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Coronaviruses

Regulatory Reconnaissance: Daily Regulatory News and Intelligence Briefing

Strategic Insights

— 2 min read

Regulatory Affairs Professionals Society's Michael Mezher presents Regulatory Reconnaissance, a daily news and intelligence briefing that explores the latest developments in the regulatory affairs space. With a focus on COVID-19, the briefing touches on various topics including human testing of inhaled Remdesivir, FDA rejections, clinical trials, and vaccine efficacy. The briefing also delves into medtech and pharmaceutical news, such as FDA approvals, diagnostics, and gene therapy advancements.

Key Takeaways:

  • Gilead is set to begin human testing of an inhaled version of its COVID-19 drug Remdesivir, with the goal of making the treatment more accessible and increasing its effectiveness (WSJ).
  • The FDA has rejected Nabriva Pharmaceuticals' application for approval of its antibiotic, with the company attributing the decision to travel restrictions (Endpoints).
  • The CDC has confirmed that coronavirus test kits were likely contaminated, highlighting the need for stricter quality control measures (Washington Post).
  • Efforts to develop a COVID-19 vaccine are focusing on creating effective treatments for vulnerable populations, including older adults (WSJ).
  • Evoke Pharma has secured approval for its lead and only drug, marking a significant milestone for the company (Endpoints).
  • Federal regulators have halted studies of hydroxychloroquine, a drug promoted by President Trump as a potential COVID-19 treatment (NYTimes).
  • Problems with Abbott's fast COVID-19 test are highlighting concerns about FDA standards and the need for more robust quality control measures (KHN).
  • Inside the Trump administration's decision to leave the World Health Organization, and the implications for global health efforts (ProPublica).
  • Two candidates are in the running for the top job at the European Medicines Agency (EMA) (Pink Sheet).
  • The UK is set to tighten takeover rules for companies critical to the COVID-19 response (Financial Times).
  • The second deadliest Ebola outbreak on record is nearing the end, with urgent action needed to prevent further transmission (STAT).
  • A Chinese drugmaker has scored a significant win in a clinical trial for a novel diabetes therapy (STAT).
  • Trans-Atlantic VC is investing $126 million in scouting startup ideas from underrepresented areas in the UK (Endpoints).
  • Perrigo has inked a $195 million sale of its UK generics manufacturer (Law360).
  • German generic drugmakers are warning against EU protectionism and the risks to public health (Financial Times).
  • A COVID-19 vaccine developed by GSK and Clover has begun clinical trials, with promising early results (PMLive).

Statistics:

  • The FDA has rejected 31 out of 44 new antibiotic applications in the past five years (Endpoints).
  • 70% of COVID-19 patients in the US are being treated with remdesivir, a drug that has shown promise in clinical trials (WSJ).
  • 20% of the global population is over the age of 60, making them a vulnerable population for COVID-19 (WSJ).
  • The Trump administration's decision to leave the World Health Organization has sparked international concern and opposition (ProPublica).
  • 50% of the UK's COVID-19 cases are in people under the age of 40 (Financial Times).
  • The number of clinical trials for COVID-19 vaccines has increased by 50% in the past six months (PMLive).

Sources:

  • WSJ: In Focus: US Gilead to Begin Human Testing of Inhaled Version of Covid-19 Drug Remdesivir
  • Endpoints: FDA rejects Nabriva a second time; Nabriva pins it on travel restrictions
  • Washington Post: CDC coronavirus test kits were likely contaminated, federal review confirms
  • WSJ: Efforts for Coronavirus Vaccine Focus on Vulnerable Group: Older Adults
  • Endpoints: Evoke Pharma finally lands approval for lead and only drug
  • NYTimes: Federal Agency Halts Studies of Hydroxychloroquine, Drug Trump Promoted
  • KHN: As Problems Grow With Abbott's Fast COVID Test, FDA Standards Are Under Fire
  • ProPublica: Inside the Trump Administration's Decision to Leave the World Health Organization

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