Regulatory Focus™ > News Articles > 5 > Recon: FDA Approves Novartis’ Kymriah for Second Type of Blood Cancer

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

Posted 02 May 2018 | By Zachary Brennan 

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

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US
  • 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-$)
In Focus: International
  • 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
Pharmaceuticals & Biotechnology
  • 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 $25 Million in Funding to Fuel Innovation and Commercial Growth (Press)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • A tiny biotech’s plot to frustrate Regeneron and Sanofi runs into a safety problem (Stat)
  • Gilead Q1 financial results (Press)
  • Foundation Medicine Launches Gene Expression Profiling Program to Identify Known and Novel Biomarkers in Advanced Cancer (Press)
  • NeoImmuneTech Announces a Clinical Trial Collaboration with Roche to Evaluate HyLeukin-7 in Combination with a PD-L1 Checkpoint Inhibitor in Advanced High-Risk Skin Cancers (Press)
Medical Devices
  • Conavi Medical Announces FDA 510(k) Clearance of the Novasight Hybrid System with Simultaneous Intravascular Ultrasound (IVUS) and Optical Coherence Tomography (OCT) Capabilities (Press)
  • iSchemaView Receives FDA Clearance for RAPID CTA (Press)
  • Evotec Expands CRISPR-Based Technology Offering with Licence from ERS Genomics (Press)
  • Japan's Ministry of Health Labour and Welfare (MHLW) granted national reimbursement for Abbott’s XIENCE Sierra (Press) (Mass Device)
  • LivaNova Reports First Quarter 2018 Results (Press)
US: Assorted & Government
  • Azar pitches value-based care (Politico)
  • NIH Seeks One Million Volunteers for Medical Database (Wall Street Journal-$)
  • 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)
Upcoming Meetings & Events Europe
  • 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)
India
  • CDSCO report on pharmacovigilance workshop (CDSCO)
  • CDSCO launches exclusive innovator promotion cell to help researchers commercialise scientific breakthroughs faster (Pharmabiz)
General Health & Other Interesting Articles
  • 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)
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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