Tag: Clinical Trials

Clinical trials are experiments or observations done in clinical research. Such prospective biomedical or behavioral research studies on human participants are designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. Clinical trials generate data on safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial – their approval does not mean that the therapy is ‘safe’ or effective, only that the trial may be conducted.

Intec Pharma’s Parkinson’s Treatment Failed in Comparison Trial

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Shares of Israel-based Intec Pharma Ltd. are down nearly 82% in premarket trading after the company announced its Phase III Parkinson’s disease therapy failed to demonstrate statistical superiority to...

Takeda Announced Results of the VISIBLE 2 Clinical Trials Evaluating Vedolizumab

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Takeda Pharmaceutical Company Limited announced top-line results from the VISIBLE 2 clinical trial evaluating the efficacy and safety of an investigational subcutaneous (SC) formulation of the gut-sel...

Eli Lilly Announced Positive Phase 3 Data for Emgality®

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Eli Lilly announced that the New England Journal of Medicine published positive Phase 3 study results of Emgality® (galcanezumab-gnlm) for the treatment of episodic cluster headache. In this study, Em...

ViiV Healthcare Launch Study for First-Ever Long-Acting Injectable Therapy for HIV

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ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced the start of the CUSTOMIZE trial (Cabotegravir plus Ril...

Takeda Announced Updated Results from its Phase IIIb/IV Clinical Trial for ADYNOVATE®

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Takeda Pharmaceutical Company Limited, R&D-driven, global biopharmaceutical company with a leadership position in rare diseases, has announced updated results from its phase IIIb/IV clinical trial...

EC and EMA Call for Sponsors to Publish Clinical Trial Results in EU Database

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The European Commission (EC), the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have co-signed a letter reminding all sponsors of clinical trials conducted in the European ...

AstraZeneca Announced positive Results from the Phase III Clinical Trials with Imfinzi

AstraZeneca announced positive overall survival (OS) results from the Phase III CASPIAN trial with Imfinzi in 1st-line extensive-stage small cell lung cancer (SCLC), a disease with significant unmet n...

Positive Phase 2 Results for IL-33 Antibody Announced by Sanofi and Regeneron

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Sanofi and Regeneron Pharmaceuticals, Inc. announced that a Phase 2 proof-of-concept trial evaluating the investigational IL-33 antibody REGN3500 (SAR440340) met the primary endpoint of improvement in...

Oramed Presented Update on Four Ongoing Clinical Programs

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Oramed Pharmaceuticals Inc., a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, provided a clinical update regarding four ongoing clinical programs. "Al...

BLINCYTO Five-Year Overall Survival Data Presented by Amgen

Amgen announced the five-year overall survival (OS) analysis from the single-arm, Phase 2 BLAST study that evaluated BLINCYTO® (blinatumomab) in patients with minimal residual disease (MRD)-positive a...

Sandoz Announced Data from Phase III ADMYRA Trial of Bosimilar Hyrimoz

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Sandoz, a Novartis division and a global leader in biosimilars, announced data from the Phase III ADMYRA trial demonstrating that the efficacy and safety of biosimilar Hyrimoz® (adalimumab) matches th...

AstraZeneca Presented Detailed Data from Calquence Phase III Clinical Trials

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AstraZeneca has presented detailed data showing that Calquence (acalabrutinib) significantly prolonged progression free survival (PFS) in patients with relapsed or refractory chronic lymphocytic leuka...

Cytel and Axio to Create Industry Leader in Analytical Solutions for Drug Development

Cytel Inc., the leading global provider of innovative analytical software and services to the life sciences industry, and Axio Research, a premier provider of biostatistics to pharmaceutical, biotechn...

BMS Announced Data from ORENCIA Phase IV Clinical Trials

Bristol-Myers Squibb Company announced data from a Phase IV mechanistic study exploring differences in the cellular and molecular mechanisms by which ORENCIA® (abatacept) and another treatment, adalim...

J&J’s INVOKANA Significantly Reduced Major Cardiovascular Events and Kidney Failure

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The Janssen Pharmaceutical Companies of Johnson & Johnson announced results of a new subgroup analysis from the landmark phase 3 CREDENCE study, showing INVOKANA® (canagliflozin) significantly red...

Clinical Trials Confirmed Cosentyx Status as Comprehensive Treatment of Psoriatic Arthritis

Novartis, a leader in rheumatology and immuno-dermatology, announced new data from the MAXIMISE trial evaluating the efficacy and safety of Cosentyx (secukinumab) in the management of axial manifestat...