Novartis invests $35m in stem cell tech company with option to acquire
Novartis has invested $35m (€26.3m) for a 15% stake in Israel-based Gamida Cell, which offers stem cell expansion technologies and therapeutics.
Archives for August 19, 2014
G-CON's containment PODs launched in response to Ebola crisis
G-CON has responded to the ongoing Ebola virus outbreak in West Africa by retooling its “vaccine facility in a box” PODs as patient isolation units to help stop the spread of the disease.
Eisai sues FDA for ‘losing one year’ of marketing to generics rivals
Eisai has accused the US FDA of unlawfully shortening market exclusivity periods for Belviq and Fycompa by starting the countdown one year before either was scheduled by the DEA.
Former Cetero researcher hit with US FDA warning letter
A researcher with the now dissolved CRO Cetero Research received a warning letter released Tuesday from the US FDA after inspectors found that he, among other things, failed to ensure that the investigation was conducted according to plan.
Organovo: 3D printed liver tissue to challenge current toxicity models
A 3D printed human liver system could offer better informed risk-based decisions earlier in the drug development process than with current in vitro models, according to developers Organovo.
Frogs, fungus and falsified data - Indian firm falls foul of US FDA
Indian drugmaker Amanta has received a warning letter after the US FDA found evidence of data falsification and unsanitary conditions – including dead and decaying frogs next to a product exit dock – during an inspection last year.
UK drug exporters shipping outside the EEA must seek MHRA approval
EU law changes mean all UK firms handling pharmaceuticals for export outside the EEA must now be inspected and pay license fees according to the MHRA.
India changes course, calls for bar codes for mono cartons in April
Nearly a month after India pushed back its deadline indefinitely for exporters to put bar codes on their primary packages, the Directorate General of Foreign Trade (DGFT) has set a new deadline of April 2015.