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Recon: FDA advisors narrowly back Merck’s COVID drug; Sanofi to buy Origimm for its acne vaccine candidate

Posted 01 December 2021 | By Michael Mezher 

Recon: FDA advisors narrowly back Merck’s COVID drug; Sanofi to buy Origimm for its acne vaccine candidate

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • FDA advisers narrowly endorse Merck's Covid-19 drug (Politico) (NYTimes) (STAT)
  • FDA finds 'low likelihood' omicron will impact COVID-19 PCR, antigen tests (MedtechDive)
  • Testing labs brace for first U.S. cases of Omicron (Politico)
  • Prosecutors Push Elizabeth Holmes of Theranos to Take Responsibility (NYTimes) (CNBC)
  • 23andMe Earmarks Cash From SPAC Deal for Drug Development (WSJ)
  • States: Sackler family members abusing bankruptcy process (AP)
  • Moderna could be sued over vaccines as court upholds patents (Reuters) (Endpoints)
  • White House says DOJ will defend government's authority to promote vaccine requirement (Reuters)
In Focus: International
  • EU brings forward Pfizer/BioNTech COVID shot for younger children to Dec 13 (Reuters)
  • Britain led the way in COVID trials, but overall clinical study activity still lags: report (Fierce)
  • Sanofi to buy Origimm Biotechnology for acne vaccine candidate (Reuters) (Fierce)
  • Increase in manufacturing capacity for COVID-19 vaccine from AstraZeneca (EMA)
  • Commission reiterates calls to step up vaccination, rapid deployment of boosters, vigilance and rapid reaction to Omicron variant (European Commission)
  • Addressing together current and new COVID-19 challenges (European Commission)
  • WHO agrees to launch talks on pact to tackle pandemics (Reuters)
Coronavirus Pandemic
  • Vaccine makers split on protection against Omicron variant (FT)
  • WHO says omicron has been found in 23 countries across the world (CNBC)
  • TGA Provisional Approval of Roche Products Pty Ltd COVID-19 treatment, tocilizumab (ACTEMRA) (TGA)
Pharma & Biotech
  • Vertex once again talks up a tiny trial with positive read-throughs, this time for a genetically driven approach to kidney disease (Fierce) (BioPharmaDive) (STAT)
  • J&J cell therapy head exits to take up post at fledgling biotech (Fierce)
  • Just how many barriers do health insurers create to fair access to medicines? (STAT)
  • What's fair? New ICER report shows payers generally ensuring fair access to drugs (Endpoints)
  • Socially responsible investor coalitions push greater access to medicines in shareholder proposals (STAT)
  • Statera Biopharma gets the OK to resume the study of a potential stockpile drug for lethal radiation exposure (Endpoints)
  • Looking to run with Big Pharma, a radiopharma startup with backing from Atlas, RA thinks it has the chops to compete (Endpoints)
  • Apollo Health Ventures pumps another $180M into the burgeoning race to slow aging (Endpoints)
  • VBI Vaccines execs tout approval of new triple-antigen hepatitis B shot. Can they sell it? (Endpoints)
  • Months after shocking investors with lung cancer win, BeyondSpring's lead drug hits roadblock at the FDA (Endpoints)
Medtech
  • Medical device security continues to be casualty of hospital-medtech divide (MedtechDive)
  • Cyber playbook sets out strategies for modeling threats to medical devices (MedtechDive) (MedtechInsight)
  • PrecisionOS gears up for 2022 launch of newly FDA-cleared surgical planning VR tool (Fierce)
Government, Regulatory & Legal
  • Amgen stalls Samsung's Enbrel biosim until 2029 in 2nd patent win of the year (Fierce)
  • Biogen loses bid to reverse loss in Mylan MS drug patent dispute (Reuters) (Fierce)
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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