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Recon: Biogen wants dialogue with CMS over Aduhelm coverage decision; GSK, Vir seek authorization for COVID antibody shot

Posted 13 January 2022 | By Joanne S. Eglovitch 

Recon: Biogen wants dialogue with CMS over Aduhelm coverage decision; GSK, Vir seek authorization for COVID antibody shot

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Senate Panel OKs Califf Nomination for FDA Chief (NYT) (Inside Health Policy)
  • US Supreme Court blocks Biden vaccine-or-test policy for large businesses (Reuters) (STAT)
  • GSK, Vir seek US approval for COVID-19 antibody therapy as shot in arm (Reuters)
  • FDA concerns at contractor Catalent site spurred on shortages of Novo Nordisk's semaglutide — report (Endpoints)
  • Pfizer says it's ready to ramp up Paxlovid production. Experts say it's not that easy (Endpoints)
  • Pfizer offers a soft sell but with a strong message on vaccines in first COVID ad (Fierce)
  • Biogen seeks dialogue with U.S. CMS about Alzheimer's drug coverage decision (Reuters) (Endpoints)
  • With its Alzheimer’s drug in turmoil, Biogen eyes a list of potential acquisitions (STAT)
  • The biggest losers from Medicare’s decision on Aduhelm may be Biogen’s competitors (STAT)
  • Novartis Seeks Nod for Covid Drug in US Before Final Test (Bloomberg)
In Focus: International
  • Swissmedic temporarily approves Regkirona COVID-19 treatment (Reuters)
  • AstraZeneca says early trial data indicates third dose helps against Omicron (Reuters)
  • Polish scientists find gene that doubles risk of serious COVID (Reuters)
  • Nigerian startups help fight scourge of fake medicines (Reuters)
  • Africa joins race to acquire Pfizer's COVID-19 Paxlovid pills (Reuters)
Coronavirus Pandemic
  • Early signs suggest Omicron has begun to peak in parts of the US, David Leonhardt writes (NYT)
  • 1,000 military health workers to deploy to U.S. hospitals -White House (Reuters) (Washington Post)
  • French Senate approves latest COVID measures and vaccine pass (Reuters)
  • Hungary to offer fourth COVID shot as Omicron cases spike (Reuters)
  • Spain to cap antigen test prices, expand booster programme (Reuters)
  • Analysis: India's new COVID-19 rules aim to free up resources but carry risks (Reuters)
  • Poorer nations reject over 100 million COVID shots as many close to expiry (Reuters)
  • Senegal authorizes COVID-19 booster shots, vaccines for children (Reuters)
  • England to cut minimum COVID self-isolation to five days (Reuters)
  • Germany's COVID-19 cases hit new record as labs warn of testing crunch (Reuters)
  • Sweden sets new record of COVID cases, sees peak at end of January (Reuters)
Pharma & Biotech
  • Intellia To Take On Pfizer Blockbuster With Gene-Editing Therapy (Scrip)
  • Cancer powerhouse AstraZeneca rolls the dice on a $75M cash bet on a buzzy upstart in the oncology field (Endpoints)
  • AstraZeneca Plans To Drug The Undruggable With Scorpion Partnership (Scrip)
  • JPM 2022: Bluebird bio hopes for clear skies ahead as it gears up for trio of gene therapy launches (Fierce)
  • A new biotech startup looks to sidestep a key problem with CAR-T cancer therapies (STAT)
  • Eye disease biotech raises $46.9M in Series B; Journey Medical Corporation shells out $20M upfront for dermatology franchise (Endpoints)
  • Three years, a clinical hold and a death later, Sarepta abandons partnered pivotal-stage gene therapy (Endpoints)
  • Denali's Alzheimer's drug faces setback at the FDA after agency slaps clinical hold on human trial start (Endpoints)
  • Has There Been A Sea Change In Trial Diversity Efforts? (Scrip)
  • JPM22: Catalent CEO John Chiminski with John Carroll -- Our predictions for the biopharma industry in 2022 (Endpoints)
  • With new Omicron data, Adagio halts trials for vaunted Covid antibody but sees a path ahead (Endpoints)
  • Vigil Neuroscience hits Wall Street with two ex-Amgen TREM2 agonists (Endpoints)
  • Notified body shortage remains pressing as industry prepares for staggered IVDR rollout (MedTechDive)
  • Philips ups recall provisions by $250M, impacted devices to more than 5M (MedTechDive)
  • JPM 2022: Renalytix plots de novo FDA nod for kidney disease AI, expands into drug response monitoring (Fierce)
  • Industry Urged White House To Invest In COVID-19 Tests Long Before Current Shortage: AdvaMed (MedTechIntelligence)
  • AstraZeneca bets $75M on Scorpion’s precision approach to tough cancer targets (MedCityNews)
  • Cardio Industry Puts Weight Behind UK Call For National CVD Strategy (MedTechIntelligence)
Government, Regulatory & Legal
  • CRO owner pleads guilty to obstructing FDA investigation into falsified clinical trial data (Endpoints)
  • Ex-Theranos CEO Elizabeth Holmes To Be Sentenced Sept. 26 (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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