Recon: UK NICE to help sponsors navigate HTA process; FDA flexes new authority to assess delayed confirmatory trials for cancer drugs
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- 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)
In Focus: International
- 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)
Pharma & Biotech
- 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)
Medtech
- 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)
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.
