In Focus: US

• U.S. consultants advocate weight-loss medicine for overweight kids (Reuters)
• Abbvie raises gross sales outlook of two immunology medicine to greater than $17.5 bln in 2025 (Reuters)
• Sen. Sanders asks Moderna to not hike COVID vaccine worth (Reuters) (STAT)
• FDA’s Califf says congressional report on Aduhelm controversy contained “no surprises” (STAT)
• FDA More and more Halting Human Trials as Corporations Pursue Dangerous, Chopping-Edge Medication (WSJ)
• An FDA pathway to clear medical gadgets is placing sufferers in danger, analysis suggests (STAT)
• Illumina, the DNA sequencing large, provides Wall Road dangerous information (STAT)
• Most Alzheimer’s sufferers would pay as much as $26,500 per 12 months for brand spanking new remedy Leqembi (CNBC)

In Focus: Worldwide

• Germany’s BioNTech buys British AI startup InstaDeep (Reuters) (FT)
• Illumina challenges EU order to maintain Grail separate (Reuters)
• Bayer flags new blood thinner as $5 bln-plus alternative (Reuters)
• Pfizer CEO guidelines out generic COVID drug Paxlovid for China (Reuters)
• Free entry to Zolgensma curbed, says Novartis (PharmaPhorum)

Pharma & Biotech

• Non-public fairness acquires a style for drug growth (Reuters)
• Folks hate drug advertisements on TV. Right here’s what they complain about most (STAT)
• FDA commissioner requires extra onshoring of medical trials (Endpoints)
• US Funding Regulation May Pace Approval Of Medication And Biologics Manufactured In Superior Methods (Pink Sheet)
• US FDA’s Use Of CRLs Hit A Excessive Word In 2022: One-Third Of Novel Agent Selections Have been Not Approvals (Pink Sheet)
• CVS Is Exploring a $10 Billion-Plus Acquisition of Oak Road Well being (Bloomberg)
• Shenzhen Kangtai Organic sees 2022 web loss on weaker COVID shot demand (Reuters)
• Novotech’s newest acquisitions develop its US presence and plant a European foothold (Endpoints)
• Alto’s hopes for mind biomarker technique rise on part 2 antidepressant information (Fierce)
• Fierce Biotech Layoff Tracker 2023: Editas edits workforce, plus extra (Fierce)
• JPM23: Mirati’s post-Krazati pipeline restock to deal with ‘highest alternative for capital’ (Fierce)
• Voyager goes massive, securing multi-billion greenback gene remedy growth take care of Neurocrine (Endpoints)
• Ionis sells partial stake in royalties from Spinraza and Novartis cardio drug to Royalty Pharma for $500M upfront (Endpoints)
• AbbVie, following in footsteps of Lilly and Takeda, pays Anima $42M to go after undruggable targets (Fierce)
• Jasper scraps pivotal plans however provides a brand new indication as extra biotechs revise pipelines (Endpoints)
• 4D Molecular pauses enrollment in Fabry trials after kidney issues in three sufferers (Endpoints)
• Sutro shells out newest replace on ovarian most cancers remedy, plans for pivotal trial (Endpoints)

Medtech

• GE HealthCare expects 5%-7% natural income development in 2023 on sturdy demand (Reuters)
• Medtronic CEO Martha: No extra divestitures deliberate for 2023, however evaluation continues (MedtechDive)
• UK To Fund ‘Synthetic Pancreas’ Expertise, However Solely For Corporations That Reduce Costs (MedtechInsight)
• ResMed responds to ‘humanitarian emergency’ over demand for CPAP gadgets with new manufacturing unit (MedtechDive)
• Beta Bionics hires Harvard diabetes knowledgeable as CMO forward of synthetic pancreas launch (MedtechDive)
• JPM23: ‘What has the pandemic finished for us?’ Freenome and different diagnostics builders on making exams extra accessible (Fierce)

Authorities, Regulatory & Authorized

• Nonetheless fuming over the federal Covid response, Republicans redirect the Home coronavirus committee (STAT)
• Teva’s opioid settlement strikes ahead with participation from 48 states (Endpoints)
• U.S. appeals court docket will not revive Zofran beginning defect instances in opposition to GSK (Reuters)
• Jet Medical and Associated Corporations Comply with Pay Extra Than $700,000 to Resolve Medical Machine Allegations (FDA)

Regulatory Recon is our common intelligence briefing for the regulatory affairs area, bringing you the highest regulatory, biopharma and medtech information tales from across the globe. Regulatory Recon is revealed every week on Monday, Tuesday and Thursday.
 
A narrative’s inclusion in Regulatory Recon doesn’t indicate endorsement by Regulatory Focus or RAPS.