Regulatory Recon: News From ASH 2017 Drugmakers Sue to Block Calif. Price Law (11 December 2017)

Posted 11 December 2017 | By

Regulatory Recon: News From ASH 2017 Drugmakers Sue to Block Calif. Price Law (11 December 2017)

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

In Focus: US

  • Drug companies sue to block California drug price law (AP) (LA Times) (Reuters) (Bloomberg) (Law360-$)
  • Tax bill may target pharma's DTC deduction, but ad industry's ready to defend it (Fierce)
  • Sympathetic Congress has not acted to derail medical device tax (Star Tribune)
  • When Buying Prescription Drugs, Some Pay More With Insurance Than Without It (ProPublica)
  • How to Save Money on Your Prescription Drugs (ProPublica)
  • Let States Lower Drug Prices (Bloomberg)
  • US drugmaker raises price of vitamins by more than 800% (Financial Times)
  • Cancer treatment progress stunted by lack of volunteers (PBS)
  • People Don't Take Their Pills. Only One Thing Seems to Help. (NYTimes)
  • AAM Calls for FTC Action to Ensure U.S. Supply of Generic Drugs for Patients (AAM)
  • Merck raises stakes in lung cancer as rivals close in (Reuters)
  • Lilly's stomach cancer drug meets main goal, but fails to improve survival rate (Reuters)
  • Teva Announces Launch of Generic Viagra Tablets in the United States (Press)
  • The Little Blue Pill: An Oral History of Viagra (Bloomberg)
  • US House committee 'may reconsider' WHO cancer agency funds (Reuters)

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In Focus: International

  • Philippines defied experts' advice in pursuing dengue immunization program (Reuters)
  • Sanofi scandal in the Philippines could spread dangerous mistrust of vaccines (STAT)
  • Life sciences: Sector Deal (MHRA)
  • EU Regulators Urge Pharma To Share Their Brexit Plans (Pink Sheet-$)
  • Chemical and pharma groups urge Gove to stick to EU regime (Financial Times)
  • GSK's new pharma head on lookout for cancer deals to boost pipeline (Reuters) (Endpoints)
  • Roche: Tecentriq cocktail slows kidney cancer progression (Reuters) (PharmaTimes) (Press)
  • Health is a fundamental human right (WHO)
  • Industry Outlines Concerns Over EU Proposals On Pharmaceuticals In The Environment (Pink Sheet-$)
  • First certified reference materials for the Alzheimer's biomarker amyloid-β (EC)
  • How To Make Collaborative HTA Work In Europe: A Guide From EUnetHTA (Pink Sheet-$)
  • Brazil's Spiraling Access Suits And The Potential Impact On Companies (SCRIP-$)
  • To succeed in emerging market medicine, anticipation and innovation are essential (Pharmafile)
  • MHRA awarded £1.3m for collaboration with the Bill and Melinda Gates Foundation and the World Health Organization (MHRA)
  • Indonesia races to contain diphtheria outbreak ahead of 2018 Asian Games (Reuters)
  • France orders international recall of Lactalis baby formula (Reuters)

