Recon: Bristol Myers buoys cell therapy interests with $3B Century deal; EMA could issue decision on Paxlovid within weeks

ReconRecon | 10 January 2022 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Pfizer CEO unsure on need for fourth dose of COVID-19 vaccine (Reuters)
  • Pfizer to pay Beam $300 million in gene-editing deal, amping up its mRNA ambitions (STAT)
  • US breaks COVID-19 hospitalization record at over 132,000 as Omicron surges (Reuters)
  • Starting later this week, some at-risk Americans become eligible for a 4th shot (NYT)
  • FDA removes clinical hold on cancer studies of Allogene off-the-shelf CAR-T treatment (STAT)
  • Biogen CEO: Company was ‘wrong’ about initial Aduhelm price, ‘courageous’ to lower it (STAT)
  • Medicare asked to reassess 2022 premium hikes after Aduhelm price cut (Reuters) (STAT)
  • Novartis-Molecular Partners COVID drug could be authorized in weeks (Reuters)
In Focus: International
  • EU regulator could issue decision on Pfizer COVID-19 pill within weeks (Reuters)
  • With peak yet to come, Europe’s healthcare groans under Omicron’s swift spread (Reuters)
  • Sanofi, Exscientia ink the next AI megadeal, signing terms on a $100M upfront pact with up to 15 drugs on the line (Endpoints)
  • Chile, a vaccine front-runner, launches fourth COVID dose (Reuters)
  • Mexico, Morocco grant emergency use approval for Merck’s COVID-19 pill (Reuters 1, 2)
Coronavirus Pandemic
  • T cells common colds can provide protection against COVID-19 study (Reuters)
  • Despite record COVID surge, Europeans ease rules for key services (Reuters)
  • Covid may raise the risk of diabetes in children, CDC researchers reported (NYT)
  • Million Indians get COVID vaccine boosters, hospitalization low (Reuters)
Pharma & Biotech
  • Bristol Myers buoys cell therapy interests with $3B biobuck deal with Bayer-backed Century, $70M upfront to ArsenalBio (Fierce)
  • JPM 2022: Pfizer locks in 2 partners to solidify status as mRNA powerhouse (Fierce)
  • JPM 2022: Moderna finds Carisma’s macrophage tech compelling enough for $45 M cancer research deal (Fierce)
  • Novartis splashes cash on COVID-19 antiviral, plans FDA filing as Molecular Partners links drug to drop in hospitalization, death (Fierce)
  • FDA approves potential blockbuster insomnia drug, a first for Swiss biotech Idorsia (Endpoints)
  • Pfizer, the new master of mRNA delivery, teams up with Beam to ship base editors straight to target tissues (Endpoints) (Fierce)
  • Merck revs up dealmaking engine ahead of JPM22, inking collaborations with AI protein design player Absci (Endpoints)
  • How durable is durable? BioMarin gears up to bring hemophilia A gene therapy to FDA again with 2-year data (Endpoints)
  • Regeneron hands off ex-US rights for cholesterol disorder drug to rare disease specialist Ultragenyx (Endpoints)
  • Bayer jumps on board Mammoth's ultra-small CRISPR tech with sights set first on liver disease (Endpoints)
  • Allogene wins a major reprieve for its leading off-the-shelf cell therapy pipeline (Endpoints)
  • A new startup thinks it's found a key to drugging 'disordered' proteins — and it has plenty of cash to get started (Endpoints)
  • Fujifilm Diosynth adds on at its NC hub, bolstering lab space with plans to bring on 145 new jobs (Endpoints)
  • EN ISO 13485 And Symbols Standards Harmonized Under EU's IVDR (MedTechInsight)
  • At Long Last, FDA Sends Draft Harmonized Quality System Regulation To OMB For Review (MedtechInsight)
  • Abbott targets consumer health, aims to turn diabetes success into wearable growth driver (MedTech Dive)
  • Medtronic recalls StealthStation neurosurgery navigation software, again (Fierce)
  • 23andMe snags 3rd FDA nod for cancer risk test, this time for prostate cancer (Fierce)
  • JPM 2022: Exact Sciences moves into hereditary cancer tests with $190M PreventionGenetics buyout (Fierce)
  • MeMed Secures $93m Financing To Commercialize Diagnostics Platform (MedtechInsight)
Government, Regulatory & Legal
  • Ex-Theranos COO May Face Trial Delay Due To COVID Surge (Law360)
  • Biden administration poised to give pharmacies a major lobbying win (STAT)
  • Purdue Pharma Authorized to Appeal Judge’s Rejection of Sackler Settlement Plan (WSJ)
  • FDA loses FOIA suit over Pfizer vaccine documents, must release 55,000 pages per month (Endpoints)
  • DOJ charges doctor with reusing single-use devices in $46M Medicare fraud scheme (Fierce)
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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