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Three years after launching Caduet, a combination of two blockbuster drugs some say is designed to extend patent life, Pfizer is in litigation to block a generic version of the drug.
The FDA is proposing rules in a draft guidance that would bar any person with more than $50,000 in ties to drug and device companies from participating in an agency advisory committee.
GlaxoSmithKline's (GSK) kinase inhibitor Tykerb gained FDA approval for use in combination with Roche's oral chemotherapeutic Xeloda for the treatment of advanced metastatic breast cancer -- specifically in tumors that produce an excess of the HER2 protein.
Pediatric drug study costs increased nearly eightfold between 2000 and 2006, while the studies have become larger and more frequent, a study from the Tufts Center for the Study of Drug Development said.
Reps. Henry Waxman (D-Calif.) and Edward Markey (D-Mass.) have introduced legislation they say goes further to strengthen the FDA's drug safety review processes than the bill's counterpart in the Senate.
Schering-Plough is buying Organon BioSciences, the human and animal healthcare unit of Akzo Nobel, for $14.4 billion to supplement its late-stage product pipeline, the company announced.
Johnson & Johnson (J&J) has disclosed that three of its subsidiaries have received three separate subpoenas from the Boston, San Francisco and Philadelphia U.S. attorney's offices relating to marketing practices for Risperdal, Topamax and Natrecor.
The draft "Safe Drug Compounding Act of 2007" would stop illegal mass manufacturing of drugs while allowing patients access to legally compounded medications, the Consumer Health Alliance for Safe Medications (CHASM) said.
A federal antitrust lawsuit filed by drug distributors against Purdue Pharma claims the drug company monopolized the OxyContin market by blocking generic versions of the drug with illegally obtained patents.
Takeda Pharmaceuticals has alerted healthcare providers about the increased risk of fractures related to Actos, Actosplus met and Duetact tablets, used to treat Type 2 diabetes mellitus.