 EPCORE NHL-1 trial of epcoritamab in patients with r/r follicular lymphoma

AbbVie and Genmab reported positive outcomes from the follicular lymphoma (FL) segment of the EPCORE NHL-1 clinical trial. The trial evaluated epcoritamab (DuoBody-CD3x


Astellas Pharma reports positive outcomes from the phase 3b trial of fezolinetant to treat VMS due to menopause

Astellas Pharma Inc. reported positive results from the phase 3b DAYLIGHT trial for fezolinetant, an investigational nonhormonal compound for treating moderate to sever


GSK reports positive data for Arexvy, its respiratory syncytial virus older adult vaccine, demonstrating protection over two RSV seasons

GSK plc shared new data from the AReSVi-006 phase III trial, assessing Arexvy (respiratory syncytial virus vaccine, adjuvanted) in adults aged 60 years and older. Resul


Escient Pharma reports positive outcomes from the phase 1 study of EP262 to treat mast cell-mediated disorders

Escient Pharmaceuticals reported positive results from a phase 1 study of EP262, a selective small molecule antagonist of MRGPRX2. EP262 can potentially treat mast cell


Merck reports topline outcomes from phase 3 KEYNOTE-585 trial in locally advanced resectable gastric and GEJ adenocarcinoma

Merck (known as MSD outside the US and Canada) released initial findings from the phase 3 KEYNOTE-585 trial. The study examined Keytruda, Merck's anti-PD-1 therapy, com


Bavarian Nordic reports initial safety outcomes from phase 3 trial of VLP-based chikungunya virus vaccine in adults =65 years of age

Bavarian Nordic A/S, an integrated vaccines company, announced positive initial results from a phase 3 clinical trial of their chikungunya virus (CHIKV) vaccine candida


Allgenesis reports positive results from the phase 1b trial of AG-80308 to dry eye disease

Allgenesis Biotherapeutics Inc. announced the topline data from their phase 1b clinical trial for AG-80308, a novel ophthalmic drug aimed at treating dry eye disease (D


CorFlow reports positive results from the MOCA I first in human trial presented at EuroPCR 2023

CorFlow Therapeutics AG has announced positive interim results from the MOCA I study at EuroPCR in Paris. The study evaluates the safety and feasibility of a real-time


Bristol Myers Squibb reports positive outcomes from the phase 2 trial of the LPA1 antagonist, BMS-986278, in patients with idiopathic pulmonary fibrosis

Bristol Myers Squibb has released positive results from a phase 2 study on BMS-986278, an oral lysophosphatidic acid receptor 1 (LPA1) antagonist, in patients with idio


Abbott reports AVEIR DR i2i study of the world's first dual-chamber leadless pacemaker satisfies all three primary endpoints

Abbott unveiled significant findings from the AVEIR dual-chamber (DR) i2i Investigational Device Exemption (IDE) study, showcasing the world's first dual-chamber leadle


BioInvent and Transgene report positive phase 1a data on oncolytic virus BT-001 in solid tumours

BioInvent International AB and Transgene have reported positive Phase 1a results for the oncolytic virus BT-001 in treating solid tumours. In a trial involving 18 patie


HanAll Biopharma’s phase III VELOS-3 trial of tanfanercept to treat dry eye disease fails to exhibit statistical importance for either of the two primary efficacy endpoints

HanAll Biopharma Co., Ltd. has announced the phase III VELOS-3 trial results evaluating tanfanercept, a novel topical anti-inflammatory treatment for moderate to severe


Lotus Clinical Research enters a strategic alliance with Trialogics for clinical trial software services.

Lotus Clinical Research, a scientific and consultative CRO, has partnered with Trialogics to strengthen their relationship and expand Lotus' use of Trialogics' clinical


Astellas Pharma, BMT CTN to report positive results from phase 3 MORPHO trial of gilteritinib in subgroups of FLT3-ITD AML patients at EHA congress.

Astellas Pharma Inc. and the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) shared findings from the phase 3 MORPHO clinical trial at the 2023 European H


Nirsevimab delivers an 83% decrease in RSV infant hospitalizations in a real-world clinical trial setting

New data from the HARMONIE phase 3b clinical trial shows an 83.21% reduction in hospitalizations due to RSV-related LRTD in infants under 12 months who received a singl


Innovent reports phase 2 trial of a higher dose of 9 mg mazdutide in Chinese adults with obesity fulfilled the 24-week primary endpoint

Innovent Biologics, Inc. announced positive results from a phase 2 clinical study of mazdutide (IBI362) in Chinese adults with obesity. The randomized, double-blind, pl


Favourable phase 2 topline outcomes show Novavax's CIC, stand-alone influenza, and high-dose Covid vaccine candidates exhibit robust immune responses

Novavax, Inc. announced positive findings for its Covid-Influenza Combination (CIC) vaccine, stand-alone influenza vaccine, and high-dose Covid vaccine candidates. The


Allgenesis reports positive AG-73305 phase 2a trial results to treat diabetic macular oedema

AllgenesisBiotherapeutics Inc., a clinical-stage speciality pharmaceutical company, has announced exciting preliminary data from the initial cohorts of the ongoing phas


AnaMar registers positive phase I results for its phase II-ready compound AM1476 to treat fibrosis

AnaMar, a clinical-stage biotech company, reports positive phase I results and completion of phase II for its orphan indication in systemic sclerosis (SSc) with lung an


US FDA reports the availability of draft guidance with updated suggestions for GCPs aiming to modernize clinical trials.

The FDA has released draft guidance on good clinical practices (GCPs) to modernize clinical trials while maintaining data integrity and participant protections. The rec


AstraZeneca's ADAURA phase III trial of Tagrisso attains unprecedented survival in early-stage EGFR-mutated lung cancer, with 88% of patients alive at five years.

Positive results from AstraZeneca's ADAURA phase III trial demonstrated that Tagrisso (osimertinib) significantly improved overall survival (OS) in early-stage (IB, II,


Cactus presents Researcher.Life 'All Access Pack'.

Cactus Communications, a science communication and technology company, has unveiled the Researcher.Life 'All Access Pack', a comprehensive suite of AI tools and service


Pfizer's Prevnar 20, the 20-valent Pneumococcal Conjugate Vaccine, receives US FDA clearance to prevent IPD in infants and children

Pfizer Inc. has received approval from the US Food and Drug Administration (FDA) for Prevnar 20, a vaccine designed to prevent invasive pneumococcal disease (IPD) and o


EMA: Multi-factor Authentication for CTIS will be Compulsory by June

Starting from 1 June 2023, users logging in to CTIS (Clinical Trials Information System), including both sponsors and Member States, will need to employ multi-factor au


Alentis Therapeutics reports positive outcomes from the phase 1 multiple-ascending dose cohorts study

Alentis Therapeutics, a biotech firm specializing in treating organ fibrosis and CLDN1+ tumours, has revealed the results of the multiple-ascending dose (MAD) portion o


Novartis announces positive results from phase III APPOINT-PNH trial of iptacopan in complement-inhibitor-naïve adults with PNH

Novartis has disclosed the findings of the phase III APPOINT-PNH study, which investigated the use of the oral monotherapy iptacopan in adults with paroxysmal nocturnal


Astellas Pharma and Pfizer report Xtandi plus leuprolide decreased the risk of metastasis by 58% in nmHSPC versus placebo plus leuprolide

Astellas Pharma Inc. and Pfizer Inc. have announced results from their phase 3 EMBARK trial, which showed that the combination of Xtandi (enzalutamide) and leuprolide r


US FDA accepts Glaukos' NDA submission for iDose TR

Glaukos Corporation, a pharmaceutical and ophthalmic medical technology company, has received notification from the US Food and Drug Administration (FDA) acknowledging


FibroGen’s MATTERHORN phase 3 trial of roxadustat to treat anaemia in patients with MDS fails to fulfil the primary endpoint

FibroGen, Inc. reported that its phase 3 clinical trial, MATTERHORN, evaluating roxadustat for treating anaemia in transfusion-dependent lower-risk myelodysplastic synd


Soligenix registers positive clinical outcomes from a compatibility study of HyBryte in treating cutaneous T-cell lymphoma

Soligenix, a late-stage biopharmaceutical company, announced positive results from a compatibility study evaluating HyBryte in treating cutaneous T-cell lymphoma (CTCL)


US FDA takes further steps to promote decentralized clinical trials

The US FDA has released a draft guidance supporting decentralized clinical trials (DCTs) for medical product development and research. DCTs allow some or all trial-rela


EMA invites public consultation to examine transparency rules for EU Clinical Trials Information System

The European Medicines Agency (EMA) is seeking feedback on transparency regulations for disclosing clinical trial information through the EU's Clinical Trials Informati


NEURO-TTRansform phase III trial in subjects with ATTRv-PN exhibits AstraZeneca & Ionis’ eplontersen meets all co-primary endpoints and secondary endpoints at 66 weeks

AstraZeneca and Ionis have reported positive results from the NEURO-TTRansform phase III trial, which evaluated the efficacy and safety of eplontersen in subjects with


AbbVie to present positive outcomes from phase 3 trial of atogepant for preventive treatment of episodic migraine among patients with previous treatment failure at AAN meeting

AbbVie's atogepant has shown positive results in the phase 3 ELEVATE study for the preventive treatment of episodic migraine in adults who have failed two to four class


IDEAYA reports favourable interim phase 2 results for the darovasertib and crizotinib combination to treat first-line metastatic uveal melanoma

IDEAYA Biosciences, Inc. has reported positive interim results from its phase 2 clinical trial on the combination of darovasertib and crizotinib for metastatic uveal me


Actinium presents positive data from the pivotal phase 3 SIERRA trial in patients with relapsed, active, or refractory AML

