Recon: FDA approves treatments for prostate cancer, Crohn’s disease; US judge refuses to halt Lilly weight-loss drug ads

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

In Focus: US

• FDA nod for Pfizer’s Talzenna plus Xtandi for prostate cancer (The Pharma Letter) (Fierce Pharma)
• FDA approves at-home subcutaneous induction for AbbVie’s Skyrizi in Crohn’s disease (The Pharma Letter)
• Peptides compounding would ‘undermine’ FDA drug approval process, ex-agency official argues (Pink Sheet)
• FDA’s complete response letter postings a gift to Chinese competitors, PhRMA says (Pink Sheet)
• Biosimilar manufacturing approvals could be accelerated via new BsUFA IV facility meetings (Pink Sheet)
• Post-Makary FDA wins over investors, but not scientists or Big Pharma (Endpoints)

In Focus: International

• EU plan to ease cross-border trial participation gathers pace (Pink Sheet)
• Tavneos’ global woes deepen with Australian withdrawal; US verdict still pending (Pink Sheet)
• EMA’s dossier maturity push is about closing quality gaps, not earlier pivotal data (Pink Sheet)
• Indian drugmaker Cipla misses profit view on US weakness, shares slip (Reuters)
• Novartis considers bypassing European government payers due to MFN (Endpoints)
• Roche’s changing plans show how MFN is complicating European drug launches (Endpoints)
• China emerges as a global epicenter for obesity innovation (The Pharma Letter)
• WuXi AppTec raises revenue forecast again in the face of DOD court case (Endpoints)
• Denmark's Gubra looks beyond metabolism, hopes for first portfolio company this year (Endpoints)

Pharma & Biotech

• After $1.9B impairment hit, Novartis stands by $12B bet on Avidity (Endpoints) (BioSpace)
• Ferring signs $1.4 billion deal to buy Gameto egg-freezing startup (Bloomberg)
• Swiss AI drug trial start-up receives funding from Spotify-backer Creandum (Reuters)
• GSK to nearly double cancer medicines in clinical trials next year (Reuters)
• Pathos AI secures $237 million in Series E financing (The Pharma Letter)
• Corxel to take oral GLP-1 public in the US via SPAC (Endpoints) (BioPharma Dive)
• BioNTech, DualityBio say ADC had ‘modest’ benefit in breast cancer study (BioPharma Dive)
• Merck drug extends survival in endometrial cancer trial, wins US priority review (Reuters)
• Roche gets a lung cancer win with its KRAS drug divarasib (STAT)
• GSK, Hansoh's bone cancer drug delays disease progression in late-stage China study (Reuters) (Fierce Biotech)

Medtech

• When AI becomes a medical device: FDA boundaries for patient-facing health tools (Medtech Insight)
• UK medtech wants MHRA to become ‘a high-performing regulator’ (Medtech Insight)
• UCSF, Conceivable Life Sciences to launch AI-robotics IVF center to cut outcome variability (Medtech Insight)

Food & Nutrition

• Dutch regulator blocks takeover of Unilever's Unox brand (Reuters)
• Scientists looking at how imperfections in produce impact safety (Food Safety News)

Government & Legal

• US judge refuses to block Eli Lilly weight-loss drug ads, rules against Novo Nordisk (Reuters)
• House lawmaker probes PBMs for ‘punitive’ audits of independent pharmacies (STAT)
• HHS relaxes security, transparency rules for health record software used by hospitals (STAT)
• Six-month window: DOJ and HHS launch healthcare FCA self-disclosure pilot (FDA Law Blog)

Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.

A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.