March 21, 2011

The generic drug industry’s main lobby in Washington is hoping to head off cuts to the Food and Drug Administration’s Office of Generic Drugs, which it said could have a “devastating impact” on those who rely on generics.

March 21, 2011

Generic drug maker Mylan is suing the Food and Drug Administration in an effort to prevent Gurgaon, India-based competitor Ranbaxy Labs from launching its generic version of Pfizer’s cholesterol medication Lipitor, according to published reports.

March 18, 2011

It's about time lawmakers start to understand the real threats posed by drug reimportation and unlicensed Internet pharmacy sites. About 20% of the current members of Congress are newly elected, and there is this recurring, cyclical fascination among politicians that we can fix everything with drug reimportation. But mandating electronic track and trace right now is a bad idea.

March 18, 2011

With respect to the Type 2 diabetes drug Avandia, British drug maker GlaxoSmithKline has another medical study to worry about.

March 17, 2011

Drug makers Gilead Sciences and Roche are suing Indian drug maker Natco Pharma concerning a generic version of an influenza treatment, according to published reports.

March 17, 2011

Commenting on a counterfeit pharmaceutical inter-agency working group report, the National Association of Chain Drug Stores stressed that it shares the goal of improving the public awareness of the risks posed from counterfeit drugs and unlawful online drug sellers, but expressed concern over the report's proposal to mandate a "track-and-trace" system in the United States, given the high cost it could pose for pharmacies.

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.