Generic Drugs

May 17, 2007
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
Darmstadt, Germany (May 13)-Mylan Laboratories Inc. and Merck KGaA have signed a share purchase agreement under which Mylan will acquire all of Merck's worldwide operations within Merck Generics, the company?s generics business.
May 10, 2007
ePT--the Electronic Newsletter of Pharmaceutical Technology
Rockville, MD (May 1)-The US Food and Drug Administration issued a report, "Critical Path Opportunities for Generic Drugs," to identify the scientific challenges, including those in manufacturing science, in developing generic drugs and the opportunities for collaborative solutions in resolving those challenges.
May 03, 2007
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
Washington, DC (April 30)-Less than two weeks after the Senate Health, Education, Labor, and Pensions Committee voted to reauthorize the Prescription Drug User Fee Act (PDUFA), the bill this week moved onto the Senate floor.
Mar 15, 2007
ePT--the Electronic Newsletter of Pharmaceutical Technology
Gurgaon, Haryana, India (Mar. 13)-Ranbaxy Laboratories Limited confirmed that it has made a nonbinding bid for the generic drug business of Merck KGaA.
Mar 01, 2007
ePT--the Electronic Newsletter of Pharmaceutical Technology
Brussels (Feb. 13)-The European Generic Medicines Association raised concerns over what it terms ?the serious lack? of resources available to member states in the European Union (EU) to deal with the regulatory workload and bottleneck in new registrations caused by the new Decentralized Procedure (DCP) for approving drugs in Europe.
Feb 22, 2007
ePT--the Electronic Newsletter of Pharmaceutical Technology
Princeton, NJ (Feb. 15, 2007)-Ranbaxy Inc., confirmed that federal officials conducted a search of its New Jersey offices on Feb. 14, 2007 and commented on its reported plan to acquire Merck's generics business.
Feb 15, 2007
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
Washington, DC (Feb. 14)?A congressional team has reintroduced the ?Access to Life-Saving Medicine Act,? which establishes a process through which the US Food and Drug Administration can approve generic copies of biologic drugs.
Jan 11, 2007
ePT--the Electronic Newsletter of Pharmaceutical Technology
Darmstadt Germany (Jan. 8)-Merck KGaA closed on its roughly CHF 16.6 billion ($13.3 billion) deal to acquire a majority stake in the European biotechnology company Serono (Geneva, Switzerland), officially launched Merck Serono SA as a new entity within Merck KGaA, outlined its integration strategy, and announced plans to divest its generics business.
Dec 15, 2006
ePT--the Electronic Newsletter of Pharmaceutical Technology
Brussels, Belgium (Dec. 5)-The debate over biosimilars in Europe was heightened last week between the European Generics Association and the International Alliance of Patients Organizations, a patient advocacy group that issued a briefing paper on biosimilars to the European Parliament, the legislative arm of the European Union (EU).
Dec 02, 2006
Pharmaceutical Technology
Brand-name manufacturers seek to protect their products.
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