Actinium Pharmaceuticals has reported positive results from its phase 3 SIERRA, randomized, multicenter, controlled trial of Iomab-B for treating acute myeloid leukaemi


EMA awards PRIME scheme status to an mRNA cancer vaccine, mRNA-4157/V940, along with Keytruda to treat patients with high-risk stage III/IV melanoma following complete resection

Moderna and Merck have announced that their mRNA cancer vaccine, mRNA-4157/V940, in combination with Merck's anti-PD-1 therapy Keytruda, has received Priority Medicines


NIH-funded study discovers Doxycycline reduces sexually transmitted infections by two-thirds

The (NEJM) New England Journal of Medicine recently published a study that showed Doxycycline, an oral antibiotic, was found to prevent the acquisition of STIs (sexuall


BenevolentAI reports top-line phase IIa outcomes for its topical pan-Trk inhibitor BEN-2293 in mild-to-moderate atopic dermatitis

BenevolentAI, a clinical-stage drug discovery and development company utilizing AI technology, has released top-line findings from its phase IIa study on BEN-2293, a to


Phase 3 LEAP-003 trial analyzing Keytruda plus Lenvima for first-line treatment of unresectable or metastatic melanoma discontinued: Merck, Eisai

Merck, also known as MSD, has provided updates on two phase 3 clinical trials, LEAP-003 and LEAP-017, which focus on investigating the effectiveness of Keytruda, Merck'


BenevolentAI reports top-line phase IIa outcomes for its topical pan-Trk inhibitor BEN-2293 in mild-to-moderate atopic dermatitis

BenevolentAI, a clinical-stage drug discovery and development company specializing in AI-enabled solutions, has released top-line results from its recent phase IIa tria


Therapy for rare bone disorders shows assurance in NIH clinical trials

A clinical trial conducted the NIH Clinical Center and the National Institute of Dental and Craniofacial Research (NIDCR) found that denosumab, a medication used to tre


Aurinia Pharma registers promising topline results from the renal biopsy sub-study of the AURORA trial

Aurinia Pharmaceuticals announced promising results from the AURORA Renal Biopsy Sub-Study evaluating Lupkynis, a novel agent approved for treating active lupus nephrit


NIH study finds that immunotherapy substantially increases the survival of people with lymphomatoid granulomatosis

A clinical trial led by the National Institutes of Health (NIH) found that patients with low-grade lymphomatoid granulomatosis treated with interferon alfa-2b can survi


Pfizer RSV Vaccine Exhibits 82% Efficacy In Severe Infection In Infants: Data From Study

Pfizer recently shared trial results for its experimental respiratory syncytial virus (RSV) vaccine, which apex health regulators are presently reviewing in the US and


Baudax Bio reports positive outcomes from 2nd interim analysis of the phase 2 randomized trial for BX1000
Baudax Bio, a pharmaceutical company focused on innovative products for hospital settings, has released positive outcomes from the second preplanned interim study of


Novartis Kisqali phase III NATALEE trial achieves primary endpoint at interim analysis exhibiting clinically meaningful benefit in a broad population of subjects with early breast cancer

Novartis has reported positive results from the phase III trial, NATALEE, evaluating Kisqali (ribociclib) plus endocrine therapy (ET) in subjects with hormone receptor-


Bristol Myers Squibb gets favourable CHMP opinion for CAR T cell therapy Breyanzi to treat relapsed or refractory large b-cell lymphoma following prior treatment

Bristol Myers Squibb has received a positive opinion from the CHMP (Committee for Medicinal Products for Human Use) of the EMA (European Medicines Agency) for Breyanzi


MHRA reforms to simplify the clinical trials process

The Medicines and Healthcare products Regulatory Agency (MHRA) is set to introduce a range of measures to facilitate faster and easier clinical trial approval in the UK


NIH-supported trial demonstrates artificial pancreas improves blood glucose control in young children

The Paediatric Artificial Pancreas (PEDAP) Trial conducted in the United States showed that artificial pancreas technology significantly improved blood glucose control


Astellas’ phase 3 China ARCHES trial of Xtandi in combination with ADT in men with mHSPC meets the primary endpoint

Astellas Pharma Inc. has reported positive topline results from its phase 3 China ARCHES study of Xtandi (enzalutamide) in combination with androgen deprivation therapy


InDex Pharma registers positive outcomes from a pharmacokinetic study with cobitolimod

In a recent announcement, InDex Pharmaceuticals Holding AB (publ) revealed that they had conducted a pharmacokinetic (PK) study on cobitolimod, and the results were pos


GSK reports positive outcomes from the phase III trial of the 5-in-1 meningococcal ABCWY vaccine candidate

GSK plc has announced positive headline outcomes from the phase III trial evaluating the tolerability, safety, and immunogenicity of the company's MenABCWY combination


Bristol Myers Squibb, 2seventy bio report positive outcomes from KarMMa-3 phase 3 trial of Abecma versus standard combination regimens to treat multiple myeloma

Bristol Myers Squibb and 2seventy bio, Inc. reported the first publication and presentation of positive outcomes from KarMMa-3, open-label, pivotal phase 3, randomized,


Inovio registers positive preliminary outcomes from the second cohort of the phase 1/2 study with INO-3107 to treat recurrent respiratory papillomatosis

Inovio announced positive preliminary results from the second cohort of its phase 1/2 2 open-label, multicenter clinical trial assessing INO-3107 for treating HPV 6 and


Pfizer reports positive outcomes from the phase 3 TALAPRO-2 trial of Talzenna in a combo with Xtandi to treat mCRPC

Pfizer announced positive outcomes from the phase 3 TALAPRO-2 trial of Talzenna (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor and Xtandi (enzalutam


Merck reports positive outcomes from the phase 3 KEYNOTE-859 study of Keytruda plus chemotherapy to treat patients with HER2-negative gastric or GEJ adenocarcinoma

Merck announced outcomes from the pivotal phase 3 KEYNOTE-859 study investigating Merck’s anti-PD-1 therapy, Keytruda, along with fluoropyrimidine- and platinum-c


Signant’s novel electronic PROMIS CAT assessment improves patient-centric drug development

Signant Health, the market leader in evidence generation for modern clinical trials, announced the ability to produce computerized adaptive tests (CATs) in clinical tri


Thermo Fisher Scientific presents Bigfoot Spectral Cell Sorter in India to help researchers advance new therapies

Thermo Fisher Scientific launched the Bigfoot Spectral Cell Sorter in India. The unique and exceptionally different cell sorting technology is easy to use and provides


Certa Therapeutics reports positive outcomes from the phase 2 scleroderma study

Certa Therapeutics (Certa) reported ground-breaking clinical study data for FT011, its novel therapy for treating severe inflammatory and fibrotic diseases.


Chugai phase III COMMODORE 2 trial evaluating efficacy and safety of crovalimab in PNH patients meets its co-primary efficacy endpoints

Chugai Pharmaceutical Co., Ltd. reported positive outcomes from the global randomized, open-label phase III COMMODORE 2 study, assessing the efficacy and safety of crov


Baudax Bio declares the positive result of an interim analysis of the phase II randomized trial for BX1000 in patients undergoing elective surgery

Baudax Bio, Inc. announced the successful result of its first interim analysis in a phase II study of BX1000 for neuromuscular blockade (NMB) in individuals undergoing


Boehringer Ingelheim reports EFFISAYIL 2 of spesolimab achieves primary and key secondary outcomes for preventing generalized pustular psoriasis flares

Boehringer Ingelheim reported that the multicenter, double-blind, randomized, placebo-controlled phase IIbEFFISAYIL 2 trial completed its primary and key secondary resu


Merck reports positive outcomes from the phase 3 KEYNOTE-966 study of Keytruda combined with chemotherapy to treat advanced or unresectable biliary tract cancer

Merck, aka MSD outside of the US and Canada, announced positive results from the randomized, double-blind phase 3 KEYNOTE-966 trial(, NCT04003636).&nb


Bristol Myers Squibb’s TRANSCEND CLL 004 study of Breyanzi completes the primary endpoint of complete response rate in r/r chronic lymphocytic leukaemia

Bristol Myers Squibb reported topline results from TRANSCEND CLL 004, a phase 1/2, single-arm, open-label, multicenter trial investigating Breyanzi (lisocabtagene maral


Using CTIS becomes compulsory for fresh clinical trial applications in European Union

January 31, 2023, onwards, submission of all initial clinical trial applications in the EU (European Union) shall require employing Clinical Trials Information System (


Roche’s phase III IMbrave050 trial of Tecentriq in combination with Avastin to treat early-stage liver cancer fulfils the primary endpoint

Roche reported that the phase III IMbrave050 global, open-label, multicentre, randomized trial achieved its primary endpoint of RFS (recurrence-free survival) at the pr


Astellas reports positive results from the phase 3 SPOTLIGHT trial of zolbetuximab at the 2023 ASCO GI Cancers Symposium

Astellas Pharma Inc. presented detailed results from the phase 3 global, double-blind, multi-centre, randomized SPOTLIGHT trial assessing first-line drug zolbetuximab,


Everest Medicines declares positive outcomes from the phase I trial of EVER206 to treat MDR gram-negative bacterial infections

Everest Medicines reported top-line outcomes from a double-blind, randomized, placebo-controlled China phase I trial on healthy subjects exhibiting that EVER206 (also k


Moderna declared top-line results from ConquerRSV phase 3 pivotal efficacy study of mRNA-1345 targeting the respiratory syncytial virus (RSV)

Moderna, Inc. announced positive top-line data from its double-blind, randomized,placebo-controlled ConquerRSV Phase 3 pivotal efficacy study of mRNA-1345, an investiga


Feinstein Institute employs ultrasound to treat brain tumours in a clinical trial

Feinstein Institutes for Medical Research, the home of the research institutions of Northwell Health and the biggest health care provider and private employer in New Yo


