EU revises API certification doc to clarify appeal policy
The EDQM has revised its policy on withdrawal of API or excipient certification to clarify the appeal process.
Archives for May 18, 2011
Alkermes' loss deepens in FY 2011 but firm upbeat on revs and EDT plans
Alkermes saw losses increase in fiscal 2011 but has issued an upbeat outlook on higher revenues, portfolio expansion and impending acquisition of Elan Drug Technologies (EDT).
Vetter completes structural work on state-of-the-art logistics facility
Prefilled injection systems specialist Vetter has completed structural work on its new facility in Erlen, Germany, eleven months after ground-breaking.
Novozymes Biopharma to launch new ophthalmic HA grade
Novozymes Biopharma will launch a new grade of its Bacillus-derived hyaluronic acid (HA) for ophthalmic delivery applications later this year.
CMO Gallus buys Centocor bio facility and plans investment
CMO Gallus BioPharmaceuticals has bought, and is investing in, a Centocor biologics facility after receiving private equity backing.
Ethical aspect of trials should be part of marketing apps
Marketing applications should contain details of clinical trial ethics and be rejected if serious violations are found, said some EMA workshop participants.