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.
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The US Food and Drug Administration (FDA) issued final guidance on 13 August regarding the types and timelines for formal meetings that sponsors can request during the development of new drugs and biological products.
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