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Regulatory Focus™ > News Articles > 2021 > 9 > Recon: CMS moves to end Trump-era MCIT rule; CureVac cuts vaccine productions plans

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

Posted 14 September 2021 | By Michael Mezher 

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

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Biden Covid team sees vaccine efficacy waning in unpublished data from Israel (Politico)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)
In Focus: International
  • 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)
Coronavirus Pandemic
  • Former Trump advisers used private emails to warn of 'critical mistakes' in pandemic response (The Hill)
Pharma & Biotech                                                                                                     
  • 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)
Government, Regulatory & Legal
  • Elizabeth Holmes trial set to resume, with more insider testimony (STAT)
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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