March 19, 2013

The Food and Drug Administration has picked Kathleen Uhl to serve as acting director of the Office of Generic Drugs, the agency said.

March 19, 2013

The question of whether a generic drug company can be held liable for harmful side effects from its medicines goes before the Supreme Court Tuesday in a case involving a New Hampshire woman who sustained several injuries after taking a generic pain drug.

March 14, 2013

A plan to significantly reduce generic drug prices in Alberta has drawn criticism from pharmacists in the Canadian province.

March 14, 2013

Amid a tide of automatic spending cuts resulting from the failure of Congress and the White House to agree on a budget, the generic drug lobby has offered some suggestions to generate savings.

March 14, 2013

The director of the Food and Drug Administration's Office of Generic Drugs is stepping down, according to published reports.

March 12, 2013

Actavis is challenging Novartis' patent on a patch used to treat Alzheimer's disease, Actavis said.

March 12, 2013

Teva Pharmaceutical Industries will sponsor a live audio webcast at the 2013 Barclays Global Healthcare Conference on Thursday, the Israeli generic drug maker said Tuesday.

March 11, 2013

Nearly 1,000 biotech drugs and vaccines for more than 100 diseases are currently under development, according to a new report.

March 8, 2013

While the Food and Drug Administration released draft guidance on regulations for biosimilars in February 2012, the final regulations have yet to appear. But already, everyone from analysts to trade groups to drug makers is preparing for a time when knock-off versions of biotech drugs will become available.

March 8, 2013

Republican and Democratic senators have re-introduced legislation that would ban patent settlements between branded and generic drug companies that critics allege violate antitrust laws, according to published reports.

March 5, 2013

Drug maker Actavis is challenging the patent for a drug used to treat testosterone deficiency or absence in men, the company said.

March 5, 2013

Generic drug maker Dr. Reddy's Labs has launched a drug used to treat certain cancers, the company said Tuesday.

March 5, 2013

The stakes are high in a case involving generic drug maker Actavis and the Federal Trade Commission that will soon go before the Supreme Court, the head of a generic drug industry lobbying group said in a conference call with reporters Tuesday.

March 5, 2013

Ranbaxy Labs will market a drug for depression under an agreement with another company, the drug maker said Tuesday.

March 1, 2013

The Supreme Court will hear arguments later this month in a case that could determine the future of many patent settlements between brand and generic drug makers.

February 28, 2013

The battle over "pay for delay" continues to heat up, and its resolution likely won't come until the nation's highest court decides on the legality of the practice.

February 28, 2013

Canadian generic drug makers expressed dismay over a new plan to reduce reimbursements for a half-dozen generic medications in most of the country's provinces. According to published reports, a group of premiers had reached a coordinated deal to reduce the prices their governments paid for six generic drugs, hoping to save the provinces nearly $100 million.

February 28, 2013

Alabama's Supreme Court ruled in January that brand-name drug companies could be sued if patients suffer complications from generic versions of their medicines, according to published reports.

February 28, 2013

The Food and Drug Administration has set user fee rates for generic drug companies, the agency said Jan. 27.

February 28, 2013

It's been long accepted that politics makes strange bedfellows. That's certainly the case with the reauthorization in 2012 of the Prescription Drug User Fee Act.

February 28, 2013

Has the explosion in generic utilization curbed pioneer-drug research and development? That's one concern floated by some pharmaceutical industry watchers, who claim that the stunning market share gains made by generic drug makers could reduce incentives for branded drug companies to spend to develop new molecular entities, conduct lengthy clinical trials, gain FDA approval and bring those new drugs to market.

February 28, 2013

The world market for generic drugs will jump more than 15% this year and reach a global total of $127.8 billion, predicted a report from British market research firm Visiongain.

February 28, 2013

Biosimilar medicines have been approved and routinely prescribed in Europe for nearly seven years, and creation of a clear pathway for Food and Drug Administration review and approval of generic versions of bioengineered drugs was enshrined into law in the United States with the passage of the Patient Protection and Affordable Care Act nearly three years ago.

February 28, 2013

Are doctors needlessly raising the costs of America's healthcare system through their prescribing habits? Absolutely, say researchers.