March 15, 2011

A drug under investigation as a treatment for a rare genetic disorder that causes abnormally high triglyceride levels in the blood has received orphan-drug designation from the Food and Drug Administration.

March 15, 2011

A generic painkiller made by Watson Pharmaceuticals does not infringe on the patent covering the branded version, a U.S. District Court has ruled.

March 15, 2011

The Food and Drug Administration on Tuesday outlined a new campaign attacking fraudulent weight-loss products marketed as dietary supplements, especially those companies that proffer a “magic pill” that almost immediately achieves weight loss.

March 15, 2011

Five senators have issued a letter to Food and Drug Administration commissioner Margaret Hamburg to expand Americans' access to affordable medications by avoiding the delay of generic drug approvals.

March 15, 2011

Patients that opt to fill their prescriptions through a $4 generic program could help garner societal savings of nearly $6 billion, a new study found.

March 14, 2011

"Fake drugs are a big threat and an exploding threat," Kumar Kibble, deputy director of Immigration and Customs Enforcement, told the news program "60 Minutes" in a segment that appeared Sunday night.

March 14, 2011

McNeil last week finalized the terms of a consent decree of permanent injunction with the Food and Drug Administration for manufacturing facilities operated by the McNeil Consumer Healthcare Division in Las Piedras, Puerto Rico; Fort Washington, Pa.; and Lancaster, Pa.

March 14, 2011

Sugar and chalk. That’s what Pfizer researchers found in a pill that was supposed to be Cytotec but was, in fact, a crude knock-off seized from a counterfeit drug lab in Peru. The "60 Minutes" segment came as no surprise to Drug Store News, which has argued for many years that drug counterfeiting is the key reason lawmakers need to forget the recurring pipe dream they share that rogue Internet sites and drug reimportation is a legitimate solution to rising healthcare costs.

March 11, 2011

While failing to improve overall survival, an investigational treatment for non-small cell lung cancer made by Sanofi-Aventis and Regeneron Pharmaceuticals did keep the disease from worsening and, overall, caused patients to respond to treatment, according to results of a late-stage clinical trial.

March 10, 2011

The Food and Drug Administration is putting its weight behind a campaign by the National Consumers League to combat poor medication adherence.

March 10, 2011

Eli Lilly on Thursday announced that it has named Greg Plowman VP oncology research and SVP for ImClone Systems research.

March 9, 2011

Eli Lilly leader John Lechleiter has become something of an evangelist for medical innovation lately. On Wednesday, the Lilly chairman, president and CEO spoke to the U.S./Japan Business Council in Tokyo to call for changes and policies in the biopharmaceutical industry that encourage innovation, or “reinventing invention,” as he called it.

March 8, 2011

The Food and Drug Administration has accepted a regulatory approval application for a Type 2 diabetes drug from Bristol-Myers Squibb and AstraZeneca, the two drug makers said Tuesday.

March 7, 2011

The board of directors of Genzyme unanimously recommended that shareholders accept French drug maker Sanofi-Aventis’ $74-per-share buyout offer, Genzyme said Monday.

March 7, 2011

Late-stage clinical trial data for a Keryx Biopharmaceuticals drug to treat kidney disease will be presented at a medical conference in Las Vegas.

March 4, 2011

The Obama administration on the official White House website identifies “5 Important Numbers on Health Reform.” These include:

Zero. The amount consumers would have to pay for premiums, co-insurance or co-payments on any preventive services;

Fifty. The number of states that now offer insurance options to all people, regardless of any pre-existing conditions;

One million. The number of doughnut-hole rebate checks mailed to seniors under Part D as of August 2010;

March 4, 2011

SUPPLIER NEWS — Impax Labs received regulatory approval from the Food and Drug Administration for its generic version of a bacterial infection treatment. The drug maker said the FDA approved its 150-mg doxycycline monohydrate capsules, a drug used to treat bacterial infections and a generic version of Adoxa, made by Nycomed subsidiary PharmaDerm. The 150-mg strength of Adoxa had sales of about $25 million during the 12 months ended in December 2010, according to Wolters Kluwer.

March 3, 2011

The Food and Drug Administration declined to approve a Merck KGaA drug designed to treat relapsing-remitting multiple sclerosis.

March 3, 2011

The head of a group representing the nation's pharmacy benefit managers got honors from the Generic Pharmaceutical Association.

March 2, 2011

A group of drug makers have sued Mylan over its attempt to gain Food and Drug Administration approval for a generic menopause drug, Mylan said Tuesday.

March 2, 2011

Following the warning letter it received last April, Perrigo announced that the Food and Drug Administration has arrived at the company's Allegan, Mich.-based facility for re-inspection.

February 28, 2011

The Food and Drug Administration has approved a GlaxoSmithKline drug for a rare blood disorder, GSK said Friday.

February 25, 2011

More than 400 drugs are in late-stage clinical development or awaiting Food and Drug Administration approval as treatments for rare diseases, according to a report by the drug industry lobby.

February 25, 2011

The Food and Drug Administration has declined to approve a biologic treatment for a rare genetic disorder by Israeli drug maker Protalix Biotherapeutics, Protalix said Friday.