Content about Branded

January 5, 2011

A generic version of the world’s top-selling cholesterol treatment is expected to hit the market this year, but the branded version’s manufacturer is trying to put the brakes on the launch, according to media reports.

NEW YORK — A generic version of the world’s top-selling cholesterol treatment is expected to hit the market this year, but the branded version’s manufacturer is trying to put the brakes on the launch, according to media reports.

Gurgaon, India-based Ranbaxy Labs plans to launch its version of Pfizer’s cholesterol-lowering drug Lipitor (atorvastatin) in the United States in November and will receive six months’ market exclusivity in which to compete directly against Pfizer’s version, under the terms of the Hatch-Waxman Act of 1984.

January 4, 2011

The Food and Drug Administration has approved a topical testosterone replacement therapy made by Endo Pharmaceuticals, Endo said last week.

CHADDS FORD, Pa. — The Food and Drug Administration has approved a topical testosterone replacement therapy made by Endo Pharmaceuticals, Endo said last week.

The drug maker announced on Dec. 29 the approval of Fortesta (testosterone) gel, a treatment for men with low testosterone, which affects nearly 14 million men in the United States.

Endo said it planned to introduce Fortesta in the United States early this year.

January 4, 2011

Pfizer will pay Danish biotech company Santaris Pharma $14 million for access to its development platform for RNA-based therapies, Pfizer said Tuesday.

SAN DIEGO — Pfizer will pay Danish biotech company Santaris Pharma $14 million for access to its development platform for RNA-based therapies, Pfizer said Tuesday.

The drug maker said the deal would expand on an existing one between Hoersholm, Denmark-based Santaris and Wyeth, which Pfizer acquired in 2009. Santaris could take in up to $600 million in milestone payments, as well as royalties on products developed under the collaboration.

January 3, 2011

This past year saw a lower-than-usual number of new drugs approved by the Food and Drug Administration, due in part to delays at the agency, according to published reports.

NEW YORK — This past year saw a lower-than-usual number of new drugs approved by the Food and Drug Administration, due in part to delays at the agency, according to published reports.

The Wall Street Journal reported that 21 new drugs were approved through the year, compared with 25 in 2009 and 24 in 2008. The lag came in part due to stricter safety regulations, the newspaper reported.

January 3, 2011

Former president George W. Bush will deliver the keynote speech at Armada Health Care’s seventh annual Armada Specialty Pharmacy Summit, the specialty pharmacy contracting organization said.

FLORHAM PARK, N.J. — Former president George W. Bush will deliver the keynote speech at Armada Health Care’s seventh annual Armada Specialty Pharmacy Summit, the specialty pharmacy contracting organization said.

The conference, which will take place May 10 to 13 at the Wynn Hotel in Las Vegas, is considered one of the top conferences in the U.S. drug industry.

January 3, 2011

The Food and Drug Administration has approved an update to the label of a Johnson & Johnson drug for HIV, the company said Monday.

TITUSVILLE, N.J. — The Food and Drug Administration has approved an update to the label of a Johnson & Johnson drug for HIV, the company said Monday.

Tibotec Therapeutics, a subsidiary of J&J, said the FDA approved a 200-mg formulation of Intelence (etravirine) for treating HIV in patients who have taken previous treatments and whose virus has become resistant to antiretroviral drugs.

December 29, 2010

Recent news that the FDA has rejected Teva's application for a new lower-dose version of multiple sclerosis drug Copaxone likely will hold off the emergence of a generic version of the drug.

NEW YORK — One door closes; another door, well, closes. And that appears to be good news for Teva. Recent news that the Food and Drug Administration has rejected the drug maker's application for a new indication for multiple sclerosis drug Copaxone likely will mean the agency will not be so quick to approve a generic version of the drug without requiring a generic company to perform full clinical trials.

December 23, 2010

Cephalon on Thursday appointed Kevin Buchi as CEO and a member of the company's board.

FRAZER, Pa. — Cephalon on Thursday appointed Kevin Buchi as CEO and a member of the company's board.

December 23, 2010

Merck on Wednesday announced that the Food and Drug Administration has approved Gardasil [human papillomavirus quadrivalent (types 6, 11, 16 and 18) vaccine, recombinant] for the prevention of anal cancer in males and females 9 to 26 years of age.

