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Regulatory Focus™ > News Articles > 2019 > 5 > Recon: Japan Clears $306k Pricetag for Novartis’ Kymriah

Recon: Japan Clears $306k Pricetag for Novartis’ Kymriah

Posted 15 May 2019 | By Michael Mezher 

Recon: Japan Clears $306k Pricetag for Novartis’ Kymriah

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Vertex to pay startup Kymera $70 million in R&D deal (STAT) (Endpoints)
  • Gilead struck anti-competitive deals to bolster profits on an HIV drug, lawsuit says (STAT) (CNBC)
  • To Combat Generic Drugs' High Prices, Civica RX To Make 2 Antibiotics (NPR) (STAT) (WSJ)
  • Alphabet is funding a new way to reduce heart disease, the leading cause of death in the US (CNBC)
  • Pfizer's atopic dermatitis treatment meets goals in late-stage study (Reuters) (Endpoints) (Press)
  • Novartis defeats challenge to validity of Afinitor patent (Reuters)
  • Merck claims key FDA okay for Bavencio in kidney cancer (PMLive) (Endpoints) (Press)
  • Johnson & Johnson to submit applications for at least 10 new drugs by 2023 (Reuters) (Endpoints)
  • FDA tells ImmunoGen to run a second phase 3, sinking stock (Fierce) (Endpoints)
  • House health care bill puts generic drug industry in bind (Roll Call)
  • Daiichi ‘disappointed’ as FDA experts spurn AML drug but vote in favor of rare tumor drug (Endpoints) (FDANews-$) (Reuters) (Press) (Press)
  • B. Braun commits $1B to expand in face of IV fluid shortages (Fierce) (MassDevice) (MedTechDive)
  • Maker of OxyContin gets hit with another state lawsuit (AP)
  • Pennsylvania sues Oxycontin maker Purdue Pharma, says it targeted elderly and vets (CNN)
In Focus: International
  • Novartis gets approval to sell Kymriah in Japan for $306,000 (Reuters) (Endpoints)
  • NHS England, Biogen reach deal on pricey drug for deadly disorder (Reuters) (The Guardian)
  • SMC Follows NICE And Backs Lilly’s Verzenios In Advanced Breast Cancer (Pink Sheet-$)
  • EMA Begins Search for Next Executive Director (Focus)
  • Doctors Are Running Out of Effective Drugs Because of Poor Financial Incentives to Develop Them (Newsweek)
  • Misguided Pricing Tactics Delay Access To Medicines, Warns NHS England (Pink Sheet-$)
  • Contemporary Asian Drug Policy (RAND)
Pharmaceuticals & Biotechnology
  • This app has saved Americans $10 billion on prescriptions so far (CNBC)
  • Microbe-Hacker Ginkgo Bioworks Pushes Further Into Medicine With Acquisition Of Genome Mining Platform And Antibiotics Discovery Deal With Roche (Forbes)
  • Almost Half of All New Drug Approvals in 2018 Relied on One Clinical Trial (Focus)
  • OPQ Reports on State of Drug Quality in FY2018 (Focus)
  • Targeted Protein Degradation Comes of Age (LifeSciVC)
  • Merck CEO, Ken Frazier's Unusual Priority – Science (Forbes)
  • Takeda addressing Gammagard Liquid supplies but says it will take time (Fierce)
  • On the path to patients, NASH drugs may hit a payer roadblock (BioPharmaDive)
  • Solid's gene therapy stumble makes Sarepta's lead clearer (BioPharmaDive)
  • A top exec at struggling Biogen jumps ship for a new job (Endpoints)
  • Power Of Rare Disease Patient Registries Touted By US FDA, Patients (Pink Sheet-$)
  • BMS Urges FDA to Clarify Guidance on Risk-Based Trial Monitoring (FDANews-$)
  • Interview: Pfizer's Smith On Building A Gene Therapy Business (Scrip-$)
  • Data regulations impeding AI use in drug research (PMLive)
  • BMJ publishes subclinical hypothyroidism guideline (PharmaTimes)
  • Getting to Know You: The Power of Direct-to-Consumer Giants Have to Understanding Our Genetics (Harvard Bill of Health)
  • J&J Sets Erleada On Real-Time Pathway For Castration-Sensitive Prostate Cancer Claim (Pink Sheet-$)
