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January 27, 2022
by Joanne S. Eglovitch

Recon: Pfizer gets conditional OK from EMA for Paxlovid; Moderna starts trial for Omicron booster shot

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Moderna starts trial for Omicron-specific booster shot (Reuters)
  • Most US local governments opt to join $26 bln opioid settlement (Reuters)
  • Roche nabs a priority review for Evrysdi, hoping to become the first oral treatment for infants with SMA (Endpoints)
  • Pfizer pushes to intervene in lawsuit seeking COVID vaccine information from FDA (Reuters) (Endpoints)
  • Under pressure, Biogen outlines ambitious diversity goals for Aduhelm study — but the Medicare fight is still on (Endpoints)
  • The Biden administration used billions in hospital Covid-19 funds to pay drugmakers (STAT)
  • A senior Biogen commercial exec exits Alzheimer's unit amid exodus as Aduhelm woes mount (Endpoints)
  • Top US FDA Drug Policy Leader Leaving For White House Detail (Pink Sheet)
  • Consortium Costs Debated As BARDA, Industry Discuss Plans For Next Pandemic Response (Pink Sheet)
In Focus: International
  • EU drug regulator OKs Pfizer COVID pill for high-risk patients (EMA) (Bloomberg) (Reuters)
  • Booster shots could cut Europe's COVID hospitalisations by up to 800,000 -EU (Reuters)
  • As Omicron-specific boosters are in the news, BioNTech to expand German site workforce by 200 employees (Endpoints)
  • China's Walvax says has most participants for large mRNA COVID vaccine trial (Reuters)
  • UK Tests Streamlined Assessment Of Requests For Trials Involving Drugs & Devices (Pink Sheet)
Coronavirus Pandemic
  • Government watchdog says HHS at 'high risk' of bungling public health crises (Politico)
  • Boosters increase protection against death from Omicron in over-50s to 95% - UKHSA (Reuters)
  • Sweden decides against recommending COVID vaccines for kids aged 5-12 (Reuters)
  • Covid-19 Curbs Eased Further in Europe as New Version of Omicron Spreads in Places (WSJ)
  • As Omicron ebbs, England revives Plan A: living with COVID (Reuters)
  • No exit from zero-COVID: China struggles to find policy off-ramp (Reuters)
  • Hong Kong may become a living laboratory in search for Covid-19 answers (STAT)
  • Patchwork system for rationing a Covid drug sends immunocompromised patients on a ‘Hunger Games hunt (STAT)
  • Hospitals are denying transplants for patients who aren’t vaccinated against Covid, with backing from ethicists (STAT)
Pharma & Biotech
  • Taysha mulls tweaks to gene therapy trial after subject dies (Fierce)
  • Immunocore Ready For First-Ever Launch After Kimmtrak’s US Approval (Scrip)
  • After a banner year, Samsung will charge forward with 'super plant' plans, and look to expand abroad (Endpoints)
  • As Sanofi keeps shrinking its US HQ footprint during pandemic, new owners scoop up its old campus (Endpoints)
  • Early research suggests Merck cancer drug may target dormant HIV (Reuters)
  • Novartis marketing vets move on to new commercial roles in biotech (Endpoints)
  • Selling shares at a discount, Zymeworks grabs $100M cash in hopes of turnaround (Endpoints)
  • Going after an old GSK target in a new way, a Yale spinout hits the clinic and nabs a modest raise (Endpoints)
  • China Biotechs Bag $740m As Ox Makes Way For Tiger (Scrip)
  • A new Third Rock startup seeks a 'second golden age' of GPCR drug discovery based on Nobel laureate's work (Endpoints)
  • Big Pharma R&D legend Paul Stoffels is trading his J&J title for the CEO role at one of the most deeply troubled biotechs in the industry (Endpoints)
Medtech
  • Playing Big: Akili To Be Bought By Chamath Palihapitiya’s SPAC In $1Bn Deal (MedTech Intelligence)
  • Philips adds even more ventilators to Class I recall caused by faulty sound-muffling foam (Fierce)(MedTech Intelligence)
  • 4 key trends for procedure-reliance medtechs in 2022 (MedTech Dive)
Government, Regulatory & Legal
  • Dying Covid Liability Laws Prompt Push for Their Revival (Bloomberg)
  • Sign-ups in Affordable Care Act marketplaces reach record 14.5 million (Washington Post) (Reuters)
  • Michigan attorney general pursues investigation into Lilly’s ‘grossly’ excessive insulin prices (STAT)
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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