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October 22, 2020
by Michael Mezher

Recon: Moderna completes enrollment in Phase 3 COVID vaccine study; Dr Reddy’s hit by cyberattack

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • An angry Azar floats plans to oust FDA’s Hahn (Politico)
  • Moderna completes enrollment in large COVID-19 vaccine study (Reuters)
  • Roche, Atea team up on potential COVID-19 pill (Reuters)
  • US likely to have enough COVID-19 vaccines for all vulnerable Americans by year end: official (Reuters)
  • Why the US doesn’t have an at-home coronavirus test yet (Politico)
  • The FDA Wanted to Ban Some Hair Straighteners. It Never Happened. (NYTimes)
  • Trump Promised Seniors Drug Discount Cards. They May Be Illegal. (NYTimes)
In Focus: International
  • Deceased AstraZeneca Trial Volunteer Didn’t Receive Vaccine (Bloomberg) (Reuters)
  • Study finds AstraZeneca's COVID-19 vaccine follows genetic instructions (Reuters)
  • In WHO overhaul push, EU urges changes to handling of pandemics (Reuters)
  • China wants to take active role in WHO reform process: foreign ministry (Reuters)
  • Fujifilm partners Shanghai firm to seek China COVID-19 approval for Avigan (Reuters)
  • South Korea sticks to flu vaccine plan despite safety fears after 25 die (Reuters)
  • Britain authorises temporary use of flu vaccine to help meet demand (Reuters)
  • Afreximbank ready to raise up to $5 bln for COVID-19 vaccines for Africa: CDC head (Reuters)
  • India's Dr Reddy's isolates data center services after cyberattack (Reuters) (Economic Times)
Coronavirus Pandemic
  • CDC broadens definition of who's at risk of getting coronavirus (Politico)
  • How much will a Covid-19 vaccine cost? (FT)
  • Wikipedia and WHO Join to Combat Covid Misinformation (NYTimes)
  • Democrats want to fire Warp Speed’s Moncef Slaoui and overhaul the program. But if Biden wins, should he? (STAT)
  • As Covid-19 intensifies, shortages of staple drugs may grow worse (STAT)
  • How Will The U.S. Distribute COVID-19 Antibody Drugs If They Get FDA Approval? (NPR)
  • Britain partners with Oxford firm to assess coronavirus vaccine T cell responses (Reuters)
  • The Coronavirus Has Claimed 2.5 Million Years of Potential Life in the US, Study Finds (NYTimes)
Pharma & Biotech
  • New rare disease gene therapy startup recruits former Sarepta executive as CEO (STAT) (BioPharmaDive)
  • Californians Asked to Pony Up for Stem Cell Research — Again (KHN)
  • European cities plead for more flu shots as winter looms, pandemic rages (Reuters)
  • 25 Drugs, Drug Classes Added to FDA's Safety Signal List (Medscape)
  • Compulsory Licensing for Pharmaceuticals in the EU: A Reality Check (Harvard Bill of Health)
  • 10th ESVAC report shows continued decrease in sales of veterinary antibiotics (EMA)
  • NICE recommends MSD's Keytruda for untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (Pharmafile)
  • Gilead's Biktarvy proves non-inferior to standard care for HIV in Black and African American patients (Pharmafile)
  • Covid-19 is pushing pharma to the cloud — and convincing the industry of its value (STAT)
  • With lumasiran on the FDA's doorstep, Alnylam reads out new PhIII data in PH1 (Endpoints)
  • Pfizer scoops up an antibiotic in rare M&A deal, bagging a virtual startup operating on a shoestring budget (Endpoints)
  • FDA blasts another U.S. drugmaker for faulty quality controls on now-recalled thyroid meds (Fierce)
  • Aurobindo Pharma arm's New Jersey unit gets warning letter from USFDA (Economic Times)
  • Can B cells break the boundaries of cell therapy? Longwood startup has $52M to prove a new engineering tech (Endpoints)
  • Azura Ophthalmics gets a $20M boost for its R&D work on eye diseases (Endpoints)
  • Peter Kolchinsky and Raj Shah's RA Capital has $461M more to play with, after 'rapid' investment in the last 15 months (Endpoints)
  • Promising better linker tech to ADC field, Araris has 'very, very ambitious' plans for the clinic (Endpoints)
  • Master dealmaker David Hung retools a SPAC sedan into a financing muscle vehicle that leaves his cancer startup with $850M and a place on Wall Street (Endpoints)
Medtech
  • With Just 7 Notified Bodies Expected By Mid-2021, How Can Companies Prepare For The IVDR? (MedtechInsight)
  • Edwards TAVR sales grow 6% but Q4 forecast disappoints (MedtechDive)
  • Eyeing big Covid-19 testing expansion, Ginkgo rolls out 50M rapid antigen diagnostics (Endpoints)
  • Abbott device growth returns as Wall Street queries staying power of COVID-19 test boom (MedtechDive)
  • FDA slates VR for lower back pain and fibromyalgia for expedited review (Mobihealthnews)
  • Robotic surgery pricier, with no measurable benefit in hernias: Cleveland Clinic trial (MedtechDive)
  • Quest Diagnostics ups guidance, notches major sales growth and gives back CARES Act cash (Fierce)
Government, Regulatory & Legal
  • Where DOJ's Opioid Blitz Stands After Purdue's Criminal Case (Law360)
  • Biden’s Big Health Agenda Won’t Be Easy to Achieve (KHN)
  • Pa. Justices OK State's Jurisdiction Over J&J In Mesh Cases (Law360)
  • Fed. Circ. Ruling Is Troubling For Generic Drug Manufacturers (Law360)
  • DOJ Can Jump Into Teva Suit, But Only On Limited Basis (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.
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