Oxford University/AstraZeneca’s COVID-19 vaccine cuts the spread of the virus by 60%, apart from having 70% efficacy in reducing infections in vaccinated individuals. While that is good news for their Indian partner, Serum Institute, the 90% efficacy shown in a subset due to a dosing error causes a dilemma.

After announcing positive topline Phase II results for its Alzheimer’s candidate late last year, Korea's GemVax releases additional data showing significant improvement in secondary outcomes, further raising expectations for the novel peptide drug.

The US FDA’s decision to ask on device adverse event reports whether the device involved had been serviced by a third party could help the agency as well as device makers, says Ricki Chase, compliance practice director at Lachman Consultant Services.