WHITEHOUSE STATION, N.J. — Merck on Wednesday announced that the Food and Drug Administration has approved Gardasil [human papillomavirus quadrivalent (types 6, 11, 16 and 18) vaccine, recombinant] for the prevention of anal cancer in males and females 9 to 26 years of age.

According to the company, Gardasil is the first HPV vaccine on the market available for use in both men and women, and the only one indicated  to help prevent cervical, vaginal, vulvar and anal cancers and pre-cancers, as well as genital warts, caused by certain types of HPV.

December 23, 2010

The Food and Drug Administration on Wednesday approved Novartis Pharmaceuticals’ Amturnide (aliskiren, amlodipine and hydrochlorothiazide) tablets for the treatment of high blood pressure, according to the pharma company.

EAST HANOVER, N.J. — The Food and Drug Administration on Wednesday approved Novartis Pharmaceuticals’ Amturnide (aliskiren, amlodipine and hydrochlorothiazide) tablets for the treatment of high blood pressure, according to the pharma company. 

Amturnide combines the only approved direct rennin inhibitor worldwide, Tekturna (aliskiren), with the widely used calcium channel blocker amlodipine and the diuretic hydrochlorothiazide (HCTZ).

December 23, 2010

The Food and Drug Administration has approved the first and only low-dose oral contraceptive to combine 0.8-mg norethindrone and 0.025-mg ethinyl estradiol in a chewable form, with four 75-mg ferrous fumarate (iron) placebo tablets, Watson Pharmaceuticals has announced.

MORRISTOWN, N.J. — The Food and Drug Administration has approved the first and only low-dose oral contraceptive to combine 0.8-mg norethindrone and 0.025-mg ethinyl estradiol in a chewable form, with four 75-mg ferrous fumarate (iron) placebo tablets, Watson Pharmaceuticals has announced.

Watson's new oral contraceptive is positioned as a novel alternative to currently available birth control pills, and the dosing combination and 24-day active hormone regimen is intended to provide users with a low level of breakthrough bleeding and short, light, predictable periods.

December 22, 2010

Takeda and its subsidiary settled the patent suits it brought against generic drug makers that sought to develop their own versions of its diabetes treatment.

DEERFIELD, Ill., and OSAKA, Japan — Takeda and its subsidiary settled the patent suits it brought against generic drug makers that sought to develop their own versions of its diabetes treatment.

December 21, 2010

Abbott has made a pact with a biopharmaceutical company to develop new cancer treatments by making small-molecule inhibitors.

ABBOTT PARK, Ill. — Abbott has made a pact with a biopharmaceutical company to develop new cancer treatments by making small-molecule inhibitors.

Under the terms of the agreement, Abbott will provide EpiTherapeutics with an up-front payment and will receive funding of research activities conducted at EpiTherapeutics. The biopharmaceutical company also is eligible, under certain conditions, to receive milestone payments as well as potential royalties on future revenues.

December 21, 2010

An Anglo-Swedish drug maker said it is discontinuing further development of a drug that is designed to prevent a respiratory virus that infects the lungs and breathing passages.

LONDON — An Anglo-Swedish drug maker said it is discontinuing further development of a drug that is designed to prevent a respiratory virus that infects the lungs and breathing passages.

AstraZeneca has requested the withdrawal of its pending biological license application for motavizumab from the Food and Drug Administration. Motavizumab is an investigational monoclonal antibody that could prevent serious respiratory syncytial virus disease.

AstraZeneca said it will incur a financial impairment charge of $445 million in fourth quarter 2010.

December 21, 2010

In a deal that will bolster its drug development capabilities, Biogen Idec has acquired a subsidiary of Swiss-based Neurimmune Holding AG.

WESTON, Mass. and ZURICH — In a deal that will bolster its drug development capabilities, Biogen Idec has acquired a subsidiary of Swiss-based Neurimmune Holding AG.

Among other assets, the agreement gives Biogen the worldwide rights to three preclinical immunotherapy programs. The three programs are focused on the discovery and development of novel human antibodies that address three central nervous system targets: alpha-synuclein, tau and TDP-43.

December 21, 2010

A judge recently blocked AstraZeneca from attempting to impede the development of generic versions of its popular cholesterol drug, according to published reports.

NEW YORK — A judge recently blocked AstraZeneca from attempting to impede the development of generic versions of its popular cholesterol drug, according to published reports.

December 21, 2010

One month after announcing it would acquire a leader in molecular imaging development, Eli Lilly announced it has completed its acquisition of Avid Radiopharmaceuticals.

