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August 17, 2021
by Michael Mezher

Recon: Pfizer seeks clearance for COVID vaccine boosters; Court revives 6,000 suits over 3M surgical warming device

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Pfizer, BioNTech Seek FDA Clearance for Covid-19 Booster (WSJ) (Reuters)
  • US expected to recommend Covid-19 vaccine booster shots for all (AP) (Reuters)
  • Antibody Cocktails to Treat Covid Take Off as Delta Surges (Bloomberg)
  • U.S. court revives nearly 6,000 lawsuits over 3M surgical warming device (Reuters) (Law360)
  • Dueling 7-figure ad campaigns set sights on a big drug price negotiation bill coming soon (Endpoints)
  • Eli Lilly unveils a complete makeover, erecting a neuroscience unit centered on Alzheimer's as it unifies oncology biz (Endpoints) (Fierce)
  • Next-gen psoriasis drug rivalry between Bristol Myers and Nimbus spills into a legal battle (Endpoints)
In Focus: International
  • Cote d'Ivoire starts Ebola vaccination of frontline workers (WHO)
  • UK regulator approves Moderna COVID-19 shot for 12 to 17-year-olds (Reuters)
  • Roche warns of global Actemra shortage as Delta variant drives huge spike in demand for COVID-19 patients (Fierce) (Endpoints) (Roche)
  • Higher risk of Bell's Palsy after Sinovac's COVID-19 vaccine – study (Reuters)
Coronavirus Pandemic
  • Thermo Fisher's COVID tests snare FDA green light for detecting delta and other variants (Fierce)
  • ‘Tainted’ Blood: Covid Skeptics Request Blood Transfusions From Unvaccinated Donors (KHN)
  • Novavax taps Sanofi, Supernus vets amid quest to get its COVID-19 vaccine over the FDA finish line (Fierce)
Pharma & Biotech
  • Discovery of rare mutation in a brain protein adds fuel to debate over cause of Alzheimer’s disease (STAT)
  • This Breast Cancer Gene Is Less Well Known, but Nearly as Dangerous (NYTimes)
  • It’s PANDA-monium at FDA (FDA Law Blog)
  • Scoop: Adam Koppel's Bain team has another $1.9B to wager on life sci companies. And he likes their odds (Endpoints) (BioPharmaDive)
  • Biosimilars versus biologics: Is marketing madness on the way as biosimilar approvals balloon? (Fierce)
  • AVEO’s Fotivda: US FDA Concerns About Overall Survival Put To Rest By TIVO-3 Final Analysis (Pink Sheet)
  • Osteoarthritis Drug Development: ‘Clinically Meaningful Endpoints’ Remain Elusive (Pink Sheet)
  • Magic mushrooms and 'toad venom' get this British biotech an oversubscribed Series B (Endpoints)
  • InnoCare bags Chinese rights to Incyte CAR-T rival Monjuvi in bid to expand in-house pipeline (Endpoints)
Medtech
  • CMS To Discuss ’Gaps In Evidence‘ In Device Trials For Certain Cerebral Conditions (MedtechInsight)
  • Abbott's Amulet FDA approval sets stage for US market fight with Boston Scientific (MedtechDive)
  • ResMed unveils new sleep apnea machine amid scramble to fill void left by Philips' CPAP recall (Fierce)
Government, Regulatory & Legal
  • 5 years after Pfizer buyout, SEC charges Medivation's ex-dealmaking lead with insider trading (Fierce)
  • Sackler Reps Say They Can't Sell Assets Without Releases (Law360)
  • Judge Lets Dana-Farber Advance Cancer Drug IP Suit (Law360)
  • Biotech Says Celgene-BMS Deal Threatens Drug Development (Law360)
  • Witness's COVID-19 Diagnosis Delays CR Bard Implant Trial (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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