Content about Pharmaceutical industry

December 13, 2010

Biotech company Genzyme still is saying “no thanks” to French drug maker Sanofi-Aventis’ tender offer of $18.5 billion, or $69 per share, to acquire it, saying the offer “substantially undervalues” the company.

CAMBRIDGE, Mass. — Biotech company Genzyme still is saying “no thanks” to French drug maker Sanofi-Aventis’ tender offer of $18.5 billion, or $69 per share, to acquire it, saying the offer “substantially undervalues” the company.

The offer has been extended until Jan. 11, Genzyme said.

Sanofi has sought to buy Genzyme since August. Genzyme, based in Cambridge, Mass., specializes in treatments for rare genetic disorders, such as Fabry disease and Gaucher disease.

December 13, 2010

Drug maker Shire has filed a patent infringement suit against Watson Pharmaceuticals and Impax Labs in response to their attempt to win approval from the Food and Drug Administration for a generic version of a Shire drug.

DUBLIN — Drug maker Shire has filed a patent infringement suit against Watson Pharmaceuticals and Impax Labs in response to their attempt to win approval from the Food and Drug Administration for a generic version of a Shire drug.

Shire announced that it had filed the suit in the U.S. District Court for the Northern District of California following the two generic drug makers’ filing of an approval application for guanfacine hydrochloride, a version of Shire’s Intuniv, used to treat hypertension.

December 13, 2010

Teva Pharmaceutical Industries has filed a citizen petition with the Food and Drug Administration, hoping to keep purported generic versions of its multiple sclerosis treatment off the market, the company said Sunday.

JERUSALEM — Teva Pharmaceutical Industries has filed a citizen petition with the Food and Drug Administration, hoping to keep purported generic versions of its multiple sclerosis treatment off the market, the company said Sunday.

Teva said its petition, concerning the drug Copaxone (glatiramer acetate), is based on what it called the inability to establish acceptable “sameness” due to the active ingredient’s complexity.

December 7, 2010

MINNETONKA, Minn. — Could the economy and the bare-knuckles competition that now defines pharmacy retailing lower the price bar even further for widely used generic drugs? It’s already happening.


December 7, 2010

Drug makers Momenta Pharmaceuticals and Sandoz have filed a lawsuit against Teva Pharmaceutical Industries in the U.S. District Court for the District of Massachusetts, alleging infringement of two patents related to a generic blood-thinning drug.

CAMBRIDGE, Mass. — Drug makers Momenta Pharmaceuticals and Sandoz have filed a lawsuit against Teva Pharmaceutical Industries in the U.S. District Court for the District of Massachusetts, alleging infringement of two patents related to a generic blood-thinning drug.

December 7, 2010

ALEXANDRIA, Va. — Simplify, simplify.


December 7, 2010

U.S. generic drug maker Watson Pharmaceuticals and Indian drug maker Natco Pharma will work together to develop and commercialize a generic drug used for bone marrow disorders, the two companies said Tuesday.

MORRISTOWN, N.J. — U.S. generic drug maker Watson Pharmaceuticals and Indian drug maker Natco Pharma will work together to develop and commercialize a generic drug used for bone marrow disorders, the two companies said Tuesday.

The agreement concerns lenalidomide tablets in the 5-mg, 10-mg, 15-mg and 25-mg strengths. The drug is a generic version of Celgene’s Revlimid, used to treat the plasma cell cancer multiple myeloma and myelodysplastic syndrome. Myelodysplastic syndrome results from the bone marrow producing blood cells that are misshapen.

December 6, 2010

The Consumer Healthcare Products Association recently named GlaxoSmithKline veteran Janet Carter-Smith chair of the CHPA Retailer Liaison Steering Committee, effective Jan. 1.

WASHINGTON — The Consumer Healthcare Products Association recently named GlaxoSmithKline veteran Janet Carter-Smith chair of the CHPA Retailer Liaison Steering Committee, effective Jan. 1.

Carter-Smith will be the third chair of this committee, succeeding David Howenstine, VP customer and industry development at Pfizer Consumer Healthcare, whose term ends at the end of the year.

December 3, 2010

The Specialty Pharmacy Nursing Network has entered a partnership with ViroPharma’s CinryzeSolutions support program, a training and monitoring program for patients using ViroPharma’s Cinryze (C1 esterase inhibitor [human]) who wish to administer the drug themselves.

