Regulatory Focus™ > News Articles > 2021 > 10 > Recon: White House reportedly eyeing Califf as FDA commissioner; EU kicks off review of AstraZeneca

Posted 14 October 2021 | By Michael Mezher 

Recon: White House reportedly eyeing Califf as FDA commissioner; EU kicks off review of AstraZeneca COVID antibody cocktail

2840 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)
In Focus: International
  • 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)
Coronavirus Pandemic                                                                                                                                       
  • 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)
Pharma & Biotech
  • 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)
Government, Regulatory & Legal
  • 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)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.


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