October 12, 2012

The Food and Drug Administration has approved a new use for a drug made by Roche division Genentech.

August 30, 2012

The Food and Drug Administration has approved a biosimilar drug made by Teva Pharmaceutical Industries for a condition that results from certain chemotherapy treatments, the drug maker said Thursday.

August 29, 2012

A panel of outside advisers to the Food and Drug Administration has backed wider use for Abbott Labs’ rheumatoid arthritis drug, Humira, for treating a type of inflammatory bowel disease.

August 23, 2012

A division of Johnson & Johnson has started a late-stage clinical trial program for a drug for rheumatoid arthritis under a partnership with British drug maker GlaxoSmithKline.

August 17, 2012

The U.S. healthcare system presents a paradox: It’s the most expensive system in the world, and yet it produces among the worst results among developed countries.

July 31, 2012

Following regulatory approval by the Food and Drug Administration's Center for Biologics Evaluation and Research, GlaxoSmithKline confirmed it has begun shipping the first lots of its 2012-2013 seasonal influenza vaccines to healthcare providers and Centers for Disease Control and Prevention distribution centers.

July 17, 2012

A subsidiary of Johnson & Johnson is hoping to win an additional approval for one of its drugs.

June 6, 2012

A generic drug maker in India and a German pharmaceutical company will collaborate to develop biosimilars.

May 31, 2012

As the Food and Drug Administration works to finalize draft guidance related to the development of biosimilar products, pharmacy groups recently weighed in with recommendations to facilitate the entry of lower-cost products into the biologic and specialty pharmaceutical markets.

May 15, 2012

Legislation proposed in the House of Representatives would speed up Food and Drug Administration approval of knock-off versions of vaccines and other biologics while requiring the agency to conduct more inspections of drug factories overseas, according to published reports.

May 11, 2012

Biotech drug maker Amgen has joined the list of companies offering testimony at a Food and Drug Administration hearing on biosimilars Friday.

May 9, 2012

The Food and Drug Administration should apply consistent regulatory standards across all biologics, Sandoz plans to state Friday in testimony at an FDA public hearing on draft guidances related to the development of biosimilars.

February 9, 2012

The Food and Drug Administration reached a major milestone on the path to a regulatory regime for follow-on biologics on Thursday with the release of draft guidance on biosimilar product development.

January 20, 2012

With the patent cliff and subsequent innovation drought moving closer, generic drug makers are looking to move up the value chain and pursue new sources of revenue, and of all the piles of pay dirt out there, biosimilars represent one of the closest things to an El Dorado, though regulations won’t take their final form for a while.


January 3, 2012

Drug maker Amgen will discuss the supplemental biologics license application of Xgeva before a Food and Drug Administration review panel next month.

December 23, 2011

Baxter and Momenta have agreed to partner to develop and market biosimilar drugs to treat cancer, autoimmune disorders and other chronic conditions.

December 20, 2011

Generic drug maker Watson and biotech manufacturer Amgen will work together to develop biosimilar antibodies for treating cancer, the two companies said.

November 17, 2011

The increase in the number of people with rheumatoid arthritis, and the challenges posed to drug makers by generics, is encouraging the development of new drugs for the disease, according to a new report by Frost & Sullivan.

November 4, 2011

The Food and Drug Administration has cleared the way for the return to market of a drug for treating immunodeficiency diseases following its recall by the manufacturer in response to patients developing internal blood clots.

November 4, 2011

In September, the Generic Pharmaceutical Association announced the appointment of Ralph Neas — former president and CEO of the National Coalition on Health Care — as its new president and CEO, replacing Kathleen Jaeger, who stepped down as president and CEO of the organization in May 2010.

October 31, 2011

Watson Pharmaceuticals and a partnering company are barred from launching a generic version of a blood-thinning drug under a federal court decision issued Friday.

October 19, 2011

PakSense has launched a new label that monitors time and temperature of such perishable items as food, vaccines, pharmaceuticals and biologics during distribution and storage.

September 22, 2011

Two drug makers have entered a collaboration for novel biologics programs in diabetes and heart failure.

September 12, 2011

It’s hard to disagree that generic drug companies have had a good run for the last several years. Branded drug companies developed a large number of drugs that proved highly effective at treating widespread medical conditions and became blockbusters, garnering billions of dollars in sales in the United States alone.