December 20, 2010

Drugs for bacterial infections and cancer, and one that could help shape regulations for biosimilars, are featured in the Food and Drug Administration’s annual "Generic Drug Roundup."

December 13, 2010

Teva Pharmaceutical Industries has filed a citizen petition with the Food and Drug Administration, hoping to keep purported generic versions of its multiple sclerosis treatment off the market, the company said Sunday.

December 7, 2010

Drug makers Momenta Pharmaceuticals and Sandoz have filed a lawsuit against Teva Pharmaceutical Industries in the U.S. District Court for the District of Massachusetts, alleging infringement of two patents related to a generic blood-thinning drug.

November 30, 2010

Recent public perception that the Food and Drug Administration had not been doing its job — ensuring that Americans' approved medical devices and medicines are relatively safe — may be impeding fast approval processes, according to a new PricewaterhouseCoopers report published Tuesday.

November 14, 2010

William Gibson, the science-fiction author who helped create the cyberpunk genre in the 1980s and...

November 9, 2010

To express it in modern parlance, follow-on biologics will be a hot mess....

November 2, 2010

The main lobbies for the biotechnology and generic drug industries, and a leading manufacturer of...

November 1, 2010

Amgen's SVP research and development, Joe Miletich, urged members of a Food and Drug Administration...

November 1, 2010

In testimony before the Food and Drug Administration on Tuesday, CVS Caremark’s SVP specialty pharmacy...

November 1, 2010

The Food and Drug Administration should ensure patient access, safety and efficacy; create a transparent...

October 4, 2010

Human Genome Sciences and Novartis have decided not to further develop an investigative biologic treatment...

September 26, 2010

Biosimilars, biogenerics, follow-on biologics—whatever the designation one prefers for knockoffs of biotech drugs—they will soon...

September 26, 2010

For all its successes, the generic drug industry has had a lot to worry about...

September 20, 2010

The Food and Drug Administration is looking for input on regulations concerning knock-off versions of...

August 29, 2010

AstraZeneca's biologics unit has received a second complete response letter from the Food and Drug...

August 15, 2010

The Food and Drug Administration has approved a prefilled dual-chamber syringe made by Pfizer for...

August 12, 2010

Emergent BioSolutions will acquire Trubion Pharmaceuticals for $96.8 million upfront, under a deal the two...

July 14, 2010

Watson Pharmaceuticals will work with a venture-backed firm to develop a biosimilar treatment for female...

June 6, 2010

After nearly a decade at the helm, Generic Pharmaceutical Association president and CEO Kathleen Jaeger...

March 29, 2010

Many people have a lot to say about the recently passed healthcare bill, but generic...

March 21, 2010

While calling it “not perfect,” an organization representing the country’s drug manufacturers called the healthcare-reform...

March 4, 2010

If Medicare Part D is to remain solvent in the future, then lawmakers may want...

March 2, 2010

An organization representing the generic drug industry is holding up a recent report by the...

February 28, 2010

With exception to those companies that are the first to win Food and Drug Administration...