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March 8, 2021
by Michael Mezher

Recon: Moderna taps Baxter to fill 60-90M vaccine doses; NHS strikes deal for Novartis’ Zolgensma

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Roche joins AstraZeneca in ditching bladder cancer indication for immunotherapies (Reuters) (Endpoints) (Press)
  • Moderna taps Baxter to support fill and finish of 60-90 million COVID-19 vaccine doses (Reuters)
  • Government Scientists Skeptical of One-Shot Regimen for Pfizer, Moderna Vaccines (WSJ) (Reuters)
  • Merck says study shows COVID-19 drug causes quick reduction in virus (Reuters) (WSJ)
  • Biden team plots the country’s first national Covid testing strategy (Politico)
  • CDC releases guidelines for vaccinated people after delay (Politico) (STAT)
  • Stimulus bill packs a windfall for FDA and Covid-19 drug, vaccine developers (Endpoints)
  • How One Firm Put an ‘Extraordinary Burden’ on the US’s Troubled Stockpile (NYTimes)
  • Landmark NY Opioid Trial Delayed Amid Virus Concerns (Law360)
In Focus: International
  • EU regulator urges caution on Sputnik COVID-19 vaccine (Reuters)
  • EU turns to US in scramble for Oxford/AstraZeneca vaccine (FT) (Reuters)
  • Novartis and NHS England reach ‘landmark’ deal for Zolgensma gene therapy for SMA (PMLive) (CNBC) (The Guardian) (NHS)
  • Oxford-AstraZeneca Covid-19 Vaccine Startup in Conflict With University Ahead of Planned IPO (WSJ) (FT)
  • Johnson & Johnson loses court appeal over pelvic mesh negligence (The Guardian)
  • From Pfizer to Moderna: who's making billions from Covid-19 vaccines? (The Guardian)
  • Pharma groups spend billions to tap into booming China healthcare (FT)
Coronavirus Pandemic
  • US says Russian-backed outlets spread COVID-19 vaccine 'disinformation' (Reuters)
  • FDA Issues Authorization for First Molecular Non-Prescription, At-Home Test (FDA)
  • FDA Authorizes Adaptive Biotechnologies T-Detect COVID Test (FDA)
  • Abbott scores testing green lights for symptomless COVID-19 cases, plus flu, RSV (Fierce)
  • Austria suspends AstraZeneca COVID-19 vaccine batch after death (Reuters)
  • Serum Institute seeks government's intervention over import of Covid vaccine raw material from US (Economic Times)
  • French 'HAS' regulator: J&J COVID vaccine could be approved in France by end of this week (Reuters)
  • New Zealand to buy enough Pfizer COVID-19 vaccines for entire population (Reuters)
  • Japan COVID-19 inoculations off to snail pace start due to vaccine, syringe shortages (Reuters)
  • India seeks funds from Quad alliance to match China's vaccine push: source (Reuters)
  • Italy approves AstraZeneca COVID-19 vaccine for over 65s: health ministry (Reuters)
  • Moderna reaches supply deal with Philippines for 13 million vaccine doses (Reuters)
  • Indonesia gets 1.1 million AstraZeneca vaccine doses via COVAX (Reuters)
  • South Korea finds no link found between deaths and coronavirus vaccine (Reuters)
  • CytoDyn’s wild weekend of data-mining study results ends in failure for its Covid treatment (STAT) (Endpoints)
Pharma & Biotech
  • Beyond immune checkpoint blockade: emerging immunological strategies (Nature)
  • Countering payers, drugmakers say net prices declined in 2020 (BioPharmaDive)
  • Gilead's CAR-T med Yescarta gets a leg up on Novartis rival with FDA nod in follicular lymphoma (Fierce)
  • Pregnant Women In Clinical Trials: Investigators Should Justify Exclusion, NIH Official Says (Pink Sheet)
  • How might pharma buddy up with Alexa? Bayer Consumer's first interactive voice ad is food for thought (Fierce)
  • Biotech IPO market looks to ramp back up as BMS partner Ikena and its immunometabolism therapies eye public offering (Endpoints)
  • AnaptysBio takes a beating as its lead drug fails its first PhII test. And 5 more trials are nearing a readout (Endpoints)
  • Further setting the stage for going public, Vivek Ramaswamy’s Roivant readies a deal to buy up a Vant’s stock — cheap (Endpoints)
  • Argenx’s Autoimmune Disease Blockbuster-In-Waiting Gets FDA Decision Date (Scrip)
  • Jazz CEO Bruce Cozadd campaigned for 6 months to buy GW Pharma. A 90% premium sealed the deal — along with $17.6M in ‘retention’ incentives (Endpoints)
  • As viral vector demand surges, fledgling CDMO Matica establishes a beachhead in Texas (Fierce)
  • AI uncovers Eli Lilly's rheumatoid arthritis drug Olumiant as potential Alzheimer's treatment (Fierce)
  • Seres stops microbiome cancer trial, deprioritizes drug as COVID-19 throttles enrollment (Fierce)
  • Gilead’s HIV therapy Biktarvy demonstrates long-term sustained efficacy (PharmaTimes) (Endpoints)
  • ViiV presents positive long-term data for combined HIV treatment (Pharmafile)
  • FDA grants Priority Review to Korsuva for CKD-associated pruritis (Pharmafile)
  • Imfinzi, 2 Other Drugs under PMDA Safety Review (PharmaJapan)
  • Inside the fall of Watson Health: How IBM’s audacious plan to ‘change the face of health care’ with AI fell apart (STAT)
Medtech
  • Insulin pump adoption seen climbing 21% in 2021 on wearables boom: survey (MedtechDive)
  • Harmonization Of The EU Regulatory Compliance Role: Many PRRC Issues To Be Clarified (MedtechInsight)
  • FDA clears ControlRad tech for reducing cath lab radiation exposure by 85% (Fierce)
  • Q&A: New Standard For Device Irritation Nudges Industry Away From Animal Testing – And Toward Tests On Lab-Made Human Skin (MedtechInsight)
Government, Regulatory & Legal
  • Lawmakers rail against huge tax breaks drug wholesalers get from opioid settlement (STAT)
  • Opioid Litigation Is Prying Open Vaults Of Big Pharma Secrets (Law360)
  • Critical Supply Chains and the FDA (Alliance for a Stronger FDA)
  • How Drug Cos. Can Adapt To New Reference Pricing Rules (Law360)
  • FDA looks to reduce toxic elements in baby food, boost inspections (Reuters)
  • Generic Drug Claims Chopped Up With Great Efficiency (Drug & Device Law)
  • Medical Marijuana Is Not Regulated as Most Medicines Are (NYTimes)
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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