Profectus Shifts to US CMO for DNA Vaccine Production
Profectus BioSciences has signed up San Diego-based CMO Althea Technologies to manufacture DNA vaccines after its deal with Boehringer Ingelheim ended due to currency issues.
Archives for February 28, 2013
Always Money for Good Ideas says Drug Delivery Pioneer
Good ideas in drug delivery will continue to attract investment though the increasing cost of clinical trials does pose a difficulty according to MIT Professor Robert Langer.
Cedarburg Hauser's DEA Approval Brings Niche Manufacturing Home
Cedarburg Hauser says US CDMOs are focusing on “niche fields” in order to gain a competitive advantage on foreign competition.
BIO, PhRMA Blast FDA Draft Guidance on E-Subs for Trial Site Data
Industry groups BIO and PhRMA are airing their discontents about US FDA draft guidance that could force sponsors to submit redundant clinical datasets for each trial site and waste time in critical pre-IND/BLA meetings.
FDA Cites API Manufacturer for Stability, Purification Violations
The US FDA has warned API manufacturer Abbey Color about its inadequate stability program and unreliable water purification system, both of which were cited as earlier violations.