Regulatory Focus™ > News Articles > 8 > Recon: NICE Rejects Gilead's Yescarta as too Expensive for NHS Use

Recon: NICE Rejects Gilead's Yescarta as too Expensive for NHS Use

Posted 28 August 2018 | By Michael Mezher 

Recon: NICE Rejects Gilead's Yescarta as too Expensive for NHS Use

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

In Focus: US
  • FDA declines to approve Akcea-Ionis genetic disease drug (Reuters) (STAT)
  • FDA approves Tetraphase Pharma's antibiotic (Reuters) (BioCentury)
  • FDA confronts its limits in push on drug pricing (BioPharmaDive)
  • Congressional Health Leaders Urge HRSA to Implement 340B Regulations (Letter)
  • Esperion's Cholesterol Combo Pill Cuts Bad Cholesterol 35% (Forbes) (Reuters) (Fierce)
  • Tafamidis Phase 3 Transthyretin Amyloid Cardiomyopathy (ATTR-ACT) Study Results Presented as Late-Breaking Data at the ESC Congress 2018 (Press)
  • Critics Trying To Stop A Big Study Of Sepsis Say The Research Puts Patients At Risk (NPR) (STAT)
  • China Has Withheld Samples of a Dangerous Flu Virus (NYTimes)
  • FDA proposes restricting compounding of three drug substances (Reuters) (Focus)
  • Aspirin disappoints for avoiding first heart attack, stroke (CBS)
  • How to Tame Health Care Spending? Here’s a One-Percent Solution (NYTimes)
  • Senators question whether Giuliani's influence scored Purdue Pharma leniency from feds (Fierce)
  • Researchers find way to mimic clinical trials using genetics (MIT Technology Review)
  • She paid $3.47 for a prescription drug. The retail price was 10,000% higher (LA Times)
  • US FDA Considering Contracting IT Services To Keep Systems Up To Date, Break Down Siloes (Pink Sheet-$)
In Focus: International
  • UK rejects Gilead's CAR-T cancer cell therapy as too expensive (Reuters) (PMLive) (PharmaTimes) (NICE)
  • Cancer powerhouse Genentech lines up an NK and T cell alliance with Affimed that’s loaded with billions in biobucks (Endpoints) (Fierce)
  • Roche Diagnostics’ chief heads for the exit (PMLive)
  • Medicines Reimbursement Policies in Europe (WHO)
  • TimesGW Pharmaceuticals/cannabis: from dope to hope (Financial Times)
  • Big pharma takes a gamble on NHS experiment (Financial Times)
  • UK: NICE Fees Plan Would Cost Life Sciences Industry £10m Each Year (Pink Sheet-$)
  • UK Changes Approach To Trials In Patients With Prior ATMP Therapy (Pink Sheet-$)
  • From $360 a year to $179,000: Drug price hike in the Netherlands prompts call for investigation (STAT)
  • Changes to the Roche Corporate Executive Committee (Roche)
  • Ultragenyx's Mepsevii Gets European Approval (BioCentury )
  • Chinese biotech Harbour lands $85M to run cancer trials (Fierce)
  • Cystic fibrosis mothers' plea over 'life-changing' drug (BBC)
  • A Dangerous Twist To The Latest Ebola Outbreak (NPR)
  • UAE pharma firm begins production at new $34m Dubai factory (Arabian Business)
Pharmaceuticals & Biotechnology
  • CRISPR biotech Editas to lose CMO as it continues push for clinical trials (Fierce)
  • Worms and genetic theft: what drives the scientist behind the new RNAi drug (STAT)
  • Alzheon IPO take two: Will investors back a downsized offering from an Alzheimer’s biotech? (Endpoints)
  • Novartis quietly hands topical treatment for rare disease to LifeMax — latest in a string of out-licensing deals (Endpoints)
  • Bayer and J&J see pathway for wider use of Xarelto despite disappointing trial (PharmaLetter-$)
  • FDA ups the ante for copycats, antibiotics, orphan drugs. But is it working? (BioPharmaDive)
  • How Scott Gottlieb is upending FDA communication, one tweet at a time (BioPharmaDive)
  • Universal Flu Vaccine Is Still Several Years Away, Fauci Says (Pink Sheet-$)
  • Vivek Ramaswamy bags $100M in risk capital to back his latest PhIII gamble at Dermavant — while Urovant dives into gene therapy (Endpoints)
