Recon: FDA officials offer updates on CAR-T safety review; Haleon recalls some batches of Robitussin over microbial contamination

• When it comes to policing pharma, the FTC says it’s on ‘an incredible winning streak’ (STAT)
• FDA OKs — but doesn’t require — a non-cancer-causing chemical for sterilizing devices (STAT)
• What to make of Gilead’s Trodelvy troubles and Elevation Oncology’s surprising rise (STAT)
• US FDA approves Dupixent to treat younger kids with esophageal condition (Reuters)
• Following CAR-T safety label changes, FDA officials share new details about secondary cancer cases (Endpoints) (Fierce Pharma)
• FDA tweaks demand for boxed warning on Gilead's CAR-T label (Fierce Pharma)
• Exclusive: Suspected fake Ozempic linked to three US cases of hypoglycemia (Reuters)
• US FDA still reviewing Liquidia's inhaled blood pressure drug (Reuters)
• FDA creates ‘super office’ to oversee device cybersecurity, digital health and supply chain (MedTech Dive)
• US pharmacy benefit lobby group ramps up spending as lawmakers close in (Reuters)

• ‘The response defies belief’: Year of inaction leaves children at risk from bad cancer drugs (STAT)
• Lilly's weight-loss drug Mounjaro coming to UK after pen cleared (Reuters)
• A PBM in Africa flips the industry’s script in a bid to make people healthier (STAT)
• Shanghai startup's gene therapy restores hearing in five deaf children, running ahead of Lilly and Regeneron trials (Endpoints)
• COVID and beyond: labs unite to boost genomic surveillance globally (Reuters)
• South America dengue spike prompts vaccination drive as bug spray runs out (Reuters)
• European Commission proposes delays for IVDR to prevent supply disruption (MedTech Dive)

• Another step toward new drugs for Parkinson’s (STAT)
• Haleon to recall batches of some adult cough syrups due to contamination (Reuters)
• As biotech VCs struggle to raise money, some debate whether the worst is over (STAT)
• Roche and Exelixis detail rare success for Cabometyx-Tecentriq combo in prostate cancer (Endpoints)
• Biotech's 2024 IPO season kicks off with heavy demand for CG Oncology in $380M listing (Endpoints)
• Glenmark, Alphamab deal worth up to $700M; Tourmaline’s $150M offering; Repare records $40M milestone (Endpoints)
• Kyverna says CAR-T manufacturing times can be cut through blood collection efficiencies (STAT)
• Oncologists want more treatment options for advanced lung cancer patients, new survey says (Endpoints)
• With record year, Samsung Biologics bucks CDMO industry's troublesome 2023 (Fierce Pharma)
• In downsizing mode, Sage will move headquarters to a smaller space (Fierce Pharma)
• Oncologists channel Oliver, asking pharma for more NSCLC drugs, more resources, more research (Fierce Pharma)

• Headspace plans to be cash-flow positive in the first quarter of 2024 (STAT)
• Exclusive: Teladoc makes job cuts, eliminates some roles in engineering and data science (Endpoints)
• Auvi-q allergy injector recruits Brittany Mahomes for new campaign (Endpoints)
• 3M on track to complete healthcare spinoff in first half of 2024 (MedTech Dive)
• Robot reveal: Intuitive submits 510(k) for next-generation system (MedTech Dive)
• Abbott says all four segments stronger than pre-pandemic (MedTech Dive)

• The White House has a pharmacy — and it was a mess, a new investigation found (STAT)
• Other states should follow New Jersey’s lead on prior authorization reform (STAT)
• Health insurer Humana warns of hit to 2025 profit, shares sink (Reuters)
• A Bold Goal: Reshoring 25% of Small Molecule API to the U.S. in 5 Years – APIIC’s Report to The White House (FDA Law Blog)