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Technology News- BioPharm News
- Shire Gains European Approval for its Gaucher Disease Treatment
- Mtech Bioprocess Scale-Up Facility to Double in Staff and Size
- ImClone Closes Plant in New Jersey, Consolidating Erbitux Manufacture
- EMA and FDA Seek Applicants for Joint GMP Inspections
- ATMI Expands Bloomington, Minnesota Manufacturing Facility
- Clinical Trials News
- CRF Health Achieves EXACT ePRO Vendor Certification for Windows Mobile Systems
- ACR Image Metrix Establishes Global Presence
- BioPharm Systems Named to the 2010 Inc. 500|5000 List of Fastest-Growing Companies in the U.S.
- CRF Health Doubles North American Headquarters
- Oracle Completes Acquisition of Phase Forward
Tag Archives: FDA
Weight-Loss Drug Qnexa Loses in FDA Committee Ruling
Vivus’ Qnexa may help in weight loss, but it also now risks losing its place in the market following FDA’s Advisory Committee’s ruling July 15. The panel of medical experts did not question the effectiveness of the drug, but rather voiced its concerns over safety of the medication.
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee [...]
Posted in FDA, Safety Also tagged Anti-obesity medication, Drug, Fen-phen, Food and Drug Administration, Health, Qnexa, Weight loss 1 Comment
Avandia on Trial
The mid-July FDA advisory committee meeting to decide the fate of GlaxoSmithKline’s Avandia (rosiglitazone) is widely viewed as a test case of how the agency’s new leadership will address controversial drugs with serious risks but confusing data. A request that GSK yank its diabetes blockbuster—three years after first being associated with an increased risk of [...]
Hamburg Delivers DIA Keynote
FDA Commissioner Margaret Hamburg delivered this year’s keynote speech in front of a packed room of pharma and bioscience personnel at the 46th annual meeting of the Drug Information Association, which opened Monday morning. Hamburg started her speech by explaining how her earliest goal as FDA chief was to build the field of regulatory [...]
Johnson & Johnson Slammed Over Manufacturing Practices, Phantom Recall
In 1982, Johnson & Johnson garnered an enduring amount of goodwill when, seemingly without any thought of lost profit, it immediately yanked Tylenol from the shelves nationwide after learning someone was slipping cyanide into bottles in Chicago. The company’s sure and swift PR response became the model for crisis management for the corporate world.
But in [...]
Posted in Corporate Responsibility Also tagged Congressional hearing, House Oversight Committee, J&J, Johnson & Johnson, Manufacturing, McNeil, Motrin, phantom recall, recall, Tylenol Leave a comment
Baxter Receives Third FDA Warning for Misleading Promotional Material