Lipella Pharma declares positive outcomes from the phase 2a study of LP-10 for haemorrhagic cystitis

Lipella Pharmaceuticals Inc. reported top-line outcomes of the company's recently concluded phase 2a clinical trial assessing the efficacy and safety of its drug candid


Clene Nanomedicine reports positive results from the phase 2 Covid-19 study of CNM-ZnAg

Clene Inc. and Clene Nanomedicine Inc. reported topline results from its phase 2 investigational study with CNM-ZnAg, an ionic and patented solution of zinc and silver,


PEARL phase III study of AstraZeneca's Imfinzi monotherapy in stage IV non-small cell lung cancer fails to meet endpoints

The PEARL, an open-label, randomised, multicentre, global phase III study for AstraZeneca's Imfinzi (durvalumab), did not fulfil statistical significance for the primar


Zymeworks documents positive outcomes from pivotal phase 2b HERIZON-BTC-01 study of zanidatamab to treat HER2-amplified and expressing BTC

Zymeworks Inc. announced positive topline outcomes from the pivotal phase 2b HERIZON-BTC-01 global, multicenter, open-label, single-arm clinical study investigating zan


Astellas Pharma phase 3 GLOW study of zolbetuximab in combo with Capox for treating Claudin 18.2 positive, HER2-negative locally progressive unresectable or metastatic gastric and GEJ cancers complete

Astellas Pharma Inc. reported positive topline outcomes from the global, double-blind, multi-centre, randomized phase 3 GLOW clinical trial evaluating the efficacy and


Daiichi Sankyo and AstraZeneca report positive outcomes from the phase 1 study of datopotamab deruxtecan to treat HR positive, HER2 low or negative metastatic breast cancer

Initial developments from the TROPIONPanTumor01 first-in-human, two-part, open-label, multicenter phase 1 trial of datopotamab deruxtecan (Dato-DXd) showed promising an


Synaptogenix declares NIH-sponsored phase 2 study of Bryostatin-1 to treat advanced Alzheimer's disease fails to achieve the primary endpoint

Synaptogenix, Inc. reported topline results from its National Institute of Health (NIH)-sponsored, randomized, double-blind, placebo-controlled phase 2 clinical study o


BioLineRx phase 1/2a trial of anti-tumour vaccine AGI-134 in solid metastatic tumours fulfils primary outcomes

BioLineRx Ltd. reported results from phase 1/2a, an open-label, multicenter study of intratumoural cancer vaccine candidate AGI-134, developed to assess the safety and


Arcellx reported positive outcomes from the CART-DdBCMA phase 1 expansion study to treat relapsed/refractory multiple myeloma

Arcellx, Inc. reported continued robust long-term responses from its CART-ddBCMA phase 1 expansion study in relapsed or refractory multiple myeloma patients, dosing of


UCB reports positive outcomes from two phase III trials of bimekizumab to treat moderate to severe hidradenitis suppurativa

UCB reported positive top-line outcomes from two placebo-controlled, randomized, parallel-group, double-blind, multicenter phase 3 clinical trials, BE HEARD I and BE HE


Novartis’ phase III APPOINT-PNH trial of iptacopan in complement-inhibitor-naïve grown-ups with PNH satisfies its primary endpoint

Novartis reported the phase III APPOINT-PNH trial (NCT04820530) of investigational oral monotherapy iptacopan in complement-inhibitor-naïve (including anti-C5 ther


Replimune declares positive results from anti-PD1 failed melanoma cohort of IGNYTE study

Replimune Group, Inc. reported an initial data snapshot from the first seventy-five (75) patients from the anti-PD1 unsuccessful cutaneous melanoma cohort of the IGNYTE


GSK reports positive data from the MOMENTUM phase III trial of momelotinib to treat myelofibrosis

GSK plc reported fresh 48-week data from the MOMENTUM, a randomised, global, double-blind phase III trial that demonstrated a majority of patients treated with investig


Novartis phase III PSMAfore trial of Pluvicto, a PSMA-targeted radioligand therapy, completes the primary endpoint

Novartis announced the pivotal phase III PSMAfore open-label, multi-centre, 1:1 randomized trial of Pluvicto (INN: lutetium (177Lu) vipivotide tetraxetan). 



Vaxxinity registers positive outcomes from phase 3 Covid-19 vaccine, UB-612

Vaxxinity, Inc. reported that its next-generation UB-612 Covid-19 vaccine, when given as a single heterologous booster dose, provoked potent neutralizing antibodies aga


AnaptysBio, GSK partnered immuno-oncology agent Jemperli satisfies primary endpoint in phase 3 RUBY trial in primary advanced and/or recurrent endometrial cancer

AnaptysBio, Inc. reported that GSK's RUBY/ENGOT-EN6/GOG3031/NSGO phase 3, two-part global, double-blind, randomised, multicentre study of Jemperli (dostarlimab) plus st


Pocket Naloxone reports positive outcomes from PK study of novel naloxone nasal swab, NaxSwab

Pocket Naloxone Corp. reported positive outcomes from its human pharmacokinetic (PK) trial of its novel naloxone nasal swab NaxSwab. The study was a crossover, randomiz


Roche declared positive results from the STRONG-HF study in patients hospitalized for acute heart failure

Roche reported promising results from the STRONG-HF (Safety, Tolerability and Efficacy of Rapid Optimization of Heart Failure) study in hospitalized acute heart failure


Kyowa Kirin, MEI Pharma declare positive results from phase II MIRAGE trial of Zandelisib in patients with indolent B-cell NHL

Kyowa Kirin Co., Ltd., reported topline results from an open-label, multicenter, single-arm phase 2 MIRAGE study assessing zandelisib, an orally dispensed investigation


Ipsen’s phase III NAPOLI 3 trial of the Onivyde regimen completes the primary endpoint exhibiting statistically significant progress in OS in previously untreated mPDAC

Ipsen reported the phase 3 NAPOLI 3 trial of Onivyde (irinotecan liposome injection) plus five fluorouracil/leucovorin and oxaliplatin (Nalirifox regimen) achieved its

24-11-2022 declares positive new results from large aortic dissection AI real-world study proclaimed new data from a large aortic dissection AI (artificial intelligence) real-world study that supports its artificial intelligence technology's detection


Merck declares positive outcomes from the phase III KEYNOTE-859 trial of Keytruda in combination with chemotherapy to treat HER2-negative gastric or GEJ adenocarcinoma

Merck (MSD outside of the US and Canada) reported positive topline outcomes from the pivotal phase III, double-blind, randomized, KEYNOTE-859 trial investigating Keytru


Processa Pharma declares positive results from the PCS12852 phase 2A trial in moderate to severe gastroparesis patients

Processa Pharmaceuticals, Inc. declares positive gastric emptying outcomes from its PCS12852 phase 2A trial in moderate to severe gastroparesis patients.


Apeiron Respiratory Therapies phase I study of inhaled APN01 fulfils primary and secondary endpoints

Apeiron Respiratory Therapies GmbH (AResT) reports positive final outcomes from a placebo-controlled, double-blind, dose-escalation phase I clinical study of inhaled al


UK MHRA endorses Pfizer/BioNTech’s bivalent Covid-19 booster vaccine

The Pfizer/BioNTech ‘bivalent’ Covid vaccine targetting both the Original strain of SARS-CoV-2 and the Omicron BA.4 and BA.5 sub-variants received UK MHRA (


Biophytis announces positive post-hoc analysis of phase 2-3 COVA trial strongly supporting the therapeutic potential of Sarconeos in Covid-19

Biophytis SA declared the complete results from its phase 2-3 COVA clinical trial evaluating Sarconeos (BIO101) in treating Covid-19-related respiratory failure.



GSK’s DREAMM-3 phase III trial of Blenrep for treating relapsed/refractory multiple myeloma could not satisfy the primary endpoint

GSK plc reported that DREAMM-3, the phase III open-label, randomised head-on superiority trial of Blenrep (belantamab mafodotin) monotherapy compared to (PomDex) pomali


Rivus Pharma announced topline results from the phase 2a trial of HU6, the controlled metabolic accelerator, at the AASLD 2022 meeting

Rivus Pharmaceuticals Inc. reported topline results from a double-blind, randomized, placebo-controlled phase 2a study assessing the efficacy and safety of HU6, a first-in-class controlled metaboli


Ionis Pharma reports positive outcomes from phase 2b RE-THINC ESRD study of fesomersen to avert thrombosis

Ionis Pharmaceuticals, Inc. reported positive outcomes from the double-blind, randomized, placebo-controlled phase 2b RE-THINC ESRD trial of fesomersen (previously IONIS-FXI-LRx), an investigationa


Phase 3 COMMANDS trial of Reblozyl by Bristol Myers Squibb achieves primary endpoint

Bristol Myers Squibb reported the COMMANDS study, a phase 3, an open-label, randomized trial assessing Reblozyl (luspatercept-aamt), completed its primary endpoint, exh


Actinium registers positive outcomes from the pivotal phase 3 SIERRA trial of Iomab-B in active relapsed or refractory AML patients

Actinium Pharmaceuticals, Inc. (Actinium or the Company) declared positive top-line outcomes from the pivotal phase 3 trial for its prospective principal product, Iomab


United Therapeutics reports positive results from EXPEDITE study of Remodulin induction before Orenitram therapy

United Therapeutics Corporation reported that an initial analysis of the EXPEDITE study in subjects suffering from WHO (World Health Organization) Group 1 pulmonary art


Novavax reports positive results from the phase 1/2 trial of its CIC vaccine candidate

Novavax, Inc. declared positive outcomes from the phase 1/2 clinical trial of its CIC (Covid-19-influenza combination) vaccine candidate. Data indicated the CIC vaccine


