Recon: NICE Rejects Novartis’ CAR-T Kymriah for Adults; CA Insurance Regulator Sues AbbVie Over Alleged Humira Kickbacks

• California insurance regulator sues AbbVie alleging Humira kickbacks (Reuters) (STAT) (Endpoints) (Financial Times)
• Clovis Oncology, execs to pay $20 million to settle SEC charges (Reuters) (Endpoints)
• In unlikely alliance, PhRMA sides with landlords in Calif. referendum on rent control (STAT)
• Clarus spearheads a big, $150M raise so Galera can flip the PhIII card on its new drug to treat radiation effects (Endpoints)
• Biotech IPOs are yet to see their shadow, as the biggest deal ever awaits (STAT)
• Two Genentech vets reunite at Immune-Onc to help steer its $33M drive to the clinic (Endpoints)
• Why Your DNA Is Still Uncharted Territory (NYTimes)
• Can patient advocates help make Akcea the next Sarepta and overcome the FDA’s rejection? (STAT)
• Facing criticism, CVS may modify its new cost-effectiveness program for covering some drugs (STAT)
• Immuno-Oncology Players Gritstone And Sutro Join The Biotech IPO Frenzy (Forbes)
• Democrats back health cuts they once hated (Politico)
• Black Patients Miss Out On Promising Cancer Drugs (ProPublica)
• How We Compared Clinical Trial and Cancer Incidence Data (ProPublica)
• A Cancer Patient’s Guide to Clinical Trials (ProPublica)
• HIV Drugs Cost $75 in Africa, $39,000 in the U.S. Does It Matter? (NYTimes)
• CBO Report on Generic Samples Bill (CBO)

• GSK grabs new drug development head from Boehringer (Reuters)
• UK rejects adult Novartis CAR-T therapy, after 'yes' in kids (Reuters) (PharmaTimes) (NICE)
• Global reach: The top 25 biopharma companies in the world (Endpoints)
• The 20 largest medical device companies in the world (MassDevice)
• EMA’s Committee for Medicinal Products for Human Use (CHMP) elects new chair (EMA)
• AstraZeneca plots China robot offensive to counter price cuts (Reuters) (Pharmafile)
• Almirall's Ilumetri scores EU approval in chronic plaque psoriasis (Pharmafile)
• Norgine buys rights to sell Shield’s iron deficiency therapy (PharmaTimes)

• Biotech leaders call for free press (Nature Biotechnology) (PMLive)
• Silverback starts to slowly edge out of stealth mode — but there’s still plenty being kept under wraps (Endpoints)
• CRISPR Partners With Viacyte To Develop Immune-Evasive Pancreatic Cells (BioCentury)
• Experts Explore Ways To Promote Use Of Real World Evidence In Clinical Trials: Latest CTTI Expert Meeting Summary Now Available (CTTI)
• FDA Urges Development Of Generic Alternatives To Bring Down Prices Of Complex Drugs (Pink Sheet-$)
• Say hello to Sophia, Novo Nordisk's new online chatbot, available 24/7 for diabetes questions (Fierce)
• Biocom Opens New Bay Area Office, Forms Advisory Group (Xconomy)
• Ono’s new CAR-T partner must be Fate (PharmaLetter-$)
• Biotech IPOs Are Booming … but for How Long? (BioSpace)
• Versant Seeking $500m For Seventh Fund (BioCentury)
• Azar To Head U.S. Biodefense Strategy (BioCentury)
• Behold the power of clinical triads (MedPage)
• Roche tackles clinical trial matching challenge (Fierce)
• BioTime names new CEO amid leadership shuffle (Fierce)
• FDA issues CRL on Ruconest sBLA (PharmaLetter-$)
• Actelion’s Opsumit shows promise in portopulmonary hypertension (PharmaTimes)

• Tocagen Announces Early Completion of Enrollment in Toca 5 Pivotal Phase 3 Brain Cancer Trial (Press)
• Catabasis Pharmaceuticals to Present New Edasalonexent Clinical Results and Phase 3 Trial Design in Duchenne Muscular Dystrophy at the World Muscle Society Congress (Press)
• Janssen Submits New Drug Application to U.S. FDA Seeking Approval of Erdafitinib for the Treatment of Metastatic Urothelial Cancer (Press)
• Alector Initiates Phase 1 Trial of AL001 for the Treatment of Frontotemporal Dementia (Press)
• UTILITY Receives Investigational New Drug Approval from US FDA (Press)
• OBI Pharma Granted FDA Orphan Drug Designation for OBI-3424 for the Treatment of Acute Lymphoblastic Leukemia (ALL) (Press)

• inui Health, formerly Scanadu, announces FDA-cleared home urine testing platform (mobihealthnews)
• Meditech Spine wins FDA nod for spinal implant system (Medical Design & Outsourcing)
• Medtronic Will Study TAVR in Low-Risk Patients with Bicuspid Valves (MDDI) (Press)
• XACT Brings in Funding and CE Mark for Robotics Navigation System (MDDI)
• Olympus Gets FDA Clearance for EZ Shot 3 Plus 25 G Endoscopic Ultrasound Needle (MedGadget)

• Biotech Cos. Must Respect Coexisting Gene Editing Patents (Law360-$)
• Bayer's Monsanto masks U.S. court to toss $289 million glyphosate verdict (Reuters)
• FTC finds Grifols’ US acquisition anticompetitive (PharmaLetter-$)
• Patenting Repurposed Drugs (Patent Docs)
• Orexigen Decision At Odds With High Court Jurisprudence (Law360-$)
• J&J Cut Corners, Pelvic Mesh Jury Hears At Philly Trial's End (Law360-$)
• Fed. Circ. Ruling Takes 'Blocking Patents' To New Places (Law360-$)
• Smith & Nephew To Pay $10.5M To Settle Knee Implant IP Row (Law360-$)
• DOJ Lays Out Arguments Opposing APA Challenges to Vacate Rules (FDA Law Blog)
• Discovery Sanctions Affirmed After Plaintiff Lost Summary Judgment (Drug & Device Law)
• Channel Medsystems sues Boston Scientific over spiked $275m buyout (MassDevice)

• FDA Advisory Committee Calendar
• Joint UNICEF–UNFPA–WHO Meeting with Manufacturers and Suppliers – 24 September 2018

• Expert view: Current trends in detection of falsified medicines (EPR)
• ABPI responds to MAC report on European migration (ABPI)
• ‘Unmerited’ hep C patent contributes to Gilead monopoly, says NGO (InPharmaTechnologist)
• Flex connectors in Halyard Closed Suction Kits – risk of interruption of ventilation (MDA/2018/030) (MHRA)

• Asia Deal Watch: BIOCAD, Shanghai Pharma Agree On Pair Of Russian/Chinese Joint Ventures (SCRIP-$)
• Exporters face hiccups in Vietnam market due to tightening of regulatory requirements (PharmaBiz)

• Johnson & Johnson has to pay patients cleared by government panel: Health ministry official (Economic Times)
• Health ministry to launch ICMED-plus to address regulatory requirements of medical device product compliance (PharmaBiz)

• Opioid Indications Under TGA Scrutiny As Australia Tackles Growing Misuse (Pink Sheet-$)
• New web hub connects consumers and health professionals with transvaginal mesh information (TGA)

• High-Dose Folic Acid Does Not Prevent High Blood Pressure of Pregnancy (NYTimes)
• Half Of US Doctors Have Pay Tied To 'Value-Based Metrics' (Forbes)
• Humana And Fitbit Expand Partnership To 5M Enrollees (Forbes)