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

• 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 $3.47 for a prescription drug. The retail price was 10,000% higher (LA Times)
• US FDA Considering Contracting IT Services To Keep Systems Up To Date, Break Down Siloes (Pink Sheet-$)

• 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)

• 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)

• 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)

• 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)

• 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-$)

• FDA Advisory Committee Calendar

• Field Safety Notice - 20 to 24 August (MHRA)

• Illumina Secures China National Drug Administration Clearance for MiSeqDx System (GenomeWeb)
• CStone's Anti-CTLA-4 Antibody CS1002 Receives IND Approval in China (Press)

• 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)

• Women Struggling to Get Pregnant Turn to Fertility Apps (NYTimes)
• Mustafa Returns: Iraqi Boy's Hope For A Prosthetic Leg Proves Complicated (NPR)