BioCentury | Jan 9, 2021
Product Development

The unfolding dosing controversy for COVID vaccines

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....
BioCentury | Dec 4, 2020
Politics, Policy & Law

Biotech’s first ‘emerging technology’ definition indicates narrow approach

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...
BioCentury | Sep 2, 2020
Product Development

EMA evaluating dexamethasone for COVID-19 as WHO meta-analysis of three steroids reiterates benefit

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...
BioCentury | Aug 25, 2020
Regulation

Politics & plasma: a BioCentury podcast

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...
BioCentury | Jul 25, 2020
Management Tracks

New CFOs for Generation Bio, IQVia; plus changes at Gracell, AskBio, Replimune, Triplet, Twist, Cellectis, Verrica and more

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...
BioCentury | Jul 2, 2020
Emerging Company Profile

Bolt’s myeloid twist on ADCs charged up with $93.5M series C

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...
BioCentury | Jun 27, 2020
Deals

Who’ll buy uniQure now?

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...
BioCentury | Mar 11, 2020
Finance

Arkin ramping up investments with $140M fund

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...
BioCentury | Feb 27, 2020
Product Development

Feb. 26 Quick Takes: Takeda acquires PvP for celiac therapy; plus Lilly, Esperion, Supernus, Moderna, Taiho-Arcus, Twist-Sophia

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...
BioCentury | Feb 25, 2020
Finance

Feb. 24 Financial Quick Takes: Bio-Thera shines in first days on STAR; plus ImmuneOnco, GenCells, Twist and Axovant

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...
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