Clinical Research Newsletter


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