Recon: China approves Pfizer’s COVID drug Paxlovid; Biogen, others respond to CMS’ coverage proposal for Alzheimer’s drugs
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- 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)
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