January 14, 2011

The Food and Drug Administration and drug maker Sanofi-Aventis are warning healthcare professionals and patients about the possibility of severe liver injury in patients taking a Sanofi heart drug.

January 14, 2011

Biotech company Genentech advised consumers to avoid alcohol prep pads distributed with some of its drugs due to possible contamination.

January 13, 2011

The Food and Drug Administration is capping the amount of the painkiller acetaminophen in prescription drugs due to the risk of liver toxicity, the agency said Thursday.

January 13, 2011

K-V Pharmaceutical announced Wednesday that the Food and Drug Administration extended its Prescription Drug User Fee Act action date to April 13 for a drug under development for preventing preterm birth.

January 13, 2011

Danish drug maker Novo Nordisk has created an online resource for diabetes patients that educates them about Novo Nordisk drugs and devices, recipes and nutritional values, and allows them to connect with other patients.

January 13, 2011

Various companies in the healthcare industry are uncertain about the benefits of the Food and Drug Administration’s risk evaluation and mitigation strategy program, and most think it needs a major overhaul, according to a study by the Tufts University Center for the Study of Drug Development.

January 12, 2011

Drug maker Merck and drug industry services organization Parexel International will work together to develop biosimilars, the two said Wednesday.

January 11, 2011

Bayer HealthCare Pharmaceuticals sought to reassure healthcare professionals and their patients that a recall of alcohol prep pads distributed with its multiple sclerosis drug did not affect the drug itself.

January 11, 2011

U.S. drug maker Eli Lilly and German drug maker Boehringer Ingelheim will collaborate to develop drugs for diabetes, the companies said Tuesday.

January 11, 2011

The Food and Drug Administration has accepted a regulatory approval application for a drug to treat Type 2 diabetes made by Merck, the drug maker said Tuesday.

January 10, 2011

The Food and Drug Administration declined to approve Endo Pharmaceuticals’ regulatory application for a painkiller designed to thwart drug abusers, Endo said Friday.

January 10, 2011

Drug maker Shionogi has launched a new medication for attention deficit hyperactivity disorder, the company said Monday.

January 10, 2011

It appears that French drug maker Sanofi-Aventis’ efforts to acquire U.S. biotech company Genzyme are getting somewhere, according to company and media reports.

January 7, 2011

A new oral treatment for Type 2 diabetes hit the shelves Friday.

January 7, 2011

Pfizer has paid Seattle Genetics $8 million to license its antibody technology, Seattle Genetics said Thursday.

January 6, 2011

The Food and Drug Administration has accepted the approval application for a chemotherapy drug to treat lung cancer from AdventRx Pharmaceuticals, the drug maker said Thursday.

January 6, 2011

The Food and Drug Administration has expanded the approved usage of a drug made by Genentech, part of Swiss drug maker Roche.

January 6, 2011

The Food and Drug Administration granted priority review to an approval application for a hepatitis C drug made by Merck, the drug maker said Thursday.

January 6, 2011

A U.S. biotech company plans to develop a biosimilar of a monoclonal antibody used to treat cancers and autoimmune disorders.

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.

January 4, 2011

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

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.

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.

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.