Content about Pharmaceutical industry

November 6, 2012
Teva appoints new president and CEO for North American generics business

Teva Pharmaceutical Industries has made a few new executive appointments, the drug maker said Tuesday.

JERUSALEM — Teva Pharmaceutical Industries has made some new executive appointments, the drug maker said Tuesday.

Teva promoted Allan Oberman, currently SVP North America generic pharmaceuticals, to president and CEO of Teva Americas Generics. In the new role, Oberman will report directly to Teva president and CEO Jeremy Levin and have continued responsibility for generics in the North American market and overall management of the company's Latin American businesses.

November 5, 2012
NewsBytes — Chain Pharmacy, 11/5/12

The Food and Drug Administration has approved a generic drug for treating blood pressure and chest pain.

FDA approves cardiovascular drug

MORRISTOWN, N.J. — The Food and Drug Administration has approved a generic drug for treating blood pressure and chest pain. Actavis announced the approval of diltiazem hydrochloride extended-release capsules.
The drug is a generic version of Valeant’s Tiazac. The branded drug and its generic equivalents had sales of about $76.3 million in 2011, according to IMS Health.



November 5, 2012
Watson-Actavis latest among generic M&As

In what its president and CEO called a “significant milestone,” Watson Pharmaceuticals announced last month that the U.S. Federal Trade Commission and European Commission had approved its acquisition of Swiss generic drug maker Actavis.

In what its president and CEO called a “significant milestone,” Watson Pharmaceuticals announced last month that the U.S. Federal Trade Commission and European Commission had approved its acquisition of Swiss generic drug maker Actavis. Watson announced the $5.6 billion acquisition of Actavis in April, a deal that is expected to make Watson the third-largest generic drug maker in the world, after Teva Pharmaceutical Industries and Mylan.

November 1, 2012
Reports: Generic extended-release drugs to get more attention from FDA

Some generic drugs may come under more scrutiny from the Food and Drug Administration amid reports that the generic version of a treatment for depression didn't work as well as the branded version, according to published reports.

NEW YORK – Some generic drugs may come under more scrutiny from the Food and Drug Administration amid reports that the generic version of a treatment for depression didn't work as well as the branded version, according to published reports.

November 1, 2012
Watson to change brand in 2013

Watson Pharmaceuticals is changing its name to Actavis following its acquisition of the Swiss drug maker, Watson said.

 

PARSIPPANY, N.J. – Watson Pharmaceuticals is changing its name to Actavis following its acquisition of the Swiss drug maker, Watson said.

 

Watson, whose $5.6 billion acquisition of Actavis received approval from the Federal Trade Commission earlier this month, said it would adopt the new name starting in 2013, with plans to start a multi-year rebranding campaign and trade under a new symbol on the New York Stock Exchange.

 

October 31, 2012
Sandoz starts phase-3 trial of biosimilar anemia drug

Generic drug maker Sandoz has started a late-stage clinical trial in the United States for a biosimilar treatment for anemia, the company said.

HOLZKIRCHEN, Germany — Generic drug maker Sandoz has started a late-stage clinical trial in the United States for a biosimilar treatment for anemia, the company said.

Sandoz, the generics arm of Swiss drug maker Novartis, said it had started enrolling patients for a phase-3 study of epoetin alfa, a biosimilar version of Epogen and Procrit, made by Amgen and Johnson & Johnson and used to treat anemia associated with chronic kidney disease.

October 26, 2012
Novartis outsources production to bring back top-selling OTC brands to market

Progress at re-opening its manufacturing facility in Lincoln, Neb., has been slow-going, Novartis reported Thursday, but the company has contracted third-party manufacturers to resume production of Excedrin, Lamisil and Triaminic.

 BASEL, Switzerland — Progress at re-opening its manufacturing facility in Lincoln, Neb., has been slow-going, Novartis reported Thursday, but the company has contracted third-party manufacturers to resume production of Excedrin, Lamisil and Triaminic. First shipments to retailers were made in October. 

October 25, 2012
FDA approves Par leukemia drug

The Food and Drug Administration has approved a generic drug for leukemia made by a subsidiary of Par Pharmaceutical Cos.

WOODCLIFF LAKE, N.J. — The Food and Drug Administration has approved a generic drug for leukemia made by a subsidiary of Par Pharmaceutical Cos.

Par said Thursday that the FDA had approved Anchen Pharmaceuticals' tretinoin capsules in the 10-mg strength.

The drug is a generic version of Roche's Vesanoid, various versions of which have annual sales of about $29 million, according to IMS Health.

