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November 8, 2011

The Food and Drug Administration on Tuesday launched a website for patients and caregivers on the safe disposal of needles and other “sharps” that are used at home, at work and while traveling.

SILVER SPRING, Md. — The Food and Drug Administration on Tuesday launched a website for patients and caregivers on the safe disposal of needles and other “sharps” that are used at home, at work and while traveling.

November 8, 2011

Eli Lilly and Amylin Pharmaceuticals are ending their diabetes-drug alliance, the two companies said Tuesday.

SAN DIEGO — Eli Lilly and Amylin Pharmaceuticals are ending their diabetes-drug alliance, the two companies said Tuesday.

Indianapolis-based Lilly and San Diego-based Amylin said they would terminate their alliance concerning exenatide, the active ingredient in the injected diabetes drug Byetta and its long-acting version, Bydureon, currently under investigation.

November 8, 2011

Purdue Pharma has launched a new way for fighting pharmacy crime, the drug maker said Tuesday.

STAMFORD, Conn. — Purdue Pharma has launched a new way for fighting pharmacy crime, the drug maker said Tuesday.

November 7, 2011

The Food and Drug Administration has appointed a new chief of staff for commissioner Margaret Hamburg, according to a letter sent to agency employees Monday.

SILVER SPRING, Md. — The Food and Drug Administration has appointed a new chief of staff for commissioner Margaret Hamburg, according to a letter sent to agency employees Monday.

In the letter, Hamburg announced the appointment of Lisa Barclay. Barclay, currently a partner at the Washington law firm Zuckerman Spaeder, will replace Molly Muldoon, who was previously chief of staff and more recently the agency's acting COO.

November 7, 2011

The Food and Drug Administration has approved a drug made by Johnson & Johnson for preventing stroke in patients with abnormal heart rhythm, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Johnson & Johnson for preventing stroke in patients with abnormal heart rhythm, the agency said.

The agency announced Friday the approval of Xarelto (rivaroxaban), an anti-clotting made by J&J subsidiary Janssen Pharmaceuticals, in patients with non-valvular atrial fibrillation. The FDA approved the drug in the 10-mg strength in July for deep-vein thrombosis in patients receiving knee and hip replacement surgery. The latest approval includes 15-mg and 20-mg strengths.

November 7, 2011

Sentinel Capital Partners has acquired Sarasota, Fla.-based WellSpring Pharmaceutical, the private equity firm said Monday.

NEW YORK — Sentinel Capital Partners has acquired Sarasota, Fla.-based WellSpring Pharmaceutical, the private equity firm said Monday.

Sentinel, which describes itself as investing in lower middle-market companies, said it bought the manufacturer of prescription and OTC drugs, which manufactures its products in Ontario, alongside Ancor Capital Partners. Financial terms of the deal were not disclosed.

November 4, 2011

In the classic “Arabian Nights” tale of Aladdin and his magic lamp, the evil sorcerer who made Aladdin retrieve the lamp containing the genie attempts to get it back by tricking Aladdin’s wife into giving it to him by roaming through the streets offering to trade “new lamps for old.”


In the classic “Arabian Nights” tale of Aladdin and his magic lamp, the evil sorcerer who made Aladdin retrieve the lamp containing the genie attempts to get it back by tricking Aladdin’s wife into giving it to him by roaming through the streets offering to trade “new lamps for old.”


November 4, 2011

The Food and Drug Administration has cleared the way for the return to market of a drug for treating immunodeficiency diseases following its recall by the manufacturer in response to patients developing internal blood clots.

HOBOKEN, N.J. — The Food and Drug Administration has cleared the way for the return to market of a drug for treating immunodeficiency diseases following its recall by the manufacturer in response to patients developing internal blood clots.

November 3, 2011

Drug maker Bristol-Myers Squibb will present 20 study abstracts at the American College of Rheumatology Annual Scientific Meeting in Chicago, the company said Thursday.

NEW YORK — Drug maker Bristol-Myers Squibb will present 20 study abstracts at the American College of Rheumatology Annual Scientific Meeting in Chicago, the company said Thursday.

Bristol said that of those, 18 contain new data from studies of Orencia (abatacept) in patients with rheumatoid arthritis or lupus nephritis.

November 3, 2011

The Food and Drug Administration has approved 35 new drugs over the past 12 months, the agency said Thursday.

SILVER SPRING, Md. — The Food and Drug Administration has approved 35 new drugs over the past 12 months, the agency said Thursday.

November 3, 2011

Novo Nordisk has donated $50,000 to an organization that raises awareness about diabetes and connects people living with it, the Danish drug maker said.

PRINCETON, N.J. — Novo Nordisk has donated $50,000 to an organization that raises awareness about diabetes and connects people living with it, the Danish drug maker said.

The company said the donation, to the Diabetes Hands Foundation, was meant to recognize the Drive the Switch program, which it said had motivated more than 10,000 people to pledge to talk to loved ones and their doctors about insulin options.

November 2, 2011

The Food and Drug Administration has approved changes to the labeling of a cancer drug made by Takeda Pharmaceuticals, the drug maker said.

CAMBRIDGE, Mass. — The Food and Drug Administration has approved changes to the labeling of a cancer drug made by Takeda Pharmaceuticals, the drug maker said.

Takeda and Millennium, the Japanese drug maker's cancer-drug subsidiary, announced Tuesday that the FDA approved a supplemental new drug application for the injectable multiple myeloma drug Velcade (bortezomib) that updates its label to include additional data from a clinical study showing that the drug extended patients' survival time.

