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

• 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)

• 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)

• 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)

• 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)

• 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)