October 25, 2012
FDA declines approval of United Therapeutics PAH drug

The Food and Drug Administration has declined to approve a drug developed by United Therapeutics Corp. for treating a potentially lethal high blood pressure condition.

SILVER SPRING, Md. — The Food and Drug Administration has declined to approve a drug developed by United Therapeutics Corp. for treating a potentially lethal high blood pressure condition.

The drug maker said it received a complete response letter from the agency for its application for a tablet formulation of the drug treprostinil. The company already markets the drug in injectable and inhaled formulations for pulmonary arterial hypertension, or PAH, a condition that causes high blood pressure in the arteries of the lungs.

October 23, 2012
Federal court orders FDA to allow Watson diabetes drug launch

A federal court has ordered the Food and Drug Administration to approve a generic diabetes drug made by Watson Pharmaceuticals, the drug maker said.

PARSIPPANY, N.J. — A federal court has ordered the Food and Drug Administration to approve a generic diabetes drug made by Watson Pharmaceuticals, the drug maker said.

Watson said the U.S. District Court for the District of Columbia granted summary judgment in favor of Watson, ruling that the FDA would have to approve its generic version of Takeda's Actos (pioglitazone hydrochloride) tablets in the 15-mg, 30-mg and 45-mg strengths.

October 23, 2012
United Therapeutics awaits FDA decision on oral PAH drug as Sandoz seeks generic approval

The Food and Drug Administration is expected to decide at the end of this week whether to approve a new oral drug for pulmonary arterial hypertension made by United Therapeutics.

NEW YORK — The Food and Drug Administration is expected to decide at the end of this week whether to approve a new oral drug for pulmonary arterial hypertension made by United Therapeutics.

October 19, 2012
HDMA Factbook: 2011 health product sales reach $294 billion

Healthcare product sales through the nation’s primary healthcare distributors hit a record high of $294 billion in 2011, according to the 2012-2013 HDMA Factbook released Friday.

ARLINGTON, Va. — Healthcare product sales through the nation’s primary healthcare distributors hit a record high of $294 billion in 2011, according to the 2012-2013 HDMA Factbook released Friday. Specifically, pharmaceutical products moved by distributors represent approximately 90% of sales in the United States.

October 18, 2012
FDA approves generic Lupin contraceptive

The Food and Drug Administration has approved a generic contraceptive made by Indian drug maker Lupin, the company said Thursday.

MUMBAI, India — The Food and Drug Administration has approved a generic contraceptive made by Indian drug maker Lupin, the company said Thursday.

Lupin announced the approval of Kurvelo (levonorgestrel and ethinyl estradiol) tablets in the 0.15 mg/0.03 mg strength.

The drug is a generic version of Teva's branded Nordette. Nordette had sales of about $59 million during the 12-month period ended in June, according to IMS Health.

October 17, 2012
FDA accepts regulatory filing for Depomed drug

The Food and Drug Administration has accepted a regulatory approval application for a drug for hot flashes from Depomed, the drug maker said.

MENLO PARK, Calif. — The Food and Drug Administration has accepted a regulatory approval application for a drug for hot flashes from Depomed, the drug maker said.

Depomed submitted its application to the FDA for Serada (gabapentin), an extended-release drug for hot flashes in menopausal women.

October 16, 2012
FTC approves Watson-Actavis merger

The Federal Trade Commission has voted to approve Watson Pharmaceutical's acquisition of Switzerland-based generic drug maker Actavis.

PARSIPPANY, N.J. – The Federal Trade Commission has voted to approve Watson Pharmaceutical's acquisition of Switzerland-based generic drug maker Actavis.

The unanimous vote in support of the merger follows Watson's agreement to divest a number of marketed and pipeline products to Par Pharmaceutical and Sandoz as a condition to obtaining FTC approval.

October 16, 2012
Par to acquire 14 generics

Par Pharmaceutical Cos. has entered into agreements with Watson Pharmaceuticals and Actavis to purchase five generic products currently marketed in the United States by Watson or Actavis, eight abbreviated new drug applications currently awaiting regulatory approval, and a generic product in late-stage development.

WOODCLIFF LAKE, N.J. — Par Pharmaceutical Cos. has entered into agreements with Watson Pharmaceuticals and Actavis to purchase five generic products currently marketed in the United States by Watson or Actavis, eight abbreviated new drug applications currently awaiting regulatory approval, and a generic product in late-stage development.

October 16, 2012
The essential value of HIEs in delivering patient-centered pharmacy care

Emerging multidisciplinary healthcare models, such as accountable care organizations and patient-centered medical homes, promise to elevate quality and lower costs by harnessing the power of provider, payer and patient collaboration. Often overlooked in the coordinated care equation, however, is the integral role pharmacists can play in delivering efficient and effective care.