  • Microbiome, Clinical Trial Enrichment Among Question Marks As US FDA Weighs Guidance On Non-Traditional Infectious Disease Treatment (Pink Sheet-$)
  • Allen-backed team uncovers distinctive human brain cell that may help control information flow (Fierce) (NPR)
  • Quiet Riot? Gene Silencing Candidates Still Ready To Make Noise In Lipid Disorders (Pink Sheet-$)
  • Death Rates From Heart Disease And Stroke Could Be Significantly Less With These Drugs, Study Says (Forbes)
  • Neuroscientists target Alzheimer’s “silent stage” (Novartis)
  • Experimental brain cancer treatment for dogs could one day help humans (CBS)
  • Fewer middle-aged stroke survivors skip medicines under Obamacare (Reuters)
  • URGENT Drug Recall for Leukotrap RC System with RC2D Filter (FDA)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • ReflectionBio Receives Orphan Drug Designation From U.S. FDA For the Treatment of Bietti's Crystalline Dystrophy (BCD) (Press)
  • Poxel Announces Completion of Patient Enrollment for the TIMES 3 Trial in the Phase 3 Registration Program for Imeglimin, an Investigational Therapeutic Agent for Type 2 Diabetes, in Japan (Press)
  • Zai Lab Doses First Patient in Phase III Trial of ZL-2306 (niraparib) in Patients with Small-Cell Lung Cancer in China (Press)
  • Biogen and Eisai Report Data from Long-Term Extension Phase 1b Study of Investigational Alzheimer’s Disease Treatment Aducanumab (Press)
Medical Devices
  • Report: Philips to cut another 280 from Andover, Mass.-based facility (MassDevice)
  • CDRH's Experiential Learning Program Submissions Open Through 26 September (FDA)
  • Corvia Medical’s interatrial shunt study meets endpoints (MassDevice)
  • Wright Medical Dishes out $435M for Cartiva (MDDI)
  • Gore tests stent graft for deadly heart condition (Medical Design & Outsourcing)
  • HeartFlow touts registry study, large hospital trial data (MassDevice)
  • Ceterix Orthopaedics Announces FDA Clearance of New Suture Cartridge, Providing Increased Flexibility and Enhanced Options for Surgeons (Press)
  • Pivotal trial of an autonomous AI-based diagnostic system for detection of diabetic retinopathy in primary care offices (Nature)
US: Assorted & Government
  • Amgen Shows New Patents Can Affect Prior BPCIA Litigation (Law360-$)
  • HHS seeks input on altering anti-kickback regulations to promote value-based healthcare (MassDevice)
  • Administration’s power to curb PBM rebates limited despite role in drug costs, experts say (MedCity)
  • Brand Drug Preemption Shuts Down Plavix Litigation in New York State Court (Drug & Device Law)
  • Can Gavin Newsom Turn California Into A Single-Payer State? (Forbes)
  • Missouri appeals court revives pelvic mesh suit against BD’s Bard (MassDevice)
  • Hospira Can't Void Amgen's $70M Biosimilar Patent Win (Law360-$)
  • 1st Circ. Says Challenge To Rx Eyedropper Size Preempted (Law360-$)
Upcoming Meetings & Events Europe
  • Field Safety Notice - 20 to 24 August (MHRA)
Asia
  • Illumina Secures China National Drug Administration Clearance for MiSeqDx System (GenomeWeb)
  • CStone's Anti-CTLA-4 Antibody CS1002 Receives IND Approval in China (Press)
India
  • Lupin gets USFDA nod to market its postherpetic neuralgia drug (Economic Times)
  • Health ministry to form state-level panels to hear patients’ grievances in J&J hip implant issue (PharmaBiz)
  • India's health ministry still 'deliberating' on findings on J&J's faulty hip implants, says JP Nadda (Economic Times)
  • Modicare: Rule of hospital stay eased for cancer fighters (Economic Times)
General Health & Other Interesting Articles
  • Women Struggling to Get Pregnant Turn to Fertility Apps (NYTimes)
  • Mustafa Returns: Iraqi Boy's Hope For A Prosthetic Leg Proves Complicated (NPR)
Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.

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