Posted 23 September 2020 | By Michael Mezher 

Recon: UK to host COVID vaccine challenge trials;  Roche, AC Immune Alzheimer’s drug flops in Phase 2 study
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US

  • FDA poised to announce tougher standards for a covid-19 vaccine that make it unlikely one will be cleared by Election Day (Washington Post) (FT) (NYTimes) (Reuters)
  • CDC Advisory Panel to Delay Vote on Initial Covid-19 Vaccine Rollout (WSJ)
  • US health agency sets October 16 deadline for states to submit vaccine plans (Reuters)
  • J&J kicks off final study of single-shot COVID-19 vaccine in 60,000 volunteers (Reuters) (NYTimes)
  • Health secretary Azar says AstraZeneca trial in United States remains on hold: CNBC (Reuters)
  • Relief Therapeutics seeks US emergency approval for drug against COVID-19 (Reuters)
  • Novartis faces delay after FDA asks for another Zolgensma study (Reuters)

In Focus: International

  • UK to test vaccines on volunteers deliberately infected with Covid-19 (FT) (Reuters)
  • Sanofi spokesman says has no role in COVID-19 human challenge trial (Reuters)
  • AstraZeneca not involved in planned COVID-19 human challenge trial (Reuters)
  • Fujifilm's Avigan shown to be effective in Japanese Phase-3 trial for COVID-19 (Reuters)
  • Sanofi, GSK sign deal with Canada to supply up to 72M COVID-19 vaccine doses (Press)
  • Novartis sells bonds tied to expanding access to medicines in poor countries (STAT)
  • Roche Alzheimer's drug fails, joining long list of trial flops (Reuters)
  • Public funding underwrote much of the development of J&J’s drug for TB, analysis finds (STAT)

Coronavirus Pandemic

  • Despite Claims, Trump Rarely Uses Wartime Law in Battle Against Covid (NYTimes)
  • Senate Democrats introduce legislation to probe politicization of pandemic response (The Hill)
  • Could A COVID-19 Vaccine Gain EUA Without Sponsor Cooperation? (Pink Sheet)
  • Scientists plead for clarity on AstraZeneca’s Covid-19 vaccine trial (FT)
  • EMA Pushes For More EU Support For COVID-19 Vaccine Work (Pink Sheet)
  • New Canadian Rule Allows Rolling Data Submissions For COVID-19 Drugs, Vaccines (Pink Sheet)

Pharma & Biotech

  • ‘No Turning Back’ On Regulatory Changes at UK MHRA (Pink Sheet)
  • Sun Pharma the latest to recall metformin after carcinogen tests come up positive (Fierce)
  • ICER rubber-stamps Vertex’s $311K CF drug Trikafta but blasts ‘monopoly’ pricing (Fierce)
  • Health Canada approves Merck’s etanercept biosimilar for new indications (Big Molecule Watch)
  • FDA Officials Cite Reasons For Denying Application Reviews Over Data Integrity Breaches (Pink Sheet)
  • Vertex, CRISPR Therapeutics’ sickle cell gene therapy wins PRIME designation (PhramaTimes)
  • Blueprint plots return to FDA with new Ayvakit data in rare condition — and the analysts cheer (Endpoints)
  • ARCH’s Bob Nelsen is backing an mRNA upstart that promises to upend the entire manufacturing side of the global business (Endpoints)
  • Immetas Therapeutics nabs $11M Series A to narrow their bispecific work targeting inflammation in age-related diseases (Endpoints)
  • As its biotechs hit the pandemic exit, Longitude raises $585M for new neuro, cancer, aging and orphan-focused fund (Endpoints)
  • With $29M in Series A, Boehringer-backed Libra looks to tackle neurodegeneration through cellular cleaning (Endpoints)
  • PhII Alzheimer's failure deals new blow to Roche, AC Immune — but the tau hypothesis is far from dead (Endpoints)
  • PureTech plans Nasdaq debut with secondary listing; GoodRx prices $725M IPO (Endpoints)
  • FDA accepts supplemental new drug application for Pfizer’s Xalkori® (crizotinib) for the treatment of pediatric ALK-positive anaplastic large cell lymphoma (Press)
  • Methotrexate once-weekly for autoimmune diseases: new measures to reduce risk of fatal overdose due to inadvertent daily instead of weekly dosing (MHRA)

Medtech

  • FDA launches years-in-the-making digital health center (MedtechDive) (Fierce) (FDA)
  • Medtronic gets FDA breakthrough tag for device to prevent infections (MedtechDive)
  • FDA De Novo OKs outpace 2019 with Spineology device, two others (MedtechInsight)
  • LabCorp to roll out Resolution Bio’s lung cancer liquid biopsy test (Fierce)
  • Legal Experts Predict How US Supreme Court Shake-Up Will Impact Medtech (MedtechInsight)
  • Japan PMD Act revisions include fast-track reviews for some medical devices and IVDs (Emergo)
  • Not Too Late? German Industry Presses For EU MRA With Post-Brexit UK (MedtechInsight)

Government, Regulatory & Legal

  • International Law Enforcement Operation Targeting Opioid Traffickers on the Darknet Results in over 170 Arrests Worldwide and the Seizure of Weapons, Drugs and over $6.5 Million (DOJ)
  • Trump's Drug Pricing Order Is More Bark Than Bite (Law360)
  • Catalyst Says FDA Is Breaking Law By Approving Rival's Drug (Law360)
  • Takeda Subsidiary Seeks $130M For Drug Firm's Spinoff Fraud (Law360)
  • Feds Slam Regeneron's Attempt To Duck Kickback Suit (Law360)
  • Continuous Manufacturing Centers Of Excellence Measure Resurfaces In US House (Pink Sheet)

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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