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August 30, 2011

The Food and Drug Administration has accepted a regulatory approval application from Progenics Pharmaceuticals and Salix Pharmaceuticals seeking an additional approval for a pain drug.

TARRYTOWN, N.Y. — The Food and Drug Administration has accepted a regulatory approval application from Progenics Pharmaceuticals and Salix Pharmaceuticals seeking an additional approval for a pain drug.

The two drug makers announced Tuesday that the FDA had accepted their supplemental new drug application for Relistor (methylnaltrexone bromide), an injectable drug for treating opioid-induced constipation.

August 30, 2011

A federal court has acted in favor of Teva Pharmaceutical Industries in the drug maker's patent infringement case against several generic drug companies seeking to market versions of its multiple sclerosis drug.

JERUSALEM — A federal court has acted in favor of Teva Pharmaceutical Industries in the drug maker's patent infringement case against several generic drug companies seeking to market versions of its multiple sclerosis drug.

August 29, 2011

The Food and Drug Administration has approved a new cancer drug made by Pfizer, the drug maker said.

NEW YORK — The Food and Drug Administration has approved a new cancer drug made by Pfizer, the drug maker said.

The FDA approved Pfizer's Xalkori (crizotinib) capsules, a treatment for patients with non-small cell lung cancer that has advanced locally or spread to other parts of the body, also known as metastasis. The drug specifically is designed to target NSCLC containing the enzyme anaplastic lymphoma kinase, as determined by a companion test also approved by the FDA.

August 29, 2011

A drug made by Pfizer and Bristol-Myers Squibb undergoing late-stage clinical trials was more effective than the generic drug warfarin in patients with atrial fibrillation, according to study results released Sunday.

NEW YORK — A drug made by Pfizer and Bristol-Myers Squibb undergoing late-stage clinical trials was more effective than the generic drug warfarin in patients with atrial fibrillation, according to study results released Sunday.

The phase-3 "ARISTOTLE" trial of Eliquis (apixaban) showed that the drug reduced the risk of stroke and systemic embolism by 21%, major bleeding by 31% and death by 11% in AF patients. The study, published in the New England Journal of Medicine, was conducted at 1,034 centers in 39 countries and enrolled 18,201 patients.

August 26, 2011

The Food and Drug Administration has approved a drug made by Shire for a rare autoimmune condition, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Shire for a rare autoimmune condition, the agency said.

The FDA announced the approval of Firazyr (icatibant) for acute attacks of hereditary angioedema in patients ages 18 years and older. HAE, which affects fewer than 30,000 people in the United States, results from improper function of C1 inhibitor, a protein that regulates how certain immune system and blood clotting pathways function.

August 26, 2011

The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating chronic pain, a J&J subsidiary said Friday.

RARITAN, N.J. — The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating chronic pain, a J&J subsidiary said Friday.

The FDA approved Janssen Pharmaceuticals' Nucynta ER (tapentadol) tablets, an extended-release drug for moderate to severe chronic pain in adults for whom a continuous, around-the-clock opioid analgesic is needed for an extended period of time.

August 25, 2011

Amgen has launched an educational campaign that targets women with postmenopausal osteoporosis at increased risk for fractures.

THOUSAND OAKS, Calif. — Amgen has launched an educational campaign that targets women with postmenopausal osteoporosis at increased risk for fractures.

The drug maker said that to promote its Act 2 Reduce Fractures campaign, which is supported by American Bone Health, the Global Healthy Living Foundation and the Older Women's League, the company has tapped award-winning actress Blythe Danner, who was diagnosed with the disease, to encourage women to learn of the risk factors and ways to improve their condition.

August 25, 2011

AstraZeneca is offering a discount savings program for its prescription acid reflux disease treatment.

WILMINGTON, Del. — AstraZeneca is offering a discount savings program for its prescription acid reflux disease treatment.

The company said its new Nexium savings card is designed to offer eligible patients instant discounts on their prescriptions for the drug. AstraZeneca noted that the offer is good for up to $50 off on 12 prescriptions of at least a 30-day supply of Nexium, must be used within 14 months of the first prescription fill and cannot be combined with any other offer. Additionally, the offer is not valid for patients that have a co-pay of $18 or less.

