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

• 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)

• 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)

• 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)

• 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)

• Biden wants to restore Obamacare. He may have trouble. (Politico)
• Lawmakers demand drug makers stop threatening to end discounts for safety-net hospitals (STAT)