Content about Clinical research

November 30, 2012
FDA approves new medullary thyroid cancer drug

The Food and Drug Administration has approved a new drug made by Exelixis for treating thyroid cancer, the agency said.

November 29, 2012
FDA approves Mylan overactive bladder drug

The Food and Drug Administration approved a new generic drug made by Mylan for urinary disorders, the company said Thursday.

November 29, 2012
FDA panel backs J&J tuberculosis drug

A Food and Drug Administration panel has voted to recommend approval for a Johnson & Johnson drug to treat tuberculosis while the agency has recommended accelerated approval for the drug, the company said.

November 29, 2012
Industry divided over patent settlements

Patent settlements between generic and branded drug companies seem like one of the most controversial and long-standing issues in the pharmaceutical world, with strong opinions on both sides.


November 29, 2012
User fee re-authorization 
fuels generics’ outlook

Generic Pharmaceutical Association president and CEO Ralph Neas called it “the most important pharmaceutical legislation since the 1984 Hatch-Waxman Act.” John Castellani, president and CEO of the Pharmaceutical Research and Manufacturers of America, said the law served “the best interests of America’s patients.”


November 28, 2012
Durbin, Blumenthal ask FDA to review energy drinks quickly

Some legislators are concerned with the way energy drinks can affect young consumers.

November 28, 2012
FDA approves Perrigo, Cobrek scalp psoriasis treatment

The Food and Drug Administration has approved a drug from Perrigo and Cobrek Pharmaceuticals for treating scalp conditions.

November 27, 2012
Wockhardt receives three FDA approvals

Indian generic drug maker Wockhardt received three new drug approvals from the Food and Drug Administration, agency records show.

November 19, 2012
FDA approves GSK drug for hepatitis C patients with low platelet counts

The Food and Drug Administration has approved a drug for a condition that can complicate treatment for hepatitis C.

November 15, 2012
Generic drugs compete in game of differentiation

The year 2012 is coming to an end, and it’s been a big year for 
generic drugs.


November 15, 2012
Generics target specialty pharmacy with biosimilars

Perhaps the iconic scene at the end of Ridley Scott’s 1991 movie “Thelma & Louise” — with Gina Davis’ and Susan Sarandon’s characters hurdling into the Grand Canyon in a green convertible — is a good metaphor for what’s happening in the generic drug industry these days.


November 15, 2012
NewsBytes — Chain Pharmacy, 11/19/12

The Food and Drug Administration has approved a generic drug for leukemia made by a subsidiary of Par Pharmaceutical Cos.


November 14, 2012
FDA wants more oversight of compounding pharmacies

Food and Drug Administration commissioner Margaret Hamburg is asking Congress to give the agency more power to regulate compounding pharmacies amid a national meningitis outbreak linked to a Massachusetts-based compounding pharmacy that has claimed dozens of lives nationwide.

November 13, 2012
Reports: AMA supports legislation against 'pay-for-delay' deals

The American Medical Association has come out in favor of legislation to stop deals between branded and generic drug makers that critics blame for delaying entry of generics into the market, according to published reports.

November 12, 2012
FDA approves new strength of HIV drug

The Food and Drug Administration has approved a new strength of a drug for HIV made by Johnson & Johnson, the drug maker said.

November 8, 2012
FDA accepts Merck application for insomnia drug

The Food and Drug Administration has accepted an application from Merck for an experimental drug for insomnia, the drug maker said Thursday.

November 7, 2012
FDA issues warning letter to company making illegal claims in support of light therapy device

The Food and Drug Administration on Monday issued a warning letter to The Avalon Effect, a company based in Franklin, Tenn., for its marketing of a light therapy product that claims to cure or treat symptoms of fungal meningitis, methicillin-resistant Staphylococcus aureus, concussions, Lyme disease and other diseases.

November 5, 2012
FDA approves J&J anti-clotting drug

The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating internal blood clots, the company said.

November 5, 2012
NewsBytes — Chain Pharmacy, 11/5/12

The Food and Drug Administration has approved a generic drug for treating blood pressure and chest pain.

November 1, 2012
Reports: Generic extended-release drugs to get more attention from FDA

Some generic drugs may come under more scrutiny from the Food and Drug Administration amid reports that the generic version of a treatment for depression didn't work as well as the branded version, according to published reports.

October 31, 2012
Sandoz starts phase-3 trial of biosimilar anemia drug

Generic drug maker Sandoz has started a late-stage clinical trial in the United States for a biosimilar treatment for anemia, the company said.

October 29, 2012
Watson launches generic version of Actos

The Food and Drug Administration has approved a Type 2 diabetes drug made by Watson Pharmaceuticals, the company said, following a federal court's order for the agency to approve the drug.

October 26, 2012
FDA approves Teva's Synribo for blood and bone marrow cancer

The Food and Drug Administration has approved what it called the second new drug in two months for a form of leukemia, the agency said Friday.

October 26, 2012
FDA cracks down on violators of dietary supplement regulations

The Food and Drug Administration on Thursday announced a pair of penal actions against companies operating outside of dietary supplement regulations.

October 26, 2012
FDA: Contamination found at Mass. compounding pharmacy linked to meningitis deaths

The Food and Drug Administration said it found a number of problems with cleanliness at a compounding pharmacy linked to a meningitis outbreak that has so far sickened hundreds of people and killed two dozen in a report released Friday.

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