Recon: FDA puts Inovio COVID-19 vaccine trial on hold; Pfizer urged to gather more safety data before seeking vaccine EUA

| 28 September 2020 | By Michael Mezher 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Inovio Covid-19 Vaccine Trial Placed on Hold After FDA Questions (WSJ) (Reuters)
  • New document reveals scope and structure of OWS, underscores vast military involvement (STAT)
  • The 8 most important leaders of Operation Warp Speed (STAT)
  • Trump’s drug card plan sows confusion – even within administration (Politico)
  • FDA coffers are tapped for a down payment on a $300M COVID-19 PSA (Endpoints)
  • J&J Covid-19 Vaccine Produced Immune Response in Earlier-Stage Study (WSJ)
  • Pfizer Urged to Wait for November to Seek Vaccine Authorization (Bloomberg Law)
  • GSK’s Nucala targets rival AstraZeneca with FDA nod for rare white blood cell disease (Fierce) (FDA)
  • One year after Fetroja approval, Shionogi expands label to include difficult-to-treat pneumonia (Endpoints)
In Focus: International
  • Trudeau says he will 'take into account' U.S. drug import plans but will put Canadians first (Reuters)
  • Brexit red tape set to create weeks of delay for patients awaiting drugs (FT)
  • Roche says 59% of SMA patients getting Evrysdi can sit: trial data (Reuters)
  • ABPI and EFPIA call for medicines prioritisation in UK/EU trade talks (PharmaTimes) (Press)
  • Gilead’s oral JAK inhibitor filgotinib wins EU approval (PharmaTimes)
  • Leader of India Says Country’s Vaccine Industry Will ‘Help All Humanity’ (NYTimes)
  • Johnson to boost WHO backing with £571m vaccine pledge (FT)
  • Changing the game to improve availability and affordability of quality-assured insulin and associated devices (WHO)
Coronavirus Pandemic
  • Positive COVID-19 test rates top 25% in some U.S. Midwest states (Reuters)
  • A Real Vaccine Before the Election? It’d Take a Miracle. (ProPublica)
  • Top White House Official Denies Pressuring FDA on Vaccine Guidelines (NYTimes)
  • Trump, White House demand FDA justify tough standards for coronavirus vaccine, raising concerns of political interference (Washington Post)
  • A layperson’s guide to how — and when — a Covid-19 vaccine could be authorized (STAT)
  • CDC director contradicts Trump on coronavirus: 'We're nowhere near the end' – NBC (Reuters)
  • CMS lowers barriers for labs seeking COVID-19 test certification (MedtechDive)
Pharma & Biotech
  • EMA Has Work Cut Out Before New Clinical Trial Portal Goes Live (Pink Sheet)
  • Italy: Pharma May Have To Disclose Confidential Info Under New Pricing Rules (Pink Sheet)
  • Taking The ‘O’ Out Of RTOR: US FDA’s Real-Time Review Primed For Expansion Beyond Oncology (Pink Sheet)
  • A Rundown Of Real-Time Oncology Review Approvals And Pending Applications (Pink Sheet)
  • MHLW Economic Affairs Chief Not Optimistic about Reaching 80% Generic Target (PharmaJapan)
  • At two-year follow-up, Evrysdi continues to show numerical improvements in data, Roche says (Endpoints)
  • Galecto reaps $64M to bring lead drug across IPF finish line, while making moves in NASH and beyond (Endpoints)
  • Gilead wins a blockbuster consolation prize with EC, Japanese approvals for filgotinib — but that barely softens the blow of the FDA's CRL (Endpoints)
  • Looking to conquer new territories, OrbiMed joins a $60M bet on a Biohaven spinout in Shanghai (Endpoints)
  • InventisBio reels in $147M to push gout and breast cancer drugs along (Endpoints)
  • Aligos Therapeutics, developing several different hep B and NASH treatments, files for $100M IPO raise (Endpoints)
  • SoftBank, Morningside help put US-China AI player on the map with $318M bet (Endpoints)
  • AbbVie: FDA Grants Orphan Drug & Fast Track Designations For Elezanumab (Nasdaq)
  • FDA gives OK for home use of CapsoVision's endoscopic camera pill (Fierce)
  • Philips launches small, push-button blood clot removal system (Fierce)
Government, Regulatory & Legal
  • US FDA’s First Amendment Defense (Pink Sheet)
  • Trump’s Executive Order on Preexisting Conditions Lacks Teeth, Experts Say (KHN)
  • The Challenges Facing Trump's Drug Pricing Order (Law360)
  • Mass. AG Says Firm Took Kickbacks To Refer Opioid Patients (Law360)
  • Swiss Referendum Outcome A Positive Step Toward Swiss/EU Future Trade Agreement (MedtechInsight)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
A story's inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.


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