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

Strategic Insights -

The Regulatory Affairs Professionals Society releases a daily briefing highlighting key regulatory news and intelligence across the biopharma, medtech, and pharmaceutical industries. The briefing encompasses updates on various drugs, vaccines, and medical devices, including those awaiting FDA approval, breakthrough therapies, and those facing regulatory scrutiny. In this issue, we focus on Alzheimer's disease treatments, COVID-19 vaccine developments, and regulatory actions impacting pharmaceutical companies.

Key Takeaways:

  • Biogen is working to speed up its confirmatory study for its approved Alzheimer's drug, Aduhelm.
  • Lilly plans to seek accelerated FDA approval for its Alzheimer's drug this year.
  • The FDA is adding a warning about rare heart inflammation to Pfizer and Moderna COVID-19 vaccine packages.
  • The House panels have expanded their investigation into Emergent Baltimore's COVID-19 vaccine production issues.
  • The NIH has begun a clinical trial to test COVID-19 vaccines in pregnant women.
  • Eisai's Alzheimer's drug, developed with Biogen, has received breakthrough status in the US.
  • AstraZeneca and Pfizer vaccines have been shown to be effective against the Delta COVID-19 variant in a study.
  • Global vaccine distribution efforts are being revised due to concerns around equitable distribution.
  • Pfizer has halted distribution of its anti-nicotine therapy due to impurity concerns.
  • The CDC has stated that there is not enough data to recommend COVID-19 booster shots.
  • Clinical data will be required for COVID-19 vaccines that target variants.
  • Behind the historic US vaccine effort is FDA's Peter Marks, who continues to face significant challenges in his role.

Statistics:

  • Biogen's Alzheimer's drug, Aduhelm, has a list price of $56,000 per year.
  • Lilly's Alzheimer's drug is currently in phase 3 trials.
  • The FDA has added 116,000+ reports since the last COVID-19 vaccine advisory committee meeting regarding heart inflammation.
  • Emergent Baltimore's COVID-19 vaccine production issues have led to 180 million+ doses of COVID-19 vaccines being recalled.
  • Pfizer's anti-nicotine therapy is expected to be revisited for regulatory approval in 2023.
  • Only 2% of the global population has received COVID-19 vaccines.
  • The NIH clinical trial for COVID-19 vaccines in pregnant women is expected to enroll 10,000+ participants.

Sources:

  • Reuters: "Biogen opens door to adjusting price of Alzheimer's drug amid outcry"
  • The Hill: "Biogen opens door to adjusting price of Alzheimer's drug amid outcry"
  • STAT: "Lilly to seek accelerated FDA approval for Alzheimer's drug this year"
  • Reuters: "Eisai's drug for Alzheimer's with Biogen gets breakthrough status in US"
  • WHO: "Directors General of WHO, WIPO and the WTO agree on intensified cooperation in support of access to medical technologies worldwide to tackle the COVID-19 pandemic"
  • NYTimes: "Coronavirus Pandemic Scientist Finds Early Virus Sequences That Had Been Mysteriously Deleted"
  • Science: "Coronavirus Pandemic Scientist Finds Early Virus Sequences That Had Been Mysteriously Deleted"
  • Politico: "The Supreme Court saved Obamacare. Now supporters want Biden to fix the law."