Pharma News

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.

Chugai Pharmaceutical Co., Ltd announced that emicizumab  received orphan drug designation by the Ministry of Health, Labour and Welfare for the prevention and reduction of bleeding episodes in patients with congenital FVIIl deficiency (hemophilia A) who developed inhibitors to FVIII. Emicizumab is a humanized bispecific antibody for subcutaneous injection under development for hemophilia A.

Chugai Pharmaceutical Co., Ltd. announced that it obtained a supplemental approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) on August 26, 2016, for the anti-cancer agent, capecitabine (Xeloda tablets 300) for the indication of “adjuvant chemotherapy for rectal cancer.” In Japan, Xeloda is currently on the market and its approved indications are “inoperable or recurrent breast cancer,” “postoperative adjuvant chemotherapy for colon cancer,” “advanced or refractory colorectal cancer, which is not amenable to curative resection” and “gastric cancer.”

Claris Lifesciences and its subsidiaries has received an Abbreviated New Drug Application (ANDA) approval for Flumazenil Injection USP, 0.5mg/SmL and 1mg/10mL multiple dose vials, in the United States of America. The ANDA approval has come for the same plant where the FDA had recently completed their Prior Approval Inspection (PAI).

Bio2 Medical has announced that the Angel Catheter has received 510(k) clearance from the United States Food & Drug Administration (FDA). This 510(k) clearance includes a first ever, prophylactic indication for a medical device to protect critically ill patients at high-risk for pulmonary embolism (PE) and contraindicated for anticoagulation.  The Angel Catheter provides a novel alternative to IVC filters for PE protection in a vast patient population that has historically been underserved. The device is designed for bedside placement, without the need for fluoroscopic guidance, and is designed to be safely retrieved in all cases once no longer indicated.

Strides Shasun Limited has received approval from the United States Food & Drug Administration (FDA) for polyethylene glycol 3350, powder for solution 17 grams/capful and 17 grams/packet (OTC).