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Northwest Biotherapeutics said in an SEC filing that KPMG LLP has resigned as
Northwest's independent auditor because the company has no audit committee.
ActivX Biosciences, a biotechnology company developing advanced proteomic technologies
for drug discovery and development, has announced the formal completion of its
acquisition by Tokyo-based Kyorin Pharmaceutical.
Meridian Bioscience has completed the acquisition
of all of the outstanding capital stock of O.E.M. Concepts for $6 million in
cash and a performance based earnout opportunity over four years of $2.3 million.
The FDA has granted its first tentative approval for an HIV drug regimen manufactured
by a generic pharmaceutical company outside of the U.S., the agency said.
The Good Automated Manufacturing Practice (GAMP) Forum, a division of the International
Society for Pharmaceutical Engineering (ISPE), will release its "GAMP Good
Practice Guide: Risk Management Approach to Electronic Records and Signatures,"
on Feb. 18 at an ISPE conference in Tampa, Fla.
Barr has elected to withdraw its pending abbreviated new
drug application (ANDA) from the FDA for a generic version of Wyeth's Premarin,
after a federal appeals court ruled that Barr's development partner misappropriated
information from Wyeth.
Curis, a therapeutic drug development company, has elected to exercise a co-development
option with its collaborative partner, Genentech, and will now share in U.S.
CepTor is a biopharmaceutical company focused on the development of cell-targeted
therapeutic products for neuromuscular and neurodegenerative diseases.