Pfizer and BioNTech register positive early results from phase 2 and 3 trials of Omicron BA.4/BA.5-adapted bivalent booster dose in subjects over 18

Pfizer Inc. and BioNTech SE reported early data from phase 2 and 3 clinical trials (NCT05472038) assessing the safety, tolerability, and immunogenicity of both organiza


SIFI reports positive outcomes from the phase 3 study of Akantior for acanthamoeba keratitis treatment at the AAO meeting

SIFI S.p.A, Italy, a foremost global ophthalmic company, reported positive outcomes from the positive phase 3 study [NCT03274895] of an investigational anti-amoebic polymer, Akantior (polihexanide


GSK reports positive results from the PERLA phase II trial of Jemperli plus chemotherapy in subjects with metastatic non-squamous NSCLC

GSK plc reported positive headline results of the PERLA phase II trial, which achieved its primary endpoint of objective response rate (ORR) by Response Evaluation Crit


Pfizer declares positive outcomes from phase 3 TALAPRO-2 study of the oral PARP inhibitor, Talzenna

Pfizer Inc. declared positive topline results from the phase 3 TALAPRO-2 study of Talzenna (talazoparib), an oral PARP (poly ADP-ribose polymerase) inhibitor, in combin


Regeneron reports positive results from aflibercept 8 mg in diabetic macular edema & wAMD patients

Regeneron Pharmaceuticals, Inc. notified the first presentations of detailed positive results from two pivotal trials investigating novel aflibercept 8 mg with 12- and


Zealand Pharma declares positive outcomes from phase 3 trial of glepaglutide in short bowel syndrome patients

Zealand Pharma A/S declared positive topline results from the pivotal, randomized, double-blind phase 3 trial of glepaglutide, a long-acting GLP-2 analogue developed fo


Ionis Pharma declares topline results from phase 2b SOLANO study in patients with hypercholesterolemia

Ionis Pharmaceuticals, Inc. announced the topline results from the phase 2b SOLANO study in patients with hypercholesterolemia. The study demonstrated that 60mg of ION4


Positive results of proposed biosimilar denosumab: Sandoz integrated ROSALIA phase I/III study

Sandoz declares further progress on its biosimilar pipeline, with the announcement of positive results from the integrated ROSALIA phase I/III clinical study for its pr


Pfizer declares positive results from the EU phase 3 study in a 20-valent pneumococcal conjugate vaccine in infants

Pfizer released positive top-line results from its pivotal EU phase 3 study in infants (NCT04546425), analyzing its 20vPnC (20-valent pneumococcal conjugate vaccine can


Danicopan add-on to Ultomiris or Soliris meets primary endpoint: ALPHA phase III trial in patients with PNH

A prespecified interim analysis of the ALPHA phase III trial analyzing danicopan (ALXN2040), oral factor D inhibitor, an investigational, as an add-on to C5 inhibitor t


Positive initial data of NTLA-2001 for transthyretin amyloidosis treatment from phase 1 study: Intellia, Regeneron

Intellia Therapeutics, Inc. and Regeneron Pharmaceuticals, Inc. declared positive interim results from an ongoing phase 1 clinical trial of NTLA-2001, in vivo CRISPR/Ca


Amgen reports positive data from phase 3 FOURIER OLE studies of Repatha in adults with ASCVD at the ESC meeting

Amgen submitted new convincing data from the phase 3 FOURIER open-label extension (OLE) studies of Repatha (evolocumab) in adults with atherosclerotic cardiovascular di


Pfizer reports positive data from the phase 3 trial of older adults for its bivalent RSV vaccine candidate

Pfizer Inc. reported positive top-line data from the phase 3 clinical trial (NCT05035212) RENOIR (RSV vaccine Efficacy study iNOlder adults Immunized against RSV diseas


Amgen reports positive results from the phase 3 study of ABP 959, a biosimilar contender to Soliris in adult PNH patients

Amgen declared positive top-line outcomes from the DAHLIA study, a randomized, double-blind, active-controlled, two-period crossover phase 3 study assessing the efficac


Daiichi Sankyo and AstraZeneca's datopotamab deruxtecan-based combinations exhibit favorable clinical activity in patients with progressive NSCLC

Early results from the TROPION-Lung02 phase Ib trial exhibited that datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab with or without platinum chemoth


Endo reports positive results from phase 2 study of collagenase clostridium histolyticum in subjects with adhesive capsulitis of shoulder

Endo International plc declared top-line results from its phase 2 study of Collagenase Clostridium histolyticum (CCH) in subjects with adhesive capsulitis (AC) of the s


Ocugen publishes positive pediatric phase 2/3 study results in children aged 2–18 years for Covaxin, the Covid-19 vaccine, in the Lancet

Biotechnology company, Ocugen Inc., declared the publication of positive pediatric phase 2/3 study results in children aged 2–18 years for the Covid-19 vaccine Co


Intellia and Regeneron declare positive provisional data from phase 1 study of CRISPR-based NTLA-2001 to treat transthyretin amyloidosis

Intellia Therapeutics Inc. and Regeneron Pharmaceuticals Inc. declared further positive provisional data from an ongoing phase 1 study of their lead investigational in vivo genome editing candidate


At ISPPD-12, Merck demonstrates positive results from phase 1/2 study of pneumococcal conjugate vaccine, V116

Merck (MSD outside the US and Canada) announced positive results from the phase 1/2 study of V116-001, the company’s investigational 21-valent pneumococcal conjug


Ionis declares phase 3 NEURO-TTRansform study of eplontersen in subjects with ATTRv-PN meets co-primary and secondary endpoints

Ionis Pharmaceuticals Inc. reported positive topline results from a 35-week interim investigation of phase 3 NEURO-TTRansform study of Ionis and AstraZeneca's eplonters


Teva showed positive provisional results from the PEARL study of Ajoy in patients with chronic migraine or episodic migraine at the EAN congress

Teva Pharmaceuticals Europe B.V. reports promising interim results from its PEARL (Pan-European Real World study), presented for the first time at the EAN (European Academy of Neurology) Congress i


AlzeCure reports positive outcomes from the phase I MAD study of ACD856 to treat Alzheimer's disease

AlzeCure Pharma AB (publ) reported completion of clinical phase I study (multiple ascending doses, MAD) with repeated dosing of the drug candidate ACD856 that focuses o


Basilea Pharmaceutica documents positive results of phase 3 ERADICATE study of ceftobiprole in Staphylococcus aureus bacteremia

Basilea Pharmaceutica Ltd reported positive topline outcomes for the phase 3 ERADICATE study, assessing ceftobiprole in the treatment of adult patients with bacterial b


USFDA holds back plasma therapy for treatment of COVID- 19


The USFDA disapproves plasma therapy as an emergent weapon for treating COVID -19 as reported on 19 August, 2020. However, currently the plasma therapy is being tested globally


The US-based firm, Advanced Penetration Technology, LLC. found a USFDA approved OTC ointment useful in treating viral infections including Covid-19


FDA registered a non- prescription over the counter ointment possessing virucidal activity has the potential to kill and treat viral infections including SARS-CoV-2, the virus respon


Bharat Biotech all set to conduct the Phase I and II clinical trials for its COVID-19 vaccine ‘Covaxin’, receives green signal from CDSCO


The Drug Controller General of India gave approval to Bharat Biotech to test its first Covid-19 vaccine via the skin through intradermal delivery.  The company would now conduct


ICMR collaborates with Serum Institute of India to develop a promising experimental corona virus vaccine to combat COVID-19 scenario


Clinical trials are the research-based studies conducted on human volunteers to evaluate a medical and therapeutical intervention by determining its effects in human health outc


Marinomed Biotech obtains promising outcomes in preclinical studies for further areas of application with its Marinosolv technology platform


A globally active biopharmaceutical company known as Marinomed Biotech AG, located in Vienna, has obtained promising outcomes in preclinical studies for further areas of ap


Improving of resuscitation outcomes in emergency departments by First-ever analysis of video recorded CPR


Less than 8% of people who experience from cardiac arrest outside of the hospital survive the incident, as per the American Heart Association.

To enhance


Immunosuppressive therapy does not enhance risk of vulvar or vaginal cancer in women with IBD


In a novel retrospective study, researchers discovered that the utilization of immunosuppressive therapy does not enhance the occurrence or recurrence of vulvar or vaginal


Exposure to Air pollution takes a heavy toll on gut bacteria, touting risk of chronic illnesses


Breathing impure air takes a huge toll on gut bacteria, enhancing risk of diabetes, obesity, gastrointestinal disorders and other chronic illnesses, new University of Color


Effective Treatment Option of Gabapentin for Alcohol Utilization Disorder, as per JAMA


About 30 million people in the U.S. attain criteria for alcohol use disorder, yet less than 1 million get medication that may be useful.

