Recon: CMS to restrict coverage of Aduhelm to only clinical trials; FDA warns of dental issues with buprenorphine

ReconRecon | 12 January 2022 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Criticized by Senators, US Health Officials Defend Omicron Response (NYTimes) (Endpoints)
  • Omnicron will infect ‘just about everybody,’ Fauci says (Washington Post)
  • FDA flags risk of dental issues from use of opioid addiction drug buprenorphine (Reuters) (FDA)
  • CMS to restrict coverage of Biogen’s controversial Alzheimer’s drug to only clinical trials  (Endpoints)
  • Biogen shares slide as Medicare restricts cover of Alzheimer’s treatments (Reuters)
  • Medicare Draft NCD For Alzheimer’s Drugs: When ‘Reasonable And Necessary’ And ‘Safe And Effective’ No Longer Align (Pink Sheet)
  • CBER Reorganization Aims To Fight Recruitment Challenges, Tackle Upcoming Gene Therapy Wave (Pink Sheet)
  • Pfizer study shows COVID-19 booster can be given along with pneumonia shot (Reuters)
  • AstraZeneca says US to buy additional 500,000 Evusheld doses (Reuters)
In Focus: International
  • Omicron less severe than Delta but still poses danger unvaccinated: WHO (Reuters)
  • Draft Intersectional global action plan on epilepsy and other neurological disorders 2022-2031 (WHO)
  • Germany's Scholz urges compulsory COVID-19 jabs for all adults (Reuters)
  • Zimbabwe says China to donate 10 mln doses of COVID vaccine in 2022 (Reuters)
Coronavirus Pandemic
  • White House taps Inglesby as COVID testing coordinator (Reuters)
  • White House will double COVID-19 tests for schools (Reuters)
  • How a tiny Swiss lab and two old blood samples created one of the only effective drugs against Omicron (and why we have so little of it) (Endpoints)
  • French Health Minister: too early to say if current COVID-19 wave has peaked (Reuters)
  • Denmark to ease coronavirus restrictions despite Omicron surge (Reuters)
  • Sweden cuts recommended gap between second and third COVID shot (Reuters)
  • Swiss halve quarantine period to five days to cope with Omicron surge (Reuters)
  • A popular at-home test detects most infectious Omicron cases, a study suggests (NYT)
  • South Korea Ministry of Food and Drug Safety approves Novavax COVID-19 vaccine (Pharmafile)
  • California hospitals find that Omicron causes fewer hospitalizations and shorter stays (NYT)
  • Which mask? What test? Covid’s latest surge spreads an epidemic of confusion (Washington Post)
Pharma & Biotech
  • As Abecma sales take off, Bristol Myers and 2seventy scrap a follow-up CAR-T (Endpoints)
  • In pursuit of better heparin manufacturing process, Ginkgo teams up with an Ohio-based biotech (Endpoints)
  • COVID-19 Boost As Pharma ROI Hits Heights Not Seen For Seven Years (Scrip)
  • Seeds of change' sprout into higher projected return on investments for the biopharma industry, according to Deloitte (Endpoints)
  • Reeling from FDA rejection, BeyondSpring axes 35% of US staffers in hopes of I/O comeback (Endpoints)
  • Daiichi Sankyo shuts down Plexxikon subsidiary to streamline Enhertu, ADC development (Endpoints)
  • Sanofi joins the alpha-synuclein bandwagon, handing Korean biotech $75M for preclinical bispecific (Endpoints)
  • Aldeyra Therapeutics Eyes First Line Market As Phase II Dry Eye Candidate Impresses (Scrip)
  • Endo pivots from NFL star John Elway to real patients in Dupuytren’s contracture awareness ads (Endpoints)
  • Quest Diagnostics sees higher 2021 profit on COVID-19 testing surge (Reuters)
  • EU Commission to consider medtech industry’s recruitment challenges (Medwatch)
  • EU Now Boasts 27 MDR Notified Bodies With Latest Italian Designation (MedtechInsight)
  • FDA: COVID-19 Antigen, Antibody Tests By LuSys Labs Could Give Wrong Results, Shouldn’t Be Used (MedtechInsight)
  • Abbott scores FDA clearance for its latest EnSite heart mapping platform (Fierce)
  • Edwards seen falling short in Q4 based on early US TAVR volume data: Jefferies (MedTechDive)
  • Country’s largest pancreatic disease patient registry launches (Medcity News)
Government, Regulatory & Legal
  • ‘Skinny labels’ on generics can save patients money, research shows, but recent court decisions cloud future (Endpoints)
  • Is The Skinny Label Back From the Dead? (FDALawBlog)
  • Florida Co-Owner of Clinical Trial Company Pleads Guilty to Obstructing FDA Inspection (DOJ)
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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