Recon: Neuralink faces federal probe over animal tests; Emergent nabs priority review for OTC opioid overdose drug

ReconRecon | 06 December 2022 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • US delays backing for patent waivers on Covid-19 therapies and diagnostics (STAT) (Reuters) (Bloomberg)
  • Musk’s Neuralink faces federal probe, employee backlash over animal tests (Reuters) (Bloomberg)
  • FDA grants priority review for Emergent’s OTC opioid drug (Reuters) (Biospace) (STAT)
  • US FDA Oncology, Device Centers Developing Public Diagnostic Standards (The Pink Sheet)
  • Ex-FDA vaccine inspectors call for better training (Politico)
  • A year after petition, NIH will finally review request to lower cancer drug’s cost by sidestepping patents (STAT)
  • CSL’s Hemgenix Gene Therapy Does Not Need A REMS, FDA Tells National Hemophilia Foundation (Pink Sheet)
  • Opinion: Congress needs to update FDA’s ability to regulate diagnostic tests, cosmetics (STAT)
  • Price hikes for some Medicare therapies unsupported by clinical benefits data-Report (Reuters)
  • Congress has its sights set too low on addiction, advocates charge (STAT)
  • CDC Sounds the Alarm on Rising Flu Hospitalizations (MedPage Today) (Reuters)
In Focus: International
  • EU regulator backs bivalent COVID shots for primary vaccination  (Reuters)
  • Britain’s health regulator backs COVID vaccine for infants from six months (Reuters
  • French drug agency says under investigation over thyroid drug (Reuters)
  • Ukraine asks hospitals to temporarily suspect planned surgeries (Reuters)
  • India’s leading state hospital recovers systems after cyber attack (Reuters)
  • Japan Discuss Faster AI Processing For Healthcare Sector (Pink Sheet)
Pharma & Biotech
  • Pfizer’s search for Paxlovid’s COVID-busting sibling leads to low-profile antiviral biotech (Fierce) (Reuters) (Endpoints)
  • Pfizer makes another billion-dollar investment in Europe and expands again in Michigan (Endpoints)
  • FDA grants orphan drug designation to Algernon's ifenprodil, while exclusivity remains unclear (Endpoints)
  • AltruBio Announces FDA Clearance on IND Application for ALTB-268, a Next-Generation Immune Checkpoint Enhancer for the Treatment of Ulcerative Colitis (Biospace)
  • In fresh blow to floundering P13K space, FDA feedback drives MEI, Kyowa to halt blood cancer program (Fierce) (Endpoints)
  • GSK, Sanofi, Takeda sign with Singapore partnership to advance biologic manufacturing  (Fierce)
  • Lilly gearing up for ‘substantial expansion’ of diabetes med manufacturing by 2025 (Fierce)
  • Fresenius Medical Clouds Turnaround Picture With CEO Change (Bloomberg)
  • ‘This is not a cure’: Consensus begins to emerge on new Alzheimer’s drug (STAT)
  • Gossamer drug for lung hypertension achieves study goal but with subpar treatment effect (STAT) (Biospace)
  • A new Vega enters the galaxy with bleeding disorder antibody set for 2023 trial (Endpoints)
  • Dermata’s mid-stage rosacea study sees far-from-rosy results, piling pressure on acne ambitions (Fierce)
  • Re-Vana reels in $12M to develop sustained-release eye implants (Fierce)
  • Innoforce opens new manufacturing site in China (Endpoints)
  • EU Data Act Must Consider ‘Sectoral Peculiarities’ Says Medtech Industry (MedTech Insight)
  • Swiss Initiative To Monitor Missing Medical Devices To Manage Current Product Crisis (MedTech Insight)
  • FDA narrows label for Abiomed’s Impella RP heart pump after mortality rose in post-approval study (Fierce)
  • ‘Troubling’ study finds Google’s kidney disease-predicting AI performs worse in women-and may not have a quick fix  (Fierce)
  • AbbVie offers up to $335M for connection with HotSpot’s preclinical small-molecule program (Fierce)
Government, Regulatory & Legal
  • Pfizer, BioNTech countersue Moderna over COVID-19 vaccine patents (Reuters) (Bloomberg)
  • EpiPen litigation comes back to haunt Teva a decade after initial settlements (Fierce)
  • Meta, Snap Defend Efforts to Deter Illegal Fentanyl Sales Online (Bloomberg)
  • Alabama Agrees to Lift Medicaid Ban on Hepatitis C Drugs (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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