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April 15, 2024
by Jason Scott

Recon: FDA places clinical hold on Neumora’s schizophrenia drug trial; WHO issues warning after falsified cough syrup ingredients seized in Pakistan

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

In Focus: US
  • Can investing in infectious disease pay off? Vir Biotechnology’s tightrope walk shows it’s a struggle (STAT)
  • FDA hits Neumora with clinical hold for schizophrenia drug after preclinical data showed convulsions in rabbits (Endpoints)
  • Adcomm backs use of minimal residual disease in multiple myeloma accelerated approvals (Endpoints)
  • FDA advisers back new endpoint for myeloma approvals, paving way for faster introduction of new drugs (Fierce Pharma)
  • The top 20 pharma companies by 2023 revenue (Fierce Pharma)
  • Eisai on your hi-fi: Leqembi maker supports creation of Alzheimer's podcast miniseries (Fierce Pharma)
  • Ivermectin Settlement Brings Relief And Worry For US FDA Communications (Pink Sheet)
In Focus: International
  • WHO warns of falsified cough syrup ingredients seized in Pakistan (Reuters)
  • Tanzania, Rwanda, Zimbabwe join African recall of J&J cough syrup (Reuters)
  • Lady Gaga's Instagram post about latest Pfizer Nurtec ODT ad earns EU ire: Politico (Fierce Pharma)
  • EMA Probe Finds No Link Between GLP-1s And Suicidal Thoughts & Actions (Pink Sheet)
  • UK Industry Gets More Time To Adapt To Post-Brexit Import Rules (Pink Sheet)
  • Estonian Biobank’s Personalized Medicine Project To Unlock New Insights For Drug R&D (Pink Sheet)
  • More than 250 websites selling fake weight-loss drugs reported by anti-counterfeit firm (Reuters)
Pharma & Biotech
  • When a cancer drug fails, oncologists often fly blind. A precision technique might light the way (STAT)
  • Ultragenyx reports early success with Angelman syndrome drug, backing up 2022 acquisition (STAT)
  • Novavax investor Shah Capital pushes for board shakeup (Reuters)
  • Organovo's drug significantly reduces liver fat in NASH study (Reuters)
  • Regeneron enters venture investing with $500M, poaches senior partner from ARCH (Endpoints)
  • Roche’s Columvi passes Phase 3 lymphoma test as competition with AbbVie, Genmab continues (Endpoints)
  • Astellas writes down another piece of its Audentes gene therapy acquisition (Endpoints)
  • Vertex's $4.9B bet; Layoffs at Novartis, Genentech, Sanofi; Star founders unveil new startups; and more (Endpoints)
  • AstraZeneca cries havoc over CKD's hit on economies, environment (Fierce Pharma)
  • Gilead enlists Grammy nominee Raheem DeVaughn in HIV education, prevention initiative (Fierce Pharma)
  • Castle Biosciences fortifies support of Esophageal Cancer Awareness Month with fundraising, educational collabs (Fierce Pharma)
Medtech
  • Exclusive: Eating disorder telehealth startup Equip raises $35M, according to filing (Endpoints)
  • Abbott’s Nadim Geloo on Triclip’s US launch, Edwards competition (MedTech Dive)
  • Roche scores FDA breakthrough status for Alzheimer’s blood test (MedTech Dive)
  • Osso VR brings surgery training app to Apple Vision Pro (MedTech Dive)
Government, Regulatory & Legal
  • Readers respond to OTC antidepressants, personalized medicine, restoring trust in public health, and more (STAT)
  • Colorado lawmakers revise effort to exempt rare disease drugs from state cost caps (STAT)
  • Mass General Brigham is ready to move on without Dana-Farber, CEO says (STAT)
  • ADHD is often overlooked in females. They need help, too (STAT)
  • Hospitals that make profits should pay taxes (STAT)
  • Exclusive: Health insurance broker GoHealth trims jobs across departments (Endpoints)
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.

A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
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