Recon: Amgen signs $2B pact with Synaffix to develop antibody conjugates; Swedish EU presidency promises action on pharma law revision

ReconRecon | 05 January 2023 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Third Patient Death Potentially Linked to Lecanemab Days Before Expected FDA Decision (Biospace) (STAT) (MedPage Today)
  • Eisai rebuts NEJM report that Alzheimer’s med contributed to patient’s stroke death (Fierce)
  • Vaxcyte’s VAX-24 Granted FDA Breakthrough Therapy Designation for the Prevention of Invasive Pneumococcal Disease in Adults (Biospace)
  • U.S. new drug price exceeds $200,000 median in 2022 (Reuters)
  • FDA policy change opens the door for abortion pill in pharmacies (Endpoints) (STAT)
  • Justice Dept.: Despite bans, abortion pills may be mailed to any state (Washington Post)
  • Sen. Burr’s Parting Gifts For US FDA Include ‘Platform’ Pathway (Pink Sheet)
  • J&J Files to Spin Off Its Consumer Health Business as Kenvue Bloomberg)
  • Takeda troops rare disease drug to regulators after glimpse at phase 3 data (Fierce)
  • Particulates, label issues prompt separate recalls for Pfizer’s Hospira and Accord (Fierce)
  • Republicans Vying for Ways and Means in Limbo Amid Chaos (Bloomberg)
  • Baby Foods With Toxic Metals Stay on US Market While FDA Dithers (Bloomberg)
In Focus: International
  • Updated EU Guide Helps Sponsors Steer Through National Clinical Trial Requirements (Pink Sheet)
  • Senior WHO official faults China for undercounting Covid deaths (STAT)
  • WHO warns of most transmissible subvariant, questions China’s covid data (Washington Post)
  • China defends its COVID response after WHO, Biden concerns (Reuters)
  • Swedish EU Presidency Promises Action On Pharma Law Revision, EMA Fees & AMR (Pink Sheet)
  • Africa CDC says Uganda’s Ebola outbreak is coming under control (Reuters)
Pharma & Biotech
  • Amgen piles $2B more into pharma’s ADC rush in Synaffix pact (Fierce) (Scrip)
  • Pfizer leads top-selling pharma forecast — Evaluate report (Endpoints)
  • Biogen splits R&D division ahead of key decision on Alzheimer’s drug (Reuters) (STAT)
  • Moderna sprints toward RSV podium behind GSK, Pfizer, with eyes on combo vax (Fierce)
  • Roivant-Pfizer inflammatory bowel drug hits high expectations in mid-stage study (STAT)
  • Catalent inks deal to manufacture Sarepta’s DMD gene therapy (Fierce)
  • Burned by FDA rejection, Y-mAbs drops 3rd of staff, cancer vaccine ambitions (Fierce)
  • On the road to human studies, next-gen gene editing contender Metagenomi hauls in an extra $100M (Endpoints)
  • GE HealthCare completes spinout into ‘more focused, more agile’ standalone company (Fierce) (Bloomberg)
  • European Commission's 2023 Schedule: Timetable Features Stakeholder Meetings This Year (MedTech Insight)
  • EU’s Eighth IVDR Notified Body Is Based In Austria (MedTech Insight)
  • Roche receives first European IVDR certificate for companion diagnostic (MedTech Dive)
  • After FDA rejection, Vivos Therapeutics mouthpiece finally cleared to treat sleep apnea (Fierce)
  • Office of Digital Transformation’s 2022 Year In Review: The MAP To Success (MedTech Insight)
Government, Regulatory & Legal
  • Pfizer wins – again - in courtroom fights versus Astellas over Lexiscan patents (Fierce) (Endpoints)
  • Sanofi expects Zantac arbitration case with Boehringer Ingelheim to be resolved early this year (Endpoints)
  • Metabolic disease outfit accuses Chinese biotech of stealing trade secrets to advance competing drug (Endpoints)
  • Chiesi Sues Aurobindo to Block Copies of Kengreal Anti-Clot Drug (Bloomberg)
  • Biotronik Defeats Whistleblower’s Nepotism Sales Scheme Lawsuit (Bloomberg)
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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