Content about Bristol-Myers Squibb

January 19, 2012

The Food and Drug Administration has declined to approve a drug for Type 2 diabetes made by Bristol-Myers Squibb and AstraZeneca, saying it needs additional clinical data, the companies said Thursday.

PRINCETON, N.J. — The Food and Drug Administration has declined to approve a drug for Type 2 diabetes made by Bristol-Myers Squibb and AstraZeneca, saying it needs additional clinical data, the companies said Thursday.

January 19, 2012

The Food and Drug Administration has approved a lower-dose formulation of a drug made by Gilead Sciences for treating HIV in children, the company said.

FOSTER CITY, Calif. — The Food and Drug Administration has approved a lower-dose formulation of a drug made by Gilead Sciences for treating HIV in children, the company said.

Gilead announced the FDA approval of Viread (tenofovir disoproxil fumarate) in the 150-mg, 200-mg and 250-mg strengths combined with other antiretroviral drugs in patients ages 6 to 12 years while also approving an oral powder formulation for children ages 2 to 5 years. The agency approved the drug in the 300-mg strength for adults in 2001 and for patients ages 12 to 17 years in 2010.

January 13, 2012

Bristol-Myers Squibb has officially launched its tender offer for Inhibitex, the drug maker said Friday.

NEW YORK — Bristol-Myers Squibb has officially launched its tender offer for Inhibitex, the drug maker said Friday.

Bristol said it had commenced a $2.5 billion offer to buy all outstanding shares of Inhibitex, an Alpharetta, Ga.-based company developing treatments for hepatitis C. The company's leading product is INX-189, an orally administered drug currently in phase-2 clinical trials.

Bristol announced its intention to buy Inhibitex Monday. The New York-based drug maker said it would make Inhibitex a wholly owned subsidiary following the acquisition.

January 9, 2012

Bristol-Myers Squibb is buying Inhibitex for $2.5 billion, the companies said.

NEW YORK — Bristol-Myers Squibb is buying Inhibitex for $2.5 billion, the companies said.

In a $26-per-share tender offer, Bristol will acquire the Alpharetta, Ga.-based developer of treatments for hepatitis C. Inhibitex's lead product is INX-189, an orally administered drug currently in phase-2 clinical trials.

January 3, 2012

Mead Johnson's infant formulas, including Enfamil Premium Newborn, are safe, according to results of testing by both the Food and Drug Administration and the Centers for Disease Control and Prevention.

GLENVIEW, Ill. — Mead Johnson's infant formulas, including Enfamil Premium Newborn, are safe, according to results of testing by both the Food and Drug Administration and the Centers for Disease Control and Prevention. These tests confirmed that the Mead Johnson products were safe, and no presence of the Cronobacter (Enterobacter sakazakii) bacteria was detected.

January 3, 2012

Mead Johnson Nutrition over the holidays conducted a new round of testing on samples of a batch of Enfamil Premium Newborn powdered formula related to a Food and Drug Administration investigation.

GLENVIEW, Ill. — Mead Johnson Nutrition over the holidays conducted a new round of testing on samples of a batch of Enfamil Premium Newborn powdered formula related to a Food and Drug Administration investigation.

Drawn from samples parallel to those being tested by public health officials and following the same methodology, the new testing did not detect any presence of Cronobacter (Enterobacter sakazakii), the company stated.

January 3, 2012

Teva Pharmaceutical Industries announced that Shlomo Yanai, president and CEO, will retire from his post in May.

JERUSALEM — Teva Pharmaceutical Industries announced that Shlomo Yanai, president and CEO, will retire from his post in May.

Yanai, who has served in this capacity for five years, has helped Teva expand from a mainly generics business to a more diversified pharmaceutical company, with expected 2012 revenue of approximately $22 billion, and an expanded footprint in the European, Asian and Latin America markets.

December 23, 2011

Drug maker Bristol-Myers Squibb and the Gladstone Institutes will collaborate to find new ways to treat Alzheimer's disease, the two said Thursday.

SAN FRANCISCO — Drug maker Bristol-Myers Squibb and the Gladstone Institutes will collaborate to find new ways to treat Alzheimer's disease, the two said Thursday.

December 21, 2011

The Food and Drug Administration has approved an HIV drug for children and adolescents, the agency said Wednesday.

SILVER SPRING, Md. — The Food and Drug Administration has approved an HIV drug for children and adolescents, the agency said Wednesday.

