rf-fullcolor.png

 

October 28, 2020
by Michael Mezher

Recon: Sanofi, GSK to supply 200M vaccine doses to COVAX scheme; US strikes deal for Lilly’s COVID antibody drug

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Pfizer CEO All but Rules Out Vaccine Before Election Day (NYTimes) (FT)
  • US strikes deal with Lilly for potential COVID-19 antibody drug (Reuters) (Endpoints) (Press)
  • Lawmakers release trove of Purdue documents detailing Sackler family’s involvement in opioid sales (STAT)
  • I'm the FDA point person on COVID-19 vaccines. We'll make sure they're safe and effective. (USA Today)
  • US pharmacies attract new flu shot customers as coronavirus surges (Reuters)
  • The coronavirus vaccine race slams into reality (Politico)
In Focus: International
  • UK says COVID-19 vaccine roll out could start before Christmas (Reuters)
  • Sanofi, GSK to supply vaccine doses to WHO-backed alliance (Reuters)
  • Russia applies for WHO emergency use tag for its COVID-19 vaccine (Reuters)
  • UK starts real-time review of Moderna's COVID-19 vaccine candidate (Reuters)
  • Back to crisis mode, EU moves to avoid COVID shortages, ease trade (Reuters) (EC)
  • Supply of potential COVID-19 vaccines to start in earnest in April: EU's von der Leyen (Reuters)
  • UK vaccine chief targets spring rollout, but impact may be limited (Reuters)
  • Molecular Partners jumps after Novartis deal for potential COVID-19 drugs (Reuters) (BioPharmaDive)
Coronavirus Pandemic
  • Scientists Warn Americans Are Expecting Too Much From a Vaccine (KHN)
  • Meet the youngest participants in Covid-19 vaccine trials: Teens and tweens (NBC)
  • Italy okays trial of osteoporosis drug to treat COVID-19 (Reuters)
  • Why You Shouldn’t Worry About Studies Showing Waning Coronavirus Antibodies (NYTimes)
  • Some Covid Survivors Have Antibodies That Attack the Body, not Virus (NYTimes)
  • How The U.S. Plans To Distribute Potential Coronavirus Vaccines (NPR)
  • States will need billions to distribute the Covid vaccine as federal funding falls short (CNBC)
  • 3M is making more N95 masks than ever as global Covid cases rise, CEO says (CNBC)
Pharma & Biotech
  • Novartis reports Q3 results, raises FY guidance (Seeking Alpha)
  • GSK Q3 top-line down 8%, Shingrix sales drop 30%, Eliipta sales +21% (Seeking Alpha)
  • GSK culls top respiratory disease prospect, delivering another blow to IL-33 field (Fierce)
  • PDUFA VII: US FDA Wants Dedicated RMAT Program Funding (Pink Sheet)
  • ‘Dying waiting’: Advocates urge Vertex to widen global access to cystic fibrosis drugs (STAT)
  • In a Battered New York Office Market, Life Science Is Flourishing (NYTimes)
  • FDA Approves Lotion for Nonprescription Use to Treat Head Lice (FDA)
  • Flagship brings 'intersystems biology' under one roof with Senda Biosciences (Fierce)
  • Tom Abrams’ Steady Leadership Guided US FDA Through Dramatic Changes In Rx Promotion (Pink Sheet)
  • Indian drugmaker failed to notify FDA multiple times about issues with its sterile injectables: letter (Fierce)
  • Bristol Myers' Richard Hargreaves pays $70M to launch a neurodegeneration alliance with a star player in the machine learning world (Endpoints)
  • Chinese rare disease player inks first deal around narcolepsy drug Wakix after grabbing $80M to build an ecosystem (Endpoints)
  • Roche's major cancer research exec Rommel jumps ship to Bayer as Moeller exits (Fierce)
  • Vacaville Unveils California Biomanufacturing Center (GEN)
  • Enhertu picks up another win for AstraZeneca and Daiichi Sankyo, joining the priority review lane for gastric cancer (Endpoints)
  • UK Confirms It Will Accept EU Marketing Authorizations For Two Years (Pink Sheet)
  • EU Framework For Patient Preference Studies Under Review (Pink Sheet)
  • A dark horse entrant into the spinal muscular atrophy field doubles its value on some PhII data (Endpoints)
  • Allergan, an AbbVie Company, Announces Positive Phase 3 Topline Results for Investigational AGN-190584 for the Treatment of Presbyopia (Press)
  • The Drug Supply Chain Security Act Pilot Project Program and Enhanced Drug Distribution Security – Public Meeting (FDA)
  • Arena's Amit Munshi spins out his neuro sub into a biotech startup, with $56M for the baptism (Endpoints)
  • RemeGen readies $514M IPO as HKEX adds jewel to the crown (Endpoints)
Medtech
  • Experts Call For Unifying Measures For EU Political And Regulatory Oversight (MedtechInsight)
  • IVDR Implementation Not Yet On Track: What The Diagnostics Sector Needs To Do (MedtechInsight)
  • FDA clears Abiomed's Breethe lung life support system, enabling use in COVID-19 (Fierce)
  • MDUFA V: FDA Looks For More User-Fee Investments; Industry Wants To Work With What’s There (MedtechInsight)
  • FDA Bumps PMA Compliance Date For AED Accessories To February 2022 (MedtechInsight) (FDA)
  • Singapore HSA will introduce UDI labeling requirements for medical devices (Emergo)
  • LabCorp sees Q3 revenue rise 33%, but doesn't follow Quest in upping guidance (MedtechDive)
Government, Regulatory & Legal
  • Department of Justice Files Complaint Against California Company To Stop Distribution of Adulterated Animal Drugs (DoJ)
  • Suboxone Manufacturer Indivior's Former Chief Executive Officer Sentenced to Jail Time in Connection with Drug Safety Claims (FDA)
  • Judge Wants New Bellwether List In Cook Vein Filter MDL (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.
×

Welcome to the new RAPS Digital Experience

We have completed our migration to a new platform and are pleased to introduce the updated site.

What to expect: If you have an existing login, please RESET YOUR PASSWORD before signing in. After you log in for the first time, you will be prompted to confirm your profile preferences, which will be used to personalize content.

We encourage you to explore the new website and visit your updated My RAPS page. If you need assistance, please review our FAQ page.

We welcome your feedback. Please let us know how we can continue to improve your experience.