Pharmaceutical industry
Glenmark Pharmaceuticals, through its subsidiaries Glenmark Generics and Glenmark Generics Inc, USA, has resolved a patent infringement lawsuit with Daiichi Sankyo Inc and Genzyme Corporation over the Abbreviated New Drug Application (ANDA) for Colosevelam hydrochloride filed with the US Food and Drug Administration (USFDA). As part of the settlement, Glenmark
Pharmaceutical industry
Tradjenta tablets, developed by Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company, are now available in pharmacies across the US. The medication was approved by the FDA on May 2, 2011, as a treatment for type 2 diabetes in adults, taken along with diet and exercise. Tradjenta should not
Pharmaceutical industry
Seattle Genetics has announced that it will receive a $5 million milestone payment from Millennium: The Takeda Oncology Company under their collaboration agreement for brentuximab vedotin (ADCETRIS), a therapy for the treatment of relapsed or refractory Hodgkin lymphoma and relapsed or refractory systemic anaplastic large cell lymphoma (ALCL). This milestone
Pharmaceutical industry
Tradjenta, a new prescription medication used in conjunction with diet and exercise to lower blood sugar in adults with type 2 diabetes, is now available at pharmacies across the country, including Walgreens, CVS, Rite Aid, and many chain and independent pharmacies. The U.S. Food and Drug Administration (FDA) approved
Pharmaceutical industry
The European Commission has granted marketing authorization to BYDUREON, a groundbreaking once-weekly treatment for type 2 diabetes. Developed by Eli Lilly and Company, along with Amylin Pharmaceuticals, Inc. and Alkermes, Inc., BYDUREON is the first of its kind to deliver glycemic control in a single weekly dose. The medication has
Pharmaceutical industry
The US Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) from Novartis to expand the Menveo(R) meningococcal vaccine indication to include infants and toddlers from 2 months of age. Menveo is already approved in the US for use in individuals 2 years
Pharmaceutical industry
The Food and Drug Administration (FDA) is issuing a draft guidance for industry and Agency staff on the establishment of performance characteristics for in vitro diagnostic devices designed to detect methicillin-resistant Staphylococcus aureus (MRSA). This draft guidance is intended to provide recommendations for studies aimed at establishing the performance characteristics
Pharmaceutical industry
Pancreatic neuroendocrine tumors (NET) are rare and difficult-to-treat cancerous growths of the pancreas, affecting only two to four people per million annually. The U.S. Food and Drug Administration (FDA) has approved Pfizer's SUTENT (sunitinib malate) as the first anti-vascular endothelial growth factor (anti-VEGF) therapy for the treatment
Pharmaceutical industry
The U.S. Food and Drug Administration (FDA) has approved updates to the label for Eli Lilly and Company's Humalog (insulin lispro injection), a rapid-acting insulin used to treat people with diabetes. The updated label now allows people with type 1 diabetes using Humalog for pump therapy to
Pharmaceutical industry
Celsion Corporation, a leading oncology drug development company, announced financial results for the year ended December 31, 2010, and provided an update on its clinical trials of ThermoDox(R), a heat-activated liposomal encapsulation of doxorubicin for the treatment of hepatocellular carcinoma (HCC). The company is nearing completion of the 600-patient
Pharmaceutical industry
Vertex Pharmaceuticals Incorporated has announced that 15 abstracts on its medicines in development for hepatitis C, including telaprevir and VX-222, have been accepted for presentation at the 46th Annual Meeting of the European Association for the Study of the Liver (EASL) in Berlin, Germany. The data presentations will provide insights
Pharmaceutical industry
The US Food and Drug Administration (FDA) has approved BENLYSTA, a medication developed by Human Genome Sciences, Inc. (HGS) and GlaxoSmithKline PLC (GSK), for the treatment of adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard therapy. This marks the first new treatment for SLE in
