Regulatory Focus™ > News Articles > 2021 > 11 > Recon: Global license deal to provide COVID antibody test tech free to poorer countries; GSK partner

Recon: Global license deal to provide COVID antibody test tech free to poorer countries; GSK partners with Arrowhead for NASH drug

Posted 23 November 2021 | By Michael Mezher 

Recon: Global license deal to provide COVID antibody test tech free to poorer countries; GSK partners with Arrowhead for NASH drug

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Elizabeth Holmes’ defense lets Theranos founder play role of young do-gooder in second day on stand (CNBC) (Law360)
  • Holmes to take stand for third day in Theranos fraud trial (Reuters)
  • Why You Can’t Find Cheap At-Home Covid Tests (KHN)
  • GSK dives into NASH, RNA interference with Arrowhead deal (BioPharmaDive)
  • Califf’s profitable industry ties spark fresh criticism (Politico)
  • Biogen Alzheimer’s Drug Shows Brain Swelling in 35% of Patients (Bloomberg) (Fierce) (JAMA)
In Focus: International
  • EMA receives application for marketing authorisation for Lagevrio (molnupiravir) for treating patients with COVID 19 (EMA)
  • AstraZeneca calls on UK to increase science investment (FT)
  • Eight years and $1.3B later, AstraZeneca finally unveils Cambridge R&D palace (Endpoints) (Reuters)
  • At busy Visp site, Lonza will up microbial services by 50% (Endpoints)
  • Global license deal to provide COVID antibody test tech free to poorer countries – WHO (Reuters) (AP) (WHO)
  • WHO issues guidelines on the treatment of children with multisystem inflammatory syndrome associated with COVID-19 (WHO)
  • Success with use of real world data in medicines research: Joining the dots of the European ecosystem (EHDEN)
Coronavirus Pandemic
  • U.S. govt asks court to immediately lift stay on COVID vaccine rule (Reuters)
  • White House says U.S. will not lock down to fight Covid as European nations implement restrictions (CNBC)
  • Senate Democrats call on Biden to push for COVID-19 vaccine patent waivers at WTO (The Hill)
  • Israel starts vaccinating young children as coronavirus cases rise (Reuters)
Pharma & Biotech
  • FDA approves pricey new treatment for ultra-rare and aggressive form of sarcoma (Endpoints) (FDA) (Fierce)
  • Vaccibody gets a new name and loads up with nearly $1B in biobucks for new vaccine pact with Regeneron (Endpoints)
  • $107B in 2+ years? Pfizer’s Covid-19 vaccine may redefine ‘megablockbuster’ by 2022 — analyst (Endpoints)
  • Califf Outlines Clinical Trial Reform Message, Which Could Travel With Him To Commissioner’s Office (Pink Sheet)
  • Sagent Pharmaceuticals recalls injectable seizure med thanks to familiar packaging glitch (Fierce)
  • Clozapine REMS Program Paused After Problems With Re-Certification (Pink Sheet)
  • Growing Complex Generic Application Load May Force US FDA Staffing Changes (Pink Sheet)
  • Dragonfly gets Merck on second TriNKET candidate since 2018 collab; Chinese eye gene therapy developer nabs $60M (Endpoints)
  • A fledgling transpacific biotech grabs a launch round to dive into oncology and autoimmune research (Endpoints)
Medtech
  • Power Morcellation Containment Devices Placed In FDA Class II (MedtechInsight)
Government, Regulatory & Legal
  • Ranbaxy Can't Shake MDL Antitrust Claims As Trial Nears (Law360)
  • PTAB Axes OxyContin Patent After Purdue Ch. 11 Delay (Law360)
  • Teva Says Mylan Is Just Unhappy About MS Drug Competition (Law360)
  • DOJ-Walmart Opioid Battle Halted As High Court Reviews CSA (Law360)
  • Sanofi Unit To Pay $180M In Disease Treatment Patent Fight (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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