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

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• FDA Advisory Committee Calendar

• 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)

• Myths and Truths about Seasonal Influenza and the Flu Vaccine (Paho)

• 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)