Recon: FDA approves Lexicon’s Inpefa for heart failure; Amylyx expects negative CHMP opinion for ALS therapy

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

In Focus: US

• Lexicon Gains After FDA Approves Inpefa for Heart Failure (Bloomberg) (Reuters) (Fierce)
• Takeda wins priority review for $400M colorectal cancer drug, licensed from Hutchmed in January (Endpoints)
• Patient Medication Guides Would Get Update Under FDA Proposal (Bloomberg)
• Regulatory tracker: FDA gives Akebia ‘path forward’ for oral anemia drug (Fierce) (BioSpace)
• Big Pharma Companies Have Higher US FDA Approval Percentage Than Everybody Else (Pink Sheet)
• US FDA Complete Response Letter Rates Vary With Sponsor Size (Pink Sheet)
• US slaps sanctions on Chinese, Mexican entities in fentanyl action (Reuters)
• Is It Time To Promote US FDA’s Biosimilars Office Out Of OND? (Pink Sheet)
• Supplemental Filings: Califf Discusses Revolving Door; Poll Examines Public Trust In FDA Approvals (Pink Sheet)
• Biden, McCarthy Forge Debt Deal in Bid to Avert US Default (Bloomberg)
• Sen. Elizabeth Warren probes abortion access amid states’ patchwork plans (STAT)

• European regulatory panel weighing against approval of Amylyx’s ALS therapy, company says (STAT) (Endpoints) (Reuters)
• European Commission to receive fewer Pfizer-BioNTech vaccine doses under amended contract (Endpoints) (Reuters)
• EMA recommends revoking authorization of Novartis' sickle cell drug (Endpoints)
• EMA To Explain How Trial Transparency & Data Redaction Can Live Together (Pink Sheet)
• EU Adopts New Rules On UK-Wide Approvals For Novel Drugs (Pink Sheet)
• UK government pledges to reverse flagging trials takeup as part of €650M life sciences ‘war chest’ (Fierce)
• UK government given more time to hand over Boris Johnson messages to COVID inquiry (Reuters)
• India's Mankind Pharma posts 43% jump in Q4 profit in first results since listing (Reuters)

• Pfizer’s hemophilia drug hits in phase 3, giving it a chance to leapfrog Novo Nordisk (Fierce) (Reuters)
• Eli Lilly, XtalPi ink $250M deal for AI-powered drug discovery (Fierce)
• Persistent Sun Pharma ready to complete Taro buyout-16 years after initial offer (Fierce)
• Top 5 highest paid biopharma R&D executives in 2022 (Fierce)
• Verastem touts mid-stage data in rare type of ovarian cancer (Endpoints)
• AstraZeneca Touts Positive Phase III Endometrial Cancer Data for Imfinzi, Lynparza (BioSpace)
• ASCO: Zentalis showcases ovarian cancer data that will take WEE1 to phase 3 (Fierce)
• Oncopeptides says Swedish authorities ended probe into CSO Jakob Lindberg over alleged insider information sharing (Endpoints)
• With cash running low, Swedish cell therapy company looks to sell off platform (Endpoints)
• Can Rain ride the storm out? Caner biotech lays off 65% of workforce after phase 3 fail (Fierce)
• Artiva boasts early NK cell therapy results, giving lifeline to partner Affimed (Endpoints)
• Mallinckrodt Lenders Pitch Restructuring as Opioid Payment Nears (Bloomberg)

• Neuralink nabs long-sought FDA nod to begin human trials of brain-computer interface (Fierce) (Bloomberg)
• Recall of Roche partner’s COVID tests labeled as Class I (MedTech Dive)
• White House Takes Steps To Advance ‘Responsible’ AI That ‘Upholds Democratic Values’ (MedTech Insight)
• UK Pro-Innovation Report Offers Promise For Medtech With MHRA/NICE Alignment (MedTech Insight)
• UK MHRA Says Genetic Biobank Could Transform Drug Safety Monitoring Through Personalized Medicine (MedTech Insight)
• Illumina accused of ‘playing delay tactics’ to push back EU decision on divesting Grail: Financial Times (MedTech Dive)
• Omron to open its first Indian medical devices plant in Tamil Nadu (Reuters)
• ‘Quite science fiction’: Brain-spine interface system helps man with paralysis walk again (Fierce)

• After price cuts, Eli Lilly inks $13.5M settlement in long-running insulin lawsuit (Fierce)
• Alnylam sticks with aggressive litigation strategy against Pfizer and Moderna, filing yet another patent lawsuit (Fierce)
• Purdue Pharma Opioid Deal Approved by Appeals Court Panel (Bloomberg) (Reuters)
• Harvard, 10x Gene-Mapping Patent Cases Prompt Vizgen ‘Bombshell’ (Bloomberg)