Content about Branded

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.

October 24, 2011

The Food and Drug Administration has approved a new drug for treating a severe form of epilepsy, the agency said Monday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating a severe form of epilepsy, the agency said Monday.

The FDA announced the approval of Onfi (clobazam) tablets, made by Catalent Pharma Solutions and Lundbeck, as an add-on treatment for seizures associated with Lennox-Gastaut syndrome in patients ages 2 years and older. The agency gave the drug orphan drug designation because the disease affects fewer than 200,000 people in the United States.

October 24, 2011

More than three-quarters of patients with multiple sclerosis using a drug made by Sanofi subsidiary Genzyme did not experience disease relapse for two years, according to results of a late-stage clinical trial revealed over the weekend.

CAMBRIDGE, Mass. — More than three-quarters of patients with multiple sclerosis using a drug made by Sanofi subsidiary Genzyme did not experience disease relapse for two years, according to results of a late-stage clinical trial revealed over the weekend.

The drug maker announced Saturday results of the "CARE-MS I" trial, the first of two phase-3 clinical trials comparing the investigational drug Lemtrada (alemtuzumab) with Pfizer's and EMD Serono's Rebif (interferon beta-1a) in patients with relapsing-remitting MS.

October 21, 2011

More than 1-in-10 Americans ages 12 years and older take antidepressants, and the rate of antidepressant use in the United States among all ages increased 400% between 1988 and 2008, according to a new report by the Centers for Disease Control and Prevention's National Center for Health Statistics.

ATLANTA — More than 1-in-10 Americans ages 12 years and older take antidepressants, and the rate of antidepressant use in the United States among all ages increased 400% between 1988 and 2008, according to a new report by the Centers for Disease Control and Prevention's National Center for Health Statistics.

October 21, 2011

The Food and Drug Administration has approved a new formulation of a testosterone therapy made by Watson Pharmaceuticals, the drug maker said Friday.

PARSIPPANY, N.J. — The Food and Drug Administration has approved a new formulation of a testosterone therapy made by Watson Pharmaceuticals, the drug maker said Friday.

Watson announced the approval of its Androderm (testosterone) transdermal system in the 2-mg and 4-mg formulation. The company said the new smaller size and lower-dose patch would provide "highly effective" testosterone administration with a 20% reduction in the active ingredient from the original strength. Watson plans to launch the new patch next month.

October 21, 2011

Two senators are trying to get the Joint Select Committee on Deficit Reduction to take up a bill that would ban so-called "pay-for-delay" patent settlements between brand and generic drug companies, according to published reports.

WASHINGTON — Two senators are trying to get the Joint Select Committee on Deficit Reduction to take up a bill that would ban so-called "pay-for-delay" patent settlements between brand and generic drug companies, according to published reports.

The Pharma Letter reported that Sens. Herb Kohl, D-Wis., and Chuck Grassley, R-Iowa, had urged the "super committee" to support a bill that would ban settlements that include any form of payment in exchange for holding off launch of a generic drug.

October 21, 2011

Sanofi Pasteur, the vaccines division of Sanofi, released data from a new study examining the ability of its Fluzone High-Dose vaccine to provoke an immune response in elderly and younger adults, compared with a standard dose of Fluzone vaccine.

SWIFTWATER, Pa. — Sanofi Pasteur, the vaccines division of Sanofi, released data from a new study examining the ability of its Fluzone High-Dose vaccine to provoke an immune response in elderly and younger adults, compared with a standard dose of Fluzone vaccine.

"The results further support the immunogenicity advantages of Fluzone High-Dose vaccine as compared to Fluzone vaccine, the standard dose comparator, in seniors 65 years of age and older," stated Peter Tsang, director clinical development, Sanofi Pasteur.

October 21, 2011

Walgreens and Novo Nordisk are working with Sharps Compliance to offer Sharps' Complete Needle Collection & Disposal System for customers who use injectable drugs.

HOUSTON — Walgreens and Novo Nordisk are working with Sharps Compliance to offer Sharps' Complete Needle Collection & Disposal System for customers who use injectable drugs.

October 20, 2011

Former Bristol-Myers Squibb executive Anthony Hooper has joined Amgen as EVP global commercial operations.

THOUSAND OAKS, Calif. — Former Bristol-Myers Squibb executive Anthony Hooper has joined Amgen as EVP global commercial operations.

In his new role, Hooper will be responsible for the drug maker's global commercial operations and will report to Amgen president and COO Robert Bradway.

"As we continue to grow, Tony's track record of delivering results and his passion for serving patients across the globe make him an outstanding addition to Amgen's leadership team," Bradway said.

