Recon: China approves Pfizer’s COVID drug Paxlovid; Biogen, others respond to CMS’ coverage proposal for Alzheimer’s drugs

• Biogen Alzheimer Drug Row Augers Flux in Fast FDA Approvals (Bloomberg)
• FDA Authorizes Lilly’s Bebtelovimab for Some Covid Treatment (Bloomberg)
• Cassava scores a win as FDA declines to intervene in petition to stop its Alzheimer’s drug trials (Fierce) (Endpoints) (STAT)
• Delayed Onset Of Tramadol IV Creates Risk Of ‘Opioid Stacking,’ US FDA Finds (The Pink Sheet)
• AstraZeneca Awarded $855M Modification From DoD for Covid Pill  (Bloomberg)
• Senseonics lands long-awaited FDA approval for 6-month implanted CGM system (Fierce)
• Gilead says COVID drug remdesivir shows antiviral activity against Omicron, other variants (Reuters)
• Biogen slams coverage proposal for amyloid-targeted Alzheimer's drugs in 31-page comment (Endpoints)
• Roche, Lilly push back against CMS painting their Alzheimer’s meds with the same brush as Biogen’s Aduhelm (Fierce) (Endpoints)

• China approves use of Pfizer's COVID drug Paxlovid (Reuters)
• EU investigates reports of menstrual disorders after mRNA COVID shots (Reuters)
• EMA Reviewing Cardiovascular & Cancer Risk From Five Janus Kinase Inhibitors (The Pink Sheet)
• Novavax applies for COVID-19 vaccine approval in Switzerland (Reuters)
• Singapore grants interim approval for Novavax's COVID-19 vaccine (Reuters)
• Vaccine access puts EU and Africa at odds ahead of summit (Politico)
• EU, Gates Foundation to support African medicines agency (Reuters)
• No Love: Chinese Oncology Firms Scramble To Cope With New US Reality (Pink Sheet)
• Merck Japan says to accelerate imports of COVID-19 treatment (Reuters)
• Moderna in final talks to build an mRNA manufacturing, R&D hub in the UK (Endpoints)

• Novavax says its vaccine is 80% effective in teens, but manufacturing questions continue to cloud future (Endpoints)
• Germans pin hopes on Novavax moving the needle among anti-vaxxers (Reuters)
• Pardes expects to start larger trial of COVID-19 antiviral pill by mid-year (Reuters)

• US FDA Seeks Ability To Include More Inactive Ingredient, Excipient Info In Brand Labeling (The Pink Sheet)
• Biotech Investors Unwind Speculative Bets as Pandemic Fears Fade (Bloomberg)
• Seagen's stock plunges after revealing a disappointing outlook for one of its core cancer drugs (Endpoints)
• FDA fingers tox assessment as cause of Denali clinical hold, leaving biotech with a to-do list to regain momentum (Fierce)
• Metacrine lays off half its staff, mainly researchers, and ditches more work to focus on IBD after NASH disaster (Fierce)
• Trump administration insider Brett Giroir is taking the reins at a biotech startup (Endpoints)
• Market issues prey on potential bounceback for antibiotics, says a new report — here's how to fix it (Endpoints)
• Small pain drug player gets snapped up in $604M buyout — and the axe will soon fall (Endpoints)
• Hunting for cutting-edge biotech, Fujifilm sets up early-stage VC fund (Fierce) (Endpoints)
• In latest antisense failure, ProQR's rare eye disease treatment falls flat (Endpoints)

• Too Slow, Too Fast, Or Just Right? Experts Weigh In On OMB’s 35-Day Review Of FDA’s Draft QSR (MedTech Insight)
• CDRH digital health chief talks new role with agency, future of the market (MedTech Dive)
• Novel SCS System Restores Mobility To People With Severe Spinal Injury, Paralysis (MedTech Insight)
• Dexcom bests its ‘best year ever’ with 27% surge to $2.5B revenue in 2021 (Fierce)
• At the CrossRoads: J&J’s DePuy Synthes acquires foot and ankle implant system maker (Fierce)
• £7m UK Fund To Help Medtech SMEs Through Regulatory Minefield (MedTech Insight)

• 5 Key Details As Endo Is Ricked Again By Opioid Default (Law360)
• Johnson & Johnson defends talc bankruptcy in court (Reuters)
• Appeals court quashes Sanofi’s big win on bellwether hair loss case (Endpoints)
• Pacira Expands Fight With Jiangsu Over Surgery-Pain Drug Patents (Bloomberg)
• SaNOtize, Lupin In Legal Row Concerning COVID-19 Nasal Spray (Scrip)