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Recon: US buys 200M more doses of Pfizer vaccine; European Commission opens in-depth investigation into Illumina's bid to acquire Grail

Posted 23 July 2021 | By Michael Mezher 

Recon: US buys 200M more doses of Pfizer vaccine; European Commission opens in-depth investigation into Illumina's bid to acquire Grail

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • United States buys 200 mln more doses of Pfizer/BioNTech COVID-19 vaccine (Reuters)
  • CDC advisers hold off on Covid booster shot call (Politico) (WSJ)
  • U.S. CDC advisers back J&J COVID-19 vaccine benefits amid neurological illness reports (Reuters)
  • Facing Headwinds on New Alzheimer’s Drug, Biogen Launches Controversial Campaign (KHN)
  • AstraZeneca's once-weekly diabetes drug gets U.S. nod for children (Reuters)
  • Drugmaker Endo settles opioid claims by Tennessee counties, cities for $35 mln (Reuters)
  • FDA classifies Philips ventilator recall as most serious (Reuters)
  • Novartis to pay nearly $178M in lawsuit over BRAF drug — and will be on the hook for royalty (Endpoints)
  • Most clinical trials failed to meet U.S. transparency requirements for recently approved drugs (STAT)
  • Philadelphia pushes back against national opioid settlement: 'This is a sellout' (The Hill)
  • Gilead to Pay Investors $1.8 Million in Fees Over Truvada Files (Bloomberg Law)
In Focus: International
  • Moderna COVID-19 vaccine gets EU regulator endorsement for teens (Reuters) (Endpoints)
  • EU pledges 200 million COVID vaccine doses to poor countries (AP)
  • Japan PM seeks faster COVID vaccine delivery from Pfizer- media (Reuters)
  • European Commission launches months-long antitrust investigation into Illumina’s $8B bid for Grail (Fierce)
  • Northern Ireland set to lose access to 2,000 medicines (FT)
Coronavirus Pandemic
  • Spacing Pfizer COVID shots boosts antibody levels in long-term study (Reuters)
  • Anticipating The FDA's Shift Away From Emergency Approvals (Law360)
  • TGA Provisional Approval of Pfizer-BioNTech COVID-19 vaccine to include 12-15 years age group (TGA)
  • Quest Diagnostics is seeing a rise in Covid tests as delta variant spreads, CEO says (CNBC)
  • WHO urges collaboration on virus origin after China rejects inquiry plan (Reuters)
  • Olympic organisers grappling with COVID testing kit shortfall – NHK (Reuters)
  • Public Health England says signs of increased reinfection risk with Delta variant (Reuters)
  • Vaccinated people make up 75% of recent COVID-19 cases in Singapore, but few fall ill (Reuters)
  • US government drops $200M into South African manufacturing operation for Covid-19 vaccines (Endpoints)
Pharma & Biotech
  • 6 top drugmakers offer perspectives on FDA's new covariates in RCTs guidance (Endpoints)
  • Alphabet firm DeepMind releases massive database of 3D protein structures (STAT)
  • U.S. sees first cases of dangerous fungus resistant to all drugs in untreated people (STAT)
  • Interchangeable Biosimilars: Insulin Likely First But Humira May Be More Important Precedent (Pink Sheet)
  • Takeda lays out $126M to tap robotics, virtual reality and more at California production site (Fierce)
  • CHMP endorses review finding no link between viral vector in Zynteglo and blood cancer (EMA)
  • Three biotechs price hefty IPOs just before the weekend, while a fourth and a SPAC seek spots on Wall Street (Endpoints)
  • Recipharm to construct new Indian fill-finish facility as part of existing relationship with Nichepharm founding family' (Endpoints)
  • Seattle's Lumen will move into new headquarters in former long-lived bakery amid trial expansion (Endpoints)
  • New data show BioMarin's troubled hemophilia gene therapy continues to fade, opening room for rivals (Endpoints)
  • Adverum faces murky future after review turns up deeper safety issues for gene therapy (Endpoints)
  • Biogen has a shaky end to H1 with a $542M write-off adding to its woes — but analysts see big revenue ahead for Aduhelm (Endpoints)
  • New NICE guideline on C. difficile rejects metronidazole prescription (Pharmafile)
  • CDRH still digging out of backlog caused by COVID-19: Shuren (MedtechDive)
  • US FDA’s Shuren: Device Center Will Roll Out New Strategic Priorities In 2022 (MedtechInsight)
  • Brain-Mapping Device US FDA-Cleared To Help Surgeons Better Visualize Surgical Area (MedtechInsight)
  •  PacBio snaps up DNA sequencing startup Omniome in deal worth up to $800M (Fierce)
  • Expansion for first FDA-approved video game for ADHD treatment (Pharmafile)
Government, Regulatory & Legal
  •  Pump Maker Loses Bid To Appeal Roche's UK Patent Win (Law360)
  • Pfizer Unit Loses Appeal In Vaccine Fight With Merck Branch (Law360)
  • CR Bard Nets 2 Wins, 1 Loss In Faulty IVC Filter Suits (Law360)
  • Missouri Supreme Court rules in favor of Medicaid expansion (The Hill)
  • Dems Want Social Media Cos. Liable For Vax Misinformation (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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