BioCentury | Jan 21, 2021
Management Tracks

MacDonald to succeed retiring Ostrach as Dynavax CFO; plus Antibiotic Resistance UK, Arix, Viridian, Avrobio, Imago, ONL, Atea, Chiasma, Tiziana, Elevar,  and Imara

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...
BioCentury | Jan 16, 2021
Politics, Policy & Law

Woodcock’s appointment as acting FDA commissioner could be audition for permanent position

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...
BioCentury | Jan 14, 2021
Politics, Policy & Law

Calls to make Woodcock permanent FDA commissioner

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...
BioCentury | Jan 13, 2021
Politics, Policy & Law

Woodcock to serve as acting FDA commissioner, Sharfstein a contender for top FDA job

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...
BioCentury | Jan 12, 2021
Deals

bluebird’s split could yield two attractive M&A targets

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,...
BioCentury | Jan 12, 2021
Product Development

Slaoui updates on COVID-19 vaccines, warns about slow enrollment in adolescent trial

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...
BioCentury | Jan 9, 2021
Finance

Targeted oncology is having a moment, again

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...
BioCentury | Jan 8, 2021
Product Development

Jan. 7 Quick Takes: Sarepta tumbles after hours on DMD miss; plus InnoCare, AstraZeneca, Astellas and Autolus

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...
BioCentury | Dec 31, 2020
Product Development

Stoffels on how J&J designed its COVID-19 vaccine for maximum impact: a BioCentury audio interview

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,...
BioCentury | Dec 31, 2020
Regulation

Dec. 30 Quick Takes: A first for Chi-Med; plus Orphazyme, BMS, FDA REMS, Pfizer, Astellas, Alkermes, Osmotica, Quanterix, Ampio and Novartis

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...
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