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3rd December 2020
by Michael Mezher

Recon: Moderna to begin testing COVID vaccine in children ages 12-17; Merck KGaA partners with Artios to develop cancer drugs

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Raimondo emerges as frontrunner for HHS secretary (Politico)
  • FDA Head Defends Covid-19 Vaccine-Approval Process (WSJ)
  • Moderna Plans to Begin Testing Its Coronavirus Vaccine in Children (NYTimes)
  • FDA chief meets with Meadows again as Trump remains frustrated with pace of vaccine approval (CNN)
  • The COVID Vaccines Are Approaching. Is the FDA Ready to Inspect the Plants Where They’re Made? (Vanity Fair)
  • AstraZeneca US Covid-19 vaccine trial results likely in late January, says health official (CNBC)
  • CVS to Give Out Covid-19 Treatment in Nursing Homes (NYTimes)
  • Fauci to meet with Biden team for first time Thursday (The Hill)
  • US secures 650,000 additional doses of Lilly’s COVID-19 antibody (PMLive)
In Focus: International
  • EU regulators talking to UK about Pfizer vaccine, WHO expert says (Reuters)
  • WHO reviewing Pfizer vaccine for possible emergency listing (Reuters)
  • Sanofi to publish COVID-19 vaccine price in development with GSK after Phase I/II trial results (Reuters)
  • Fortune or foresight? AstraZeneca and Oxford's stories clash on COVID-19 vaccine (Reuters)
  • Canada could rule on Pfizer's COVID-19 vaccine within the next week - health official (Reuters)
  • Moscow to open COVID-19 vaccination centres on Saturday – mayor (Reuters)
  • Inovio signs COVID-19 vaccine manufacturing deal with Japan's Kaneka (Reuters)
  • China Poised to Be First to Distribute Virus Vaccine in Latin America, U.S. Official Says (NYTimes)
  • Africa foresees 60% of people vaccinated against COVID in two to three years (Reuters)
  • Merck KGaA agrees research deal with Artios for 'DNA damage' cancer drugs (Reuters)
  • U.N. Reclassifies Cannabis as a Less Dangerous Drug (NYTimes)
  • Global equitable access to COVID-19 vaccines estimated to generate economic benefits of at least $153B in 2020-21, and $466B by 2025, in 10 major economies – Eurasia Group (WHO)
Coronavirus Pandemic
  • IBM warns hackers targeting COVID vaccine 'cold chain' supply process (Reuters) (NYTimes)
  • WHO looks at possible 'e-vaccination certificates' for travel (Reuters)
  • Feds Look to Pharmacists to Boost Childhood Immunization Rates (KHN)
  • Frozen Covid vaccines can reach developing nations, says DHL (FT)
  • ‘There absolutely will be a black market’: How the rich and privileged can skip the line for Covid-19 vaccines (STAT)
  • Health chiefs rule out private sector jumping vaccine queue (FT)
  • No guarantee Pfizer vaccine will be distributed direct to English care homes, official says (Reuters)
  • Many Trial Volunteers Got Placebo Vaccines. Do They Now Deserve the Real Ones? (NYTimes)
  • World’s Largest Vaccine Maker Sues Trial Volunteer Who Alleged Side Effects (Vice)
  • Placebo-Controlled Trials of Covid-19 Vaccines — Why We Still Need Them (NEJM)
  • FDA Approval of Remdesivir — A Step in the Right Direction (NEJM)
  • Repurposed Antiviral Drugs for Covid-19 — Interim WHO Solidarity Trial Results (NEJM)
  • A Large, Simple Trial Leading to Complex Questions (NEJM)
Pharma & Biotech
  • AbbVie pays Frontier $55M to pursue hard-to-drug targets (Fierce)
  • Lonza plots 2 manufacturing suites for antibody-drug conjugates at Switzerland site (Fierce)
  • Medicare Walks Back Proposed Payment Policy For 505(b)(2) Physician Administered Drugs (Pink Sheet)
  • Jazz and PharmaMar's Zepzelca combo misses main goal in small cell lung cancer sub-population (Pharmafile)
  • Pharma payments to physicians still deliver a big 'return on investment' in prescription growth, study finds (Fierce)
  • KBI plans $150M facility in Research Triangle Park with mystery co-investor (Endpoints)
  • MHLW to Issue Notification to Urge Drug Makers’ Prompt Info Provisioning on Supply Shortages (PharmaJapan)
  • Neurogene secures EMA orphan designation for gene therapy in rare, inherited aspartylglucosaminuria (Pharmafile)
  • FDA Credits Recent Drug Approval to Patient Community Engagement; We Applaud the Agency for the Recognition and Its Legacy of PFDD (FDA Law Blog)
  • Recommendations for Screening, Testing, and Management of Blood Donors and Blood and Blood Components Based on Screening Tests for Syphilis (FDA)
  • Agenda for “EU Big Data Stakeholder Forum” (EMA)
Medtech
  • Zimmer Biomet picks up chest surgery toolmaker A&E Medical for $250M cash (Fierce)
  • Medtechs, working with FDA, offer guidance for remote control of medical devices during pandemic (MedtechDive)
  • Compare And Contrast: New UKCA Marking System Will Stress Safety, Quality and Agility (MedtechInisght)
  • GAO/NAS Report On AI In Health Care Critical Of FDA Slowness On SaMD Rulemaking (MEdtechInsight)
  • iRhythm goes back to drawing board as CMS reverses national pricing move (MedtechDive)
  • CMS finalizes expanded artificial heart, ventricular assist device coverage (MedtechDive)
Government, Regulatory & Legal
  • Theranos Judge Says Virus Won't Delay Ex-CEO's March Trial (Law360)
  • Ex-Insys Manager Avoids Prison For Opioid Kickback Scheme (Law360)
  • Fla. Pharmacy Gets Chance To Prove Case Against McKesson (Law360)
  • Abbott Can't Escape Infringement Claims Over HIV Testing (Law360)
  • Biopharm Biz Buries Hatchet Over Parkinson's Drug For $7.5M (Law360)
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.