Wednesday, November 11, 2015
Amgen has announced that the FDA has approved the Biologics License Application for Imlygic (talimogene laherparepvec), a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous and nodal lesions in patients with melanoma recurrent after initial surgery. Imlygic has not been shown to improve overall survival or have an effect on visceral metastases. Imlygic is the first oncolytic viral therapy approved by the FDA based on therapeutic benefit demonstrated in a pivotal study.
The FDA has approved Amgen’s Biologics License Application for IMLYGIC (talimogene laherparepvec), a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous and nodal lesions in patients with melanoma recurrent after initial surgery. [Read More]
Arena Pharmaceuticals has announced that, at the request of the board of directors, company President and CEO Jack Lief has retired from the company, including the board. Dr. Harry Hixson, a director of Arena since 2004, has been appointed to serve as interim chief executive officer and interim principal financial officer. Arena will immediately initiate a search for a new chief executive.
The FDA has accepted its Biologics License Application (BLA) under the 351(k) pathway for Sandoz’s proposed biosimilar to Amgen’s U.S.-licensed Enbrel (etanercept)—a tumor necrosis factor alpha (TNF-alpha) inhibitor. Sandoz, a Novartis company, is seeking approval for all indications included in the label of the reference product, which is used to treat a range of autoimmune diseases including rheumatoid arthritis and psoriasis affectingabout 1.3 million and 7.5 million people (respectively) in the U.S.
EMD Serono, the U.S. biopharmaceutical business of Germany-based Merck, has appointed Joseph Leveque, M.D., as U.S. chief medical officer. Leveque will be responsible for working with the regulatory, medical and development teams to enhance EMD Serono’s clinical presence in the U.S. and to drive the execution of crucial medical initiatives.
Repatha, the second drug approved in a new class of drugs known as PCSK9 inhibitors, has been approved by the FDA for use in addition to diet and maximally tolerated statin therapy in adult patients with heterozygous familial hypercholesterolemia (HeFH), homozygous familial hypercholesterolemia (HoFH), or clinical atherosclerotic cardiovascular disease, such as heart attacks or strokes, who require additional lowering of LDL cholesterol.
The antibiotics market is at risk of losing another decade to inadequate levels of research and innovation, according to international intellectual property firm Marks & Clerk’s new report From rare to routine—medicines for rare diseases, vaccines and antibiotics. Research highlights the striking difference between research levels into rare diseases, vaccines and antibiotics across the globe.