January 5, 2011

The Food and Drug Administration has extended by six months the market exclusivity of a lung disease drug for use in children.

January 5, 2011

A generic version of the world’s top-selling cholesterol treatment is expected to hit the market this year, but the branded version’s manufacturer is trying to put the brakes on the launch, according to media reports.

January 5, 2011

Supplier News — The Food and Drug Administration has approved a generic drug for hypertension made by Mylan. Mylan announced the approval of nifedipine extended-release tablets in the 30-mg, 60-mg and 90-mg strengths. The drug is a generic version of Bayer’s Adalat CC. Nifedipine tablets had sales of around $82 million during the 12-month period ended June 2010, according to IMS Health.



 

January 5, 2011

Responding to what she termed an “unprecedented” shortage of prescription medicines for such serious conditions as cancer, Sen. Amy Klobuchar, D-Minn., is promising new legislation to deal with the problem.

January 5, 2011

CHICAGO — At first glance, there doesn’t seem a natural connection between the CD-ROM version of “Who Wants To Be A Millionaire?” and health education. But one company’s smashing success with interactive games led to its venture into prevention and disease management.


January 4, 2011

Par Pharmaceutical has started shipping a generic version of a hypertension drug, the company said Monday.

January 4, 2011

Generic drug maker Par Pharmaceutical has begun shipping its version of a treatment for heart rhythm problems, the company said Monday.

January 4, 2011

Pfizer will pay Danish biotech company Santaris Pharma $14 million for access to its development platform for RNA-based therapies, Pfizer said Tuesday.

January 3, 2011

The Food and Drug Administration approved three drugs made by Glenmark Generics last month and gave tentative approval to a fourth, the Indian generic drug maker said.

January 3, 2011

The Internal Revenue Service has released its guidance on the healthcare-reform law’s tax on drug makers, according to documents posted on the agency’s website.

January 3, 2011

Sandoz has launched higher dosages of its authorized generic version of a hypertension drug, the generics division of Swiss drug maker Novartis said Monday.

December 29, 2010

Recent news that the FDA has rejected Teva's application for a new lower-dose version of multiple sclerosis drug Copaxone likely will hold off the emergence of a generic version of the drug.

December 22, 2010

The European Food Safety Authority has granted GlaxoSmithKline a positive opinion for a health claim related to its "toothkind" drinks, according to BeverageDaily.com, an online news service.

December 22, 2010

The Pharmaceutical Research and Manufacturers of America has added four new members to its board.

December 22, 2010

Takeda and its subsidiary settled the patent suits it brought against generic drug makers that sought to develop their own versions of its diabetes treatment.

December 21, 2010

A judge recently blocked AstraZeneca from attempting to impede the development of generic versions of its popular cholesterol drug, according to published reports.

December 21, 2010

A Mylan subsidiary has settled a lawsuit brought on by the Department of Justice four years ago.

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 17, 2010

Patent settlements between branded and generic drug companies, sometimes called “pay-for-delay” deals, aren’t going away any time soon.

December 17, 2010

The Food and Drug Administration has turned down AstraZeneca’s regulatory approval application for a drug to treat heart disease, the drug maker said.

December 15, 2010

Novartis on Wednesday announced that its merger agreement with Alcon has been settled to the tune of $12.9 billion. The new $8.7 billion Alcon eye care division, which includes CIBA Vision and selected ophthalmic medicines, will be led by current Alcon president and CEO Kevin Buehler.

December 15, 2010

A new Consumer Reports poll released Monday found that only one-fifth of U.S. adults were aware of having purchased food, medication or a product (other than a car) that was recalled in the past three years.

December 15, 2010

Drug maker Watson Pharmaceuticals said it has filed a regulatory approval application for a generic painkiller, challenging the patent that covers the branded version.

December 14, 2010

GlaxoSmithKline on Monday announced its acquisition from Darwin Private Equity of Maxinutrition, a U.K. company that manufactures protein-enhanced functional nutrition products.