The FDA announced the approval of Merck's Isentress (raltegravir) for HIV-1 infection in patients ages 2 to 18 years. The chewable form of the drug will be available for children ages 2 to 11 years.

"Many young children and adolescents are living with HIV, and this approval provides an important additional option for their treatment," FDA Office of Antimicrobial Products director Edward Cox said.

 

December 20, 2011

The World Health Organization has approved three generic second-line treatments for HIV made by Mylan, the drug maker said Tuesday. The drugs will be delivered to people in developing countries living with HIV and AIDS.

PITTSBURGH — The World Health Organization has approved three generic second-line treatments for HIV made by Mylan, the drug maker said Tuesday. The drugs will be delivered to people in developing countries living with HIV and AIDS.

December 15, 2011

A study conducted by Bristol-Myers Squibb and AstraZeneca found that adding an investigational compound to an existing Type 2 diabetes treatment may help reduce blood-glucose levels among patients.

DUBAI — A study conducted by Bristol-Myers Squibb and AstraZeneca found that adding an investigational compound to an existing Type 2 diabetes treatment may help reduce blood-glucose levels among patients.

December 8, 2011

Mead Johnson Nutrition Wednesday evening announced a number of management changes under Mead Johnson president and CEO Steve Golsby.

GLENVIEW, Ill. — Mead Johnson Nutrition Wednesday evening announced a number of management changes under Mead Johnson president and CEO Steve Golsby.

“Given the growing size and complexity of our global operations, I recognized the need to refine our management structure in order to drive superior performance and operationalize our ambitious strategic plan,” Golsby said.

December 2, 2011

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.

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.

November 17, 2011

Bristol-Myers Squibb and AstraZeneca presented an analysis Wednesday of 14 clinical trials at the American Heart Association's Scientific Sessions in Orlando, Fla., the companies said.

PRINCETON, N.J. — Bristol-Myers Squibb and AstraZeneca presented an analysis Wednesday of 14 clinical trials at the American Heart Association's Scientific Sessions in Orlando, Fla., the companies said.

The phase-2b and phase-3 trials all involved the investigational Type 2 diabetes drug dapagliflozin and, the companies said, showed that use of the drug did not lead to an unacceptable risk to adult patients' cardiovascular health compared with other treatments.

November 15, 2011

Perrigo on Tuesday announced it received Food and Drug Administration clearance to market and distribute infant formula that contains 100% partially hydrolyzed whey protein.

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.

November 14, 2011

A drug under development by Pfizer and Bristol-Myers Squibb for preventing internal blood clots failed to show superiority over a treatment already on the market, the companies said Monday.

NEW YORK — A drug under development by Pfizer and Bristol-Myers Squibb for preventing internal blood clots failed to show superiority over a treatment already on the market, the companies said Monday.

The two drug makers announced Monday results of the phase-3 "ADOPT" study, which was designed to compare the safety and effectiveness of Eliquis (apixaban) with enoxaparin in preventing venous thromboembolism in patients with acute medical illness. Sanofi sells enoxaparin under the brand name Lovenox, and it is available as a generic.

November 7, 2011

The Food and Drug Administration has approved a drug made by Bristol-Myers Squibb for treating head and neck cancer, the agency said Monday.

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.

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.

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 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 11, 2011

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.


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.


October 6, 2011

Genomics has the potential to revolutionize the treatment of cancer and the drug industry, and the New York Pharma Forum is sponsoring a symposium on the subject in December.

NEW YORK — Genomics has the potential to revolutionize the treatment of cancer and the drug industry, and the New York Pharma Forum is sponsoring a symposium on the subject in December.

The symposium, titled "The Genomics Revolution: Cancer and Beyond," will feature a panel discussion with executives from drug makes like Bristol-Myers Squibb and Daiichi Sankyo, as well as experts from the Yale Cancer Center and PricewaterhouseCoopers.

October 3, 2011

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.

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.

September 28, 2011

Sagent Pharmaceuticals has launched its new chemotherapy drug.

SCHAUMBURG, Ill. — Sagent Pharmaceuticals has launched its new chemotherapy drug.

Sagent sent that its paclitaxel injection USP is available in 30-mg, 100-mg and 300-mg latex-free, multi-dose vials. Paclitaxel is indicated for use alone or with other drugs to treat ovarian cancer, breast cancer, non-small cell lung cancer and AIDS-related Kaposi's sarcoma, Sagent said.

September 28, 2011

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.

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.