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July 29, 2021
by Michael Mezher

Recon: Emergent to resume J&J vaccine production; Sanofi raises profit forecast

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Citing New Data, Pfizer Outlines Case for Booster Shots (NYTimes)
  • J&J says US FDA agrees to extend shelf life of its COVID-19 vaccine (Reuters)
  • Emergent to resume J&J COVID-19 vaccine production at Baltimore plant (Reuters) (WSJ)
  • U.S. House panel seeks J&J documents on baby powder bankruptcy plans (Reuters)
  • AstraZeneca CEO hopeful COVID-19 vaccine may still have role in U.S. (Reuters)
  • U.S. FDA allows Lilly's COVID-19 drug to be taken without remdesivir (Reuters)
  • Deep Genomics raises $180 million to automate drug discovery (STAT)
  • Doctors Blast Biogen Alzheimer Approval as ‘Regulatory Failure’ (Bloomberg) (Endpoints) (NEJM 1, 2, 3)
  • Lawmakers ask Defense Department about using a controversial maneuver to lower drug prices (STAT)
In Focus: International
  • Sanofi raises profit forecast after second quarter beat (Reuters) (FT)
  • New Zealand gives provisional nod to AstraZeneca's COVID-19 vaccine (Reuters)
  • AstraZeneca COVID-19 sales jump as drugmaker navigates vaccine challenges (Reuters)
  • AstraZeneca exploring options for COVID-19 vaccine business – executive (Reuters)
  • Israel to offer Pfizer booster jab to the over 60s – reports (Reuters)
  • AstraZeneca vaccine shipped to Canada, Mexico before adequate plant inspections (Reuters)
  • Pharma firm Advanz fined after thyroid drug price hike of 6,000% (The Guardian)
Coronavirus Pandemic
  • Cuba says Iran to start producing one of its COVID-19 vaccines (Reuters)
  • McConnell aims to boost U.S. Republican vaccination rate by countering 'bad advice' (Reuters)
Pharma & Biotech
  • FDA approves the first interchangeable biosimilar insulin. Will it really lower the cost? (STAT)
  • Here’s why simply approving Aduhelm can’t guarantee a golden age of Alzheimer’s R&D (STAT)
  • Merck and Pfizer back a Michigan startup's mission to advance tumor profiling (Endpoints)
  • AstraZeneca and Amgen quietly admit tezepelumab defeat as the Dupixent challenger heads to FDA (Endpoints)
  • Resilience shells out $110M for bluebird bio site, kickstarting new collaboration (Endpoints)
  • Flush with cash, Rakuten billionaire Mickey Mikitani looks to take his photoimmunotherapy platform global (Endpoints)
  • Eli Lilly teams up with KRAS drug pioneer Yi Liu targeting small molecule I/O with $70M upfront (Endpoints)
  • Dutch HTA Body Hits Out At Bluebird’s Zynteglo Pricing (Pink Sheet)
  • As leading synbio players bask in spotlight, US/China startup lands $100M to find its own niche (Endpoints)
  • Waiting For Inspections, Biocon Seeks US FDA Stance On Mutual Recognition Agreement Route (Pink Sheet)
  • Novartis China Drive Paying Off, Sales Soar On Reimbursement Inclusion (Scrip)
Medtech
  • Thermo Fisher slashes COVID-19 testing guidance by $900M (MedtechDive)
  • Medtronic nets heartening FDA nod for AI algorithms to detect afib, arrhythmia (Fierce)
  • As Stryker boosted by electives comeback, CEO downplays delta variant risk to procedures (MedtechDive)
  • Exo nabs $220M as hand-held ultrasound race heats up (Fierce)
  • Baxter Reports Second-Quarter 2021 Results (Press)
  • Strata Oncology gets $90M boost from Pfizer, Merck and more for genomic cancer testing (Fierce)
Government, Regulatory & Legal
  • Opioid Distributors Pin Blame On Others As W.Va. Trial Ends (Law360)
  • Endo, Arnold & Porter Accused Of Cover-Up In Opioid MDL (Law360)
  • McKinsey Says Cherokee Opioid Suit Can't Go To State Court (Law360)
  • Pfizer Court Fight Could Legalize Medicare Copays and Unleash ‘Gold Rush’ in Sales (KHN)
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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