October 20, 2011

Bristol-Myers Squibb announced changes to its senior management team, including the appointment of its U.S. pharmaceuticals president.

NEW YORK — Bristol-Myers Squibb announced changes to its senior management team, including the appointment of its U.S. pharmaceuticals president.

October 20, 2011

A diabetes drug made by Eli Lilly and Amylin Pharmaceuticals has received approval from the Food and Drug Administration for use with an insulin product made by Sanofi.

INDIANAPOLIS — A diabetes drug made by Eli Lilly and Amylin Pharmaceuticals has received approval from the Food and Drug Administration for use with an insulin product made by Sanofi.

Lilly and Amylin said Byetta (eventide) won approval from the FDA as an add-on therapy for patients with Type 2 diabetes taking Sanofi's Lantus (insulin glargine [rDNA origin]) who have not achieved adequate blood sugar control on Lantus alone.

October 20, 2011

On average, 20,000 children under the age of 5 years are hospitalized due to flu symptoms each year, the Loyola University Health System announced Thursday in a press release encouraging parents to have their children inoculated.

MAYWOOD, Ill. — On average, 20,000 children under the age of 5 years are hospitalized due to flu symptoms each year, the Loyola University Health System announced Thursday in a press release encouraging parents to have their children inoculated.

October 20, 2011

The Senate voted 55-45 Thursday to scrap an appropriations bill amendment that would have allowed personal importation of prescription drugs.

WASHINGTON — The Senate voted 55-45 Thursday to scrap an appropriations bill amendment that would have allowed personal importation of prescription drugs.

The amendment had been proposed for the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Bill. The Senate's vote drew applause from an organization representing retail pharmacy chains.

October 20, 2011

Vertex Pharmaceuticals has filed for Food and Drug Administration approval of a drug for cystic fibrosis, the company said.

CAMBRIDGE, Mass. — Vertex Pharmaceuticals has filed for Food and Drug Administration approval of a drug for cystic fibrosis, the company said.

Vertex announced the submission to the FDA of an application for approval and priority review of Kalydeco (ivacaftor), which it said was potentially the first medicine to target the underlying cause of cystic fibrosis, namely mutations in the CFTR gene that causes defective or missing CFTR proteins that inhibit the flow of salt and water across cell membranes and lead to mucus buildup.

October 19, 2011

Abbott on Wednesday morning announced plans to separate into two publicly traded companies, one in diversified medical products and the other in research-based pharmaceuticals.

ABBOTT PARK, Ill. — Abbott on Wednesday morning announced plans to separate into two publicly traded companies, one in diversified medical products and the other in research-based pharmaceuticals.

"Today's news is a significant event for Abbott, and reflects another dynamic change in our company's 123-year history, strengthening our outlook for strong and sustainable growth and shareholder returns," Abbott chairman and CEO Miles White said.

October 19, 2011

ParaPRO on Saturday presented data showing the effectiveness of Natroba (spinosad) topical suspension, 0.9% against head lice and nits following one treatment without nit combing.

BOSTON — ParaPRO on Saturday presented data showing the effectiveness of Natroba (spinosad) topical suspension, 0.9% against head lice and nits following one treatment without nit combing. Those data about the pediculicide, derived from a naturally occurring soil bacterium, were presented in a poster session at the American Academy of Pediatrics National Conference and Exhibition here.

October 19, 2011

Takeda Pharmaceuticals has started a late-stage clinical trial program for a drug to treat Type 2 diabetes, the drug maker said.

OSAKA, Japan — Takeda Pharmaceuticals has started a late-stage clinical trial program for a drug to treat Type 2 diabetes, the drug maker said.

October 18, 2011

The Healthcare Distribution Management Association on Tuesday named six new members to its board of directors.

ARLINGTON, Va. — The Healthcare Distribution Management Association on Tuesday named six new members to its board of directors — Maria Burns, Burlington Drug Co. VP and corporate secretart; Gregory Drew, Value Drug Co. president; Terrance Haas, Harvard Drug Group CEO; David Neu, AmerisourceBergen president; Dale Smith, H. D. Smith chairman and CEO; and Albert Thomas, senior director and general manager of VaxServe, a Sanofi Pasteur company.

October 18, 2011

Johnson & Johnson Tuesday morning pledged significant support behind the relaunch of several McNeil Consumer products into the marketplace in 2012, and feels confident impacted brands — Tylenol and Motrin, among others — will be able to recapture market share, despite significant private-label erosion.

NEW BRUNSWICK, N.J. — Johnson & Johnson Tuesday morning pledged significant support behind the relaunch of several McNeil Consumer products into the marketplace in 2012, and feels confident impacted brands — Tylenol and Motrin, among others — will be able to recapture market share, despite significant private-label erosion.