Recon: Pfizer to cut sales staff as provider meetings move virtual; US buys 600k more doses of GSK-Vir COVID therapy

ReconRecon | 11 January 2022 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • US FDA Advisory Committees: Flipping FDAA Mandate on its Head (Pink Sheet)
  • Pfizer to cut US sales staff as meetings with healthcare providers move to virtual (Reuters)
  • CDC eyes recommending higher quality masks: report (The Hill)
  • Future of Biogen’s Aduhelm hinges on Medicare Alzheimer’s coverage (Reuters)
  • Recall report: Another month, another issue with NDMA (Endpoints)
  • Trial by fire: More study protocols are experiencing substantial – and costly – changes (STAT)
  • Pfizer CEO says Omicron variant targeted vaccine is most likely outcome (Reuters)
  • FDA amends J&J vaccine fact sheet to include rare bleeding risk (Reuters)
  • US secures 600,000 more doses of GSK-Vir’s COVID-19 therapy  (Reuters)
In Focus: International
  • WHO body says COVID-19 vaccines ‘may need to be updated’ for Omicron (Reuters)
  • EU drug regulator expresses doubt on need for fourth booster dose (Reuters)
  • English Reimbursement Win For Janssen’s Oral Multiple Sclerosis Drug (Pink Sheet)
  • PharmaMar shares soar after drug study suggests efficacy against Omicron (Reuters)
  • BioNTech says developed method to detect high-risk variants (Reuters)
  • BioNTech committed to seeking China approval for COVID-19 vaccine (Reuters)
  • In Southern Africa, Success Against HIV Offers Hope for Beating Back Another Virus (NYT)
  • South African studies suggest Omicron has higher ‘asymptomatic carriage’ (Reuters)
Coronavirus Pandemic
  • Too soon to treat COVID-19 like flu as Omicron spreads – WHO (Reuters)
  • White House limiting size of gatherings amid omicron wave (The Hill)
  • Omicron is Brazil’s dominant coronavirus variant, minister says (Reuters)
  • Mexico expecting nearly 27 mln COVID-19 vaccines in coming weeks (Reuters)
Pharma & Biotech
  • Busy Amgen swings another deal, this time with RNA drugging player Arrakis for 'several billion' (Endpoints) (STAT)
  • Continuing push beyond Covid-19 vaccines, Moderna partners with 'CAR-M' biotech on in vivo cancer cell therapies (Endpoints)
  • A new AI startup has emerged, and Pfizer likes what it sees (Endpoints)
  • The Quality Lowdown: Pandemic Site Evaluation Creativity On Display As COVID Clampdown Returns (Pink Sheet)
  • Enzyvant’s Path From Complete Response Letter To FDA Approval For Rethymic Included CMC Revamp (Pink Sheet)
  • Novartis snaps up the rights to a Covid-19 antiviral after seeing mid-stage results. So where are the data? (Endpoints)
  • BioNTech and Crescendo Biologics team up to develop multi-specific precision immunotherapies (Biopharma Reporter)
  • Regeneron, 2seventy name the target of their first solid tumor CAR-T, aim for 2023 IND (Fierce)
  • 7 blockbusters: Analysts spotlight 2022’s crop of drugs most likely to win top marketing status — 2 drugs dominate (Endpoints)
  • Sarepta's second shot at showing its Duchenne gene therapy delivers positive data but underwhelms — shares tumble (Endpoints)
  • JPM 2022: Amicus axes gene therapy program for type of Batten disease, advances another (Fierce)
  • Amicus gets hit with an 'unexpected' setback on a gene therapy tapped to lead $600M SPAC spinout (Endpoints)
  • Korean conglomerate SK takes out stake in cell and gene therapy CDMO with plans for a major hiring spree outside Philly (Endpoints)
  • Selecta turns to synbio player for $1.1B capsid deal; BioNTech signs $790M immunotherapy deal (Endpoints)
Medtech
  • Two MDR-Designated European Notified Bodies Become One (Medtech Intelligence)
  • Device User Fee Talks Stalled as a Deadline Approaches (MedTech Strategist)
  • European Regulatory Roundup 2021: Extensive Reshaping Of Underlying Medical Device And IVD Structures (Medtech Intelligence)
  • Medtronic CEO: Company on track to hit guidance, omicron impact ‘uncertain’ (MedTech Dive)
  • Renalytix Collaborates With ADA To Improve Early Detection Of Kidney Disease (Medtech Intelligence)
  • Usability of COVID-19 Antigen Home Test Kits: Which at-home tests are easiest to use?  (ECRI)
Government, Regulatory & Legal
  • First transplant of genetically altered pig heart into person sparks ethics questions (STAT)
  • District Court interprets EKRA (FDA Law Blog)
  • Del. High Court Relieves Chubb Of Defending Opioid Suits (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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