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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
Category Archives: FDA
Patients Want to Talk. Do You?
Why are companies rushing to the web when traditional engagement with patient groups remains so under-exploited, asks Jacky Law.
It used to be so easy. Patients listened to doctors, doctors listened to pharma and everyone was happy. There was even a time when payers listened to pharma, reimbursing their prices with very few questions asked. Now [...]
Also posted in E-Media, Europe, Global, Guest Blog, Legal Tagged patient communication, patient education, patient groups, Pharma, Regulatory, social media 1 Comment
Feds Threaten to Pull ProAmatine for Lack of Postmarket Data (Updated 8/18)
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FDA on Monday announced that it was looking to withdraw approval for the low-blood-pressure treatment midodrine hydrochloride because the companies manufacturing the drug failed to provide data from post-approval studies.
The kicker: The drug was approved 14 years ago.
FDA gave midodrine hydrochloride—branded by Shire as ProAmatine and produced by a half-dozen generics firms—the green [...]
Advisory Panel Rejects Avastin For Breast Cancer Treatment
An FDA advisory panel on Tuesday voted 12–1 to discontinue Avastin (bevacizumab) as a treatment for advanced breast cancer due to post-market studies stating that the treatment does not to increase patient lifespan by any significant length of time.
This is a huge problem for Roche who purchased the treatment as part of its merger with [...]
Also posted in Safety Tagged Avastin, Bevacizumab, Breast cancer, Cancer, Chemotherapy, Clinical trial, Food and Drug Administration, Genentech, Roche Leave a comment
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 [...]
Also posted in Safety Tagged Anti-obesity medication, Drug, FDA, Fen-phen, Food and Drug Administration, Health, Qnexa, Weight loss 1 Comment
Baxter Receives Third FDA Warning for Misleading Promotional Material