RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

Regulatory Focus™ > News Articles > 2020 > 9 > Recon: US COVID vaccine distribution plans; EU plans new biomedical research agency

Recon: US COVID vaccine distribution plans; EU plans new biomedical research agency

Posted 16 September 2020 | By Michael Mezher 

Recon: US COVID vaccine distribution plans; EU plans new biomedical research agency

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • US plans to distribute COVID-19 vaccine immediately after regulators authorize it (Reuters) (Politico)
  • Trump says coronavirus vaccine could be weeks away (Reuters)
  • HHS chief overrode FDA officials to ease testing rules (Politico)
  • US FDA's Hahn plans 'significant' work with AstraZeneca in COVID-19 trial inquiry (Reuters)
  • Pfizer says late-stage coronavirus vaccine study shows moderate side effects (Reuters)
  • Lilly: antibody drug cuts hospitalization among moderate COVID patients (Reuters) (STAT) (Endpoints) (NYTimes)
  • Illumina Nears Deal to Buy Health-Care Startup Grail (Bloomberg) (Endpoints)
In Focus: International
  • Japan commits $165 million to WHO's global coronavirus vaccine programme (Reuters)
  • China says has seen positive results in China-UAE phase 3 COVID-19 vaccine trials (Reuters)
  • Serum Institute gets approval to resume India trial of AstraZeneca COVID vaccine: source (Reuters)
  • Turkey begins Phase III trials of Chinese coronavirus vaccine: media (Reuters)
  • Russia to sell COVID-19 vaccine to India's Dr. Reddy's Laboratories (Reuters)
  • EU to build biomedical agency, convene health summit, says Von der Leyen (Reuters)
  • Israel's Betalin Therapeutics plans IPO to fund diabetes trials (Reuters)
  • WHO’s three messages for UN75 (WHO)
Coronavirus Pandemic
  • Bridging the Gap at Warp Speed — Delivering Options for Preventing and Treating Covid-19 (NEJM)
  • COVID Vaccine Trials Move at Warp Speed, But Recruiting Black Volunteers Takes Time (KHN)
  • Even as Cases Rise, Europe Is Learning to Live With the Coronavirus (NYTimes)
  • Up Is Down — Pharmaceutical Industry Caution vs. Federal Acceleration of Covid-19 Vaccine Approval (NEJM)
  • Schumer calls for HHS Secretary Azar to resign immediately as Democrats probe coronavirus reporting (CNBC)
  • Roche gets FDA nod for faster combo coronavirus-flu test (MedtechDive)
  • U.S. could have capacity of 3 million COVID-19 tests per day, HHS official says (Reuters)
  • Coronavirus (COVID-19) Update: Daily Roundup September 15, 2020 (FDA)
Pharma & Biotech
  • Top FDA official exits; Sun Genomics closes $9.25M Series A (Endpoints) (Politico)
  • Nearly two years after their narrow PhIII failure, Orphazyme gets speedy look at the FDA (Endpoints)
  • Regenerative tissue developer Aziyo Biologics files for $58M IPO (Fierce)
  • Study Shows RWD Can Replace Placebo Data In Duchenne Trials (Pink Sheet)
  • Using AI to sequence fungi genomes for cancer treatments, Hexagon Bio nets $47M in Series A (Endpoints)
  • A month after losing its lead program, Unity Biotechnology cuts 30% of staff in restructuring (Endpoints)
  • Versant teams up with Stanford gene editing experts on a $45M next-gen play — marrying CRISPR and AAV to fix sickle cell (Endpoints)
  • Cygnal's Pearl Huang recruits former Merck colleague John Wagner to realize broad exoneural vision in the clinic (Endpoints)
  • Metacrine, a Rich Heyman biotech targeting NASH and other liver diseases, raises $85M from IPO (Endpoints)
  • Ex-Allergan CMO takes the helm at Lewis Cantley's metastasis-focused biotech startup (Endpoints)
  • Takeda to Divest TachoSil® to Corza Health for €350 Million (Press)
  • Peyona: potential for dosing errors (EMA)
  • EU IVDR: Risk Of Noncompliance Is A Real Threat Under Current Deadline Pressures (MedtechInsight)
  • ControlRad wins FDA nod for radiation reduction technology (MassDevice)
  • Varian wins FDA clearance for cancer therapy software (MassDevice)
  • Roche receives FDA approval for expanded use of the CINtec PLUS Cytology test to aid clinicians in preventing cervical cancer (Press)
Government, Regulatory & Legal
  • Biden wants to restore Obamacare. He may have trouble. (Politico)
  • Lawmakers demand drug makers stop threatening to end discounts for safety-net hospitals (STAT)
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.

Tags: US, worldwide

Regulatory Focus newsletters

All the biggest regulatory news and happenings.