The one dose versus two controversy for COVID vaccines has a few twists left, with the incoming Biden administration departing from FDA’s conservatism in favor of giving more people their first shot sooner....

The U.S. Department of Commerce’s first biotech-focused definition of “emerging technology” suggests industry won’t have to wage the type of pushback campaigns that followed the Department of the Treasury’s initial definition of “sensitive data.” The...

EMA includes RECOVERY data in review of dexamethasone MAAEMA said it has begun evaluating dexamethasone from Taw Pharma to treat hospitalized COVID-19 patients, and is considering CHMP’s review of the U.K’s RECOVERY trial data in...

Ex-FDA officials are mixed on the merits of an agency decision to grant an EUA for COVID-19 convalescent plasma, but there is widespread agreement that the process was marred by political posturing, including statements by...

Fresh off its $200 million IPO last month, Generation Bio Co. (NASDAQ:GBIO) has added Matthew Norkunas as CFO. Norkunas, who succeeds interim CFO Stephen DiPalma, was CFO of SomaLogic Inc. IQVia Holdings Inc. (NYSE:IQV) has...

Bolt’s $93.5 million series C round will enable the Stanford spinout to clinically test whether its myeloid-activating antibody conjugate can provide durable treatment to a broad swath of HER2-positive solid tumor patients. Led by Sofinnova...

UniQure’s out-licensing deal for its lead gene therapy program in hemophilia B may have disappointed investors, but that does not preclude the Dutch company from remaining an attractive takeout target. Investors immediately soured on Wednesday’s...

Arkin Holdings closed its second biopharma fund Monday at $140 million, more than double its debut fund, which launched with $60 million in 2016 and was fully committed at the end of 2019. As with...

Takeda gains another celiac candidate via PvP takeout After PvP Biologics Inc. finished a Phase I trial demonstrating proof of concept of its celiac disease therapy, Takeda Pharmaceutical Co. Ltd. (Tokyo:4502; NYSE:TAK) exercised its option...

Fast start for Bio-Thera on Shanghai’s STAR board Bio-Thera Solutions Ltd. (Shanghai:688177) jumped RMB27.44 (84%) to RMB60.20 in its first day of trading Friday before edging up to RMB60.90 Monday on Shanghai’s STAR board. The...