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April 26, 2021
by Michael Mezher

Recon: Sanofi to help manufacture Moderna vaccine; EU sues AZ over vaccine supply issues

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • US ends J&J COVID-19 vaccine pause; shots to resume immediately (Reuters) (STAT) (FDA)
  • Sanofi to Help Make Moderna Covid-19 Vaccine for US (WSJ) (Press)
  • Millions Are Skipping Their Second Doses of Covid Vaccines (NYTimes)
  • FDA lifts hold on UniQure gene therapy study after review of cancer case (BioPharmaDive) (Endpoints)
  • FDA to scrutinize unproven cancer drugs after 10-year gap (AP)
  • FDA says Voyager can trek on as it removes trial hold for Huntington's gene therapy test (Fierce)
  • CEO of vaccine maker Emergent sold $10 million in stock before company ruined Johnson & Johnson doses (Washington Post)
In Focus: International
  • US to share AstraZeneca shots with world after safety check (AP)
  • EU sues AstraZeneca over breach of COVID-19 vaccine supply contract (Reuters)
  • Biotech behind AstraZeneca vaccine aims to raise $117m at IPO (FT)
  • Moderna vaccine to be reviewed for WHO emergency listing on April 30 - WHO spokesman (Reuters)
  • Health Canada to start real-time review of Medicago COVID-19 vaccine (Reuters)
  • EMA Says Yes To Eight New Medicines, Holds Fire On Others (Pink Sheet) (EMA)
  • AstraZeneca vaccines sent to Mexico from Baltimore plant safe - deputy health minister (Reuters)
  • Health Canada finds Astrazeneca COVID-19 vaccines from Baltimore plant safe, of high quality (Reuters)
  • South African study using J&J vaccine will resume on Wednesday (Reuters)
  • UK lawmakers call for PM Johnson to publish big pharma lobbying messages (Reuters)
  • Israel examining heart inflammation cases in people who received Pfizer COVID shot (Reuters)
Coronavirus Pandemic
  • South Korea’s Moon to meet Novavax CEO on vaccine production (Korea Herald)
  • Vaccine makers say IP waiver could hand technology to China and Russia (FT)
  • FDA says health care workers should stop reusing N95 masks (The Hill)
  • U.S. to provide vaccine components, medical supplies as India battles COVID-19 spike (Reuters)
  • India's federal government won't import vaccines, leaving it to states (Reuters)
  • Moderna applies for emergency COVID-19 vaccine use in the Philippines (Reuters)
  • Japan PM Mulls Legal Revision on Trial Requirement for Vaccines (PharmaJapan)
  • S.Korea signs with Pfizer for additional 40 mln COVID-19 vaccine doses (Reuters)
  • Malaysia says AstraZeneca vaccine safe, will be used for over 60s (Reuters)
Pharma & Biotech
  • GlaxoSmithKline boss Dame Emma Walmsley set to face test of strategy (The Times)
  • The price of a Vertex cystic fibrosis treatment stirs anger in Australia (STAT)
  • ADC Therapeutics scores FDA approval for anti-CD19 blood cancer med Zynlonta (Fierce) (FDA)
  • Sanofi starts off 'pipeline-in-a-product' rilzabrutinib in rare skin disease, but eyes bigger prize (Fierce)
  • As­traZeneca and Sanofi tout break­through in €645M al­liance against lead­ing cause of in­fant death (Endpoints)
  • FDA gives Ax­some speedy re­view for de­pres­sion drug, while oth­er in­di­ca­tions wait in the wings (Endpoints)
  • AstraZeneca drives biomarker testing with a string of efforts—and a new leader (Fierce)
  • Vertex picks a horse in race for opioid painkiller replacement (Fierce)
  • Regeneron CEO Schleifer, chief scientist Yancopoulos bag massive $270M payday (Fierce)
  • Christoph West­phal and the crew at No­var­tis-backed TScan aren't wait­ing to take their pre­clin­i­cal TCR pitch to Nas­daq (Endpoints)
Medtech
  • DJO Global continues string of orthopedic acquisitions with purchase of device maker MedShape (Fierce)
  • Philips raises guidance as elective procedures exceed pre-pandemic levels (MedtechDive)
  • J&J Device Businesses Return To Growth Led By Electrophysiology And Surgery (MedtechInsight)
  • Swiss Medtechs Demand Renewed Negotiation Efforts As Latest EU Talks Falter (MedtechInsight)
  • SMEs Buffeted About By EU MDR Delays Will Not Be Able To Financially Sustain Products (MedtechInsight)
  • Cordis Recalls Precise PRO Rx US Carotid System Due to Risk of Separation in Device During Use (FDA)
Government, Regulatory & Legal
  • $1 Million in Toxic Bleach Sold as ‘Miracle’ Cure, Officials Say (NYTimes) (FDA)
  • The Fifth Circuit Addresses Pay-for-Delay Agreements: Money for Nothing (and Patent Settlements for Free?) (FDA Law Blog)
  • What Opioid Crisis? Drugmakers Test Bold Claim In Calif. Trial (Law360)
  • Gilead, Shire Beat FCA Suits In NJ Over Marketing Programs (Law360)
  • UK Judge Won't Invalidate Alcon's Glaucoma Treatment Patent (Law360)
  • Fed. Circ. Won't Rehear Amgen Drug Patent Fight (Law360)
  • DC Circ. Struggles With FDA Stance Over Electric Shock Ban (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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