Recon: FDA schedules VRBPAC meeting for Pfizer’s EUA request for children under 5; J&J, distributors to pay $590M to settle tribes’ opioid claims

ReconRecon | 01 February 2022 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Pfizer submits data for US authorization of COVID shots for kids under 5 (Reuters) (NYT) (Washington Post) (The Guardian)
  • FDA Advisory Committee Meeting to Discuss Request for Authorization of Pfizer-BioNTech COVID-19 Vaccine for Children 6 Months Through 4 Years of Age (FDA)
  • More Democrats flag ‘questions,’ remain uncertain about Biden’s FDA pick, Robert Califf (STAT)
  • Drug distributors, J&J to pay $590M to settle US tribes' opioid claims (Reuters) (Washington Post)
  • Pfizer ends $3B drug dream despite phase 2b success, leaving Regeneron with a clear run at cardiovascular market (Fierce)
  • After sputtering on the launch pad, Novavax finally gets its EUA application in. Does it matter? (Endpoints)
  • Gilead COVID drug takes top spot for US hospital spending -report (Reuters)
  • Experimental HIV vaccine, based on Moderna’s mRNA technology, now in clinical trial (Washington Post)
In Focus: International
  • Nigeria sets up $149 million fund to fight HIV/AIDS (Reuters)
  • Merck's COVID pill is last choice for US patients, global use varies (Reuters)
  • DARPA deputy returns home to the UK to lead a new $1B government research agency (Endpoints)
  • Spanish regulator authorizes phase III trials of Hipra’s COVID vaccine (Reuters)
  • Takeda shunts jewel of Shire takeover to new spinoff Oak Hill (Fierce)
Coronavirus Pandemic
  • Many countries yet to see peak in Omicron wave, should ease curbs slowly -WHO Reuters)
  • South African scientists will study link between COVID variants and untreated HIV (Reuters)
  • A tenth of England’s 2022 COVID cases suspected reinfections, data suggests (Reuters)
  • US Covid-19 Hospitalizations Extend Their Fall While Deaths Keep Rising (WSJ)
  • Covid Pill Dispensing Costs Push Pharmacies to Call on Medicare (Bloomberg)
Pharma & Biotech
  • The big shakeup at a badly rattled Biogen continues as 2 longtime board members hit the exits (Endpoints)
  • CMS’ Biogen decision could spell problems for Lilly, Roche Alzheimer’s drugs, half of surveyed neurologists say (Fierce)
  • Pfizer names new top development executive as Covid remakes the company (STAT)
  • Roche building bispecific franchise outside oncology with Vabysmo approval (BioCentury)
  • Taysha ready to engage with regulators on approval pathway for the biotech’s first gene therapy in rare disease (Fierce)
  • Troubled cancer center in Connecticut handed Form 483 by FDA, again (Endpoints)
  • Gamida Cell readies stem cell transplant therapy for FDA submission but seeks strategic partners amid staffing cuts (Fierce)
  • Biotech's very bad start to the year continues as microcap gene therapy player Sio ditches CEO, lead partnership (Endpoints)
  • Orphazyme CEO departs for Leo Pharma as both companies face major restructurings (Endpoints) (Fierce)
  • Mark Cuban's new cost-plus-15% generic drug company is really a compounding pharmacy (Endpoints)
  • ‘Digital sleuthing’ helps pharma connect with the right social media influencers (Fierce)
  • Breakthrough device program 'far exceeding' FDA expectations after record year (MedTech Dive)
  • With Congressional Deadline Looming, FDA And Industry Schedule MDUFA Meeting (MedTech Insight)
  • Illumina’s embrace of long-read technology signals a shift in the DNA-sequencing market (STAT)
  • Latest earnings show medtechs grappling with healthcare staffing shortages, supply chain (MedTech Dive)
  • Empowered Diagnostics lands FDA Class I recall tag for 286K unauthorized COVID tests  (Fierce)
  • Pfizer signs up to promote Alex Therapeutics’ smoking cessation app in Germany (Fierce)
  • Glooko adds AI-powered coaching to its digital diabetes management tools with Xbird acquisition (Fierce) (MedTech Insight)
  • Robots Are The Future – And The Future Is Now (MedTech Insight)
Government, Regulatory & Legal
  • Purdue Pharma judge extends Sacklers' US litigation shield to Feb 17 (Reuters)
  • Chinese agency says suspects arrested in AstraZeneca insurance fraud probe (Endpoints)
  • CMS’ narrow coverage proposal for Biogen’s Aduhelm gins up public support: analyst (Fierce)
  • Contact Lens Vendor Hit With $3.5M Penalty For Violating US Law (MedTech Insight)
  • ‘Pharma Bro’ Shkreli Reaches $28 Million Class Action Settlement (Bloomberg)
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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