INDIANAPOLIS — One month after announcing it would acquire a leader in molecular imaging development, Eli Lilly announced it has completed its acquisition of Avid Radiopharmaceuticals.

December 21, 2010

A biopharmaceutical company exclusively will develop and commercialize oral formulations of a drug maker's insulins.

PRINCETON, N.J. — A biopharmaceutical company exclusively will develop and commercialize oral formulations of a drug maker's insulins.

Emisphere will be paid $57.5 million in potential product development and sales milestone payments by Novo Nordisk — of which $5 million dollars will be payable upon signing — as well as royalties on sales. Further financial details of the agreement were not disclosed.

December 21, 2010

Pfizer on Monday announced that it intends to recall one lot — approximately 19,000 bottles — of Lipitor 40-mg tablets (atorvastatin calcium) distributed in the United States because of one customer’s report of an uncharacteristic odor related to the bottles in which these lots of Lipitor were packaged.

NEW YORK — Pfizer on Monday announced that it intends to recall one lot — approximately 19,000 bottles — of Lipitor 40-mg tablets (atorvastatin calcium) distributed in the United States because of one customer’s report of an uncharacteristic odor related to the bottles in which these lots of Lipitor were packaged.

The bottles were supplied by a third-party bottle manufacturer. A medical assessment found that the risk of health consequences to patients appears to be minimal, Pfizer reported.

December 21, 2010

A healthcare accrediting organization is revising three products in its Pharmacy Quality Management suite of programs.

WASHINGTON — A healthcare accrediting organization is revising three products in its Pharmacy Quality Management suite of programs.

URAC said its pharmacy committee approved revisions to its mail service, specialty pharmacy, and workers' compensation and property and casualty for pharmacy benefit management accreditation programs. The products revised include:

  • Mail-service pharmacy, version 2.0;

  • Specialty pharmacy, version 2.0; and

December 20, 2010

Manchester College has received a $35 million grant from the Lilly Endowment to launch a new school of pharmacy.

FORT WAYNE, Ind. — Manchester College has received a $35 million grant from the Lilly Endowment to launch a new school of pharmacy.

Manchester College, a college of 1,278 students affiliated with the Church of the Brethren and based in North Manchester, Ind., said the grant would allow it to develop its first doctoral program on a campus in the nearby city of Fort Wayne, Ind. The Lilly Endowment was founded in 1937 with stock in Indianapolis-based drug maker Eli Lilly.

December 20, 2010

Valeant Pharmaceuticals' former SVP and corporate controller has been appointed to the role of interim CFO.

MISSISSAUGA, Ontario — Valeant Pharmaceuticals' former SVP and corporate controller has been appointed to the role of interim CFO.

Philip Loberg immediately replaces the drug maker's current CFO, Peggy Mulligan. The company has initiated a search to identify a permanent replacement.

December 17, 2010

The Food and Drug Administration has approved a new oral contraceptive developed by Bayer.

WAYNE, N.J. — The Food and Drug Administration has approved a new oral contraceptive developed by Bayer.

Safyral is a combination of Yasmin, also developed by Bayer, with 451 mcg levomefolate calcium, which is a B vitamin known as a folate. It is the second oral contraceptive from Bayer that features folate.

December 17, 2010

The Food and Drug Administration has turned down AstraZeneca’s regulatory approval application for a drug to treat heart disease, the drug maker said.

WILMINGTON, Del. — The Food and Drug Administration has turned down AstraZeneca’s regulatory approval application for a drug to treat heart disease, the drug maker said.

The agency sent AstraZeneca a complete response letter requesting additional analyses of data from a clinical study of Brilinta (ticagrelor), but did not request additional studies. The drug is designed to treat acute coronary syndromes.

A complete response letter means that the FDA has completed its review of a drug application, but issues remain that preclude final approval.

December 17, 2010

Frank Baldino, the founder, chairman and CEO of Cephalon, has died, the company said.

FRAZER, Pa. — Frank Baldino, the founder, chairman and CEO of Cephalon, has died, the company said.

Cephalon announced that Baldino, 57, had died Thursday evening while on medical leave, calling him a pioneer in the biotechnology industry and an inspirational leader who would be “sorely missed.” Baldino, who received his doctorate in pharmacology from Temple University, founded the company in 1987 after several years at E.I. duPont de Nemours & Co.