Recon: FDA grants priority review for Biogen-Eisai’s Alzheimer’s drug; Senate Democrats advance drug-price deal

ReconRecon
| 06 July 2022 | By Joanne S. Eglovitch 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • FDA decision on Eisai, Biogen Alzheimer's drug due in January (Reuters) (Fierce) (The Pink Sheet) (Bloomberg)
  • NBC pundit, public health expert Vin Gupta in line for top Biden administration spot (Politico)
  • Roche’s Lunsumio eyes year-end FDA verdict to be first bispecific for non-Hodgkin lymphoma (Fierce)  (Pharmaphorum)
  • Coherus, Junshi’s Cancer Checkpoint Gets Second Chance with FDA (Biospace)
  • Omicron sub-variants BA.4, BA.5 make up 70% of COVID variants in U.S. – CDC (Reuters)
  • OIG report accuses FDA of not following policies for foreign drug inspections (Endpoints)
  • U.S. Senate Democrats advance drug-price deal (Reuters)
  • Texas drug manufacturer smacked with FDA warning letter over multiple violations (Endpoints)
  • A New OTC Pathway At Last: The Acronym Isn’t The Only Thing That’s Changed (The Pink Sheet)
  • ARPA-H Biomedical Research Agency Gets Funding Boost In US House Appropriations Bill (The Pink Sheet)
  • CMMI Finds Implicit Bias In Kidney, Heart And Joint Replacement Models (Inside Health Policy)
In Focus: International
  • EMA Firms Up February 2025 Date For Shortages Monitoring Platform (Generics Bulletin)
  • Access In Jeopardy If Generics Excluded From EU Centralized Procedure (Generics Bulletin)
  • BioNTech looking into taking legal steps against CureVac (Reuters)
  • CureVac files patent lawsuit in Germany against BioNTech over mRNA technology (Reuters)
  • WHO: More than 6,000 monkeypox cases reported, another emergency meeting set (Reuters)
  • Sanofi jumpstarts effort to supply 30 'essential' drugs to lower-income countries (Endpoints)
  • Greece reports first toddler death of severe acute hepatitis (Reuters)
Pharma & Biotech
  • Pfizer lines up access to 'doggybone DNA' in manufacturing of mRNA vaccines, gene therapies and more (Endpoints)
  • Viatris starts yet another insulin recall over potential missing labels (Fierce)
  • Boehringer Ingelheim, Evotec band with diagnostics player to tackle 'superbugs' through joint venture (Endpoints) (Fierce) (Biospace)
  • Syros Gets ‘Tyme’ To Bring Lead Candidate To Pivotal Readout (Scrip)
  • Heart inflammation emerges in a Sarepta Duchenne patient, clouding an otherwise positive readout (Endpoints)
  • Older Class of Drugs May Show Promise for Some Alzheimer’s Signs  (Bloomberg)
  • Cancer Drug Greatly Reduces Deaths in Hospitalized Covid Patients (New York Times)
  • Codiak gets $2.5M from CEPI to forge way out of pandemic, prep for disease X (Fierce)
  • How To Make Clinical Trials More Diverse (The Pink Sheet)
  • Beyond a CRISPR treatment’s encouraging results, some scientists see a need for more data on risk (STAT)
  • The biotech scorecard for the third quarter: 18 stock-moving events to watch (STAT)
Medtech
  • Fairtility welcomes EU approval for embryo assessment AI (Fierce)
  • US Lawmakers: Hearing Aid Manufacturers Tried To Undermine OTC Proposal (MedTech Insight)
  • American Contract Systems’ COVID-19 test recall gets Class I label from FDA (MedTech Dive)
  • Wearables are a growing part of doctor-patient talks for cardiac patients: Study (MedTech Dive)
  • Novartis UK teams up with Medtronic, others to support digital cardiovascular disease startups (Fierce) (MedTech Insight)
  • Ra Medical notches FDA catheter clearance amid mass layoffs, potential restructuring (Fierce)
Government, Regulatory & Legal
  • Novo Sues Sun Pharma Twice to Block Copies of Saxenda, Victoza  (Bloomberg)
  • Bristol-Myers, Alembic Settle Patent Suit on Top Seller Revlimid (Bloomberg)
  • AliveCor ECG patent ruling sets stage for block on Apple Watch imports (MedTech Dive)
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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