A randomized clin


Being Overweight in Middle Age enhances the risk of Prostate Cancer


Advanced prostate cancer etiology is understood very poorly. Few have evaluated the role of early adulthood BMI and adult BMI changes on risk of advanced forms of prostate


Artificial Intelligence may enahnce Management of Sleep Disorders, as per AASM


The potential utilization of Artificial Intelligence in the field of sleep medicine, leading to advance diagnosis and treatment is administered by a position statement from


EC approves marketing authorization of AbbVie shortening Maviret treatment duration to 8 weeks for treatment of naïve chronic HCV patients with GT 3 infection


A research-based global biopharmaceutical company, AbbVie, declared that the European Commission has granted a change to the marketing authorization for Maviret (glecaprevi


Phase 3 clinical trial of AstraZeneca for DANUBE for Imfinzi and tremelimumab for treatment of bladder cancer does not meets primary end point


AstraZeneca has Declared that the phase 3 DANUBE clinical trial for Imfinzi plus tremelimumab and Imfinzi (durvalumab) is unblockable, Stage IV (metastatic) bladder cancer


New manganese-zinc ferrite nanoparticles can potentially be utilized in cancer treatment


A team of Russian scientists has made chemically manganese-zinc ferrite nanoparticles that can potentially be utilized in cancer treatment. Due to their advance and unique


Dynacure initiates patient dosage in phase I/II study of DYN101 for treatment of CNM and myotubular


A clinical stage drug development company known as Dynacure is committed on enhancing the lives of patients with rare and orphan disorders declared that the first patient h


Phenelzine May have regeneration to combat Recurrent Prostate Cancer


Monoamine oxidase A (MAOA) stimulates prostate cancer growth and metastasis in pre-clinical models. They evaluated the impacts of phenelzine (a monoamine oxidase inhibitor)


Electrical Stimulation aids in Treatment of Chronic Constipation in Females, as per Clinical Trial


Management of chronic constipation is frustrating as patients frequently remain dissatisfied with laxative treatments. Chronic constipation impacts about 15 percent of the


EMA furnishes positive opinion for acelarin of NuCana in combination with cisplatin for treatment of biliary tract cancer


A clinical-stage biopharmaceutical company known as NuCana declared that the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) has furn


1st patient treatment in phase I trial initiated by Actinium Pharmaceuticals of Actimab-A CLAG-M to treat AML


A clinical-stage biopharmaceutical company, Actinium Pharmaceuticals, declared that the 1st patient has initiated treatment in the third and final cohort of the Actimab-A C


Study offers new proof about optimal way for treatment of BRCA carriers with breast cancer


The BRCA gene family which is generally known as the breast cancer genes acts in the repairing of damaged DNA. Inherited mutations in the genes BRCA1 or BRCA2 elevate the r


Newly recognized genetic signatures in common pediatric cancer make way for precision medicine


Nemours Children's Health System researchers used Next Generation Sequencing (NGS) to more accurate identification of genomic characteristics of leukemias in children, the


During pregnancy, stress can cause lifetime of immune system deficiencies


Mice under exposure to stress in the womb and soon after birth can anticipate a lifetime of immune system deficiencies that interferes the ability to ward off infections an


As per the Study, Distraction by technology during mealtimes may lower food intake


Distraction by technology during mealtimes may lower the amount of food a person eats, nutrition scientists recommended in a new study.

When 119 young adu


Liver fibrosis linked with one type of heart failure, despite of HIV or hepatitis C status


While there is a linkage between heart failure and liver fibrosis, the mechanisms for this linkage are presently unclear but may be of particular significance for people li


Researchers create new coating to lower pain and risk of infection for users of catheter


Researchers from the School of Pharmacy at Queen’s University Belfast (QUB) have created a new antimicrobial coating which can be used to urinary catheters and other medic


Researchers discover automated CT biomarkers which predict precise CV events and mortality


Researchers at the National Institutes of Health (NIH) and the University of Wisconsin have showed that using artificial intelligence (AI) to study CT scans can make more accura


Capability to deliver high-fidelity images by Seismic imaging of the human brain


UCL and the Imperial College London researchers stated that their proof-of-concept study, advertised today in npj Digital Medicine, makes the way for the development of hig


Binaural On-the-spot beats and mindfulness lowers negative impacts of mental fatigue


A psychobiological state known as mental fatigue caused due to extended periods of demanding cognitive activity which leads to slower reaction times and attention deficienc


Tramadol consumption associated to enhanced risk of Hip Fracture`

Tramadol has been suggested as one of the first‐line or second‐line therapies for patients with chronic non-cancer pain by several professional organizations. These involve fibromyal


Innovent Biologics starts patient recruitment in pivotal trial of Pemigatinib for treatment of advanced cholangiocarcinoma in Chinaq


A world-class biopharmaceutical company known as Innovent Biologics Inc, that develops and commercializes high quality medicines for the treatment of autoimmune, cancer, metabolic an


PureTech commences clinical trial of LYT-100 for treatment of lymphoedema and fibrotic conditions


A clinical stage biotherapeutics company, PureTech Health, focussed on developing, discovering and commercializing highly distinguished medicines for devastating diseases, declared t


Novel NGS technique provides quick, precise diagnosis of sepsis


In the Journal of Molecular Diagnostics a report appeared by Elsevier detailing a new technique that uses real-time next-generation sequencing (NGS) to analyze tiny amounts of microb


MRI-Targeted Biopsy enhances Diagnosis of Aggressive Prostate Cancer


Researchers have discovered that MRI-targeted biopsy can greatly enhance prostate cancer diagnosis and lower the chances of patients being either over treated or undertreat


Consumption of antibiotics during Infancy may enhance Childhood Obesity Risk


Antibiotic consumption during the second trimester and infancy could enhance the risk of childhood overweight or obesity, a current meta-analysis advertised in the Journal


New insight offered by study into neurofibromin-deficient ER+ breast cancer


An international team of researchers headed by scientists at Baylor College of Medicine has new information into the function of neurofibromin, a tumor suppressor geenrated


Researchers Develop minimum Invasive, Cost-Effective Blood Test for Detection of Deposits of Alzheimer Proteins in Brain


A minimal invasive as well as cost-effective blood test has been created by the researches from the National Institute of Ageing here which can diagnose Alzheimer's disease


Light Therapy may aid in Elevating Mood in People with A Concussion


Researchers have discovered that exposure of people with mild traumatic brain injury to early morning blue light therapy may lower depression and other concussion symptoms.


New Drug May effectively Reduce lethal Brain Swelling after Stroke


Stroke is typically caused due to blood clot in the brain and can result in death within minutes. In the UK alone, more than 100,000 strokes occur annually, on an average o


Hyper somnolence among Elderly May enhance Risk for Cancer, Diabetes and High BP


Hyper somnolence is described as excessive daytime sleepiness even after having seven or more hours of sleep. It can be deteriorating for some people, impacting the way tha


Phase III study of AbbVie for Venclexta in combo with low-dose cytarabine for treatment of acute myeloid leukemia fails to reach primary endpoint


A research-based global biopharmaceutical company known as AbbVie has declared the VIALE-C (M16-043) trial of Venclexta (venetoclax) in combination with low-dose cytarabine


IO Biotech declares positive results from phase II trial of lead cancer therapeutic vaccine, IO102


A clinical-stage biopharmaceutical company known as IO Biotech is developing novel, immune modulating anti-cancer therapies grounded on its proprietary T-win technology, de


Pre-hospital Treatment in Mobile Units lowers the Disability in Stroke Patients


Mobile stroke units well-equipped with CT for prehospital thrombolysis not only lowers the time of treatment, but had higher rates of thrombolysis and decreased risk for di


Intracranial Stents Safely lowers the Recurrence Risk of Ischemic Stroke as per the WOVEN Trial


Intracranial stents safely lowers the risk of recurrence is the observation of WOVEN trial which is one of the largest on-label, intracranial stenting trial to-date with lo


Tele-monitoring along with phone counseling enhances blood pressure control among minority stroke survivors


Inserting phone-based lifestyle counseling to home blood pressure tele-monitoring is an impactful strategy to enhance long-term blood pressure control among minority stroke


2 out of 3 young mothers suffers from mental health problems, as demonstrated in a study


New research from McMaster Hospital of Children demonstrates that 2 out of 3 young mothers have at least one mental associated health problem.



Advancement in surgical care for patients suffering from pancreatic cancer


Priorly this year, researchers and doctors celebrated the news that the 5-year survival rate for pancreatic cancer had surpassed into double digits for the first time up fr


Addendum ICH E9 accepted


The ICH E9(R1) Addendum to describing the proper Estimand for a Clinical Trial / Sensitivity Analyses reached Step 4 of the ICH Process. The topic was sponsored by the ICH


Advice by FDA for financers of Adaptive Design Clinical Trials


The FDA advertised a new guideline on Adaptive Design Clinical Trials for Drugs and Biologics. The document offers guidance to sponsors on the appropriate usage of adaptive


NIH study demonstrates maternal obesity associated to ADHD and behavioral problems in children


Maternal obesity may enhance the risk of a child for attention-deficit hyperactivity disorder (ADHD), as per the analysis by researchers from Human Development (NICHD), par


Prevention of Postanesthetic Shivering without Severe Side Effects using Ketamine


Postanesthetic shivering without severe side effects can be prevented by using ketamine, as per the recent study in the journal BMC Anesthesiology. The study further discov


Symptomatic or Radiographic Knee OA elevates Risk of Mortality


People with radiographic or symptomatic knee osteoarthritis (OA) are at elevated risk of all‐cause mortality, as per the recent study advertised in the journal Arthritis


Vitamin E impactful, Safe Treatment for NASH in HIV Patients


HIV-infected patients are at enhanced risk of non-alcoholic steatohepatitis (NASH). Vitamin E is suggested for the treatment of NASH in the general population. However, its


ICU Patients benefitted by Vitamin C, lowers Duration of Mechanical Ventilation


Critically ill patients may benefit from the uptake of vitamin C, a current meta-analysis in the Journal of Intensive Care has indicated. As per the study, vitamin C shorte


Air Pollution by Emissions from Automobile associated to Neonatal Heart Attack


Myocardial infarction is a vital form of cardiovascular disease worldwide. Researchers at Yale University have discovered that even a few hours' exposures to ambient ultraf


As per Lancet, Early Administration of Dexamethasone impactful For ARDS Treatment


Early administration of dexamethasone could lower the span of mechanical ventilation and overall death in patients with established moderate-to-severe acute respiratory distress synd


Span of Antibiotic Treatment not linked with UTI Recurrence in Children


Persistent with antimicrobial stewardship efforts, a current study has discovered that the span of antibiotic treatment for uncomplexed urinary tract infection (UTI) is not


Few Drops of Blood May provide assistance in Diagnosis of Autism Spectrum Disorder


Throughout the United States few drops of blood are accumulated from every newborn which are then preserved on filter paper and analyzed for dozens of genetic and congenita


Early commencement Of Treatment in Schizophrenia May Not Slow down the Progression of Disease


Overall mental health initiates to decline in Individuals with schizophrenia once the onset of symptoms. This gradual fall often continues for many decades, regardless of w


Enhanced Estradiol Levels May result in Impotence as per the Study


Erectile dysfunction is a consistent inability to acquire an erection sufficient to allow satisfactory sexual intercourse and is on the elevation globally. It has a negativ


IDMA requests DCGI to continue with Rs15,000 registration fee for 83 FDCs granted prior to New Drugs & Clinical Trials Rules


The Indian Drug Manufacturers Association (IDMA) has requested the Drugs Controller General of India (DCGI) seeking registration fees of Rs15,000 to continue instead of Rs.


