Regulatory Recon: Kite CAR-T Drug Hits Primary Endpoint in NHL Study Trump's 2018 Budget Would Cut Basic Science Spending by 10% (28 February 2017)

Posted 28 February 2017 | By Michael Mezher 

Regulatory Recon: Kite CAR-T Drug Hits Primary Endpoint in NHL Study Trump's 2018 Budget Would Cut Basic Science Spending by 10% (28 February 2017)

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

In Focus: US

  • Despite 21st Century Cures Act victory, road forward is murky for rare disease community (BioWorld)
  • Johnson & Johnson lifts lid on drug pricing data, shows 3.5% net hike in 2016 (CNBC) (WSJ) (PharmaLetter-$) (J&J)
  • Roche to start new trial of AC Immune drug against Alzheimer's (Reuters) (Fierce) (Press)
  • Kite Pharma CAR-T Cancer Therapy Shows Strong, Durable Effect in Lymphoma Patients (Street) (Reuters) (STAT) (Press)
  • FDA green lights AstraZeneca type-2 diabetes drug (Pharmafile) (Press)
  • FDA to expedite review of Teva drug for movement disorder (Reuters) (Press)
  • How to Fight a Soaring Drug Price: Innovate (NYTimes)
  • Trump's 2018 Budget Will Squeeze Civilian Science Agencies (Science)
  • RNA Therapeutics: The Commercial Tipping Point (Nature Biotechnology)
  • Trump Concedes Health Law Overhaul is 'Unbelievably Complex' (NYTimes)
  • Republicans will fail in Obamacare repeal bid: top Senate Democrat (Reuters)
  • Valeant's Declining Sales Show Turnaround Has Long Way to Go (Bloomberg)
  • The Fight for Obamacare has Turned (NYTimes)
  • As President Finalizes His Speech, Medtech Sector Urges Device Tax Repeal (AdvaMed)
  • US insurers balk at expensive 'miracle drugs' (Financial Times)
  • Trump meets insurers, promises catastrophic year for Obamacare (Reuters 1, 2) (Politico)
  • Merck KGaA, Pfizer get priority review for bladder cancer drug (Reuters) (Press)
  • Pacemakers may malfunction near certain appliances or tools (Reuters)
  • Orphan drugs attract rich returns for pharmaceuticals (Financial Times) (EP Vantage)
  • Small patient groups pose challenge for clinical trials (Financial Times)
  • Trump Targets Regulations Again With New Executive Order (Focus)
  • Maryland Goes a Step Further to Rein in Drug Price Spikes (Focus)
  • Sklamberg Departing FDA (BioCentury)
  • Allergan's Biosimilar Pullback Won't Be the Last (Bloomberg)
  • DIY Gene Editing: Fast, Cheap—and Worrisome (WSJ)

In Focus: International

  • Comment: Building Cross-Border Healthcare Networks (Financial Times) (European Commission)
  • Data Integrity Failures Undermine Trust That Can't Easily Be Won Back, EMA Official Says (Pink Sheet-$)
  • NHS Funding Cleared for New Specialised Treatments (PharmaTimes)
  • A Frontline Perspective: The Advent of Cell and Gene Therapy for Rare Diseases (ABPI)
  • NHS Patient Care and Treatment Errors: Developing a Learning Culture. (Harvard Bill of Health)
  • Deadly, Drug-Resistant 'Superbugs' Post Huge Threat, WHO Says (NYTimes) (Forbes)
  • Rival for Opdivo as Keytruda Launches for NSCLC in Japan at Same Daily Price (Pink Sheet-$)
  • New essential Orange and Green Guides 2017 – out now (MHRA)
  • Broad To Be Awarded EU CRISPR-CPF1 Patent (BioCentury)

US: Pharmaceuticals & Biotechnology

  • CDER Revises Good Review Practices Policy (FDA)
  • Combination therapies: the new standard in treating chronic illnesses (PharmaLetter-$)
  • NCI launches study of African-American cancer survivors (NIH)
  • Study: Nanotechnology could cut dose of HIV treatment in half (MassDevice)
  • Off-Label Promotion Decisions Likely Made Case-by-Case, US FDA Official Says (Pink Sheet-$)
  • Abuse-Deterrent Opioids: US FDA Follows The 'Route Of Abuse' To Exclusivity (Pink Sheet-$)
  • Rare Disease Day: Accelerating innovation for patients in need (PhRMA)
  • Why drug pricing seems so complicated (BioPharmaDive)
  • Shire's Wellhoefer On Genetic Disease R&D And Expanding Access To Medicines (SCRIP-$)
  • Biogen provides 'relationship advice' for outsourcing in pharma (OutsourcingPharma)
  • Vital statistics? Big Pharma undervaluing commercial data, expert (InPharmaTechnologist)
  • Astellas and Affinivax Announce Worldwide Partnership for MAPS Vaccine targeting Pneumococcal Disease (Press)
  • Edex (alprostadil for injection) 10 mcg 2 Pack by Endo Pharmaceuticals: Recall - Potential Lack of Sterility Assurance (FDA)
  • Psychotropic Drug Use by Older Adults (NYTimes)
  • Sanofi And Regeneron To Present New Data On Dupixent (Dupilumab) For Moderate-To-Severe Atopic Dermatitis At Upcoming Medical Congresses (Press)
  • Baxter and ScinoPharm Announce Exclusive Strategic Partnership for Generic Oncology Injectables (Press)
  • Advaxis pens backloaded $358M cancer delivery tech deal (Fierce)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings & Designations

