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November 22, 2021
by Michael Mezher

Recon: Pfizer touts long-term efficacy data for COVID vaccine in adolescents; House panel seeks interview with Hahn

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • CDC expands eligibility for Covid-19 booster shots to all adults (STAT)
  • Johnson & Johnson touts ‘golden moment’ to pursue pharma-led future (FT)
  • Concerns Grow Over Safety of Aduhelm After Death of Patient Who Got the Drug (NYTimes)
  • Bluebird, after delays, gets speedy FDA review for beta thalassemia gene therapy (BioPharmaDive)
  • CBO: Democrats' package saves about $160B on drug prices (The Hill)
  • A worrisome safety signal slows Merck's HIV ambitions (BioPharmaDive)
  • Pfizer's COVID-19 vaccine trial data shows long-term efficacy in adolescents (Reuters) (STAT)
  • FDA delays its decision on Bristol Myers' $13B heart drug another three months (Endpoints)
  • The Elizabeth Holmes Trial: Theranos Founder Takes the Stand (WSJ)
  • House COVID-19 panel seeks interview with former Trump FDA leader Hahn (The Hill)
  • FDA Approves First Drug to Improve Growth in Children with Most Common Form of Dwarfism (FDA)
In Focus: International
  • EQT, BioNTech investor consider bid for Novartis arm Sandoz -report (Reuters)
  • EU says decision on J&J COVID-19 vaccine booster dose 'within weeks' (Reuters) (EMA)
  • EMA starts review of Paxlovid for treating patients with COVID-19 (EMA)
  • How Covid has raised the profiles and fortunes of India’s pharma entrepreneurs (FT)
  • Japan sees 'drug lag' as foreign pharmas pass up the market amid pricing pressure, industry group warns (Fierce)
  • First COVID vaccine doses donated by EU begin arriving in Africa- GAVI (Reuters)
  • Israel eyes setting up its own vaccine production facility (Reuters)
  • Resumption of India's COVAX vaccine supply delayed by Nepal – sources (Reuters)
  • Baidu in partnership with Sanofi to use its algorithm in mRNA vaccine, therapy development (Reuters)
Coronavirus Pandemic
  • Name that vaccine: From Comirnaty to Spikevax to Nuvaxovid, Covid-19 shots' brand names remain little-known (Endpoints)
  • Activists urge Biden to push for intellectual property waiver for COVID-19 vaccines (Reuters)
  • 90% of U.S. federal employees have received at least one COVID-19 dose - White House (Reuters)
  • First Known Covid Case Was Vendor at Wuhan Market, Scientist Says (NYTimes)
  • Biden administration suspends enforcement of business vaccine mandate to comply with court order (CNBC)
Pharma & Biotech
  • Biomanufacturing companies getting hit by hackers potentially linked to Russia (The Hill)
  • FDA is temporarily suspending certain Clozapine REMS program requirements to ensure continuity of care for patients taking clozapine (FDA)
  • Labcorp adds to drug development, device testing services with Toxikon buy (Fierce)
  • Limited access to antibiotics is driving resistance, warns watchdog (FT)
  • Pressure grows for funding to tackle ‘silent pandemic’ of antimicrobial resistance (FT)
  • Verily’s Amy Abernethy hints at clinical trial blueprint for 2022 (STAT)
  • BD upsizes San Diego presence with new 220K-square-foot biosciences R&D facility (Fierce)
  • Amgen's Otezla, Repatha and biosimilars put on notice, with challenging years ahead (Fierce)
  • Safety threat forces Enanta to scrap HBV trials — sending discovery team back to drawing board (Endpoints)
  • Daiichi Sankyo looks to bring FLT3 drug back from the dead with late-stage win in early AML patients (Endpoints)
  • Bouncing back from a PhII flop in schizophrenia, Neurocrine steers into the busy M4/M1 pathway with a $100M cash deal (Endpoints)
  • BioCryst gets massive cash infusion to the tune of $350M, thanks to old and new investors (Endpoints)
  • Connect Biopharma celebrates a mid-stage win for its Dupixent rival, but shares tank after investors clamor for data (Endpoints)
  • Xencor says goodbye to its former lead drug, selling all rights to Lonnie Moulder's new startup (Endpoints)
Medtech
  • Pear's digital therapeutic for alcohol use disorder bears fruit with FDA breakthrough tag (Fierce)
  • FDA reemphasizes heart perforation risks of leadless pacemakers, with market set to grow (Fierce)
  • Stryker dismisses robotics threat from J&J, Zimmer with bullish forecast (MedtechDive)
  • Latest breakthrough device designations go to brain-computer interface, exo-suit (MedtechDive)
  • EU’s First IVDR Expert Panel View Published (MedtechInsight)
Government, Regulatory & Legal
  • Sanofi clinches 2nd bellwether win in chemotherapy hair loss litigation (Fierce)
  • Bayer, Amgen Unit Drop IP Suit Over Cancer Drug Generic (Law360)
  • Businesses Appeal £100M CMA Fine For Overpriced Drug (Law360)
  • Illumina Defends Validity Of DNA Sequencing Patents At 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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