August 25, 2011

Hi-Tech Pharmacal has acquired marketing and distribution rights for a product designed to treat coughs and upper respiratory symptoms associated with an allergy or a cold.

AMITYVILLE, N.Y. — Hi-Tech Pharmacal has acquired marketing and distribution rights for a product designed to treat coughs and upper respiratory symptoms associated with an allergy or a cold.

The generic drug maker said it attained rights for TussiCaps, available in 10-mg/8-mg and 5-mg/4-mg formulations, from Mallinckrodt. Hi-Tech's ECR Pharmaceuticals subsidiary, which markets branded prescription products, will promote TussiCaps, the only extended-release prescription cough-cold capsule product approved by the Food and Drug Administration.

August 25, 2011

Novo Nordisk is investing 1 billion Danish kroner ($193.9 million) into new office buildings in Bagsværd, Denmark.

BAGSVÆRD, Denmark — Novo Nordisk is investing 1 billion Danish kroner ($193.9 million) into two new office buildings in Bagsværd, Denmark.

The drug maker said the new premises will house Novo Nordisk’s top management, 1,100 administrative employees and a number of shared facilities.

August 24, 2011


A worldwide flood of counterfeit and unsafe medications is seeping into the United States and other developed countries via the Internet and porous borders, threatening public health and the security of the pharmaceutical supply chain.


A worldwide flood of counterfeit and unsafe medications is seeping into the United States and other developed countries via the Internet and porous borders, threatening public health and the security of the pharmaceutical supply chain. In response, federal drug safety overseers and such drug manufacturers as Pfizer are working to shore up the integrity of drug supplies and stop production of fake and adulterated pharmaceuticals at their source.


August 24, 2011

The final outcome of the battle between Israel’s Teva Pharmaceutical Industries and Canada’s Valeant Pharmaceuticals International to buy Cephalon serves as a good illustration of why it helps to have a plan B.


The final outcome of the battle between Israel’s Teva Pharmaceutical Industries and Canada’s Valeant Pharmaceuticals International to buy Cephalon serves as a good illustration of why it helps to have a plan B.


In May, Teva beat out Valeant’s $5.7 billion offer to buy Frazier, Pa.-based Cephalon with a $6.8 billion offer of its own, acquiring Cephalon’s hefty pipeline in the process. And last month, Teva bought Taiyo Pharmaceutical Industry, Japan’s third-largest generics company, for $934 million.


August 24, 2011


Dispensing narcotics and other highly abused prescription drugs, pharmacies have always been potential targets for robbery and burglary. But a series of violent crimes over the past year and a half have thrown a spotlight on the dangers faced by pharmacy workers and customers, and have galvanized public opinion for tougher laws.



Dispensing narcotics and other highly abused prescription drugs, pharmacies have always been potential targets for robbery and burglary. But a series of violent crimes over the past year and a half — including the killing of a pharmacist, a teenage clerk and two customers in Medford, N.Y., in June, as well as the murders of a pharmacist in Trenton, N.J., and a store clerk in Sacramento, Calif. — have thrown a spotlight on the dangers faced by pharmacy workers and customers, and have galvanized public opinion for tougher laws.


August 23, 2011

The Food and Drug Administration will decide whether or not to approve a new usage for a cancer drug made by Amgen by next year, the drug maker said.

THOUSAND OAKS, Calif. — The Food and Drug Administration will decide whether or not to approve a new usage for a cancer drug made by Amgen by next year, the drug maker said.

August 23, 2011

The Food and Drug Administration has approved a chemotherapy drug made by Sandoz, the drug maker said Tuesday.

PRINCETON, N.J. — The Food and Drug Administration has approved a chemotherapy drug made by Sandoz, the drug maker said Tuesday.

Sandoz, the generics division of Swiss drug maker Novartis, announced the approval and launch of docetaxel, an injectable chemotherapy drug that the company said was the 11th cancer drug it has launched in the United States.

August 22, 2011

A new drug made by AstraZeneca is available in pharmacies following its regulatory approval in July, the company said Monday.

WILMINGTON, Del. — A new drug made by AstraZeneca is available in pharmacies following its regulatory approval in July, the company said Monday.