  • Hey, big spender: Pharma's $6.6B TV ad outlay outranks most other industries, report says (Fierce)
  • Harnessing the patient voice in real-world evidence: the essential role of patient-reported outcomes (Nature)
  • Importing Drugs From Canada Not Viable For Lowering US Prices (Forbes)
  • EUSA Pharma nabs new executives, including the recently ousted Abeona CEO (Fierce)
  • Repeat GMP Violations Spur FDA to Ban Canadian OTC Drugmaker Imports (Focus)
  • FDA Warns Five Homeopathic Product Manufacturers for GMP Violations (Focus)
  • Applauding a Japan-US Research Partnership (NIH)
  • Meet the 2019 CNBC Disruptor 50 companies (CNBC)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • GenSight Biologics Reports Positive 96-Week Data from REVERSE Phase III Clinical Trial of GS010 for the Treatment of Leber Hereditary Optic Neuropathy (LHON) (Press)
  • FDA Lifts Partial Clinical Hold on Phase 3 AIM2CERV Study of Axalimogene Filolisbac (Press)
  • Landos Biopharma Announces Publication of Results from First-in-Human Phase 1 Study of BT-11 in Healthy Volunteers (Press)
  • Sensorion Announces the Positive Data Safety Monitoring Board (DSMB) Review and Continuation of the Phase 2 Clinical Trial for SENS-111 in Acute Unilateral Vestibulopathy (AUV) (Press)
Medical Devices
  • FDA’s Proposal to Limit Device Predicates Fails to Garner Industry Support (Focus)
  • Report: AI-based med devices could leave makers liable for ‘learned’ changes (MassDevice)
  • Massachusetts’ medical device hub: What you need to know (MassDevice)
  • Abbott and NIH Join Forces to Advance Neuroscience Research (MDDI)
  • FDA Finalizes Guidance on Non-Clinical Bench Performance Testing Information in Premarket Submissions (FDA Law Blog)
  • Zebra Medical Vision lands FDA approval for AI pneumothorax alert product (MedCity)
  • FDA Grants Market Clearance for the OrSense NBM200; the First Noninvasive Hemoglobin System Cleared for Use in Blood Donation Centers (Press)
  • Gore Receives FDA Approval for the GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL (Press)
US: Assorted & Government
  • Alabama Senate passes nation's strictest abortion ban (Politico)
  • Lawmakers weigh Part D out-of-pocket cap instead of rebate proposal: report (Fierce)
  • Hawley bill would limit export of biotech to China (BioCentury)
  • Majority of sunscreens would flunk proposed FDA safety tests, report to say (CNN)
  • Illumina Files a 2nd Patent Lawsuit Against BGI (MDDI)
  • Massachusetts pols took $40G in donations from pharma companies sued by AG (Boston Herald)
  • W.D. Va. Rejects Fraudulent Joinder and Fraudulent Misjoinder Arguments; Remands Case (Drug & Device Law)
  • SEC Proposes Targeted Regulatory Relief for Certain Small Public Companies from Sarbanes-Oxley 404(b) (BIO)
Upcoming Meetings & Events Europe
  • BIA Urges Biotechs To Flag Risks From UK R&D Tax Credit Reform (Scrip-$)
  • May 2019 Regulatory Roundup: Europe on the verge of MDR (Emergo)
  • Apply for manufacturer or wholesaler of medicines licences (MHRA)
  • Lithuania's new assessment procedure for reimbursable medicines: will there be any positive changes?  (Pharmaletter-$)
  • Court Restrains Dr Reddy’s In Indian Belviq Case (Scrip-$)
  • Pharma exports record over 10% growth during 2018-19, herbals decline while formulations achieve highest growth (PharmaBiz)
  • Medical device annual reporting - Sponsor obligations (TGA)
Other International
  • Myths and Truths about Seasonal Influenza and the Flu Vaccine (Paho)
General Health & Other Interesting Articles
  • Scans Suggested the Boy Had Cancer. But No Doctor Could Prove It. Why? (NYTimes)
  • Birth rate in US falls to lowest level in 32 years, CDC says (NBC)
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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