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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: Regulatory
Judgment Day for Avandia
Judgment Day has finally arrived for GSK’s Avandia. FDA’s Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees met July 13 and 14 to finally recommend, after months of deck-stacking against GSK, that the drug be severely restricted, if not outright pulled from the market. In the vote, 12 of 33 panelists [...]
HTA Concerns From European Drug Agency
The EMA’s Thomas Lönngren has gone public with his disquiet over organizations such as NICE. But pharma still needs more allies in fighting what it sees as the failings of the health technology assessment bodies, says Pharm Exec Europe’s Brussels correspondent, Reflector.
Europe’s pharmaceutical firms were never very keen on Britain’s influential National Institute for Health [...]
Also posted in Europe, Global, Guest Blog, Safety, Strategy Tagged EU, European Medicines Agency, European Union, NICE, Regulatory Leave a comment
Industry and FDA Brace for Change
While the convention floor of the 46th annual meeting of the Drug Information Association bustled with the usual vendors touting the latest and greatest clinical trial technology, the panels (particularly those that featured FDA members) had a remarkably somber tone.
The main refrain was: “Things are going to change and everyone must step up or get [...]
Also posted in Strategy Tagged Clinical trial, DIA, Evidence-based medicine, Janet Woodcock, Pharmaceutical drug, Randomized controlled trial, Research 1 Comment
Post-Approval Regulatory Priorities: Progress or Pile-Up?
An enduring falsehood about the pharmaceutical industry is that the heavy lifting ends with a successful new drug registration. What comes after is the equivalent of a well-funded retirement, where providers embrace the therapy, payers meet the price, and patients push the boundaries of clinical practice toward lucrative new indications. The reality, however, is starkly [...]
Posted in Regulatory Tagged approval, Celebrex, FDA, Geodon, Harvard Medical School, post-approval strategies 1 Comment
And What Exactly is a Stakeholder?