AstraZeneca announced the availability of the anti-platelet drug Brilinta (ticagrelor) for reducing the rate of thrombotic cardiovascular events in patients with acute coronary syndrome.

The Food and Drug Administration approved Brilinta on July 20. AstraZeneca said the drug has been shown to reduce the rates of cardiovascular death, heart attacks and stroke, compared with other drugs on the market.

August 19, 2011

The Food and Drug Administration has approved a new biotech drug for treating two types of lymphoma, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new biotech drug for treating two types of lymphoma, the agency said Friday.

August 19, 2011

Canada-based drug maker Valeant Pharmaceuticals International has acquired a Kaunas, Lithuania-based specialty pharmaceutical company.

MISSISSAUGA, Ontario — Canada-based drug maker Valeant Pharmaceuticals International has acquired a Kaunas, Lithuania-based specialty pharmaceutical company.

Valeant said it completed its acquisition of Sanitas Group, which operates in Central and Eastern Europe and Russia markets.

The deal, which initially was announced by Valeant in May, was valued at EUR314 million (about $450 million) in cash.

August 18, 2011

Valeant Pharmaceuticals on Thursday announced the resignation of Michael Van Every from its board of directors.

MISSISSAUGA, Ontario — Valeant Pharmaceuticals on Thursday announced the resignation of Michael Van Every from its board of directors.

The company said Van Every, who has served on the board since 2004, resigned due to health reasons.

August 18, 2011

Endo Pharmaceuticals has ended its research program and collaboration with Grunenthal.

CHADDS FORD, Pa. — Endo Pharmaceuticals has ended its research program and collaboration with Grunenthal.

The announcement comes shortly after the companies revealed their mid-stage clinical trial results for axomadol — designed to treat chronic low back pain — did not meet the predetermined endpoint.

Endo licensed exclusive rights to develop and market axomadol in the United States and Canada from Grunenthal in February 2009.

August 18, 2011

Johnson & Johnson has launched several new tools on a website aimed at ensuring patients with pain get the drugs they need while staying safe.

RARITAN, N.J. — Johnson & Johnson has launched several new tools on a website aimed at ensuring patients with pain get the drugs they need while staying safe.

J&J subsidiary Janssen Pharmaceuticals added resources and tools to PrescribeResponsibly.com for physicians and pharmacists to support appropriate and responsible treatment of pain. The site was originally launched early last year.

August 17, 2011

The American Diabetes Association, with help from drug maker Eli Lilly, once again is hosting a free communitywide event in Atlanta that's designed to educate African-Americans on diabetes management.

ATLANTA — The American Diabetes Association, with help from drug maker Eli Lilly, once again is hosting a free communitywide event in Atlanta that's designed to educate African-Americans on diabetes management.

August 17, 2011

The Food and Drug Administration has approved a new drug and companion diagnostic test for the most dangerous type of skin cancer, the agency said Wednesday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug and companion diagnostic test for the most dangerous type of skin cancer, the agency said Wednesday.

The FDA announced the approval of Genentech's and Daiichi Sankyo's Zelboraf (vemurafenib), for patients with late-stage melanoma that can't be removed by surgery. Genentech is the U.S. division of Swiss drug maker Roche.

August 17, 2011

Patients with gout taking a drug made by Savient Pharmaceuticals experienced "significant" improvements, according to results of two late-stage clinical trials published in the Journal of the American Medical Association.

EAST BRUNSWICK, N.J. — Patients with gout taking a drug made by Savient Pharmaceuticals experienced "significant" improvements, according to results of two late-stage clinical trials published in the Journal of the American Medical Association.

August 16, 2011

A special group of patients who participated in a trial of a heart disease drug made by Daiichi Sankyo and Eli Lilly showed fewer heart attacks, strokes and deaths related to cardiovascular disease than patients taking a competing drug, according to an analysis of study results.

INDIANAPOLIS — A special group of patients who participated in a trial of a heart disease drug made by Daiichi Sankyo and Eli Lilly showed fewer heart attacks, strokes and deaths related to cardiovascular disease than patients taking a competing drug, according to an analysis of study results.