As per JAMA, Prophylactic Treatment of Migraine not impactful in Pediatric Age Group


Researchers from the University of Basel have come to a conclusion that in pediatric age group preventive pharmacological treatment of migraine is no more impactful than pl


Childbearing and Breastfeeding May Prevent Early Menopause


Early prevention of menopause can be done by childbearing and breastfeeding as per the finding of one of the largest studies. Description of the study has advertised in the


Researchers in Canada discovered traces of Vitamin C deficiency disease Scurvy


In a current study, researchers have discovered traces of a disease called as Scurvy in Canada. The deteriorating condition is remembered as a disease of pirates.


Kala Pharmaceuticals declares Completion of Enrollment of STRIDE 3 Trial for EYSUVIS™ (KPI-121 0.25%) for Dry Eye Disease


A biopharmaceutical company, Kala Pharmaceuticals, Inc., committed on the development and commercialization of therapeutics utilizing its proprietary AMPPLIFY™ mucus-


Novel Head-to-Head Phase III Data Show SKYRIZI™ (risankizumab) Superior to Cosentyx® (secukinumab) across Primary and All Ranked Secondary Endpoints in Adults with Moderate to Severe Plaque Psorias


A research-based global biopharmaceutical company, AbbVie, today declared that SKYRIZI™ attained both primary and all ranked secondary endpoints, involving superiorit


Data Missing on demonstrates Failure of Research Culture


2 years ago the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) enacted a “final rule” clarifying how and when universities, comp


Anti-dementia Drug 'crisdesalazine' of GNT Pharma shows Efficacy in Phase 3 Clinical Study with Companion Dogs with Dementia


GNT Pharma has successfully done Phase 3 clinical trial for crisdesalazine, a novel drug to treat canine cognitive dysfunction syndrome or Alzheimer’s disease.



Phase 2 clinical study of respiratory drug to treat Parkinson’s disease unveils promising results


The Cure Parkinson’s Trust (CPT) is enthusiastic to declare the publication of the outcomes of a Phase 2 clinical trial examining ambroxol as a potential treatment to decrease


As per study, risk of colorectal cancer remains despite modern treatment for ulcerative colitis


Patients suffering from the inflammatory bowel disease ulcerative colitis have a increased risk of dying from colorectal cancer, despite modern therapeutics, even though the ris


Root of fatal malaria infection claimed to be found in new study


As per the professor Ian Cheeseman from Texas Biomedical Research Institute that they don't know what is inside malaria infections, or how many different genetically distinct st


Women experiencing repeat miscarriages could be treated with diabetes drug



Targeted ultrasound kills cancerous cells while leaving healthy ones


Ultrasound waves of scaled intensity and frequency have demonstrated hope in breaking apart different types of cancerous cells without harming healthy blood cells.

The w


Phase III KEYNOTE-604 trial of Merck for Keytruda in combo with chemotherapy attains one of its dual primary endpoints of PFS for treatment of patients with ES-SSCLC


Merck declared that the phase III KEYNOTE-604 trial evaluating Keytruda, Merck’s anti-PD-1 therapy, in combination with chemotherapy attained one of its dual primary endpo


New blood test to enhance triage for elderly concussion patients


The blood test, though, was not precise at quantifying patients who did have brain tissue.
A new blood test could precisely quantify elderly concussion patients without brain ti


As per JAMA, Shorter sleep duration in children may elevate risk of psychiatric disorders later


Sleep duration in children can help in anticipating the future occurrence of psychiatric disorder, a recent study has indicated. Targeting sleep duration thus could be useful fo


Pain caused by ureteral stenting could be eased by Local administration of vasodilators


Each year, more than half a million Americans go to the emergency room for kidney stone related problems. Ureteral stents and Kidney stones can cause ureteral colic and pain.


Phase II trial of Spectrum Pharma of poziotinib in priorly treated NSCLC patients with EGFR exon 20 insertion mutations fails


A biopharmaceutical company known as Spectrum Pharmaceuticals, Inc. committed on new and innovative and targeted oncology therapies, has reported that its pre-specified primary&


An easy and better testing method for patients with Parkinson’s disease


Parkinson’s disease is a neurodegenerative disorder that demonstrates symptoms such as tremor, limb rigidity, slow movements and gait, and balance problems. It impacts about 10


As per JAMA, Single dose of HPV vaccine gives similar protection as multiple doses


Launched first in 2006, the multi-dose human papillomavirus (HPV) vaccine can prohibit most anal and cervical cancers among children and young adults which came in contact to the vir


Lumasiran RNAi Therapeutic obtained Primary and Secondary Endpoints


A Phase 3 study examining the lumasiran RNAi therapeutic has reached its primary and secondary endpoints. Alnylam Pharmaceuticals, which manufactures the drug, reports that the


Reduction in cumulative exposure to obesity may substantially reduce risk of diabetes


As found in the recent study in EASD


Overdose deaths by Opioid on the elevation curve among children


Opioid epidemic in developed countries is harmful for both adults and children, and is constricting the respective health care systems. Researchers performed research to illustr


Pain relieving can be done by Acupuncture which helps in reduction of usage of opioids in Cancer


Acupuncture and/or acupressure may lead to vital reductions in the cancer pain intensity, reduction of requirements for opioids for the said purpose, indicates a recent study ad


Phase III study of GSK of Benlysta in patients with lupus nephritis obtains primary endpoint


GSK declared positive headline outcomes for intravenous (IV) Benlysta (belimumab) in the largest controlled phase III study in active lupus nephritis (LN), an inflammation of the kid


Adamas declared Results from Phase III Trial of ADS-5102


A company committed to developing and delivering medicines known as Adamas Pharmaceuticals, Inc., which are involved in making a clinically meaningful difference to people impac


Positive results from phase III study declared by BioMarin for vosoritide in children with achondroplasia


A worldwidel biotechnology company known as BioMarin Pharmaceutical has announced positive final outcomes from its randomized, double-blinded, placebo-controlled phase III 


LUSTER phase 3 studies of Novartis in patients with uncontrolled GINA 4/5 asthma fails to attain endpoint


Topline outcomes were declared by Novartis from its pivotal global phase 3 LUSTER-1 and LUSTER-2 studies traversing the efficacy and safety of the investigational oral, once-dai


New standards required for enhancing the design of clinical trials for MS patients


The group of working people of Akda,


Lilly and Boehringer Ingelheim declared EMPERIAL studies outcomes of empagliflozin in chronic heart failure


Eli Lilly and and Boehringer Ingelheim Company declared outcomes from the EMPERIAL- Reduced and EMPERIAL-Preserved studies associated to functional endpoints with empaglifl


Positive results announced by Reprieve Cardiovascular from first-in- human trial with PVM System for AHF


A pioneering medical device company known as Reprieve Cardiovascular is committed on enhancing results for patients suffering from acute decompensated heart failure (ADHF), 


Pivotal Phase III study declared by FerGene for nadofaragene firadenovec attained its primary endpoint obtaining a complete response at three months


Fergene  declared positive results from the pivotal Phase III clinical trial
accessing nadofaragene firadenovec (rAd-IFN/Syn3), an investigational gene therapy, to treat hi


Phase 3 of Roche IMspire150 trial of Tecentriq plus Cotellic; Zelboraf for priorly untreated BRAF V600 mutation-positive advanced melanoma attains primary endpoint


Phase 3 IMspire150 study was declared by Roche, in people with priorly untreated BRAF V600 mutation-positive advanced melanoma, attained its primary endpoint of progression-free su


Kisqali data of Novartis demonstrate superior overall survival in comparison to fulvestrant and constant efficacy across advanced breast cancer patient subgroups in MONALEESA-III


MONALEESA-III data demonstrates Kisqali (ribociclib) plus fulvestrant showed a statistically vital enhancement in overall survival, with an almost 30% reduction in risk of death in


Positive Tucatinib HER2CLIMB Trial outcomes by Seattle Genetics in Locally Advanced or Metastatic HER2-Positive Breast Cancer


Seattle Genetics, Inc. has made an announcement regarding the positive pivotal data from the HER2CLIMB trial examining tucatinib in patients with HER2-positive metastatic brea


Gracell declares progressive results from Multiple Human clinical trials to


xamine FasTCAR and dual CAR cell platform technologies

A clinical-stage immune cell therapy company known as Gracell Biotechnologies Co, Ltd has


Sage Therapeutics declares Planned Progression of SAGE-718 to Phase II in Huntington's Disease


Sage Therapeutics has made declaration that it plans to advance SAGE-718, a new, 1st-in-class, oxysterol-based positive allosteric modulator (PAM) of N-methyl-D-aspartate (NMD


Forty Seven, Inc. declares Up-to-date Data from Ongoing Clinical study of Magrolimab in Patients with Myelodysplastic Syndrome and Acute Myeloid Leukemia


