Industry News

Catalyst Pharmaceuticals, Inc.  announced  that it has reached an agreement with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the protocol design, clinical endpoints, and statistical analysis approach to be taken in Catalyst's upcoming Phase 3 study evaluating Firdapse® (amifampridine phosphate) for the symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS).

Sanofi and Regeneron Pharma Inc. announced the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the Biologics License Applications (BLA) for sarilumab, an investigational interleukin-6 receptor (IL-6R) antibody for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA).

GSK announced new data for its shingles candidate vaccine Shingrix, at the Infectious Disease Week (IDWeek) scientific conference in New Orleans, Louisiana, USA. The data examined co-administration of GSK’s candidate vaccine with the flu vaccine; a flexible dosing schedule; and the vaccine’s impact on quality of life.

Allergan plc announced that it has received approval from the US Food and Drug Administration (FDA) for Restasis Multidose (Cyclosporine Ophthalmic Emulsion) 0.05%, a preservative-free, multi-dose bottle offering the same preservative-free formulation of Restasis since the launch in 2003. Restasis is the one and only prescription treatment FDA approved to help patients with a type of chronic dry eye make more of their own tears.

IBM and  Teva pharma announce a significant expansion of their existing global e-Health alliance with a focus on two key healthcare challenges: the discovery of new treatment options and improving chronic disease management. Both projects will run on the IBM Watson Health Cloud.

Medtronic plc announced the U.S. Food and Drug Administration (FDA) approval and U.S. launch of the CoreValve(TM) Evolut(TM) R 34 mm valve-the largest sized transcatheter aortic valve replacement (TAVR) system available in the U.S. The new Evolut R 34 mm valve is approved for severe aortic stenosis patients who are at high or extreme risk for surgery with an annulus size ranging from 26-30 mm. This large valve segment is estimated to account for approximately 25-30 percent of the eligible global TAVR patient population. Previously, some of these patients were unable to receive a TAVR due to the larger size of their native diseased aortic valve.

Daiichi Sankyo, Inc. and Inspirion Delivery Sciences LLC (Inspirion) have entered into a strategic collaboration agreement in the US to commercialize FDA-approved MorphaBond (morphine sulfate) extended-release tablets, CII. The agreement also provides Daiichi Sankyo, Inc. with the rights to commercialize a separate investigational Inspirion compound in the US, if approved by the US Food and Drug Administration (FDA).

AstraZeneca, a global, science-led biopharmaceutical company, announced positive results from the phase III SOLO-2 trial designed to determine the efficacy of Lynparza (olaparib) tablets (300mg twice daily) as a monotherapy for the maintenance treatment of platinum-sensitive relapsed, BRCA-mutated ovarian cancer. Results from the trial demonstrate a clinically-meaningful and statistically-significant improvement of progression-free survival (PFS) among patients treated with Lynparza compared to placebo and provide additional evidence to support the potential use of Lynparza in this patient population.

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Astellas Pharma Inc. and Pfizer Inc. announced the US Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) to update the US product labeling for Xtandi (enzalutamide) capsules to include new clinical data versus bicalutamide from the TERRAIN study. The data demonstrate improvement in radiographic progression-free survival (rPFS) in patients with metastatic castration-resistant prostate cancer (CRPC) who were treated with enzalutamide compared to patients who were treated with bicalutamide.