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Regulatory Focus™ > News Articles > 2022 > 1 > Recon: Pfizer says Paxlovid appears effective against omicron; Unilever ends pursuit of GSK consumer

Recon: Pfizer says Paxlovid appears effective against omicron; Unilever ends pursuit of GSK consumer arm

Posted 19 January 2022 | By Joanne S. Eglovitch 

Recon: Pfizer says Paxlovid appears effective against omicron; Unilever ends pursuit of GSK consumer arm

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Senate Finance chair investigates Bristol Myers over an allegedly abusive overseas tax shelter (STAT)
  • ‘Dangling’ Cancer Indications In US: New Year Brings New Withdrawals Of Accelerated Approvals (The Pink Sheet)
  • Pfizer says COVID-19 antiviral pill effective against omicron (The Hill)
  • US to make 400 million N95 masks available for free to fight COVID-19 pandemic -official (Reuters) (the Hill)
  • With $3 billion, Hal Barron and other biotech veterans launch a disease ‘reversal’ company (STAT) (Endpoints)
  • FDA misses MDUFA V deadline after months of contentious talks (MedtechDive)
In Focus: International
  • WHO sees slowdown in omicron surge (The Hill)
  • WHO official says world has 'chance to end' worst of COVID-19 this year (The Hill)
  • Unilever Walks Away From Glaxo Consumer-Healthcare Deal (WSJ)
  • EMA: Multiple COVID-19 Booster Programs ‘Not Sustainable’ In Long Term (The Pink Sheet)
  • EU Extends Provisions For Ensuring Post-Brexit Flow Of Medicines (The Pink Sheet)
  • UCB buys its way to epilepsy showdown with Jazz with $1.9B Zogenix acquisition (Endpoints)
  • Vaccine group Gavi says additional $5.2 bln needed to ensure supply (Reuters)
  • Valneva says early studies show COVID-19 vaccine effective against Omicron (Reuters)
  • Billionaire Soon-Shiong opens new vaccine plant in South Africa (Reuters)
Coronavirus Pandemic
  • New data show those who recovered from Covid-19 were less likely than vaccinated to get infected during Delta wave (STAT)
  • US Postal Service To Distribute Biden’s Free COVID-19 Rapid Antigen At-Home Tests Starting This Week (MedtechIntelligence)
  • CDC adds 22 countries to level four travel warning list (The Hill)
  • At least 20% of Americans have been infected with COVID-19, data show (The Hill)
  • Measures to stem spread of omicron in UK dropped (The Hill)
  • Germany tops 100,000 daily COVID-19 cases for first time (Reuters)
  • India's new COVID-19 cases hit eight-month high, full impact weeks away (Reuters)
  • Japan widens COVID-19 curbs as Omicron drives record infections (Reuters)
Pharma & Biotech
  • Patent thickets are thwarting U.S. availability of lower-cost biosimilar medicines, study finds (STAT)
  • AstraZeneca rolls out 'unprecedented' 3-year survival data for PD-L1/CTLA4 combo in liver cancer (Endpoints)
  • An unorthodox proposal for Biogen's Medicare-mandated Aduhelm trial (Endpoints)
  • Fierce JPM Week: After ‘objectively astonishing’ progress on mRNA, biotech looks to tinker with winning formula (Fierce)
  • China Gene Therapy Developers Rush To Clinic In 'Winner Takes All' Battle (Scrip)
  • Sensorion sinks as leading hearing loss program flounders in phase 2 trial, calling future indications into question (Fierce)
  • Jazz Trumpets 2025 Strategy With Neurology, Oncology Focus (Scrip)
  • Almost three years after whiffing in a confirmatory study, Merck touts new data for Keytruda in HCC (Endpoints)
  • Regenerative med biotech ProKidney inks $825M merger to back CKD cell therapy (MedCityNews)
  • A new startup wants to take antisense and siRNA one step further, and build more potent drugs than Ionis and Alnylam (Endpoints)
  • With its lead CAR-T flashing some PhI data, Arcellx readies a jump to Nasdaq (Endpoints)
  • A George Church spinout fighting the viral vector bottleneck in cell and gene therapy lands $55M (Endpoints)
  • Secondary patents prove to be key in biosimilar blocking strategies, researchers find (Endpoints)
Medtech
  • FDA Codifies Down-Classification For Devices Such As The Apple Watch ECG App (MedtechIntelligence)
  • Smith & Nephew kicks in $135M for 3D-printed, cementless knee implant maker Engage Surgical (Fierce)
  • CDRH pledges greater focus on women's health data (MedTechDive)
  • Sema4 shells out $623M to scoop up a leading diagnostics player and its trove of data (Endpoints)(MedTechIntelligence)
  • Swedish Company’s Novel Device At The Heart Of Milestone Transplant Surgery (MedTechIntelligence)
Government, Regulatory & Legal
  • Teva Agrees To $420m Securities Settlement For Alleged Price Fixing (Generics Bulletin) (Law360)
  • Purdue Urges 2nd Circ. To Quickly Undo Ch. 11 Plan Rejection (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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