Forty Seven, Inc. which is a clinical-stage and immuno-oncology company comitted on creating therapies to start off macrophages in the fight against cancer has made the declaration


Topline Data showed by Astex Pharmaceuticals from the ASCERTAIN Phase III Study of New, Oral Hypomethylating Agent Cedazuridine and Decitabine (ASTX727) in MDS and CMML


A fully owned subsidiary of Otsuka Pharmaceutical Co. Ltd., known as Astex Pharmaceuticals, Inc., based in Tokyo, Japan has showed topline data from the ASCERTAIN phase III tria


Phase 3 data by Novartis on new inhaled dual combination QMF149 show vital improvement across key asthma outcomes in comparison to monotherapy


Novartis, declared data from the 52-week pivotal phase 3 PALLADIUM clinical trial which showed that QMF149 is a once-daily fixed-dose combination of indacaterol acetate and mometason


Positive phase III ACHIEVE I trial results by Allergan for ubrogepant


Positive phase III ACHIEVE I trial results were declared by Allergan for ubrogepant (UBR-MD-01), a robust phase III clinical trial examining the safety, efficacy and tolerability of


Clinical Trials Results on Curecode with Neuromide Skin Care Brand declared by Dr. Raymond Labs


K-Beauty’s leading skincare company, Dr. Raymond Labs which is committed for development and marketing innovative, affordable clinic-level skincare at home, declared the releas


Pfizer and Sangamo declare Updated Phase I/II Results demonstrating Sustained Increased Factor VIII Activity Through 44 Weeks followed up by SB-525 Gene Therapy Treatment


Together, Pfizer, Inc. and a genomic medicine company, Sangamo Therapeutics, Inc., declared updated follow-up results from the Phase I/II Alta study examining investigational SB-525


Positive Top-line Results by ACADIA Pharmaceuticals from Pivotal Phase III HARMONY Trial of Pimavanserin in Patients with Dementia-Related Psychosis


Positive top-line results were presented by ACADIA Pharmaceuticals from its Phase III HARMONY study. HARMONY was a phase III study which was
double-blinded, placebo-controlled,


Phase III trial Positive results for Toujeo in children and adolescents with type 1 diabetes


As per the reports submitted at the International Society for Pediatric and Adolescent Diabetes (ISPAD) 45th Annual Conference in Boston, children and adolescents aged between 6 to 1


Positive data were reported by OSE Immunotherapeutics from phase I clinical trial of anti-IL-7 receptor antagonist OSE-127


A clinical-stage biotechnology company known as OSE Immunotherapeutics, declared completion and positive results from the phase I study of OSE-127, a humanized monoclonal antibody wi


Positive results by Biogen from phase II LILAC study of BIIB059 for treatment of lupus patients


Positive results from the phase II LILAC study were declared by Biogen Inc for examining the efficacy and safety of BIIB059, a fully humanized IgG1 monoclonal antibody (mAb) targetin


Roche decalred positive results from SAkuraSky study of satralizumab for treatment of neuromyelitis optica spectrum disorder


Roche declared the positive data from SAkuraSky, a pivotal phase 3 study of the investigational medicine satralizumab to treat neuromyelitis optica spectrum disorder (NMOSD).


Positive Results demonstrated by TauRx's Alzheimer's Drug in Large Clinical Trials


An unexpected result was published by TauRx which is based in Aberdeen, Scotland and Singapore for the pharmacokinetic analysis of the drug hydromethylthionine (LMTM) in Alzheimer&rs


42-month Positive DSMB Recommendation for Continuation of Phase III RESOLVE-IT Study of Elafibranor in NASH for GENFIT


A late-stage biopharmaceutical company known as GENFIT is committed to the discovery and development of innovative therapeutic and diagnostic solutions in metabolic and liver regar


Phase 3 ALTA-1L Trial demonstrate Promise for Patients with Non-Small Cell Lung Cancer


The ongoing phase 3 ALTA-1L trial of brigatinib (Alunbrig) in comparison to crizotinib (Xalkori) indicated that brigatinib reduced the risk of disease progression or death in adults


Promising Efficacy in Phase IIb MDNA55 Clinical Trial reported by Medicenna


A clinical stage immuno-oncology company, known as Medicenna Therapeutics Corp., has submitted updated clinical results from its Phase IIb trial of MDNA55 in patients with recurrent


FDA approval to Medtronic for IN.PACT AV DCB


The US Food and Drug Administration has granted approval to Medtronic for its IN.PACT AV Drug-coated Balloon (DCB) which is a paclitaxel-coated balloon for the treatment of failing A


Mylan pulled up by USFDA for manufacturing violations at Andhra plant


Mylan Laboratories has been pulled up by the USFDA for violating good manufacturing norms, involving lapses in handling raw materials and issues regarding cleaning of equipment, at i


Phase II ELEVATE study by VistaGen AV-101 as an adjunctive treatment of MDD fails to meet endpoint


VistaGen Therapeutics, declared topline results from the ELEVATE study, a phase II study of AV-101, its NMDA (N-methyl-D-aspartate) receptor glycine site antagonist, as an ancillary


Novartis Phase III PREVENT trial of Cosentyx in patients with nr-axSpA meets primary endpoint


A leader in rheumatology and immuno-dermatology, Novartis, proclaimed elaborated results from the phase 3 PREVENT trial, examining the efficacy and safety of Cosentyx (secukinumab) i


Positive phase III TULIP 2 trial by AstraZeneca for anifrolumab to treat SLE


AstraZeneca presents elaborated results from the positive phase 3 TULIP 2 trial for anifrolumab, a possible new drug for the treatment of moderate to severe Systemic Lupus Erythemato


Positive Topline Results declared by Therapix Biosciences regarding Phase IIa Clinical Trial of THX-110 for Obstructive Sleep Apnea Program


Therapix Biosciences Ltd. declared topline results from its Phase IIa clinical study at Assuta Hashalom Medical Center in Israel, recommending that THX- 110, a combination of dronabi


DURECT Corporation declares Positive Results from the Phase IIa Clinical Trial of DUR-928 in Alcoholic Hepatitis Patients


DURECT Corporation, declared the results from its Phase IIa clinical trial of DUR-928 in Alcoholic Hepatitis (AH).

As stated by the principal investigator in the trial, Dr. T


Results presented by Indalo Therapeutics of Phase I Clinical Trial study for Lead Antifibrotic Drug Candidate IDL-2965


Indalo Therapeutics is involved in discovering and developing integrin antagonists for patients plagued by serious fibrotic diseases such as idiopathic pulmonary fibrosis (IPF) and n


Novartis Cosentyx demonstrates uplifting results in comparison to Humira from EXCEED head-to-head trial for treatment of psoriatic arthritis


Novartis, declared results from the EXCEED head-to-head trial Cosentyx (secukinumab) comparing to Humira (adalimumab) in patients with active psoriatic arthritis (PsA). While Cosenty


Phase III study of AbbVie SELECT-PsA 2 of Rinvoq for treatment in psoriatic arthritis met primary and all ranked secondary endpoints


AbbVie, proclaimed positive top-line data from the SELECT-PsA 2 phase III study. In the trial, both the doses of Rinvoq met the primary endpoint of ACR20 response at week 12 in compa


Positive results reported by Paratek Pharma for phase II studies of omadacycline in urinary tract infections


A commercial-stage biopharmaceutical company, Paratek Pharmaceuticals shared the outcome of its two exploratory phase II clinical studies examining the safety and efficacy in patient


Promentis Pharma declares positive results for phase IIA study of SXC-2023 targeting new glutamatergic mechanism and completion of enrollment for phase II trichotillomania study


Promentis Pharmaceuticals is developing technologically advanced therapies for neuropsychiatric disorders. It has successfully completed a behavioral biomarker study for its lead com


TGA Australia approval to Mallinckrodt’s Uvadex for use with Therakos Cellex photopheresis system


The Therapeutic Goods Administration (TGA),Australia has given the approval to Mallinckrodt Pharmaceuticals, for Uvadex (methoxsalen). The approval is given for extracorporeal admini


Positive results from phase I/IIa trial reported by ORYX with oncolytic virus ParvOryx in metastatic, inoperable pancreatic cancer


A translational medicine company named ORYX focusses on oncolytic virotherapy and cancer vaccines, reported positive clinical trial results from a dose-escalating phase I/IIa trial w


IPC directs pharmacy institutes for mandate use of PvPI-ADR mobile app for reporting ADRs for promotion of patient safety


The Indian Pharmacopoeia Commission (IPC) has suggested to pharmacy institutes to mandate use of PvPI-ADR mobile application by the students for reporting Adverse Drug Reactions (ADR


MorphoSys declared positive results from L-MIND trial of combination of tafasitamab and lenalidomide in comparison to lenalidomide alone


A clinical-stage biopharmaceutical company, MorphoSys AG, proclaimed top line results from the initial analysis of the etrospective observational matched control cohort (Re-MIND). Th


Phase III POSEIDON trial by AstraZeneca of Imfinzi & tremelimumab for 1st line treatment of stage IV NSCLC obtains primary endpoint


AstraZeneca, proclaimed positive Progression-free Survival (PFS) results for Imfinzi (durvalumab) and tremelimumab, an antibody of anti-CTLA4 when incorporated to chemotherapy, from


Therapix Biosciences announced positive results from pre-clinical study of THX-210 to treat epilepsy


Therapix Biosciences Ltd proclaimed positive results in its pre-clinical study evaluating THX-210, a proprietary novel pharmaceutical preparation containing non-psychoactive cannabin


Lilly’s Phase 3 SEQUOIA trial fail to meet primary endpoint for pegilodecakin plus Folfox compared to Folfox alone in patients with metastatic pancreatic cancer


