Focus on Covid-19 does not distract the FDA
Non-Covid-19 medical device approvals tick up alongside the agency’s pandemic efforts.
The pandemic releases its grip on clinical trials
The vast majority of industry-sponsored studies suspended because of Covid-19 resumed quickly, a new analysis finds.
Company Events
The year immuno-oncology could break into perioperative settings
Keytruda could soon be approved in periadjuvant breast cancer, but adjuvant lung cancer, a bigger setting, is 2021’s big showdown.
Go or no go? New Year approval decisions for the US regulators
Aurinia’s only project is due in front of the FDA, and outcomes are expected for Merck KGaA, Bayer and Merck & Co.
First-quarter catalysts for the smaller players
Important data releases are on the cards for Rhythm, Wave and Supernus, among others.
Interviews
Apellis takes the complement fight to Astrazeneca
The smaller company believes that its complement C3 inhibitor could make Soliris and Ultomiris redundant in PNH.
Kinaset takes a sledgehammer to an asthma conundrum
The nascent company hopes to prove that its inhaled pan-Jak is best in class.
Thermo Fisher and the new variant
Pinpointing new forms of the coronavirus could be vital, particularly if it mutates in response to vaccination, the company says.