Recon: Gilead’s Trodelvy falters in lung cancer study; EMA weighs cardiovascular indications for Novo’s Wegovy

• Investigators fault Lilly plant for manufacturing issues (STAT)
• Gilead’s Trodelvy fails in lung cancer and raises new questions on antibody drug conjugate drugs (STAT)
• In ‘march-in’ rights, some see a tool to lower drug prices. Others see a threat to intellectual property (STAT)
• The Senate health committee looks into its first subpoena in 40 years (STAT)
• Fate of most remaining Zantac lawsuits weighed by Delaware judge (Reuters)
• ‘The Largest Reorganization In FDA’s History’: ORA Overhaul Better Thought Of As Agency-Wide Reorg (MedTech Insight)

• Some countries are moving to digital prescription drug information for patients. The U.S. shouldn’t follow suit (STAT)
• Cameroon begins routine malaria shots in global milestone (Reuters)
• World risks missing deadline for pandemic accord, says WHO chief (Reuters)
• EU drug watchdog to consider wider use of Wegovy weight-loss drug (Reuters)
• UK NHS Will Not Fund “Artificial Pancreas” Unless Companies Lower Prices (MedTech Insight)

• Physician buy-in will make or break VC firm General Catalyst’s bold hospital deal (STAT)
• FDA scolds Novartis over a misleading TV ad for a breast cancer treatment (STAT)
• Ionis touts PhIII success for rare disease drug amid company's push to commercialize drugs independently (Endpoints)
• Lackluster data on Alzheimer's drugs lead to end of Roche-AC Immune partnership (Endpoints)
• Sagimet’s positive PhIIb NASH data; FDA lifts hold on Pharvaris IND; Dianthus raises $230M (Endpoints)
• ArriVent outlines plans for $135M IPO in second biotech listing of 2024 (Endpoints)
• LunaDNA, a connector of patients and pharmaceuticals, to shutter (Endpoints)
• Coherus sells Sandoz its Lucentis biosimilar for $170M to focus on oncology assets (Endpoints)
• Apnimed hires Pfizer, Biohaven veteran as chief commercial officer (Endpoints)
• Hibernation research could lead to new weight loss medicines — could it also help astronauts in space? (Endpoints)
• In bid to extend cash runway, Cara to lay off workers, discontinue PhIII program in chronic kidney disease (Endpoints)
• Exclusive: Two biotechs merge to form Calluna, with €75M in hand to focus on immunotherapy antibodies (Endpoints)
• BioNTech challenges AstraZeneca with breast cancer precision drug trial (Reuters)

• New tool for tracing blood cells’ ancestry might one day help predict disease risk (STAT)
• 3 bellwether companies to watch as medtech earnings season begins (MedTech Dive)
• Invitae sells reproductive health assets amid liquidity concerns (MedTech Dive)
• Medtronic’s closed-loop neuromodulation device cuts overstimulation in trial (MedTech Dive)
• Abbott starts study of PFA device in humans, targets 2024 US trial (MedTech Dive)
• FDA, CMS defend plans to increase oversight of laboratory developed tests (MedTech Dive)

• Why many more people are lining up for a flu shot than a Covid vaccine (STAT)
• The FDA and FTC need to crack down on TikTok and Instagram influencers pitching prescription drugs (STAT)
• Feds bar Theranos founder Elizabeth Holmes from government health programs (STAT)
• CDER’s Office of Compliance Kicks Off Annual Report Season with Rundown of 2023’s Major Public Health Enforcement Initiatives (FDA Law Blog)
• Comments On Off-Label Communications Guidance Point Out Possible First Amendment Violations (MedTech Insight)