SARASOTA, Fla. — The Specialty Pharmacy Nursing Network has entered a partnership with ViroPharma’s CinryzeSolutions support program, a training and monitoring program for patients using ViroPharma’s Cinryze (C1 esterase inhibitor [human]) who wish to administer the drug themselves.

Cinryze is a drug administered via infusion for the treatment of hereditary angioedema, and the partnership will allow patients to receive training and follow-up support from SPNN nurses, as well as direction from their physicians.

November 30, 2010

A generic version of a drug indicated to treat attention deficit hyperactivity disorder has hit a roadblock.

HAYWARD, Calif. — A generic version of a drug indicated to treat attention deficit hyperactivity disorder has hit a roadblock.

November 30, 2010

The president of drug maker Merck now will fill an additional position at the company: CEO.

WHITEHOUSE STATION, N.J. — The president of drug maker Merck now will fill an additional position at the company: CEO.

Merck's board of directors elected president and board member Kenneth Frazier as the company's next leader, effective Jan. 1. Frazier will succeed Richard Clark, who has served as Merck's CEO since 2005. Clark will continue as chairman of the board, the drug maker said.

November 30, 2010

The Food and Drug Administration has granted market exclusivity for a generic version of a medication designed to treat indoor and outdoor allergies.

ALLEGAN, Mich. — The Food and Drug Administration has granted market exclusivity for a generic version of a medication designed to treat indoor and outdoor allergies.

Perrigo said Monday that its licensor and supplier Synthon received regulatory approval for levocetirizine tablets, a generic version of UCB/Sepracor's Xyzal, which is marketed in the United States by Sanofi-Aventis.

The levocetirizine tablet is the only approved generic product having a label containing all indications, Perrigo said.

November 30, 2010

The spate of recent product recalls may be eroding consumer confidence in the Food and Drug Administration, according to a PricewaterhouseCoopers survey of 1,000 Americans released Tuesday.

NEW YORK — The spate of recent product recalls may be eroding consumer confidence in the Food and Drug Administration, according to a PricewaterhouseCoopers survey of 1,000 Americans released Tuesday.

Approximately one-half of respondents reported they think the FDA does a good job, but more than one-third (36%) of U.S. consumers said they have lost confidence in the FDA over the past two years as a result of high profile safety concerns and product recalls.

November 30, 2010

Ranbaxy Pharmaceuticals has received final approval for its generic Alzheimer's drug from the Food and Drug Administration, giving the drug maker 180 days of market exclusivity.

GURGAON, India, and PRINCETON, N.J. — Ranbaxy Pharmaceuticals has received final approval for its generic Alzheimer's drug from the Food and Drug Administration, giving the drug maker 180 days of market exclusivity.

Ranbaxy Pharmaceuticals, a subsidiary of Ranbaxy Labs, will manufacture and market donepezil hydrochloride tablets, a generic version of Aricept, in the 5-mg and 10-mg strength in the United States.

November 30, 2010

Recent public perception that the Food and Drug Administration had not been doing its job — ensuring that Americans' approved medical devices and medicines are relatively safe — may be impeding fast approval processes, according to a new PricewaterhouseCoopers report published Tuesday.

NEW YORK — Recent public perception that the Food and Drug Administration had not been doing its job — ensuring that Americans' approved medical devices and medicines are relatively safe — may be impeding fast approval processes, according to a new PricewaterhouseCoopers report published Tuesday.

The report, “Improving America’s Health V,” determined that the FDA’s renewed vigor for enforcing regulations may be straining the working relationship between regulator and the industry being regulated.

November 29, 2010

The Food and Drug Administration has extended its review period for a multiple sclerosis drug made by EMD Serono, the drug maker said Friday.

ROCKLAND, Mass. — The Food and Drug Administration has extended its review period for a multiple sclerosis drug made by EMD Serono, the drug maker said Friday.

EMD Serono — the U.S. subsidiary of German drug maker Merck KGaA, which uses the name to avoid confusion with U.S.-based Merck — said the FDA had extended the review time for cladribine tablets to Feb. 28. The drug is a disease-modifying drug for relapsing MS.