Emerging multidisciplinary healthcare models, such as accountable care organizations and patient-centered medical homes, promise to elevate quality and lower costs by harnessing the power of provider, payer and patient collaboration. Often overlooked in the coordinated care equation, however, is the integral role pharmacists can play in delivering efficient and effective care.

October 15, 2012
FDA could consider faster approvals for some drugs

The Food and Drug Administration may be willing to speed up trials for drugs that could be a big benefit to society despite their risks.

SILVER SPRING, M.D. — The Food and Drug Administration may be willing to speed up trials for drugs that could be a big benefit to society despite their risks.

According to several published reports, FDA commissioner Margaret Hamburg recently told a group of scientific advisers that the agency is considering allowing makers of drugs having a societal benefit to conduct faster clinical trials with a smaller group of patients than is now required.

October 12, 2012
FDA approves Sandoz dermatology drug

The Food and Drug Administration has approved a drug made by Sandoz for treating symptoms of various skin diseases.

PRINCETON, N.J. — The Food and Drug Administration has approved a drug made by Sandoz for treating symptoms of various skin diseases.

Sandoz, the generics arm of Swiss drug maker Novartis, announced the approval of desoximetasone ointment in the 0.25% strength. The drug is a generic version of Taro Pharmaceutical Industries' Topicort and, according to Sandoz, is the first Fougera dermatology product Sandoz has launched since its $1.5 billion acquisition of the company in May 2012.

October 11, 2012
Merck KGaA to donate $1.3 million per year to academic MS research

A German drug maker is pledging millions of dollars for multiple sclerosis research, the company's U.S. subsidiary said Thursday.

ROCKLAND, Mass. — A German drug maker is pledging millions of dollars for multiple sclerosis research, the company's U.S. subsidiary said Thursday.

October 10, 2012
FDA approves generic cardiovascular drug

The Food and Drug Administration has approved a generic drug for treating blood pressure and chest pain.

MORRISTOWN, N.J. — The Food and Drug Administration has approved a generic drug for treating blood pressure and chest pain.

Actavis announced Wednesday the approval of diltiazem hydrochloride extended-release capsules.

The drug is a generic version of Valeant's Tiazac. The branded drug and its generic equivalents had sales of about $76.3 million in 2011, according to IMS Health.

October 10, 2012
GPhA appoints CVS Caremark public policy director

An executive from CVS Caremark will guide policy for a generic drug industry trade association.

WASHINGTON — An executive from CVS Caremark will guide policy for a generic drug industry trade association.

The Generic Pharmaceutical Association said Wednesday that it had appointed CVS Caremark senior director of public policy Christine Simmon to run its policy shop as SVP policy and strategic alliances, effective Oct. 24. Christine Simmon previously worked for the GPhA as VP policy, public affairs and development from 2002 to 2006.

October 10, 2012
Mylan settles suit over asthma, allergy drug

Mylan has settled a patent infringement suit over a drug used to treat respiratory diseases, Mylan said.

PITTSBURGH — Mylan has settled a patent infringement suit over a drug used to treat respiratory diseases, Mylan said.

The generic drug maker said it resolved a patent litigation suit filed by Shionogi and Cima Labs over prednisolone sodium phosphate orally disintegrating tablets, a generic version of Orapred ODT. Mylan is hoping to market its generic version of the drug in the 10-mg, 15-mg and 30-mg strengths. The drug is used to treat asthma and certain allergic conditions.

October 9, 2012
NCPA survey challenges MAC, audits

Abusive auditing and unfair reimbursement practices harm community pharmacists’ ability to provide critically needed patient counseling and care to seniors, according to a new survey released Sept. 18 by the National Community Pharmacists Association.


Abusive auditing and unfair reimbursement practices harm community pharmacists’ ability to provide critically needed patient counseling and care to seniors, according to a new survey released Sept. 18 by the National Community Pharmacists Association.


NCPA polled more than 350 community pharmacists about their recent experience with audits conducted by pharmacy benefit managers and other Medicare Part D plan intermediaries. The survey also asked about generic drug reimbursement caps known as maximum allowable costs, or MACs. 


Among the findings:


October 9, 2012
NewsBytes — Chain Pharmacy, 10/15/12

Drug maker Dr. Reddy’s Labs has launched a generic antibiotic drug, the company said. The India-based company announced the launch of amoxicillin tablets, capsules and oral suspension.

Dr. Reddy's launches antibiotics