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September 8, 2021
by Michael Mezher

Recon: Sanofi acquires Kadmon for $1.9B; COVAX cuts 2021 delivery target by 1.425B doses

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Moderna turns to biotech startup to ramp up Covid vaccine manufacturing (STAT)
  • As experts debate boosters, vaccinated people are calling their own shots (Washington Post)
  • Heather Bresch, Joe Manchin’s daughter, played direct part in Epipen price inflation scandal (The Intercept)
  • Novavax begins early-stage trial for combined influenza/COVID-19 vaccine (Reuters)
  • Fraud trial of Theranos founder Elizabeth Holmes set to begin (Reuters)
  • Top Pfizer scientist defends Covid vaccine booster push and jab’s potency (FT)
In Focus: International
  • Sanofi acquires Kadmon for $1.9B, adding transplant medicine drug (STAT) (Reuters) (Endpoints)
  • COVAX vaccine 2021 delivery target cut to 1.425 billion doses (Reuters) (FT) (WHO)
  • AstraZeneca boss Soriot says do not rush needlessly into COVID booster vaccines (Reuters)
  • UK's Exscientia, Gates Foundation partner to develop variant-resistant COVID-19 drugs (Reuters)
  • UK start-up uses AI to design antiviral pills to prevent pandemics (FT)
Coronavirus Pandemic
  • Vietnam to mix Moderna and Pfizer-BioNTech COVID-19 vaccines – media (Reuters)
  • Hetero To Debut Biosimilar Actemra, Giving India Grasp On Supplies Security (Scrip)
Pharma & Biotech
  • With industry's blessing, FDA launches novel excipient review pilot program (Endpoints)
  • In another sign of RNA’s growing popularity, the cancer startup Replicate is relaunching (STAT)
  • 'The sky is not falling.' Cautious optimism follows FDA meeting on gene therapy risks (BioPharmaDive)
  • The Pandemic Has Set Back the Fight Against H.I.V., TB and Malaria (NYTimes)
  • Moderna surfaces as the first partner for Jim Wilson's rare disease nonprofit, donating an mRNA program at no cost (Endpoints)
  • Inside Verily’s make-or-break push to turn its most promising ideas into profits (STAT)
  • Months after landing Canadian site from government, Resilience announces a big mRNA partner (Endpoints)
  • 'Like a kid in a candy shop': Michael Ehlers gets behind RNA 'copy machine' tech (Endpoints)
  • J&J’s prostate cancer drug recommended by NICE (Pharmafile)
  • Insilico puts undruggable cancer targets in its crosshairs with Huadong alliance (Fierce)
  • As bluebird plans its big split, rare disease head Andrew Obenshain recruits Ironwood vet as CFO (Endpoints)
  • MacroGenics flips over an OS dud for cancer drug Margenza in surprising turnaround from earlier data (Endpoints)
  • Years after Pfizer passed on a buyout option, AM-Pharma finds a new partner for its kidney drug (Endpoints)
  • Merck KGaA entrusts secretive startup with a mid-stage cancer drug targeting master signaling pathway (Endpoints)
  • One of Tachi's newly born legacy biotechs raises $135M and enlists an A-list board to advance late-stage vaccine (Endpoints)
Medtech
  • EU expert panel starts accepting applications to review high-risk IVDs (MedtechDive)
  • Bill Gates-backed Vicarious Surgical targets Intuitive, J&J, Medtronic in abdominal robotic surgery (MedtechDive)
  • The Regulatory Growing Pains For Digital Health Companies (Law360)
  • Spine devices, recalls and endovascular stents on FDA's fall meeting lineup (MedtechDive)
  • Merck taps Illumina to develop companion diagnostics for ovarian cancer treatments (Fierce)
Government, Regulatory & Legal
  • AbbVie Settles Patent Dispute Over Muscle Stimulation Tech (Law360)
  • SEC Says Mallinckrodt Ch. 11 Plan Releases Should Be Opt-In (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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