THOUSAND OAKS, Calif., July 23, 2015 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for Kyprolis® (carfilzomib) for Injection to seek an expanded indication for the treatment of patients with a form of blood cancer, relapsed multiple myeloma, who have received at least one prior therapy. Kyprolis currently has accelerated approval in the U.S. for the treatment of patients with relapsed multiple myeloma as a monotherapy. read more
Janssen Submits Supplemental New Drug Application to U.S. FDA for All-Oral, Once-Daily OLYSIO® (Simeprevir) in Combination with Sofosbuvir
TITUSVILLE, N.J., July 23, 2015 /PRNewswire/ — Janssen Therapeutics, Division of Janssen Products, LP (Janssen), today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) to update the label for once-daily, all-oral OLYSIO® (simeprevir). OLYSIO® is a hepatitis C virus (HCV) NS3/4A protease inhibitor, currently approved for use with sofosbuvir for adults with genotype 1 chronic hepatitis C (CHC) infection as a 12-week treatment for patients without cirrhosis or a 24-week treatment regimen for patients with cirrhosis. Sofosbuvir is a nucleotide analog NS5B polymerase inhibitor marketed by Gilead Sciences, Inc.read more
EUROPEAN COMMISSION APPROVES AMGEN’S NEW CHOLESTEROL-LOWERINGMEDICATIONREPATHA™ (EVOLOCUMAB), THE FIRST PCSK9 INHIBITOR TO BE APPROVED IN THE WORLD, FOR TREATMENT OF HIGH CHOLESTEROL (Repatha is not approved in the US)
PR Newswire, THOUSAND OAKS, Calif. (July 21, 2015) – Amgen (NASDAQ:AMGN) today announced that the European Commission (EC) has granted marketing authorization for Repatha™ (evolocumab), the first proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor to be approved in the world, for the treatment of patients with uncontrolled cholesterol who require additional intensive low-density lipoprotein cholesterol (LDL-C) reduction. Repatha is a human monoclonal antibody that inhibits PCSK9, a protein that reduces the liver’s ability to remove LDL-C, or “bad” cholesterol, from the blood.1 Elevated LDL-C is an abnormality of cholesterol and/or fats in the blood,2,3 and is recognized as a major risk factor for cardiovascular disease (CVD).4,5 read more
Lupin Acquires GAVIS to Expand US Generic Business
MUMBAI, India, July 23, 2015 /PRNewswire/ — Pharma Major Lupin Limited (Lupin) has entered into a definitive agreement to acquire privately held GAVIS Pharmaceuticals LLC and Novel Laboratories Inc. (GAVIS), subject to certain closing conditions, in a transaction valued at USD 880 million, cash free and debt free. The transaction has been unanimously approved by the Boards of Directors of Lupin and GAVIS. The acquisition enhances Lupin’s scale in the US generic market and also broadens Lupin’s pipeline in dermatology, controlled substance products and other high-value and niche generics. GAVIS brings to Lupin a highly skilled US based R & D organization which would complement Lupin’s Coral Springs, Florida, inhalation R&D center. GAVIS’s New Jersey based manufacturing facility will become Lupin’s first manufacturing site in the US.
TOKYO–(BUSINESS WIRE)–Panasonic Healthcare Co., Ltd. (hereafter “Panasonic”) took part in the International Modern Hospital Show 2015, which was held from July 15 to 17, 2015 at the Tokyo Big Sight. Under the theme, “A new era for health, medical care, and welfare – enhancing integration and comprehensive regional care systems (*1),” Panasonic showcased innovative medical IT systems brought to life by Medicom in the “Medicom Communication Square” within the Panasonic booth. read more