  • Bausch + Lomb and NicOx resubmit US NDA for novel glaucoma candidate (PharmaLetter-$)
  • Eagle Pharmaceuticals' Pemetrexed NDA Accepted for Filing by the FDA (Press)
  • BioCryst's Hereditary angioedema drug-trial results not compelling. (The Street)
  • OncoSec wins fast track designation for electroporation combo therapy (MassDevice)
  • Xbrane Biopharma reports positive in-vitro biosimilarity data on ranibizumab biosimilar (Biosimilar News)
  • FDA To Review Acelrx's Pain Candidate (BioCentury)
  • Merck CMV Vaccine Headed For US, EU Submissions (BioCentury) (SCRIP-$)

US: Medical Devices

  • FDA Removed Medical Device Establishments from its Database that Did Not Register for 2017  (Registrar Corp)
  • Is Illumina on the Verge of a Breakout (The Street)
  • See that? Regeneron simulates retinal disease with virtual and augmented reality app (Fierce)
  • MedCrypt and QuiO partner to protect devices from cyberattacks (MassDevice)
  • Integra LifeSciences slides on Q4 sales miss (MassDevice)
  • FDA green-lights Cagent Vascular's Serranator Alto PAD balloon catheter (MassDevice) (Press)
  • Viewray Wins 510(k) for Mridian Linac System (MassDevice)
  • Velano Vascular wins FDA 510(k) for Pivo needle-free blood draw device (MassDevice)
  • Takeda and Cognition Kit partner for Apple Watch-based study on depression (MobiHealthNews)
  • Medtronic touts 5-year economic analysis data from CRT-focused Reverse study (MassDevice) (Press)
  • FDA Amends Rule on Gastroenterology-Urology Surgical Instruments (FDA)

US: Assorted & Government

  • EHRs: HHS Needs to Improve Planning and Evaluation of Its Efforts to Increase Information Exchange in Post-Acute Care Settings (GAO)
  • Supreme Court Won't Hear 'Flanax' Foreign Trademark Case (Law360-$)
  • Eli Lilly, Pfizer Urge Fed. Circ. To Undo Sanofi IP Ruling (Law360-$)
  • Bennet Reintroduces RACE for Children Act to Boost Pediatric Cancer Research (Bennet)
  • NV State Senate Passes Bill to Allow Biosimilar Substitution (Albuquerque Journal)
  • Direct OTC Purchases With Pre-Tax Accounts Swing On ACA Change, Not Repeal (Pink Sheet-$)
  • Hospitals, Both Rural And Urban, Dread Losing Ground With Health Law Repeal (KHN)
  • Buyer Beware, No Buyer's Remorse in New Jersey (Drug & Device Law)
  • Metallurgy firm exec cops to $75k bribe of Stryker engineer (MassDevice)
  • California Introduces Bill to Prohibit Prescription Drug Coupons (FDA News-$)
  • Vitamins gone gummy (NYTimes)
  • Family-reported errors may go undocumented on hospital records (Reuters)
  • FDA Meeting to Discuss the Meaning and Use of the Term "Healthy" for Foods (FDA Law Blog)

Upcoming Meetings & Events


  • Joint Declaration For An Ambitious EU Industrial Strategy (Medicines for Europe)
  • MHRA Unveils 'Regulatory Ready' Stem Cell Lines (Focus)
  • Synergy Biomedical Receives CE Mark for Biosphere Putty (Press)


  • Pros and Cons for Setting Up "International Center for Regenerative Medicine": LDP, Komeito Lawmakers (PharmaJapanWeb)


  • India needs regulatory body for medical devices: Kiran Mazumdar-Shaw (Economic Times)
  • Lupin gets USFDA nod to market cancer drug (Economic Times)
  • Daiichi moves to block Fortis stake sale again (Economic Times)
  • Maha FDA seizes illegal orthopaedic implants worth over Rs.2 cr from Mumbai firm (PharmaBiz)


  • Scopis Receives FDA 510(K) and Health Canada MDL Clearance for Its Cutting-Edge Surgical Navigation System for ENT Surgery (Press)

General Health & Other Interesting Articles

  • Magnesium may not ease nighttime leg cramps (Reuters)
  • A lifetime in treatment: one haemophiliac's story (Financial Times)

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.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @Michael_Mezher or send him an email at

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

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