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

• 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)

• 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)

• 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)

• 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)