BioCentury | Oct 27, 2020
Product Development

FDA advisory committee member opposes COVID vaccine EUA based on interim data

Paul Offit, a member of FDA’s vaccines advisory committee, said Tuesday that he and other members of the committee are unlikely to recommend emergency use authorization of COVID-19 vaccines based on interim analyses of Phase...
BioCentury | Oct 24, 2020
Product Development

Infusion confusion: the rollout of mAbs for COVID-19 could be chaotic

FDA could soon grant emergency use authorization to one or more COVID-19 monoclonal antibodies. Rather than being celebrated for creating lifelines that could keep hundreds of thousands of Americans out...
BioCentury | Oct 23, 2020
Finance

SPAC to the future: an old-time IPO alternative may be back to stay

Investors and bankers believe specialist-backed SPACs could become a cyclical part of biotech's fund-raising equation with some clear advantages over traditional IPOs for the right type of company....
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
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 3, 2020
Product Development

Departing Alnylam, Greene has messages for industry from company building to product pricing

As Barry Greene departs Alnylam, he believes the modality he nurtured from plan to reality has the potential to sit alongside mAbs and small molecules as an agent of choice. Greene announced in August...
BioCentury | Oct 2, 2020
Finance

Election volatility may drive investors toward low-risk opportunities in 4Q

The increasing likelihood of a contested U.S. presidential election means the markets could be in for a high dose of volatility in 4Q20, pushing the pause button on a record year for IPOs and sending...
BioCentury | Sep 29, 2020
Finance

With $77M series B, condensates company Dewpoint aiming for proof of concept

Dewpoint’s $77 million series B round affords the company “breathing room to make good decisions” as it chooses programs to develop and partner based on the science of biomolecular condensates, CEO Amir Nashat told BioCentury....
BioCentury | Sep 26, 2020
Politics, Policy & Law

Warp Speed’s Slaoui expects two COVID-19 vaccines this year, rebuts Sen. Warren

Two COVID-19 vaccines and two drugs that reduce mortality from the disease will be authorized by the end of 2020, Moncef Slaoui, chief scientific adviser to Operation Warp Speed, predicted in an interview...
BioCentury | Sep 16, 2020
Product Development

Pace of Monjuvi’s growth may dictate how quickly MorphoSys can rebuild its pipeline

MorphoSys’ first marketed therapeutic, Monjuvi, has the makings of a blockbuster, but the company and partner Incyte will need to execute on the drug’s launch and planned label expansions to generate the...
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