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

• 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)

• 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)

• 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 3^rd 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)

• 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)