Recon: UK NICE to help sponsors navigate HTA process; FDA flexes new authority to assess delayed confirmatory trials for cancer drugs

• FDA touts new authority as ODAC hosts adcomm to review delayed confirmatory trials for accelerated approvals (Endpoints)
• Study suggests Covid rebound is far more common with Paxlovid than without (STAT)
• Accord Healthcare resumes production of cancer drug cisplatin amid shortages (Reuters)
• Patent buyouts could spur vital innovation in antibiotics, vaccines, and other medical fields (STAT)

• NICE Launches ‘Concierge System’ To Guide Companies Through HTA Process (MedTech Insight)
• Pfizer to cut 500 jobs at UK site as part of wider cost cuts (Reuters)
• Add chickenpox vaccine to UK child immunisation programme - vaccine advisors (Reuters)

• Legend Biotech’s deal with Novartis is a reminder that biotech’s bear market has a few haves, and many have-nots (STAT)
• AstraZeneca's Imfinzi plus chemoradiotherapy fail main goal of late stage trial (Reuters)
• Verve won trial success with a gene-editing milestone. Why don't investors like it? (Endpoints)
• Theseus Pharmaceuticals lays off most workers and seeks 'strategic alternatives' after cancer pipeline failure (Endpoints)
• Almirall’s new AI deal with Absci; Jazz partners with Autifony; SAB raises $67M (Endpoints)
• J&J and Bayer's Xarelto proves its worth across PAD subgroups in 2 new analyses (Fierce Pharma)
• Capturing COVID: Biopharma through the lens during the pandemic (Fierce Pharma)
• Stagnant sales for Dermavant's Vtama cast doubt on its blockbuster potential (Fierce Pharma)
• Pharma asks 'what’s up, doc?' as industry seeks to get inside the heads of HCPs in 2024 (Fierce Pharma)
• Madrigal, eyeing a NASH drug launch in 2024, nabs Dupixent commercial mastermind Carole Huntsman as CCO (Fierce Pharma)
• FDA rules Otsuka marketing claim overstates Rexulti efficacy, threatening cornerstone of huge TV push (Fierce Pharma)

• Why Andreessen Horowitz's Vineeta Agarwala sees communication as the next opportunity for AI in healthcare (Endpoints)
• Olympus receives Class I recall label for another bronchoscope safety issue (MedTech Dive)
• Large registry study upholds safety findings for Boston Scientific’s Farapulse device (MedTech Dive)
• Wegovy study details revive debate over GLP-1 impact on devices (MedTech Dive)
• FDA warns providers about using surgical mesh for breast surgery after BD label update (MedTech Dive)
• Deals Shaping The Medtech And Diagnostics Industry, October 2023 (MedTech Insight)

• AMA urges coverage of obesity treatments as payers balk at costs (STAT)
• One-quarter of Americans have little to no confidence in scientists to act in public’s best interests, per report (STAT)
• Biden initiative aims to accelerate women’s health research (MedTech Dive)
• UnitedHealth pushed employees to follow an algorithm to cut off Medicare patients’ rehab care (STAT)
• Upstart PBMs aim to shake up the market (Modern Healthcare)
• Catalent delays quarterly filing with SEC on $700 mln impairment charge (Reuters)
• Henry Schein says customer data breached in cyber incident (MedTech Dive)
• Hard Truths About Mistruths: US FDA’s Califf Switching Gears On Misinformation Fight (MedTech Insight)