November 29, 2010

Generic drug maker Impax Labs is challenging the patent covering a drug used to treat high cholesterol, the company said Friday.

HAYWARD, Calif. — Generic drug maker Impax Labs is challenging the patent covering a drug used to treat high cholesterol, the company said Friday.

Impax said it had filed an approval application with the Food and Drug Administration for niacin and simvastatin extended-release tablets in the 1,000 mg/20 mg strength. The drug is a generic version of Abbott Labs’ Simcor.

November 24, 2010

Most of the newly elected and re-elected Republican members of Congress, Tea Party candidates in particular, vowed to whittle down or repeal healthcare reform once in office, but the healthcare companies that stand to benefit hope to change their minds, as some of their lobbying activities last quarter have shown.

WHAT IT MEANS AND WHY IT'S IMPORTANT — Most of the newly elected and re-elected Republican members of Congress, Tea Party candidates in particular, vowed to whittle down or repeal healthcare reform once in office, but the healthcare companies that stand to benefit hope to change their minds, as some of their lobbying activities last quarter have shown.

(THE NEWS: Report: PhRMA's lobbying efforts total more than $5 million in Q3. For the full story, click here)

November 22, 2010

A generic drug maker has entered an agreement to purchase another drug maker's U.S. penicillin site ...

HYDERABAD, India A generic drug maker has entered an agreement to purchase another drug maker's U.S. penicillin site.

Dr. Reddy's and GlaxoSmithKline have inked a deal in which GSK will transfer ownership of its penicillin manufacturing site in Bristol, Tenn., and rights for the Augmentin and Amoxil brands in the United States to Dr. Reddy’s, an India-based drug maker.

This transaction is expected to close within the first half of calendar year 2011. Further financial terms and conditions of the agreement were not disclosed.

November 22, 2010

WOODCLIFF LAKE, N.J. Par Pharmaceutical has begun shipments of a generic treatment for asthma, the drug maker said Monday.

Par announced that it started shipping zafirlukast tablets in the 10-mg and 20-mg strengths. The drug is a generic version of AstraZeneca’s Accolate.

Accolate has sales of $50 million in the United States per year, according to IMS Health.

November 22, 2010

The pharmaceutical lobby spent more than $5 million lobbying the government during the third quarter ...

NEW YORK The pharmaceutical lobby spent more than $5 million lobbying the government during the third quarter, according to published reports.

Based on a filing with the government, BusinessWeek reported that the Pharmaceutical Research and Manufacturers of America spent $5.2 million lobbying on issues ranging from healthcare legislation to drug importation and marketing.

This compared with $6.8 million in third quarter 2009, according to the magazine.

November 21, 2010

Pfizer has extended the deadline of its $3.6 billion offer to buy King Pharmaceuticals, Pfizer...

NEW YORK Pfizer has extended the deadline of its $3.6 billion offer to buy King Pharmaceuticals, Pfizer said Monday.

 

Pfizer said it had extended its tender offer to Dec. 17 because certain conditions had not been met, but the two companies plan to have it finished by the end of this year or the beginning of next year.

 

 

King, based in Bristol, Tenn., specializes in branded opioid prescription painkillers.

 

November 21, 2010

Indian generic drug maker Dr. Reddy’s Labs has launched a version of an asthma drug...

HYDERABAD, India Indian generic drug maker Dr. Reddy’s Labs has launched a version of an asthma drug for the U.S. market, the company said.

Dr. Reddy’s announced the launch of zafirlukast tablets in the 10-mg and 20-mg strengths. The drug is a version of AstraZeneca’s Accolate, which had sales of $50 million during the 12-month period ended in August, according to IMS Health.

November 21, 2010

A drug maker will pull a common prescription painkiller from the market following the release...

SILVER SPRING, Md. A drug maker will pull a common prescription painkiller from the market following the release of clinical data that it could cause heart problems.

 

November 18, 2010

Johnson & Johnson and the U.S. government are suing two generic drug makers to stop...

NEW YORK — Johnson & Johnson and the U.S. government are suing two generic drug makers to stop them from launching a generic drug for HIV, according to published reports.

 

Bloomberg reported Thursday that Tibotec, a subsidiary of J&J, and the government were separately suing Mylan and Lupin over a generic version of the drug Prezista (darunavir ethanolate), alleging patent infringement.