Industry News

Mylan N.V. announced the U.S. launch of Glipizide Extended-release Tablets, 5 mg and 10 mg, the generic version of Pfizer's GLUCOTROL XL®. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Collegium Pharmaceutical, Inc.  announced that the United States Food and Drug Administration (FDA) has granted tentative approval to the Company's New Drug Application (NDA) for Xtampza™ ER (oxycodone) extended-release capsules for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

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Protalix BioTherapeutics, Inc.  announced that it recently held an End-of-Phase II meeting with the U.S. Food and Drug Administration (FDA) to discuss the Company's proposed BLA plan for PRX-102 for the treatment of Fabry disease. Official FDA meeting minutes indicate the FDA's acceptance of the Company's path forward for a phase III clinical trial to support a full BLA approval.

Mallinckrodt plc, a leading specialty biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has cleared INOmax DSIR® Plus MRI device for delivery of INOMAX® (nitric oxide) for inhalation during MRI procedures.

Following the recommendation by an independent Data Monitoring Committee (DMC), Gilead Sciences, Inc.  announced that its Phase 3 Study 115 evaluating Zydelig (idelalisib) added to standard therapy in previously-treated chronic lymphocytic leukemia (CLL) patients will be unblinded early. The DMC recommendation is based upon a predefined interim analysis indicating a statistically significant benefit in efficacy for progression-free survival (PFS) and overall survival (OS) in patients receiving Zydelig plus bendamustine and rituximab, compared to those receiving only bendamustine and rituximab. The safety profile of Zydelig was consistent with prior studies. Detailed results from this study will be presented during a late-breaking abstracts session (#LBA-5) at the Annual Meeting of the American Society of Hematology (ASH) in Orlando, Florida taking place December 5-8.

Baxalta Incorporated, a global biopharmaceutical leader dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, announced today that its state-of-the-art recombinant biologic manufacturing facility in Singapore received U.S. Food and Drug Administration (FDA) approval to produce ADVATE [Antihemophilic Factor (Recombinant)] bulk drug substance (BDS). The site received regulatory approval from the European Medicines Agency in January 2014 for the production of ADVATE.

NeuroSigma, Inc. (NeuroSigma), a California-based life sciences company, announced that it has received CE Mark approval for its Monarch eTNS System as treatment for attention-deficit/hyperactivity disorder (ADHD) in adults and children age 7 and older. This CE Mark approval is the first for any non-drug treatment of ADHD in the European Union (EU).

Gilead Sciences, Inc. announced it will present 32 scientific presentations related to its approved medicines and investigational therapies for the treatment of chronic hepatitis C virus (HCV) infection at The Liver Meeting 2015 in San Francisco.

U.S. Food and Drug Administration granted accelerated approval for Darzalex (daratumumab) to treat patients with multiple myeloma who have received at least three prior treatments. Darzalex is the first monoclonal antibody approved for treating multiple myeloma. Darzalex is marketed by Janssen Biotech of Horsham, Pennsylvania.

Coherus BioSciences and Baxalta has recently announced that CHS-0214, a proposed biosimilar of Enbrel (etanercept), met its primary endpoints in a confirmatory, double-blind, randomized, controlled, two-part phase 3 study. This on-going 52-week study is evaluating the efficacy and safety of CHS-0214 compared to Enbrel in patients with moderate-to-severe chronic plaque psoriasis. Coherus and Baxalta initiated a collaboration to develop and commercialise CHS-0214 in September of 2013.