Regulatory Focus™ > News Articles > 2021 > 6 > Recon: US buys another 200M doses of Moderna vaccine; First patient receives Biogen Alzheimer's drug

Recon: US buys another 200M doses of Moderna vaccine; First patient receives Biogen Alzheimer's drug

Posted 16 June 2021 | By Michael Mezher 

Recon: US buys another 200M doses of Moderna vaccine; First patient receives Biogen Alzheimer's drug

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • US buys 200 mln more Moderna COVID-19 vaccine doses (Reuters)
  • First patient receives controversial Biogen Alzheimer's drug (Reuters)
  • Regeneron’s antibody therapy cuts deaths among some hospitalised COVID-19 patients -study (Reuters) (STAT)
  • US authorizes another 14 mln doses of Johnson & Johnson's COVID-19 vaccine -sources (Reuters)
  • Lawmakers revive legislation to accelerate the development of new antibiotics (STAT)
  • Former FDA chief Hahn defends his jump to Flagship Pioneering, the firm behind Moderna (STAT)
  • ‘A litany of flaws’: Advocacy group urges HHS to boot FDA officials over Alzheimer’s drug approval (STAT) (Endpoints)
  • FDA approves Mallinckrodt's regenerative skin burn graft after 4-month delay (Fierce) (FDA)
  • Bucks County Drug Manufacturer and Two Executives Charged with Conspiracy to Defraud the FDA (FDA)
In Focus: International
  • EU approval of Russia's Sputnik V vaccine delayed, sources say (Reuters)
  • Russia's RDIF expects EMA approval of Sputnik V COVID-19 vaccine within two months -Ifax (Reuters)
  • EU says J&J to miss vaccine supply target in second quarter (Reuters)
  • Australian spinout eyes the clinic with a prophylactic nasal spray for Covid-19 (Endpoints)
Coronavirus Pandemic
  • HTop Trump officials pushed the Covid-19 lab-leak theory. Investigators had doubts. (Politico)
  • England seeks to make COVID-19 vaccinations compulsory for care workers (Reuters)
  • India says gap between vaccine doses based on scientific evidence (Reuters)
  • LetsGetChecked receives EUA for use of at-home COVID-19 collection kit by minors (MedtechDive)
Pharma & Biotech
  • Sanofi agrees to inject tens of millions of pounds into UK pension scheme (FT)
  • Opinion: CMS needs to do FDA’s job and limit the use of Biogen’s pricey new Alzheimer’s drug (Endpoints)
  • NICE Decision On Arthritis Opens Door For Biosimilars In England (Pink Sheet)
  • US FDA’s Botanical Drugs Guidance Will See Rare Outing For Amryt’s Filsuvez NDA (Pink Sheet)
  • EU Council Calls for Discussions On New Pricing Mechanisms (Pink Sheet)
  • EU Health Ministers Back Stronger Pandemic Role For EMA (Pink Sheet)
  • With $71M investment, French CDMO Yposkesi set to double capacity and become a viral vector force (Fierce)
  • Novo Nordisk to research oral obesity treatment; Dana-Farber taps into Harbour BioMed's mice platform in multiyear deal (Endpoints)
  • A UK biotech looks to upset the preclinical model for liver drug development, and now it's gearing up for the clinic (Endpoints)
  • After a decade in the type 2 diabetes game, Fractyl Laboratories recharges with a fresh $100M and a new name (Endpoints)
  • Amid sluggish sales and dueling lawsuits, Novartis bows out of Amgen partnership, slashes staff (Endpoints)
  • Lupin Announces FDA Acceptance of aBLA for Pegfilgrastim Biosimilar (Big Molecule Watch)
  • An Israeli biotech is looking to make its name in the jam-packed CD47 space. Is bifunctionality the answer? (Endpoints)
  • Chinese oncology specialist Zai Lab brokers a deal with MacroGenics for up to 4 bispecifics with a modest down payment (Endpoints)
  • Another life sciences SPAC has popped up from a small biotech CEO with the help of Takeda, Novartis veterans (Endpoints)
  • Michel Sadelain puts his name and new cell engineering tech behind 'agnostic' CAR-T startup chasing epigenetic antigens (Endpoints)
  • Novartis receives FDA Breakthrough Therapy designation for investigational 177Lu-PSMA-617 in patients with metastatic castration-resistant prostate cancer (mCRPC) (Press)
  • The 340B Program Soared to $38 Billion in 2020—Up 27% vs. 2019 (Drug Channels)
  • Stryker Seeks Exemption For Patient-Transport Devices (MedtechInsight)
  • FDA advisory panel to review TransMedics' liver preservation device (MedtechDive)
  • Netherland’s DEKRA Is Latest Notified Body Designated Under EU IVDR (MedtechInsight)
  • Fractyl nets $100M to complete development of its intestine-washing device for Type 2 diabetes (Fierce)
  • Chinese regulatory bodies provide updates on revised medical device regulations (Emergo)
Government, Regulatory & Legal
  • Drugmakers Can't End Calif. Opioid Trial, Judge Rules (Law360)
  • Gilead Wants Whistleblowers' Drug Rx Kickback Suit Killed (Law360)
  • Mallinckrodt Ch. 11 Plan Disclosure Challenges Shot Down (Law360)
  • The Kodak insider trading drama continues as CEO set for questioning in NY state probe (Endpoints)
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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