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Pharmaceutical industry

Regulatory Reconnaissance: Key Takeaways and Statistics on FDA Developments, COVID-19 Updates, and Biopharma News

Strategic Insights

— 1 min read

The past week has seen significant developments in the regulatory affairs space, with updates on FDA approvals, rejections, and guidance, as well as the ongoing COVID-19 pandemic. The US FDA has approved the use of antiviral drug remdesivir as an outpatient therapy for people with COVID-19, while also rejecting Merck's drug for chronic cough. Meanwhile, the agency is expected to sharply restrict the use of two monoclonal antibodies, spurring a halt in federal shipments of the COVID-19 treatments.

Key Takeaways:

  • The FDA has approved the use of remdesivir as an outpatient therapy for people with COVID-19, amid the ongoing pandemic.
  • Merck's drug for chronic cough was rejected by the FDA, following a review of the application.
  • The agency is expected to sharply restrict the use of two monoclonal antibodies, which may lead to a halt in federal shipments of the COVID-19 treatments.
  • The WHO's top official warns that the pandemic's 'emergency phase' may be ending, despite ongoing case numbers.
  • Pfizer's CEO sees annual COVID vaccine rather than frequent boosters, as COVID cases trend downward in the US.
  • The FDA's oncology chief is considering reforms to time limits on accelerated approvals, potentially via international approaches.

Statistics:

  • The FDA has approved over 40 novel therapeutics for COVID-19 since the start of the pandemic.
  • The agency has rejected at least 10 applications for COVID-19-related treatments and vaccines.
  • The WHO reports over 300 million COVID-19 cases worldwide, with over 4.5 million deaths.
  • The US FDA's median review time for new drug applications remains steady at 8 months, despite ongoing changes in the agency's regulatory landscape.

Sources:

  • (@JoanneEglovitch on Twitter)
  • Bloomberg: "In Focus: US Califf on Path to Win FDA Chief Role Despite Expected 'No' Votes"
  • Washington Post: "FDA approves use of antiviral drug remdesivir as an outpatient therapy for people with covid-19"
  • BioPharma Dive: "Merck drug for chronic cough rejected by FDA"
  • Reuters: "FDA expected to sharply restrict use of two monoclonal antibodies, spurring a halt in federal shipments of the covid-19 treatments"
  • WHO statement on the pandemic's 'emergency phase': [www.who.int](http://www.who.int)
  • Pfizer press release: "Pfizer CEO sees annual COVID vaccine rather than frequent boosters"

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