November 2, 2011

Drug maker Perrigo has filed for regulatory approval of a generic topical drug for treating testosterone deficiency, prompting a patent infringement suit from the branded version's manufacturer.

ALLEGAN, Mich. — Drug maker Perrigo has filed for regulatory approval of a generic topical drug for treating testosterone deficiency, prompting a patent infringement suit from the branded version's manufacturer.

November 2, 2011

It's official. Pfizer will be exploring a potential switch of its blockbuster lipid-lowering drug Lipitor (atorvastatin calcium).

NEW YORK — It's official. Pfizer will be exploring a potential switch of its blockbuster lipid-lowering drug Lipitor (atorvastatin calcium).

November 1, 2011

Pfizer soon may lose its distinction of having the highest global sales of any drug company, according to life sciences industry analysis firm EvaluatePharma.

LONDON — Pfizer soon may lose its distinction of having the highest global sales of any drug company, according to life sciences industry analysis firm EvaluatePharma.

The next contender for the title is France's Sanofi, which EvaluatePharma said was expected to take the top spot next year and stay there through 2016.

October 31, 2011

A Johnson & Johnson subsidiary has sent a regulatory application to the Food and Drug Administration seeking approval for one of its drugs in treating diabetes-related pain.

TITUSVILLE, N.J. — A Johnson & Johnson subsidiary has sent a regulatory application to the Food and Drug Administration seeking approval for one of its drugs in treating diabetes-related pain.

October 31, 2011

President Barack Obama issued an executive order Monday to address the growing problem of drug shortages.

WASHINGTON — President Barack Obama issued an executive order Monday to address the growing problem of drug shortages.

October 31, 2011

Select Walgreens across the country will offer free blood-glucose testing during National Diabetes Month this November, Walgreens announced Monday.

DEERFIELD, Ill. — Select Walgreens across the country will offer free blood-glucose testing during National Diabetes Month this November, Walgreens announced Monday.

October 28, 2011

The Food and Drug Administration has approved a supplemental new drug application related to a drug made by Abbott, the company said.

ABBOTT PARK, Ill. — The Food and Drug Administration has approved a supplemental new drug application related to a drug made by Abbott, the company said.

October 28, 2011

Icagen officially is a wholly owned subsidiary of Pfizer.

NEW YORK — Icagen officially is a wholly owned subsidiary of Pfizer.

As part of the transaction, which first was announced in July, Icagen now will be part of Pfizer’s worldwide research and development organization and also will be integrated into Neusentis, Pfizer’s pain, sensory disorders and regenerative medicine research unit.

The aggregate transaction value, which includes the value of the shares that already were owned by Pfizer, was about $56 million.

October 27, 2011

Drug makers Bristol-Myers Squibb and Gilead Sciences announced an agreement to develop and commercialize a fixed-dose combination treatment for patients with HIV.

FOSTER CITY, Calif. — Drug makers Bristol-Myers Squibb and Gilead Sciences announced an agreement to develop and commercialize a fixed-dose combination treatment for patients with HIV.

The two companies said the drug will combine Bristol's Reyataz (atazanavir sulfate) and Gilead's boosting agent cobicistat, which is designed to increase blood levels of certain HIV medicines to potentially allow for one-pill, once-daily dosing. Gilead is currently studying Reyataz and cobicistat in phase-2 and phase-3 trials.

October 27, 2011

An experimental vaccine for hepatitis B made by Dynavax Technologies appears to work better in patients with diabetes than current treatments, the company said.

BERKELEY, Calif. — An experimental vaccine for hepatitis B made by Dynavax Technologies appears to work better in patients with diabetes than current treatments, the company said.

October 25, 2011

An advisory committee of the Centers for Disease Control and Prevention is recommending that all boys ages 11 and 12 years old get vaccinated against human papillomavirus, the CDC said Tuesday.

ATLANTA — An advisory committee of the Centers for Disease Control and Prevention is recommending that all boys ages 11 and 12 years old get vaccinated against human papillomavirus, the CDC said Tuesday.

The agency said the Advisory Committee on Immunization Practices voted for recommending routine vaccination of boys with three doses of HPV4 to protect against the virus. The vaccination is able to prevent such HPV-related conditions as cancer and prevent the spread of the virus to sexual partners. The recommendation is still subject to the CDC's approval, the agency said.

October 25, 2011

Eli Lilly is withdrawing one of its drugs from the market after clinical trials showed it to be ineffective.

INDIANAPOLIS — Eli Lilly is withdrawing one of its drugs from the market after clinical trials showed it to be ineffective.

The drug maker announced Tuesday the withdrawal of Xigris (drotrecogin alfa [activated]) from all markets following results of the "PROWESS-SHOCK" study, which found that it did not produce a statistically significant reduction in 28-day, all-cause death in patients with septic shock. The company said there were no new findings regarding the drug's safety profile.

October 24, 2011

A drug made by Coria Labs for treating acne now is available in a convenient, ready-to-use pump, the drug maker said Monday.

BRIDGEWATER, N.J. — A drug made by Coria Labs for treating acne now is available in a convenient, ready-to-use pump, the drug maker said Monday.

Coria announced the availability of the Acanya Gel (clindamycin phosphate and benzoyl peroxide) pump in the 1.2%/2.5% strength for acne vulgarism.

The drug is the only Food and Drug Administration-approved once-daily combination of an antibiotic and benzoyl peroxide for treating inflammatory and non-inflammatory acne, the company said.