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.

Eisai to Voluntarily Withdraw BELVIQ®/BELVIQ XR® in the U.S.

Eisai Inc. announced that it will voluntarily withdraw from the market and discontinue sales of BELVIQ® (lorcaserin HCl) CIV and BELVIQ XR (lorcaserin HCl) CIV in the U.S. This action is being taken a...

Two Original Orphan Medicinal Products by GENERIUM Approved for Clinical Studies

GENERIUM, a Russian biopharmaceutical company involved in the development and commercialisation of pharmaceutical products for the treatment of orphan, oncological and socially significant diseases, r...

Kleo Receives IND Authorization to Proceed from FDA for its Multiple Myeloma Therapeutic

Kleo Pharmaceuticals, Inc., an immuno-oncology company developing next-generation, fully synthetic bispecific compounds designed to emulate or enhance the activity of biologics, announced that it has ...

RINVOQ™ (upadacitinib) Meets Primary and Key Secondary Endpoints in Phase 3 Study in Psoriatic Arthr...

abbvie
AbbVie, a research-based global biopharmaceutical company, announced positive top-line results from the Phase 3 SELECT-PsA 1 clinical trial. In this study, both doses of RINVOQTM (upadacitinib; 15 ...

Teva Announces Positive Results from AJOVY® (fremanezumab) Two Phase 2/3 Trials in Japan

Teva Pharmaceutical Industries Ltd. announced positive results from two Phase 2/3 trials evaluating AJOVY® (fremanezumab) in patients in Japan. AJOVY is under development in Japan by Otsuka Pharmaceut...

Global CRO Market Will Grow to Reach a Value of $71.7 Billion by 2024

The global healthcare industry spent $167 billion on R&D in 2018. A research report has identified that pharma is continuing to externalise R&D operations to contract research organisations (C...

Merck KGaA Invests in Biotech Development Center in Switzerland

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Merck KGaA, a leading science and technology company, announced an investment of € 250 million in a new facility in Corsier-sur-Vevey, Switzerland – the Biotech Development Center – dedicated to biote...

First Therapeutic Clinical Trials to Study Cannabinol

InMed Pharmaceuticals Inc., a clinical stage biopharmaceutical company developing therapeutics targeting diseases with high unmet medical needs, revealed the rare cannabinoid cannabinol ("CBN") as the...

Only 41 Percent Clinical Trials of US Comply with Reporting Regulations

A new study has revealed that only 41 percent of US clinical trials reported their findings to the trial registry within the year time limit mandated by the US Food and Drug Administration Amendment A...

UK Accounts for Over 12% of Global Cell and Gene Therapy Clinical Trials

The Cell and Gene Therapy Catapult (CGT Catapult) released their 2019 UK advanced therapies medicinal products (ATMPs) clinical trials database showing that the 127 ongoing trials represent a ~45% inc...

Sechenov University Launches New Partnership with Italian Government

Sechenov University signed a landmark memorandum with the President of the Puglia Region Michele Emiliano, the director of the Pugliese Oncology Network, and Rusatom Healthcare. Through this new pa...

DURECT Corporation Presented Results from DUR-928 Clinical Trial

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DURECT Corporation announced the results from its Phase 2a clinical trial of DUR-928 in patients with mild to moderate plaque psoriasis. Twenty-two patients completed the study, applying DUR-928 topic...

AXS-07 Achieved Key Secondary Endpoints in Phase 3 Migraine Trial

Axsome Therapeutics, Inc., a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that AXS-07, Axsome’s nov...

Sol-Gel Reported Positive Results of Phase III Trials of Twyneo

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Shares in Sol-Gel Technologies surged as much as 154% after the company reported that Twyneo, an investigational combination of tretinoin and benzoyl peroxide, led to significant improvements on all c...

Sosei Presented the First Phase I Clinical Start from Discovery Collaboration With Pfizer

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Sosei Group Corporation has been notified by its strategic alliance partner Pfizer that it has dosed the first subject in a clinical trial with a new drug candidate nominated from the multi-target dru...

Lumasiran RNAi Therapeutic Met Primary and Secondary Endpoints

A Phase III study investigating the lumasiran RNAi therapeutic has met its primary and secondary endpoints. Alnylam Pharmaceuticals, which produces the drug, reports that the therapeutic saw success i...