Pharma News

The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.

Pfizer Inc. is voluntarily recalling one lot of 30-count Effexor XR® (venlafaxine HCl) 150 mg extended-release capsules, one lot of 90-count Effexor XR (venlafaxine HCl) 150 mg extended-release capsules, and one lot of 90-count Greenstone...

Baxter International Inc. has initiated a voluntary recall in the US of a single lot of DIANEAL PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose 6000mL (Ambu-Flex II) to the hospital/user level. The recall is being initiated as a...

Daiichi Sankyo Company Limited announced a series of organizational and personnel changes, effective April 1, 2014. Organizationally, within its Corporate Strategy Division, the current Corporate Strategy Department and the Global Brand...

Eisai Co., Ltd. and Biogen Idec have entered into a collaboration to develop and commercialize two of Eisai's clinical candidates for Alzheimer's disease (AD), E2609 and BAN2401. The agreement also provides Eisai with an option to jointly...

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...