Regulatory Focus™ > News Articles > 9 > Recon: NICE Rejects Novartis’ CAR-T Kymriah for Adults; CA Insurance Regulator Sues AbbVie Over Alle

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

Posted 19 September 2018 | By Michael Mezher 

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

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • 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, $39,000 in the U.S. Does It Matter? (NYTimes)
  • CBO Report on Generic Samples Bill (CBO)
In Focus: International
  • GSK grabs new drug development head from Boehringer (Reuters)
  • UK rejects adult Novartis CAR-T therapy, after 'yes' in kids (Reuters) (PharmaTimes) (NICE)
  • Global reach: The top 25 biopharma companies in the world (Endpoints)
  • The 20 largest medical device companies in the world (MassDevice)
  • EMA’s Committee for Medicinal Products for Human Use (CHMP) elects new chair (EMA)
  • AstraZeneca plots China robot offensive to counter price cuts (Reuters) (Pharmafile)
  • Almirall's Ilumetri scores EU approval in chronic plaque psoriasis (Pharmafile)
  • Norgine buys rights to sell Shield’s iron deficiency therapy (PharmaTimes)
Pharmaceuticals & Biotechnology
  • Biotech leaders call for free press (Nature Biotechnology) (PMLive)
  • Silverback starts to slowly edge out of stealth mode — but there’s still plenty being kept under wraps (Endpoints)
  • CRISPR Partners With Viacyte To Develop Immune-Evasive Pancreatic Cells (BioCentury)
  • Experts Explore Ways To Promote Use Of Real World Evidence In Clinical Trials: Latest CTTI Expert Meeting Summary Now Available (CTTI)
  • FDA Urges Development Of Generic Alternatives To Bring Down Prices Of Complex Drugs (Pink Sheet-$)
  • 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)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • 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)
Medical Devices
  • 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)
US: Assorted & Government
  • 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 $275m buyout (MassDevice)
Upcoming Meetings & Events Europe
  • Expert view: Current trends in detection of falsified medicines (EPR)
  • ABPI responds to MAC report on European migration (ABPI)
  • ‘Unmerited’ hep C patent contributes to Gilead monopoly, says NGO (InPharmaTechnologist)
  • Flex connectors in Halyard Closed Suction Kits – risk of interruption of ventilation (MDA/2018/030) (MHRA)
  • Asia Deal Watch: BIOCAD, Shanghai Pharma Agree On Pair Of Russian/Chinese Joint Ventures (SCRIP-$)
  • 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)
General Health & Other Interesting Articles
  • 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)
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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