Eli Lilly and Company proclaimed top-line results from its phase III SEQUOIA trial accessing pegilodecakin plus Folfox (folinic acid, 5-FU, oxaliplatin) in comparison to Folfox alone


FDA approval to Myeloma, Label Update in HER2+ Breast Cancer, Breakthrough Status in Prostate Cancer


An approval by FDA has been received for multiple myeloma which is an updated label in breast cancer, a breakthrough therapy designation in prostate cancer, grants awarded for resear


FDA approval to new medication Reyvow to treat acute migraine


An approval has been given by the U.S. Food and Drug Administration (FDA) for a new medication to treat acute migraine with or without aura called Reyvow. As per its manufacturer, El


Lilly Presents Positive Results for Taltz® (ixekizumab) in Paediatric Patients with Moderate to Severe Plaque Skin Problem


Eli Lilly and Company proclaimed that Taltz met co-primary endpoints in paediatric patients with moderate to severe plaque skin problem, demonstrating that 89% of patients treated wi


Incyte announced positive 52-Week results from irregular part two study of Ruxolitinib cream in patients with skin disorder


Incite announced the positive 52-week results from its irregular, double-blind, dose ranging, part two study evaluating ruxolitinib cream, a non-steroidal,&n


FDA Approval to Prevent Venous Thromboembolism


The US Food and Drug Administration (FDA) has paved the way for the geko device for stimulation of calf muscles to prevent venous thrombosis in non-surgical patients at risk for veno


Failed Phase III Clinical Trial of Keytruda for Mesothelioma


Results obtained from a phase III clinical trial distinguishing Keytruda (pembrolizumab) to standard chemotherapy highlights the immunotherapy drug still has a long way to go as a vi


Positive Results from Phase III IRIDIUM by Sosei Heptares regarding Study of Inhaled Combination QVM149 in Patients with Uncontrolled Asthma


Sosei Group Corporation has made an announcement regarding Novartis by sharing the positive results from its Phase III IRIDIUM trial.

The results demonstrated the combination


Roche presented positive results for phase III study of satralizumab for treatment of neuromyelitis optica spectrum disorder

Full pivotal phase III study results were presented by Roche for satralizumab as a monotherapy for neuromyelitis optica spectrum disorder (NMOSD), a rare, debilitating central nervous system diseas


Chugai presented results regarding Second Positive Global Phase III Clinical Study of Satralizumab in NMOSD at ECTRIMS 2019

An announcement has been made by Chugai Pharmaceutical Co., Ltd., regarding the results from SAkuraStar Study which were demonstrated at the Congress of European Committee for Treatment and Researc


Positive data from phase III CASPIAN trial of Imfinzi presented by AstraZeneca for treatment of extensive-stage SCLC at WCLC 2019

Detailed results from phase III CASPIAN trial were presented by AstraZeneca, demonstrating Imfinzi (durvalumab) significantly enhanced overall survival (OS) in patients with previously-untreated ex


Novartis announces positive data from 5-year OLPT of Aimovig in patients with episodic migraine

An announcement has been made by Novartis regarding positive data from 5-year open-label treatment period (OLTP) accessing sustained efficacy and long-term safety of Aimovig (erenumab) in patients


Phase III study of CheckMate -498 trial of Opdivo in patients with newly diagnosed MGMT- unmethylated GBM fails to meet one of its primary endpoints

Bristol-Myers Squibb Company announced the phase 3 CheckMate -548 trial updates, accessing the addition of Opdivo (nivolumab) to current radiation therapy with temozolomide as compared to alone sta


Alnylam Pharma announces positive results from ORION-11 phase 3 study of inclisiran to treat hypercholesterolemia

One of the leading RNAi therapeutics company Alnylam Pharmaceuticals, Inc, provides complete positive results from the ORION-11 phase 3 study of inclisiran, an RNAi therapeutic in development for t


Phase III study show results of Xofluza reduces risk of developing flu after contact with an infected person by 86% : Roche

An announcement by Roche regarding the phase III BLOCKSTONE study demonstrated preventive treatment with Xofluza (baloxavir marboxil) after exposure to an infected household member significantly le


Phase III ASCLEPIOS I & II studies of ofatumumab by Novartis versus Aubagio for treatment of relapsing forms MS meets primary endpoints

An announcement by Novartis has been made regarding positive results for ofatumumab (OMB157) from the phase III ASCLEPIOS I and II studies. In both head-to-head studies, ofatumumab showed superiori


Discontinuation of AbbVie R&D program as MERU phase 3 trial of Rova-T for SCLC treatment fails to meet endpoint

AbbVie has announced regarding MERU, a phase 3 trial accessing Rova-T as a first-line maintenance therapy for advanced small-cell lung cancer (SCLC), showed no survival benefit at a pre-planned int


Phase III TULIP 2 trial of anifrolumab by AstraZeneca for treatment of systemic lupus erythematosus meets primary endpoint

An announcement has been made by AstraZeneca regarding the phase III TULIP 2 trial for anifrolumab, which is a potential novel medicine for the treatment of systemic lupus erythematosus (SLE), met


AstraZeneca gets positive results from phase III ETHOS trial of triple-combo therapy Breztri Aerosphere to treat COPD

An announcement was made by AstraZeneca regarding positive results of phase III ETHOS trial for triple-combination therapy Breztri Aerosphere, formerly PT010, in patients with moderate to very seve


Positive results announced by AstraZeneca regarding phase III ETHOS trial of triple-combo therapy Breztri Aerosphere to treat COPD

An announcement was made by AstraZeneca regarding positive results from phase III ETHOS trial for triple-combination therapy Breztri Aerosphere, formerly PT010, in patients with moderate to very se


Waiving clinical trials for EU approved medical devices soon: Health ministry

The Union health ministry is likely to forgo the need of clinical trials conduction in India for European Union (EU) approved medical devices through an amendment of Rule 63(1) under the Medical De


Phase IIb CONDUCT study by InDex Pharma with cobitolimod in ulcerative colitis meets primary endpoint

InDex Pharmaceuticals announced positive top line results from the dose optimization study CONDUCT, which is accessing cobitolimod for the treatment of moderate to severe ulcerative colitis. The st


Successful Completion of PAVmed Clinical Safety Study Procedures for CarpX™ 510(k) Re-submission

A highly distinguished, multiproduct medical device company, PAVmed Inc., has made an announcement that all 20 patients of its first-in-human (FIH) 510(k) clinical safety study underwent successful


1,213 adverse events reported for medical device in country since 2014 : MvPI

The Indian Pharmacopoeia Commission (IPC) receives 1,213 adverse events related with medical devices since 2014 across the country. IPC is the national coordinating centre to have materiovigilance


10 million individual may get killed by 2050 due to indiscriminate utilization of antibiotics: Survey by Delhi IPA

The students of Indian Pharmaceutical Association, Delhi branch conducted a survey regarding the indiscriminate antibiotics use. They estimate that around 10 million individuals may lose their live


Positive clinical trial results for MemorEM and Alzheimer’s TEMT trial

Positive clinical trial results for MemorEM and Alzheimer’s TEMT trial


Positive results have been announced by NeuroEM Therapeutics fo


Positive clinical trial results for Olaparib in advanced prostate cancer

The earlier results of an important phase III clinical trial demonstrates that the genetically targeted drug olaparib exceeds positive outcomes for men with advanced prostate cancer whose tumours h


Suspected ADRs associated with anti-retroviral drugs: PvPI

The Pharmacovigilance Programme of India (PvPI) reveals that major suspected adverse drug reactions associated with anti-retroviral drugs such as efavirenz, lamivudine and tenofovir.

PvPI i


Olaparib shows important PFS Benefit in Phase III mCRPC Trial

Olaparib (Lynparza) showed a statistically major improvement in radiographic progression-free survival (rPFS) compared with enzalutamide (Xtandi) or abiraterone acetate (Zytiga) in men with metasta


Recent Success of KEYTRUDA in Triple-Negative Breast Cancer proves I-SPY 2 Adaptive Platform Approach to Phase II Clinical Trials

The I-SPY 2 TRIAL is a combined effort among academic investigators from 20 prominent cancer research centers across the U.S. and Quantum Leap Healthcare Collaborative, the FDA, and the Foundation


Positive results for phase I trial of T20K for multiple sclerosis treatment

A Swedish biotech company, Cyxone renowned for autoimmune diseases announced that phase I clinical trial of T20K successfully attained its objective of confirming T20K's safety and tolerability in


Positive Phase 2 Results reported for Dry Powder Inhaler Formulation of Ensifentrine

A biopharmaceutical company, Verona Pharma plc, announces the positive Phase II data for dry powder inhaler (“DPI”) formulation of its lead development product, Ensifentrine. It is mean


Response required for Nestle’s clinical trials

Nestle is facing heat following the instructions of the Union Health Ministry to the Indian Council of Medical Research. Nestle was involved in conducting research in Indian hospitals which is agai


MONALEESA-3, a phase-III trial by Novartis of Kisqali to improve overall patient survival with HR+/HER2- advanced breast cancer

Novartis announced that Kisqali (ribociclib) achieved statistically significant improvement in overall survival during phase III MONALEESA-3 clinical trial. This being the second phase III clinical


Phase III study trial of Transgene oncolytic virus stopped for futility

A phase 3 trial of liver cancer of Transgene and SillaJen’s oncolytic virus has been halted early for futility.

SillaJen designed the 600-subject trial to exhibit whether administerin


MHRA Revised Clinical Investigation Guidance in Lined with EU MDR

Medical device clinical investigation guidance underwent a revision in 2013 by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for reflecting the EU’s medical device


National guidelines for gene therapy product development issued by Health Ministry

Draft national guidelines for gene therapy development and clinical trials have been placed in public domain by the Union Health Ministry for suggestions from concerned parties like scientists, aca