Recon: White House reportedly eyeing Califf as FDA commissioner; EU kicks off review of AstraZeneca COVID antibody cocktail
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- White House zeroes in on Califf to head FDA as deadline nears (Washington Post)
- U.S. FDA advisers weigh case for COVID-19 vaccine booster shots (Reuters) (STAT)
- J&J COVID-19 shot gets better boost from Moderna or Pfizer in NIH study (Reuters) (NBC)
- Data from Federal Scientists Raise Questions About J.&J. Booster Shots (NYTimes)
- Biden official warns Moderna to 'step up' on vaccine doses for the world (The Hill)
- Pfizer will use a warranty to refund the cost of a lung cancer drug if it doesn’t work (STAT)
- ‘Sociability’ hormone oxytocin didn’t help kids with autism, study finds (STAT) (NEJM)
- EPA Takes First Step Toward Ethylene Oxide Reporting (Law360)
- Boston Scientific, Sterigenics potential targets of EPA ethylene oxide reporting requirements (MedtechDive)
- In its search for a new FDA commissioner, the White House is relying on insiders for advice (STAT)
- New Toxic Drug Impurities Detected in Some Heart Pills in U.S. (Bloomberg)
- Merck carves out path in first-line advanced cervical cancer with new FDA win for Keytruda juggernaut (Endpoints)
- EU starts real-time review of AstraZeneca COVID-19 antibody cocktail (Reuters) (EMA)
- Hungary will receive technology to produce Sputnik V COVID-19 vaccine -foreign minister (Reuters)
- Second Ebola case confirmed in eastern Congo, health official says (Reuters)
- Factbox: Front runners in development of antibody drugs against COVID-19 (Reuters)
- Deaths from tuberculosis rose in 2020, for the first time in a decade, the W.H.O. says. (NYTimes)
- More Americans are getting Covid vaccine boosters than first doses in rush for third shots (CNBC)
- Covid Testing, Turnaround Times Are Still Uneven This Far Into Pandemic (KHN)
- Poland donates million COVID-19 shots to Iran (Reuters)
- Atlas backs a longtime Vertex employee’s quest to bring CF success to numerous other diseases (Endpoints)
- Broad Institute hires René Salazar to tackle biomedical research's diversity problem (Endpoints)
- Bristol Myers wants to pull out of its Abraxane deal in China. BeiGene says no way (Endpoints)
- A California biotech steps into the viral vector space with new site build of $75M (Endpoints)
- ICH Q9 Revision Delayed By Three Months To Address Subjectivity in Risk Assessments, Other Factors (Pink Sheet)
- In the packed oncolytic virus space, a German biotech with a unique approach makes investors reach deeper into their wallets (Endpoints)
- Exelixis, Storm join up in collaboration and license agreement; Teligent files for bankruptcy (Endpoints)
- Novartis' discovery team hires Genentech vet Shiva Malek to lead early-stage oncology work (Endpoints)
- AstraZeneca oncology R&D chief Susan Galbraith: 'You're going to need orthogonal combinations' (Endpoints)
- Lexeo Therapeutics and FUJIFILM announce partnership to co-develop gene therapies (Pharmafile)
- EU Revamps Plans To Ease Medicines Trade Between GB and NI (Pink Sheet)
- EU proposes to delay IVD Medical Device Regulation, citing COVID-19 backlog (MedtechDive)
- Pear Therapeutics Obtains First Medicaid Coverage For PDTs (MedtechInsight)
- Medtronic pledges R&D boost, brand refresh, amid rising Big Tech rivalry (MedtechDive)
- Exscientia AI study spots which blood cancer therapies work and which don’t (Fierce)
- Laborie expands GI profile with purchase of Pelvalon and its female fecal incontinence device (Fierce)
- Pfizer Gives Gov't More Time To Study $2.3B Trillium Deal (Law360)
- Philips Hit With $200M Suit By CPAP Cleaner Co. Over Recall (Law360)
- Allergan Inks $30M Deal With Restasis Buyers In Antitrust Suit (Law360)
- Pharma Co. Teligent Opens Ch. 11 in Del. With $130M Debt (Law360)
- Bayer Tells High Court To Curb Flanax Fight Again (Law360)
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