Dynavax Technologies Corp. (NASDAQ:DVAX) hired Kelly MacDonald as SVP and CFO, effective March 1. She succeeds CFO Michael Ostrach, who is retiring after 14 years and will remain with the vaccine company as an adviser. MacDonald was...

Politics, Policy & Law When Janet Woodcock moves into the FDA commissioner’s office next week, she will take charge, at least on an acting basis, of an agency that has been pummeled for months. President...

News that President-elect Joe Biden plans to ask Janet Woodcock to run FDA on an interim basis in the weeks or months after his inauguration is being celebrated by biopharma companies and patient advocates, who...

David Kessler is out of the running for nomination as FDA commissioner, leaving Joshua Sharfstein as a front-runner to lead FDA, sources briefed by the Biden transition team told BioCentury. While the list of candidates...

bluebird’s decision to focus on rare diseases and spin out its cancer business by year-end could provide the focus both units need to execute on their pipelines and attract potential partners and buyers.  Nick Leschly,...

If clinical trials yield positive results, Johnson & Johnson’s COVID-19 vaccine could be authorized in the U.S. by mid-February, the Oxford/AstraZeneca vaccine could receive Emergency Use Authorization in late March, and a vaccine from Novavax...

The pandemic has only deepened the already heavily-weighted oncology focus of many portfolios, and it’s targeted oncology opportunities that are catching the eyes of buysiders in 2021. A combination of...

Sarepta microdystrophin gene therapy misses endpointShares of Sarepta Therapeutics Inc. (NASDAQ:SRPT) fell 50% to $84.45 in after-hours trading after  microdystrophin gene therapy SRP-9001 missed the primary functional endpoint of improvement in NSAA total score compared to...

Johnson & Johnson’s COVID-19 vaccine won’t be the first to reach the market, but it could be one of the most important. The company has made scientific and business decisions about the vaccine’s profile that,...

Chi-Med’s surufatinib approved in ChinaChina’s National Medical Products Administration (NMPA) approved an NDA from Hutchison China MediTech Ltd. (NASDAQ:HCM; LSE:HCM) for Sulanda surufatinib to treat non-pancreatic neuroendocrine tumors. The FGFR, VEGFR and CSF1R inhibitor is...