Pharma News

Oragenics announced that it has received feedback from the U.S. Food and Drug Administration (FDA) in response to the Company’s request for a Type C meeting, concerning Phase 2 study protocols for the Company’s OM therapeutic candidate, AG013. As part of the clinical protocol for the study, Oragenics expects to file the Investigational New Drug (IND) update in late 2016 and initiate the study with AG013 in the United States and Europe during early 2017.

Cempra, Inc., a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, announced that the U.S. Food and Drug Administration (FDA) has scheduled a meeting of the Antimicrobial Drugs Advisory Committee on November 4, 2016 in Silver Spring, Maryland to discuss the safety and efficacy of solithromycin to treat community-acquired bacterial pneumonia (CABP).

Amgen announced data presented at the European Society of Cardiology (ESC) Congress 2016 showing Repatha® (evolocumab) consistently reduced low-density lipoprotein cholesterol (LDL-C) in patients across cardiovascular (CV) risk subgroups or with familial hypercholesterolemia (FH).

Orexigen Therapeutics, Inc. announced that Valeant Canada, a subsidiary of Valeant Pharmaceuticals International, Inc., or its affiliates, will commercialize Contrave® (naltrexone HCl / bupropion HCl extended release) in Canada. Under the terms of the agreement between Valeant and Orexigen's wholly owned subsidiary Orexigen Therapeutics Ireland Ltd., Valeant will be responsible for obtaining Canadian regulatory approval and for all commercialization activity and expenses. Orexigen will supply Contrave tablets to Valeant Canada or its affiliates for an agreed transfer price and certain potential regulatory and sales milestone payments. Orexigen expects Valeant to file with Health Canada for regulatory approval by January 2017.

Takeda Pharmaceutical Company Limited announced the launch of a bold, new Access to Medicines (AtM) strategy, aimed at increasing access to its innovative and potentially life-saving medicines for patients with some of the highest unmet medical needs. For decades, the company has provided product, funding and access in many parts of the world, based on regional needs. The new AtM strategy builds on that by focusing on geographies and therapy areas with the highest unmet need.

Cynapsus Therapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for APL-130277, a product candidate for the treatment of OFF episodes in patients with Parkinson’s disease (PD).

GlaxoSmithKline plc (GSK) will provide updates on emerging areas of research with data from across its comprehensive respiratory portfolio of approved medicines, investigational programmes and scientific collaborations, at the European Respiratory Society (ERS) International Congress, 3rd -7th September, London, UK. More than 30 abstracts from the company will be featured at the meeting.

Mylan N.V. announced that its U.S. subsidiary will launch the first generic to EpiPen® Auto-Injector (epinephrine injection, USP) at a list price of $300 per generic EpiPen® two-pack carton, which represents a discount of more than 50% to the Mylan list price, or wholesale acquisition cost ("WAC"), of the branded medicine. The authorized generic will be identical to the branded product, including device functionality and drug formulation. Mylan expects to launch the product in several weeks, pending completion of labeling revisions. Upon launch, the product will be available as a two-pack carton in both 0.15 mg and 0.30 mg strengths. Mylan also intends to continue to market and distribute branded EpiPen®.

Tonix Pharmaceuticals  Holding Co. which is developing next-generation medicines for fibromyalgia and post-traumatic stress disorder (PTSD), announced that it has received the final meeting minutes from the U.S. Food and Drug Administration (FDA) from an  End-of-Phase 2/Pre-Phase 3 meeting. These minutes confirmed the FDA’s acceptance of Tonix’s proposed Phase 3 studies and the planned New Drug Application (NDA) data package to support the registration of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for the treatment of PTSD.