The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
Boehringer Ingelheim Pharmaceuticals Inc.and Eli Lilly and Company report that FDA has issued a complete response letter for the new drug application of the investigational sodium glucose co-transporter-2 (SGLT2) inhibitor...
The pharmaceutical industry weighed in on President Obama's fiscal year (FY) 2015 budget proposal, citing concerns over budget cuts to R&D spending and Medicare among chief issues. Biotechnology Industry Organization (BIO) President...
Teva Pharmaceutical Industries Ltd. reports approval of the generic equivalent to Evista® (raloxifene) tablets, 60 mg, in the United States. Teva was first to file, making the product eligible for 180 days of marketing exclusivity. Teva will begin...
The biopharmaceutical company Theravance reported on a plan to separate its businesses into two independent, publicly traded companies, a move expected to be completed during the second quarter 2014. This decision was reached following a...
Roche has elected Christoph Franz as the new chairman of the board of directors, replacing Franz B. Humer. He has been a member of the Roche Board since 2011. In a Roche statement, Franz said: "I would like to thank the shareholders...
Otsuka Pharmaceutical Co., Ltd., which in 2009 became the first Japanese company to complete a memorandum of understanding (MOU) with the Ministry of Health and Welfare of South Korea for a cooperative relationship in pharmaceutical product...
Actavis plc has filed an abbreviated new drug application (ANDA) with FDA seeking approval to market dronedarone hydrochloride tablets 400 mg. Actavis' ANDA product is a generic version of Sanofi's Multaq®, which is an antiarrhythmic...
Takeda Pharmaceutical Company Limited (Takeda) reports that Christophe Weber's official start date as Takeda's chief operating officer (COO) is April 1, 2014. Mr. Weber is expected to become president and representative director, in...
Actavis has filed an abbreviated new drug application (ANDA) with FDA seeking approval to market colchicine tablets USP, 0.6 mg. Actavis' abbreviated new drug application (ANDA) product is a generic version of Takeda's Colcrys®,...
AstraZeneca has received FDA approval for Bydureon® Pen (exenatide extended-release for injectable suspension) 2 mg as an adjunct to diet and exercise to improve glycaemic control in adults with Type 2 diabetes. Bydureon is the...
Perrigo Company has acquired a basket of value-brand over-the-counter products sold in Australia and New Zealand from Aspen Global Inc. for $51 million in cash. The products are primarily sold through the mass retail channel and include...
Abide Therapeutics has entered into a strategic collaboration with Celgene Corporation to discover and develop new drugs in inflammation and immunology. Abide has developed technologies to selectively target serine hydrolases, an enzyme families...
Bayer plans to acquire 100% of the shares of Dihon Pharmaceutical Group Co., Ltd., Kunming Yunnan, China, a privately held pharmaceutical company specializing primarily in over-the-counter (OTC) and herbal traditional Chinese medicine (TCM)...
Novartis reported that it will be closing its R&D site in Horsham, UK and will close research operations by the end of June. "This is a result of a global review of our R&D locations and where best to co-locate research teams to...
The biopharmaceutical company Ardelyx has licensed to Sanofi its novel phosphate transport NaP2b inhibitor program (also known as NaPi2b, Npt2b and SLC34A2). Ardelyx will receive an undisclosed upfront payment from Sanofi. Total development and...
