Recon: CDC recommends Pfizer booster for 12- to 15-year-olds; Stryker to buy Vocera for nearly $3B

ReconRecon | 06 January 2022 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • CDC recommends Pfizer's COVID-19 booster for ages 12 to 15 (Reuters) (NYT)
  • Lifesaving Covid Treatments Face Rationing as Virus Surges Again (NYTimes)
  • All vaccinated participants with severe COVID-19 in CDC study had at least one risk factor (The Hill)
  • Biden, in Shift Prepares Americans to See Covid-19 as Part of Life (WSJ)
  • Containing Covid-19 requires rapid tests that are highly sensitive to infections. Why is the FDA asking for something different? (STAT)
  • Medical device maker Stryker to buy Vocera Communications for $2.97 bln (Reuters)
In Focus: International
  • Omicron may be less severe in young and old, but not 'mild' – WHO (Reuters)
  • UK Regulator Issues 41 Innovation Passports In First Year Of New Pathway (The Pink Sheet)
  • China rushes to develop an mRNA vaccine as doubts grow over local jabs (FT)
  • Gavi and India's Bharat Biotech discuss possible COVAX use of Covaxin (Reuters)
  • UK PM Johnson says COVID-19 shots will stay voluntary, attacks anti-vax movement (Reuters)
  • Italy mandates boosters for ages 50 and up (The Hill)
  • Canada signs deal to buy 20,000 doses of GSK COVID-19 drug Sotrovimab (Reuters)
  • Chilean health ministry is urged to issue a compulsory license for the Pfizer Covid pill (STAT)
Coronavirus Pandemic
  • NIH collaborating with Clear Creek to develop COVID-19 therapies (BioCentury)
  • As Covid policies divide America, Ontario doubles down (again) (Politico)
  • Infections at record high, hospitalisations low as Omicron sweeps Israel (Reuters)
  • Italy's coronavirus cases hit new daily record of 219,441 Thursday (Reuters)
  • Argentina breaks COVID-19 case record as daily infections near 100,000 (Reuters)
  • Study raises doubts about rapid Covid tests’ reliability in early days after infection (STAT)
  • Omicron spreads in India's big cities but hospitalisations still low (Reuters)
  • Austria shortens coronavirus quarantine, presses ahead with mandatory jabs (Reuters)
  • Portugal eases COVID-19 rules as hospitalisations low amid record cases (Reuters)
  • Philippines' Duterte threatens unvaccinated people with arrest (Reuters)
Pharma & Biotech
  • Novartis is 'all in' on siRNA, inking a new collaboration with Alnylam to develop alternative to liver transplants (Endpoints)
  • The case for Califf: Don’t let politics prevent confirmation of best FDA commissioner candidate (STAT)
  • Amgen partners with Flagship's machine learning startup, promising up to $1.9B as Big Pharma ups bet on AI (Endpoints)
  • PureTech Takes On Roche With Improved-IPF-Drug (Scrip)
  • Executives On The Move: Changes At GlaxoSmithKline, aTyr Pharma And More (Scrip)
  • In new post-Merck role, Roger Perlmutter rakes in half a billion dollars to change the way scientists look at proteins (Endpoints)
  • Covid-19 roundup: Investors call to link CEO salaries to vaccine access; Why there aren't more initial supplies of the Pfizer pill (Endpoints) (STAT)
  • Merck KGaA beefs up its mRNA work with a $780M buyout of a booming player (Endpoints)
  • Sanofi tears up Sangamo cell therapy deal in pivot to off-the-shelf approaches (FierceBiotech)
  • Longtime Zymeworks CEO, co-founder Tehrani hits the exit in favor of serial biotech entrepreneur (Endpoints)
  • ‘It’s almost negligible’: More top hospitals aren’t offering controversial Alzheimer’s drug Aduhelm (STAT)
  • Abbott, Quidel COVID-19 antigen tests found to lag PCR in detection of omicron (Medtech Dive)
  • Emerging Data Raise Questions About Antigen Tests and Nasal Swabs (NYT)
  • Swiss Industry Makes Breakthrough For Local Market Device Labeling (MedTechIntelligence)
  • Goodbye IMI, Hello IHI: New EU Partnership Prepares To Invite Research Proposals (MedTechIntelligence)
Government, Regulatory & Legal
  • Delaware Judge Dismisses Guardant Cancer Test IP Suit (Law360)
  • Ex-DEA Official Says Cardinal 'Barely' Monitored For Opioids (Law360)
  • Stockholders Sue AmerisourceBergen In Del. Over Opioids (Law360)
  • Pfizer, Allele Biotech End COVID Vax IP Fight (Law360)
  • Pfizer, Roche, AstraZeneca and J&J face newly revived lawsuit claiming they funded terrorism in Iraq (FiercePharma
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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