Content about Pharmaceutical industry

March 24, 2011

Procter & Gamble and Teva Pharmaceutical Industries will bring their over-the-counter product lines and capabilities together in a deal they expect to be completed this fall.

CINCINNATI — Procter & Gamble and Teva Pharmaceutical Industries will bring their over-the-counter product lines and capabilities together in a deal they expect to be completed this fall.

March 24, 2011

The Food and Drug Administration has approved a generic drug for cardiovascular disease made by Qualitest Pharmaceuticals.

HUNTSVILLE, Ala. — The Food and Drug Administration has approved a generic drug for cardiovascular disease made by Qualitest Pharmaceuticals.

Qualitest announced Thursday the approval of toresmide tablets in the 5-mg, 10-mg, 20-mg and 100-mg strengths.

The drug is used to treat edema associated with congestive heart failure, kidney disease or hepatic disease, and also for hypertension.

March 24, 2011

Sandoz has introduced an authorized generic version of a herpes treatment made by parent company Novartis, the company said Thursday.

PRINCETON — Sandoz has introduced an authorized generic version of a herpes treatment made by parent company Novartis, the company said Thursday.

Sandoz announced the launch of famciclovir tablets, an authorized generic of Famvir, used to treat genital herpes and cold sores in patients with healthy immune systems, and to treat shingles and herpes simplex infections of the skin and mucosa in patients with HIV.

Authorized generics are branded drugs sold under their generic chemical names at a reduced price, often through third-party companies.

March 23, 2011

Though more than 7-in-10 drugs dispensed in the United States today are generics, and the Food and Drug Administration holds generics to the same standards as branded drugs, misgivings among the general public still exist, fed by the occasional media report of patients experiencing bad side effects after taking certain generic drugs.

PITTSBURGH — Though more than 7-in-10 drugs dispensed in the United States today are generics, and the Food and Drug Administration holds generics to the same standards as branded drugs, misgivings among the general public still exist, fed by the occasional media report of patients experiencing bad side effects after taking certain generic drugs.

March 22, 2011

Hi-Tech Pharmacal was granted final approval from the Food and Drug Administration for its treatment of duodenal ulcers.

AMITYVILLE, N.Y. — Hi-Tech Pharmacal was granted final approval from the Food and Drug Administration for its treatment of duodenal ulcers.

The drug maker said its abbreviated new drug application for ranitidine syrup in the 15-mg/mL strength was approved. Ranitidine syrup is a generic version of GlaxoSmithKline’s Zantac syrup, which garnered sales of $21 million for 12 months ended in December 2010, according to IMS sales data.

Hi-Tech currently has 13 products awaiting approval at the FDA, the company said.

March 22, 2011

Less than 20% of surveyed patients with nasal allergies find their symptoms are completely controlled over a one-week period of treatment, according to a survey performed by drug maker Teva Pharmaceutical Industries.

SAN FRANCISCO — Less than 20% of surveyed patients with nasal allergies find their symptoms are completely controlled over a one-week period of treatment, according to a survey performed by drug maker Teva Pharmaceutical Industries.

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.

WASHINGTON — 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.

Republicans in Congress have sought to reduce government spending by making large cuts to various domestic programs and agencies, including the FDA, which critics of the plan said could jeopardize food and drug safety.

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.

NEW YORK — 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.

WHAT IT MEANS AND WHY IT'S IMPORTANT — 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.

LONDON — 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.

NEW YORK — 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.

Bloomberg reported that Gilead and Roche were accusing Natco of patent infringement due to its efforts to gain approval from the Food and Drug Administration for a generic version of Tamiflu (oseltamivir phosphate). Natco became the first company to file for approval of a generic version in February.

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.

ALEXANDRIA, Va. — 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.

CAMBRIDGE, Mass. — 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.

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

Watson said the U.S. District Court for the District of Delaware ruled that Watson’s generic version of Cephalon’s Fentora (fentanyl buccal tablets) does not infringe on two patents that were set to expire in March 2019, according to Food and Drug Administration records.

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.

SILVER SPRING, Md. — 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.

WASHINGTON — 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.

PITTSBURGH — 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.

NEW YORK — "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.

FORT WASHINGTON, Pa. — 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.

The consent decree is subject to approval by the U.S. District Court for the Eastern District of Pennsylvania.

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.

WHAT IT MEANS AND WHY IT’S IMPORTANT — 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 NEWS: '60 Minutes' examines drug counterfeit problem. For the full story, click here)

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.

TARRYTOWN, N.Y. — 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.

Sanofi and Regeneron announced Thursday results of the phase-3 “VITAL” trial of aflibercept. Patients were administered either the drug or placebo in addition to docetaxel chemotherapy.

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.

SILVER SPRING, Md. — 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.

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

Plowman will oversee the oncology research efforts of both Lilly and ImClone, the drug maker's subsidiary that it acquired in 2008. He will report to Jan Lundberg, EVP science and technology and Lilly Research Labs president, as well as Bernhard Ehmer, ImClone president.

Prior to accepting the position at Lilly, Plowman served as senior director of research for Genentech for six years. He officially will join the company March 28.

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.

TOKYO — 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.

PRINCETON, N.J. — 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.

The FDA accepted the application for dapagliflozin, an investigational drug for adults with the disease. The Centers for Disease Control and Prevention estimated that 1-in-11 U.S. adults has diabetes, with 90% to 95% of them having Type 2 diabetes.

The agency expects to take action on the application in late October.