Recon: CMS moves to end Trump-era MCIT rule; CureVac cuts vaccine productions plans

• Biden Covid team sees vaccine efficacy waning in unpublished data from Israel (Politico)
• Pioneering Gene Therapy Freed Her of Sickle Cell. Is a Cure at Hand? (NYTimes)
• Emergent to make Providence Therapeutics potential COVID-19 vaccine (Reuters)
• US judge grants Purdue Pharma's $7M exec bonus plan, faces blunt criticism (Reuters)
• Fourth boy dies in Astellas-Audentes gene therapy trial, raising fresh fears for the field (Endpoints)
• CMS moves to scrap MCIT rule due to clinical evidence concerns (MedtechDive)
• FDA Asks Full DC Circ. To Consider Electric Shock Device Ban (Law360)
• Republicans ask FDA for details on any White House pressure on boosters (The Hill)

• UK would not have approved Valneva COVID vaccine, health secretary says (Reuters)
• CureVac slashes COVID-19 vaccine production plans (Reuters)
• UK plans COVID boosters for over 50s to cope with "bumpy" winter (Reuters)
• WHO-backed vaccine hub for Africa to copy Moderna COVID-19 shot (Reuters)
• Less than 3.5 % of Africans vaccinated against COVID - Africa CDC (Reuters)

• Former Trump advisers used private emails to warn of 'critical mistakes' in pandemic response (The Hill)

• Rosana Kapeller raises $77M in bid to make repeatome drugs a reality (Endpoints)
• Ebola vaccine built on same technology as Covid-19 jab from J&J shows long-lasting success (Endpoints)
• Sanofi dumps Principia Biopharma's San Francisco labs with plans to immediately cut 38 jobs (Fierce)
• Lightstone Ventures unveils $375M third fund, this time expanding its wishlist in blossoming CNS field (Endpoints)
• Bending PDUFA’s Cost Curve: PhRMA Looking For Sustainable Program Growth (Pink Sheet)
• PDUFA VII’s Big Commitments: ‘Goal Inflation’ Accelerates (Pink Sheet)
• Ready, Set, Go: China To Use Patient-Reported Outcomes In Clinical Studies (Pink Sheet)
• Spurred on by OrbiMed partner's diagnosis, Vanqua Bio takes aim at neurodegenerative disease with blue-chip backers (Endpoints)
• Bill Haney adds another $133M to Skyhawk's coffers, as the RNA startup guns for the clinic (Endpoints)
• Takeda eyes vaccine business growth amid COVID-19 partnerships and dengue progress, CEO says (Fierce)
• Five months after getting slapped with a clinical hold, KalVista gets the OK to restart oral HAE program (Endpoints)
• The team behind eFFECTOR's SPAC deal is back after going from launch to merger in just 4 months (Endpoints)
• How Jan Skvarka and Trillium went from down and out to buyout with Pfizer (Endpoints)
• Shanghai biotech tackling kidney disease gets another round of cash (Endpoints)
• Jacobus Pharmaceutical Company Inc. Issues Voluntary Worldwide Recall of Ruzurgi® (amifampridine) 10 mg Tablets Due to Yeast, Mold, and Bacterial Contamination (FDA)

• Services firm Mesa buys out molecular diagnostics player for a cool $300M as genetics testing gains steam (Endpoints)
• Zoll snaps up Itamar Medical in sleep apnea tech deal topping $538M (Fierce)
• Masimo finds pot of gold with CE mark for Rainbow SuperSensor, to monitor 12 blood parameters at once (Fierce)
• Medtronic launches AI pilot program to tackle race, gender disparities in cardiac care (Fierce)
• MedTech Europe calls for urgent clarification of EU artificial intelligence proposal (MedtechDive)

• Elizabeth Holmes trial set to resume, with more insider testimony (STAT)