Regulatory Affairs Professionals Society's Daily Regulatory News and Intelligence Briefing

Strategic Insights -

The Regulatory Affairs Professionals Society releases a daily intelligence briefing, Regulatory Reconnaissance, that provides a comprehensive overview of the latest regulatory news and updates from around the world. The briefing highlights key developments in the pharmaceutical and medical device industries, including new product approvals, clinical trials, and regulatory policies. A quarter of Americans are hesitant about receiving a coronavirus vaccine, according to a Reuters/Ipsos poll. Prominent scientists have denounced the end of a coronavirus grant, while doctors question the FDA's protocol for plasma treatment of coronavirus patients. The briefing also covers the approval of the first generic for Amarin's Vascepa and the FDA's investigation into a lab that has questioned tens of thousands of COVID-19 test results in Florida.

Key Takeaways:

  • A quarter of Americans are hesitant about receiving a coronavirus vaccine, according to a Reuters/Ipsos poll (Reuters).
  • The FDA has approved the first generic for Amarin's Vascepa, which may lead to a fish oil price war (Endpoints, Press).
  • The FDA has started an investigation into a lab that has questioned tens of thousands of COVID-19 test results in Florida (USA Today).
  • Prominent scientists have denounced the end of a coronavirus grant in the United States (NYTimes, Science).
  • Doctors are questioning the FDA's protocol for plasma treatment of coronavirus patients (Yahoo).
  • The US FDA has approved a Parkinson's treatment from Sunovion Pharma (Reuters, Endpoints).
  • The US FDA has approved a COVID-19 vaccine trial, which will be conducted by Sinovac (Reuters).
  • Roche has acquired Stratos Genomics, a US gene sequencing tech company (Reuters, Press).
  • Britain has agreed to buy 10 million antibody tests from Roche and Abbott (Reuters).
  • Human trials of a British coronavirus vaccine are expected to reach 10,000 participants (Reuters, BBC).
  • South Korea's Samsung Biologics has signed a $231 million supply deal with GSK (Reuters, Endpoints).
  • The FDA has approved a rapid coronavirus test used in the White House, with high accuracy (Reuters).
  • The US government has urged the WHO to start a review of the pandemic response, seeking reforms (Reuters).

Statistics:

  • 25% of Americans are hesitant about receiving a coronavirus vaccine (Reuters/Ipsos poll).
  • 10 million antibody tests will be purchased by Britain from Roche and Abbott (Reuters).
  • $231 million: the value of the supply deal signed by South Korea's Samsung Biologics with GSK (Reuters, Endpoints).
  • 10,000 participants: the expected number of participants in human trials of a British coronavirus vaccine (Reuters, BBC).
  • 34M: the value of the Celgene deal that has won initial approval (Law360).

Sources:

  • Reuters
  • Endpoints
  • Press
  • NYTimes
  • Science
  • Yahoo
  • USA Today
  • BBC
  • Fierce
  • Phlow
  • Reuters
  • Nikkei
  • PharmaTimes
  • MassDevice
  • KHN
  • Law360
  • TGA
  • Regulatory Focus
  • RAPS