Recon: FDA Approves Novartis’ Kymriah for Second Type of Blood Cancer

• U.S. approves Novartis cell therapy for lymphoma (Reuters) (Press) (Market Watch) (Fierce)
• Kymriah’s label throws lymphoma potential into doubt (EP Vantage)
• A dying scientist and his rogue vaccine trial (Wired)
• Janssen to Acquire BeneVir Biopharm to Advance Immunotherapy Regimens for $140m Upfront (Press) (Mass Device) (Endpoints) (Fierce)
• White House drug price initiative to include negotiation tools, list prices, Azar says (Modern Healthcare-$)
• Drug industry faces Trump-fueled storm over prices (The Hill)
• Scientists alarmed by report White House may tighten limits on Chinese researchers in U.S. (Stat)
• Questions Raised About Study Of Device To Ease Opioid Withdrawal (NPR)
• US Office Of New Drugs Revamp Taking Shape: More Review Divisions Coming, But Who Will Lead Them? (Pink Sheet-$)

• Accounting concerns wipe $6 billion off Samsung BioLogics market value (Reuters) (FT-$)
• Kenyan Clinic Rejects Trump Abortion Policy, Loses $2 Million In U.S. Aid (NPR)
• Breast cancer screening failure may have shortened 270 lives in England (Reuters) (New Scientist) (UK Gov)
• Chinese investors back Refuge Bio’s $25M B round as it steers gene engineering tech to an IND (Endpoints)
• Consultation: Complaints handling - Advertising therapeutic goods to the public (TGA)
• One In Five New EU Filings Are For Biosimilars (Pink Sheet-$)
• NICE recommends Janssen psoriasis drug that showed superiority to Humira (PharmaLetter-$)
• Shortfall of IVDR-Designated Notified Bodies a Real Possibility (Focus)
• WuXi to open Ireland manufacturing plant (BioCentury-$)
• Seminar Briefing: The UK Biotech Sector and Brexit (Office of Health Economics)
• Industry stakeholder meeting on Brexit and operation of the centralised procedure for human medicinal products (EMA)
• Public statement on withdrawal of the marketing authorization of Zinbryta in the European Union (EMA)
• Newly prequalified Quality Control Laboratory (WHO)
• Access to Generic Drugs in Canada (Health Canada) 

• As Biogen turns 40, biotech worries the glory days may be over (Stat)
• Executive’s Fraud Trial Puts Valeant in Uncomfortable Light (WSJ-$)
• Better together? AbbVie’s Humira and Pfizer’s Lyrica again outspend other brands (Fierce)
• Novo Nordisk eyeing a number of M&A opportunities to expand in rare disease (S&P Global)
• 4 more states consider biosimilar substitution bills (Goodwin)
• Merck KGaA, SFJ Enter Agreement (Contract Pharma)
• BeiGene appoints new president (Contract Pharma)
• Bristol-Myers Squibb and Flatiron Health Expand Collaboration with a Three-Year Agreement (Press)
• Avedro Announces $25 Million in Funding to Fuel Innovation and Commercial Growth (Press)

• A tiny biotech’s plot to frustrate Regeneron and Sanofi runs into a safety problem (Stat)
• Gilead Q1 financial results (Press)
• Foundation Medicine Launches Gene Expression Profiling Program to Identify Known and Novel Biomarkers in Advanced Cancer (Press)
• NeoImmuneTech Announces a Clinical Trial Collaboration with Roche to Evaluate HyLeukin-7 in Combination with a PD-L1 Checkpoint Inhibitor in Advanced High-Risk Skin Cancers (Press)

• Conavi Medical Announces FDA 510(k) Clearance of the Novasight Hybrid System with Simultaneous Intravascular Ultrasound (IVUS) and Optical Coherence Tomography (OCT) Capabilities (Press)
• iSchemaView Receives FDA Clearance for RAPID CTA (Press)
• Evotec Expands CRISPR-Based Technology Offering with Licence from ERS Genomics (Press)
• Japan's Ministry of Health Labour and Welfare (MHLW) granted national reimbursement for Abbott’s XIENCE Sierra (Press) (Mass Device)
• LivaNova Reports First Quarter 2018 Results (Press)

• Azar pitches value-based care (Politico)
• NIH Seeks One Million Volunteers for Medical Database (Wall Street Journal-$)
• CVS Health prescription drug sales surge as Aetna merger looms (Washington Examiner)
• Defense Health Agency Should Improve Tracking of Serious Adverse Medical Events and Monitoring of Required Follow-up (GAO)
• As White House seeks big cuts in global health research, new state-by-state analysis shows US government investment brings jobs (GHTC)

• FDA Advisory Committee Calendar

• AstraZeneca comments on 'Draft qualification opinion on plasma fibrinogen as a prognostic biomarker (drug development tool) for all-cause mortality and COPD exacerbations in COPD subjects' (EMA) (EMA)
• Heads of Medicines Agencies (HMA) / European Medicines Agency (EMA) Joint Big Data Task Force meeting: identifying solutions for big data challenges (EMA)

• CDSCO report on pharmacovigilance workshop (CDSCO)
• CDSCO launches exclusive innovator promotion cell to help researchers commercialise scientific breakthroughs faster (Pharmabiz)

• WHO says unprecedented dengue outbreak hits La Reunion (Reuters)
• Vaping Products That Look Like Juice Boxes and Candy Are Target of Crackdown (NY Times) (FTC)
• Cops Forced A Company To Share A Customer’s Identity For The Golden State Killer Investigation (Buzzfeed)
• The Pain Hustlers (NY Times Magazine)