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November 13, 2020
by Michael Mezher

Recon: Swissmedic begins rolling review of Moderna COVID vaccine; COVAX raises $2B

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • US government partners with pharmacy chains to increase COVID-19 vaccine access (Reuters)
  • An FDA adviser on why his panel took a skeptical view on Biogen’s Alzheimer’s drug (STAT)
  • Indivior hit with $600 million in civil and criminal penalties over marketing of opioid addiction treatment (The Hill) (DoJ)
  • Labs sound alarm on coronavirus testing capacity, supplies (Politico)
  • Vaccine alliance expects to hold talks with Biden team on COVAX (Reuters)
In Focus: International
  • Switzerland starts 'rolling review' of Moderna COVID-19 vaccine (Reuters)
  • Vaccine alliance secures $2 billion to fund COVID shots for poor nations (Reuters)
  • World's top intensive care body advises against remdesivir for sickest COVID patients (Reuters)
  • Indonesia to start mass COVID-19 vaccination this year (Reuters)
  • Canada bets on imports as home-grown COVID-19 vaccine heads to large-scale trials (Reuters)
  • Israel signs deal with Pfizer for potential COVID-19 vaccine (Reuters)
  • Australian COVID-19 vaccine candidate produces antibody response in early tests (Reuters)
  • Pfizer in talks with Brazil to supply COVID-19 vaccine by early 2021 (Reuters)
  • Measles Deaths Soared Worldwide Last Year, as Vaccine Rates Stalled (NYTimes)
Coronavirus Pandemic
  • Covid vaccine presents pharma with shot at redemption and profits (FT)
  • Until a Vaccine Arrives, a Worrisome Road Ahead (NYTimes)
  • No Brexit delays for UK vaccine imports, minister says (Reuters)
  • EU May Disclose Some Details Of COVID-19 Vaccine Contracts (Pink Sheet)
  • China approves Shanghai Fosun's unit to run human testing for BioNTech's COVID-19 vaccine (Reuters)
  • South Korean firm to produce 150 mln doses a year of Russian COVID-19 vaccine: RDIF (Reuters)
  • Spain's Reig Jofre to have capacity for 50 million COVID-19 vaccine doses a year (Reuters)
  • Relief Therapeutics says 150 enrolled in COVID drug trial (Reuters)
  • Qiagen seeks EUA for COVID-19 antigen test aiming for positive results in 2 minutes (MedtechDive)
  • Pill used to treat OCD and anxiety may prevent Covid-19 from worsening, a preliminary study suggests (STAT)
  • Interferon beta-1a candidate for COPD advances to PhIII to test its potential against Covid-19 (Endpoints)
Pharma & Biotech
  • Shortage of monkeys slowed down Eli Lilly's Covid-19 antibody partner. And it's a problem for everyone (Endpoints)
  • BioMarin CEO Bienaimé beats a retreat from Europe, yanking their application for hemophilia A gene therapy (Endpoints)
  • For COVID Drugs, Months of Frantic Development Lead to Few Outright Successes (Scientific American)
  • New Powers For EMA Under EU ‘Future Proofing’ Plans (Pink Sheet)
  • NICE green light for Cablivi in rare blood-clotting disorder (PharmaTimes)
  • Regulators Find Room For ICH Q3D Metal Impurity Risk Assessments To Improve (Pink Sheet)
  • Australian Industry Maps Path To Better Use Of Real World Evidence (Pink Sheet)
  • As the curtain closes on the Trump presidency, biotech wrestles with its future in a divided America (Endpoints)
  • California voters approve another round of funding for stem cell research (STAT)
  • No thanks: Roche backs out of EGFR-related protein degraders in revised deal with C4 (Endpoints)
  • Shanghai Junshi delays drug trials, focuses on COVID-19 treatment (Reuters)
  • Healthcare group Sanofi invests 50 million euros in Jeito Capital (Reuters)
  • Cancer clinical trial enrollment has plummeted. Will patients come back amid Covid-19? (STAT)
  • The ‘prescription escalator’ may be to blame for rising out-of-pocket drug spending (STAT)
  • After Novo Nordisk's acquisition of Corvidia, Ram Aiyar takes the helm at Korro Bio; Silverback gets a new CFO to go along with its IPO (Endpoints)
  • Seer heads to Nasdaq with $150M IPO; IN8bio postpones public debut amid record year on Wall Street (Endpoints)
Medtech
  • 3 ways Biden's COVID-19 approach could impact medtech (MedtechDive)
  • Medtronic launches connected smart insulin pen gained in Companion Medical deal (Fierce)
  • Cook Medical Recalls Fixed Core Wire Guides, Due to Device Damage from a Manufacturing Error (FDA)
  • Dialysis device maker Outset Medical tops revenue targets in first quarter since IPO (MedtechDive)
Government, Regulatory & Legal
  • PTAB Mylan Decision Could Be Boon To Drug Innovators (Law360)
  • Pfizer Unit Hit With Another Suit Over Tossed Lyrica Patent (Law360)
  • Lawmakers introduce bill to eliminate use of dogs in pharmaceutical testing (STAT)
  • Sanofi Fails to Stop Fraud Suit Alleging Gifts for Prescriptions (Bloomberg)
  • Transition for permitted indications for listed medicines ends 5 March 2021 (TGA)
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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