Industry News

- Read more about FLAME study shows superiority of Novartis' Ultibro® Breezhaler® over Seretide® in reducing COPD exacerbations
Novartis announced positive first results from the Phase III FLAME head-to-head trial examining the rate of chronic obstructive pulmonary disease (COPD) exacerbations. Once-daily Ultibro® Breezhaler® (indacaterol/glycopyrronium) 110/50 mcg met its primary endpoint (non-inferiority) and furthermore demonstrated superiority to twice-daily Seretide® (salmeterol/fluticasone) 50/500 mcg in reducing the rate of all COPD exacerbations (mild/moderate/severe) over one year of treatment.
- Read more about Dr. Reddy's completed fondaparinux intellectual property purchase
Dr. Reddy's Laboratories announced that it has completed the purchase of worldwide exclusive intellectual property rights for Fondaparinux sodium, its generic anti-coagulant drug, from its Australian partner, Alchemia Limited. Earlier, the company had signed a term sheet for this transaction in September, 2015.
- Read more about Mylan Launches Generic Viramune XR® Extended-Release Tablets, 100 mg
Mylan announced the U.S. launch of Nevirapine Extended-release Tablets, 100 mg, the generic version of Boehringer Ingelheim's Viramune XR®. 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 used in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in children 6 to less than 18 years of age. The launch adds to Mylan's growing portfolio of ARV medicines across the globe, and represents the company's continued commitment to stem the tide of HIV/AIDS. Nearly 50% of those being treated for HIV/AIDS in the developing world, for example, rely on a Mylan product.
- Read more about Mylan launches Generic GLUCOTROL XL® Tablets
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.
- Read more about Collegium Announces FDA Tentative Approval for Xtampza(TM) ER, a Novel Abuse-Deterrent Analgesic for Chronic Pain
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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- Read more about Protalix BioTherapeutics to Conduct Phase III Clinical Trial for PRX-102 for the Treatment of Fabry Disease Following a Successful End-of-Phase II Meeting With FDA
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.
- Read more about Mallinckrodt Pharmaceuticals receives FDA clearance for INOmax DS(IR)® Plus MRI device
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.
- Read more about Gilead’s Zydelig with Bendamustine and Rituximab Shows Superior Efficacy to Bendamustine/Rituximab in Phase 3 Study of Patients with Relapsed Chronic Lymphocytic Leukemia
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.
- Read more about Baxalta Singapore facility receives FDA approval in providing reliable supply to hemophilia patients
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.
- Read more about NeuroSigma's Monarch eTNS System to treat ADHD receives CE Mark approval
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).