Top News

Sep 12, 2017
By BioPharm International Editors
Alexion’s restructuring will reduce its global workforce by 20%, including closing a manufacturing facility in Rhode Island.
Aug 30, 2017
By BioPharm International Editors
FDA approves Novartis’ CAR-T therapy, marking the first time a cell therapy based on gene transfer has been approved in the United States for any indication.
Aug 08, 2017
The Senate voted 94–1 to approve legislation reauthorizing user fees and a series of program changes.
Jul 21, 2017
By BioPharm International Editors
A Merck, Pfizer, and Corning collaboration resulted in development of Corning Valor Glass for improved drug storage and delivery and will create US jobs.
Jul 10, 2017
By BioPharm International Editors
After FDA found a “significant shift in the route of abuse,” Endo voluntarily removes OPANA ER from the market.
Jun 29, 2017
By BioPharm International Editors
The agency announced a plan to eliminate its existing orphan designation request backlog.
Jun 12, 2017
The landmark decision determined that biosimilar makers can notify manufacturers before receiving FDA approval.
Jun 08, 2017
FDA asked Endo Pharmaceuticals to remove Opana ER from the market, citing the potential for abuse.
May 15, 2017
By BioPharm International Editors
Thermo Fisher will acquire Patheon for approximately $7.2 billion, including the assumption of approximately $2 billion of net debt.
May 09, 2017
User fee reauthorizations, a hiring freeze, and opioid epidemic await the new FDA commissioner Scott Gottlieb.
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