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COVID-19 vaccines

Regulatory Reconnaissance: Daily Regulatory News and Intelligence Briefing

Strategic Insights

— 2 min read

Regulatory Affairs Professionals Society released daily news and intelligence briefings, covering major regulatory, biopharma, and medtech stories from around the globe. Key storylines include the US CDC panel endorsing Moderna vaccine for Americans, vaccine distribution efforts, and approvals of new treatments and medications.

Key Takeaways:

  • The US CDC panel has endorsed the Moderna vaccine for Americans, with frontline workers and people over 74 prioritized for shots.
  • The FDA has declined approval of Novartis' cholesterol-lowering drug, and COVID-19 vaccination drives are underway in nursing homes.
  • The Biden administration is planning to receive a coronavirus vaccine on Monday, marking the beginning of the US inoculation effort.
  • The Sacklers' $10 billion transfer from their company was motivated by fear of OxyContin lawsuits.
  • AstraZeneca's Tagrisso has received broader FDA approval for lung cancer, and a third COVID-19 vaccine could arrive in the US next month.
  • The Warp Speed official has taken blame for overcounting COVID-19 vaccine allocations.
  • Pfizer's COVID-19 vaccine has been approved in the EU, with an agreed-upon price of 15.50 euros per dose.
  • Switzerland and the UK have begun administering Pfizer's COVID-19 vaccine, and the WHO expects a limited rollout by the end of January.
  • Japan's government board has found inconclusive data on the efficacy of a COVID-19 drug candidate, Avigan.
  • Nestle has received European Commission approval for its peanut allergy drug, Palforzia.
  • Agios has sold its cancer business to a French drug maker for up to $2 billion, focusing on inherited diseases instead.
  • The UK is expediting drug trials post-Brexit, and pharmacies are playing a crucial role in the vaccine distribution effort.
  • The FDA has approved experimental drugs for long-haul COVID-19 patients and issued guidelines on COVID-19 vaccination after allergic reactions.
  • The WHO has stated that there is no need for major alarm over the new coronavirus strain, and the EU executive has been asked to set guidelines on Britain travel curbs.

Statistics:

  • The US CDC panel has endorsed the Moderna vaccine for Americans.
  • 500,000 COVID shots have been administered in the UK.
  • 20,000 people have been recruited for COVID-19 vaccine trials in China.
  • COVID-19 vaccination drives are underway in over 20 countries.
  • The FDA has received applications for over 10 new COVID-19 vaccines.
  • The Warp Speed program has allocated over 1 million COVID-19 vaccines in the US.
  • Pfizer has shipped over 10 million COVID-19 vaccines worldwide.
  • The EU has approved the Pfizer-BioNTech COVID-19 vaccine for use in the region.

Sources:

  • New York Times
  • Reuters
  • STAT
  • Fierce
  • Pink Sheet
  • Regulatory Affairs Professionals Society
  • FDA
  • Department of Justice
  • CNBC
  • Law360
  • Big Molecule Watch
  • Regulatory Focus
  • RAPS

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