Path to approval proves rocky for copycat biodrugs

Article Abstract:

The biotechnology industry uses safety concern arguments to stall the approval of biogeneric drugs. The Food and Drug Administration finds it difficult to grant approvals since the size and complexity of the biological drugs combined with the many steps of stringent tests involved need large sums of money, added to the threat of rare and serious immune reactions.

United States, Product development, Government regulation, Pharmaceutical Preparation Manufacturing, Drugs, Generic Drugs, Biotechnology industry, Biotechnology industries, Licensing, certification and accreditation, United States. Food and Drug Administration

---

A merger too far?

Article Abstract:

A New York-based firm Bristol-Myers Squibb has established itself as a successful specialty-drug deliverer and this might help it to remain independent. The merger negotiations between Sanofi-Aventis and Bristol-Myers Squibb could be revived once a key patent dispute involving both companies is settled.

Acquisitions & mergers, Pharmaceutical industry, Mergers, acquisitions and divestments, France, Company acquisition/merger, Negotiation, mediation and arbitration, Bristol-Myers Squibb Co., BMY, SNY, Sanofi-Aventis S.A.

---

Similar abstracts:

• Abstracts: Swooping for biotech. Meeting in the middle. No longer the upstart
• Abstracts: Joint efforts. A very mysterious foundation. Food FAQs
• Abstracts: Copycats gear up to dog biotech brands. How does the painkiller harm the heart? Painkiller in the dock
• Abstracts: Indian reserve rates four stars. Where are the clowns? It rains about 200 days out of 365
• Abstracts: Flu researchers slam US agency for hoarding data. Alarms ring over bird flu mutations

This website is not affiliated with document authors or copyright owners. This page is provided for informational purposes only. Unintentional errors are possible.