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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).
The anticancer agent Treakisym for Injection 100 mg (bendamustine hydrochloride, "Treakisym") has been approved in Japan for an additional indication of chronic lymphocytic leukaemia (CLL). Treakisym is the subject of a licensing agreement concluded between Eisai and SymBio Pharmaceuticals Limited.
Treakisym was initially approved in Japan in October 2010 for relapsed or refractory low-grade B-cell non-Hodgkin's lymphoma and mantle cell lymphoma. Under the licensing agreement concluded between the two companies, Eisai has been marketing the product in Japan since its launch in December 2010.
Symbio filed an application for this additional indication in December 2015 in response to a development request from the Japanese Ministry of Health, Labour and Welfare's Study Group on Unapproved and Off Label Drugs with high unmet medical needs. Chronic lymphocytic leukaemia is a blood cancer characterized by neoplastic transformation and excess propagation of lymphocytes, a type of white blood cell, in the bone marrow. With approximately 2,000 patients with chronic lymphocytic leukaemia in Japan as well as an incidence rate of new cases of approximately 0.3 in 100,000, this is a disease with high unmet medical need. Furthermore, Treakisym has been designated as an orphan drug for chronic lymphocytic leukaemia in Japan.
Eisai positions oncology as a key therapeutic area and is aiming to discovery revolutionary new medicines with the potential to cure cancer. Eisai remains committed to maximizing the value of Treakisym as well as its in-house developed anticancer agents including Halaven and Lenvima, seeking to contribute further to addressing the diverse needs of patients with cancer and their families.
Bendamustine hydrochloride is an anticancer agent originally synthesized by German (formerly 'East German') pharmaceutical company Jenapharm and is marketed in Europe under the brand names Ribomustin and Levact as a treatment for non-Hodgkin's lymphoma, multiple myeloma and chronic lymphocytic leukaemia. In the United States the product has been approved by the US Food and Drug Administration and is currently marketed under the brand name Treanda for the treatment of chronic lymphocytic leukemia and relapsed indolent B-cell non-Hodgkin's lymphoma. Eisai concluded an exclusive licensing agreement with SymBio in August 2008 concerning the joint development and marketing of Treakisym in Japan, which was followed by a subsequent agreement between the two companies in May 2009 concerning the development and marketing of the agent in Singapore and South Korea.
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.
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Strides Shasun Limited announced that it has received approval from the United States Food & Drug Administration (USFDA) for Ranitidine Tablets USP, 150 mg and 300 mg.
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).
U.S. Food and Drug Administration issued a revised guidance recommending universal testing of donated Whole Blood and blood components for Zika virus in the U.S. and its territories.
Mylan NV announced that the US Patent and Trademark Office (USPTO) has ruled in favour of Mylan in its inter partes review (IPR) proceeding and found all claims of two related Copaxone 40 mg/mL patents to be unpatentable. The US Patent Nos. are 8,232,250 and 8,399,413, which are owned by Yeda Research & Development Co., Ltd. and licensed to Teva Pharmaceuticals Industries Ltd. A decision by the PTAB on Mylan's third petition seeking inter partes review of US Patent No. 8,696,302 is expected on or before September 1, 2016.
Mallinckrodt plc announced the U.S. Food and Drug Administration (FDA) has granted the company's request for a Fast Track designation for its Investigational New Drug (IND) application for Synacthen® Depot in the treatment of Duchenne muscular dystrophy (DMD). Synacthen Depot is a depot formulation of Synacthen (tetracosactide), a synthetic 24 amino acid melanocortin receptor agonist. Synacthen Depot is approved and marketed outside of the U.S. for certain autoimmune and inflammatory conditions, but has never been approved for use in patients in the U.S.
Evgen Pharma plc announced that it has received a Clinical Trial Approval (CTA) from the UK’s regulatory agency for the commencement of its Phase II clinical trial of SFX-01 in breast cancer.
Mylan N.V. and Biocon Ltd. announced that the European Medicines Agency (EMA) has accepted for review Mylan's Marketing Authorization Application (MAA) for a proposed biosimilar Trastuzumab, which is used to treat certain HER2-positive breast and gastric cancers. This is the second biosimilar submission developed by the partnership that has been accepted for review in Europe. Last month, Mylan's MAA for the proposed biosimilar Pegfilgrastim was accepted for review by EMA.
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