Content about Bristol-Myers Squibb

PITTSBURGH — Under the President's Emergency Plan for AIDS Relief, the Food and Drug Administration has given tentative approval to a generic HIV and AIDS drug made by Mylan, the company said.

The drug maker's Mylan Labs subsidiary received tentative approval for atazanavir sulfate and ritonavir tablets in the 300-mg/100-mg strength. The FDA's tentative approval of the drug under PEPFAR means it will be eligible for purchase in certain developing countries.

ALLEGAN, Mich. — Perrigo on Tuesday announced it received Food and Drug Administration clearance to market and distribute infant formula that contains 100% partially hydrolyzed whey protein. The store-brand Comfort Care infant formula is designed for babies with fussiness or gas and will be sold as a nutritionally comparable version of Gerber Good Start gentle infant formula at leading retailers in 2012.

Sales of the national brand are estimated to be $55 million for the latest 52-weeks, as measured by SymphonyIRI Group.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Bristol-Myers Squibb and Eli Lilly & Co. for treating head and neck cancer, the agency said Monday.

The FDA announced the approval of Erbitux (cetuximab) for use with chemotherapy in treating head and neck cancer that had spread to other parts of the body. The drug originally was approved in 2004 for treating certain cases of late-stage colon cancer in patients who had stopped responding to chemotherapy.

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.

The recent film “Contagion” depicts the world descending to chaos due to the spread of an extremely deadly virus. But in reality, one of the most serious epidemics doesn’t come from an infectious agent but from people’s life choices.


PRINCETON, N.J. — Bristol-Myers Squibb will present 22 study abstracts next month at the 62nd annual meeting of the American Association for the Study of Liver Diseases in San Francisco, the company said.

Key presentations set to take place at the meeting, called The Liver Meeting, include studies on the hepatitis B drug Baraclude (entecavir) and drugs under development for hepatitis C and liver cancer.

NEW YORK — Supermarket pharmacies could see a slight rise in gross profits next year as branded drugs lose patent protection and go generic, according to a new report by Moody's Investors Service.

CHICAGO — A new study has found that a recently approved drug for HIV produces fewer unpleasant side effects during the first three months of therapy than the standard treatment, according to published reports.


As the clock winds down on the patent exclusivity of the industry’s biggest blockbuster drug in November, speculation continues to grow that Pfizer will look to flip the switch on an OTC version of Lipitor (atorvastatin) before generic competition whittles away at the $7 billion behemoth. 


NEW YORK — A drug made by Pfizer and Bristol-Myers Squibb undergoing late-stage clinical trials was more effective than the generic drug warfarin in patients with atrial fibrillation, according to study results released Sunday.

The phase-3 "ARISTOTLE" trial of Eliquis (apixaban) showed that the drug reduced the risk of stroke and systemic embolism by 21%, major bleeding by 31% and death by 11% in AF patients. The study, published in the New England Journal of Medicine, was conducted at 1,034 centers in 39 countries and enrolled 18,201 patients.

NEW YORK — Bristol-Myers Squibb will acquire San Diego-based Amira Pharmaceuticals for $325 million, the two companies said Friday.

Amira develops pharmaceutical drugs for treating inflammatory and fibrotic diseases, and the deal includes milestone payments of up to $150 million on top of the upfront purchase price. Amira’s drugs include AM152, an investigational treatment for idiopathic pulmonary fibrosis, currently in early-stage clinical trials and set to enter mid-stage trials.

WILMINGTON, Del. — A Food and Drug Administration committee of experts has advised against approving a drug for Type 2 diabetes made by AstraZeneca and Bristol-Myers Squibb, the companies said Tuesday.

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 9-6 against recommending approval for dapagliflozin, saying that data from a two-year clinical trial program that included about 6,000 people did not support the drug’s approval for use in patients along with changes to diet and exercise.