BioCentury | Oct 29, 2020
Product Development

Vowing transparency at interim COVID-19 vaccine readout, Moderna expects ‘dialogue’ with FDA about unblinding study

Contrasting comments from Pfizer management on Tuesday, Moderna promised full transparency with regard to interim results from its Phase III COVE study of COVID-19 vaccine mRNA-1273. The company pledged to report either a positive or...
BioCentury | Oct 28, 2020
Product Development

Novavax redesigns U.K. trial to align with global COVID-19 vaccine trials

Novavax has modified the U.K. Phase III trial of its COVID-19 vaccine candidate to ensure that it could support EMA approval and, the company believes, potentially support authorization or approval in the U.S. EMA recommended...
BioCentury | Oct 28, 2020
Deals

Thrive takeout by Exact Sciences could herald consolidation trend for early cancer detection companies

Thrive’s acquisition by Exact Sciences is the second in what could be a trend of big testing technology players investing in, and then buying up, early cancer detection companies. The news came along with upbeat...
BioCentury | Oct 26, 2020
Deals

Bayer’s $2B deal for AskBio follows biotech’s decision to bet on its own pipeline

Gene therapy company AskBio chose last year to raise VC cash and invest in its pipeline rather than continue to rely solely on licensing and transaction revenues that had kept it afloat since 2001. That...
BioCentury | Oct 24, 2020
Regulation

Advice now, consent later, on COVID-19 vaccines

FDA’s Oct. 22 vaccines advisory committee meeting was principally intended to reassure the public that career staff will make decisions about COVID-19 vaccines and will not be influenced by political preferences or timetables. A second...
BioCentury | Oct 23, 2020
Regulation

Gilead’s Veklury becomes first FDA approved COVID-19 therapy, with NIH adaptive trial as focal point

Data from NIH’s master protocol trial was the cornerstone for the first FDA approval of a COVID-19 therapy, granted to Gilead’s Veklury Thursday. The approval highlights the critical role of master protocols for generating substantive evidence...
BioCentury | Oct 21, 2020
Regulation

Ethics arising from EUAs could disrupt COVID-19 vaccine trials

FDA and its vaccines advisory committee are facing ethical and practical conundrums that, unless they are resolved quickly, threaten to undermine the development of COVID-19 vaccines. The most pressing challenge centers on whether it is...
BioCentury | Oct 17, 2020
Finance

Novartis Venture Fund’s move to earlier, riskier bets starting to pay off

Over the last three and a half years, Novartis Venture Fund has remade its team and narrowed its remit to early-stage opportunities in therapeutics. The fund’s 2020 exits suggest the strategic shift may...
BioCentury | Oct 17, 2020
Product Development

How the PanCAN master protocol could promote innovation in pancreatic cancer

The motivation for launching the first adaptive platform trial in pancreatic cancer is to stimulate therapeutic innovation in an indication sorely in need of new ideas. The hope of the non-profit...
BioCentury | Oct 16, 2020
Product Development

WHO data show quartet of therapies fail to reduce COVID death

Data from WHO’s SOLIDARITY trial reiterate the results of NIH’s ACTT: Veklury does not provide a survival benefit in COVID-19. The interim results from WHO’s open-label master protocol trial, published Thursday in medRxiv, showed that Veklury remdesivir...
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