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)
- 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)
- Vietnam to mix Moderna and Pfizer-BioNTech COVID-19 vaccines – media (Reuters)
- Hetero To Debut Biosimilar Actemra, Giving India Grasp On Supplies Security (Scrip)
- 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)
- 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)
- AbbVie Settles Patent Dispute Over Muscle Stimulation Tech (Law360)
- SEC Says Mallinckrodt Ch. 11 Plan Releases Should Be Opt-In (Law360)
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