Clinical News-CliniExpert

Gilead Sciences Statement on Request to Rescind Remdesivir Orphan Drug Designation

March 25, 2020 -- Gilead has submitted a request to the U.S. Food and Drug Administration to rescind the orphan drug designation it was granted for the investigational antiviral remdesivir for the tre

Aldeyra to Screen Clinical-Stage Compounds for Activity in COVID-19 Infection

LEXINGTON, Mass.--(BUSINESS WIRE)--Mar. 24, 2020 -- Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced that it will begin screening its library of novel reactive aldehyde species (RAS

Two Additional Coronavirus Patients Treated at Leading New York Hospital with CytoDyn’s Leronlimab, Bringing the Total to Four Patients

VANCOUVER, Washington, March 23, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 ant

Gilead Sciences Statement on Access to Remdesivir Outside of Clinical Trials

March 22, 2020 -- Gilead is working to rapidly assess the safety and efficacy of remdesivir as a potential treatment for COVID-19 through multiple ongoing clinical trials. Enrollment in clinical trial

U.S. Food and Drug Administration (FDA) Grants Emergency IND for Two Coronavirus Patients Treated in New York with CytoDyn’s Leronlimab

VANCOUVER, Washington, March 19, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 ant

Rhythm Pharmaceuticals Receives Orphan Drug Designation from U.S. FDA for Setmelanotide for the Treatment of Alström Syndrome

BOSTON, March 18, 2020 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a late-stage biopharmaceutical company aimed at developing and commercializing therapies for the treatment of ra

Novartis Announces NEJM Publication of Three Pivotal Trials Showing Durable and Potent Efficacy of Inclisiran, an Investigational First-in-Class siRNA Cholesterol-Lowering Therapy

East Hanover, N.J., March 18, 2020 -- Novartis announced today the publication of three pivotal Phase III clinical trials for inclisiran, a potential first-in-class small interfering RNA (siRNA) inves

Pfizer Announces Positive Top-Line Results from Third Phase 3 Trial of Abrocitinib for Moderate to Severe Atopic Dermatitis, Which Showed Improvements in Skin Clearance, Disease Extent and Severity, and Itch

March 18, 2020 -- Pfizer Inc. (NYSE:PFE) announced today that JADE COMPARE (B7451029) met its co-primary efficacy endpoints. The Phase 3 study evaluated the safety and efficacy of abrocitinib, an inve

Sage Therapeutics Announces Development Plan for Zuranolone (SAGE-217) Following Breakthrough Therapy Guidance Meeting with the U.S. Food & Drug Administration

CAMBRIDGE, Mass.--(BUSINESS WIRE) - March 18, 2020 -- Sage Therapeutics, Inc. (NASDAQ: SAGE), a biopharmaceutical company committed to developing novel therapies with the potential to transform the li

Pfizer Announces Top-Line Results from Phase 3 Study of 20-Valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-Naïve Adults Aged 18 Years or Older

March 18, 2020 -- Pfizer Inc. (NYSE:PFE) today announced top-line results from one of its Phase 3 studies (NCT03760146), which evaluated the safety and immunogenicity of its 20-valent pneumococcal con

CanSinoBIO’s Investigational Vaccine Against COVID-19 Approved for Phase 1 Clinical Trial in China

TIANJIN, CHINA, March 17, 2020 -- CanSino Biologics Inc. (“CanSinoBIO”, HK6185), an innovative biopharmaceutical company dedicated to vaccine R&D and commercialization, announced today that its Re

Merck Announces Top-Line Results from Phase 3 Trials Evaluating Gefapixant, an Investigational Treatment for Refractory or Unexplained Chronic Cough

KENILWORTH, N.J.--(BUSINESS WIRE)-- March 17, 2020 -- Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced top-line efficacy results from two ongoing pivotal Phase 3 t