ASH2017 Roundup

  • Five Winners - And One Loser - From Medicine's Big Meeting About Blood (Forbes)
  • Gilead's new drug keeps 56 percent of lymphoma trial patients alive (Reuters) (Financial Times)
  • Q&A: Inside the rollout of Yescarta, one of the first approved CAR-Ts (STAT)
  • Novartis CAR-T therapy leads to durable response in lymphoma study (Reuters) (Endpoints) (NEJM) (NEJM Editorial)
  • 'Unheard of' responses to bluebird CAR-T therapy seen in myeloma study (Reuters) (Endpoints) (Fierce) (STAT) (Press)
  • Early data suggest CAR-T therapies could be delivered outpatient, cutting costs (STAT)
  • CAR-T therapies prove durable, stopping cancer for months — even years — in some patients (STAT)
  • Blueprint elbows its way to center ring with early data and a plan to seek quick FDA OK (Endpoints) (Press)
  • Seattle Genetics CEO Clay Siegall has an answer for the skeptics doubting Adcetris data for Hodgkin lymphoma (Endpoints) (Press)
  • Roche lymphoma drug drives high remission rate, longer survival: study (Reuters) (Endpoints) (Press)
  • Excitement Builds Around Gene Therapy Cures For Hemophilia (Forbes) (NEJM)
  • ASH winners and losers: Hemophilia therapies show promise, Syros stumbles (STAT)
  • Spark Trails BioMarin In Hemophilia Gene Therapy Race (Forbes) (Endpoints) (EPVantage)
  • Roche's Hemlibra continued to substantially reduce bleeds in people with haemophilia A with inhibitors (Press)
  • ASH: J&J, AbbVie tout long-term Imbruvica data in the face of a new AstraZeneca threat (Fierce)
  • Seattle Genetics Highlights Updated Analyses from Phase 3 ALCANZA Clinical Trial of ADCETRIS (Brentuximab Vedotin) in CD30-Expressing Cutaneous T-Cell Lymphoma (Press)
  • Seattle Genetics Highlights Five-Year Survival Results from Phase 1 Trial of ADCETRIS (Brentuximab Vedotin) in Frontline Mature T-Cell Lymphoma (Press)
  • bluebird bio Announces Updated Clinical Results from Ongoing Phase 1 Multicenter Study of LentiGlobin Gene Therapy in Severe Sickle Cell Disease at American Society of Hematology (ASH) Annual Meeting (Press)
  • bluebird bio Presents New Data from Clinical Studies of LentiGlobin Gene Therapy in Transfusion-Dependent β-Thalassemia at American Society of Hematology Annual Meeting (Press)
  • Four-Year Phase 3 Data Analysis Shows Durability of Response of Jakafi (ruxolitinib) in Patients with Polycythemia Vera (Press)
  • Acceleron Announces Updated Results from Ongoing Phase 2 Trials of Luspatercept in Myelodysplastic Syndromes at the 59th Annual Meeting of the American Society of Hematology (Press)
  • ADC Therapeutics Announces Interim Phase I Data from its Novel Antibody-Drug Conjugate ADCT-301 (Press)
  • Verastem Announces Clinical Data from the Pivotal Phase 3 DUO Study: Duvelisib Significantly Improves Progression Free Survival in Relapsed or Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma (Press)
  • Sprycel (dasatinib) Added to Standard Chemotherapy Demonstrates Three-Year Survival Benefit in Pediatric Patients with Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Press)
  • Syros tanks on single-digit response rate in AML, MDS trial (Fierce) (Endpoints) (Press)
  • Syros Announces New Preclinical Data on SY-1365, Its First-in-Class Selective CDK7 Inhibitor, Pointing to a Potential Biomarker of Response and Combination Approach (Press)
  • Italfarmaco Presents Positive Phase II Study Results for Givinostat in Polycythemia Vera Patients at the ASH Annual Meeting (Press)
  • FDA Accepts Supplemental Biologics License Application (sBLA), Assigns Priority Review to Merck's KEYTRUDA (pembrolizumab) for Treatment of Relapsed or Refractory Primary Mediastinal Large B-Cell Lymphoma (PMBCL) (Press)

Pharmaceuticals & Biotechnology

  • FDA issued the fewest warnings over pharma advertising this year since 1997 (Pharmafile)
  • Will New FDA Regulation On IRB Review Speed Patient Access To Experimental Drugs? (Health Affairs)
  • Tre bien, Trevyent: Demand by FDA 'low bar,' Steadymed advancing PAH drug/device (BioWorld)
  • FDA DSCSA Public Meeting #2, Still A Gulf (RxTrace)
  • Gilead backs $60M Hookipa round to fund immunotherapy R&D (Fierce)
  • 'Epigenetic CRISPR' edits DNA without cutting it (Fierce)
  • Biopharma Schizophrenia: High Demand For Innovation Vs. Pleas For 'Me-Too' Drugs (Forbes)
  • 2017's Word Of The Year In Health Law And Bioethics: Uncertainty (Harvard Bill of Health)
  • Two New Draft Guidances Helping to Implement The Cures Act (FDA Law Blog)
  • Business as usual at Amgen following voluntary evacuation at Cali site (BiopharmaReporter)
  • Want to Quit Smoking? FDA-Approved Products Can Help (FDA)
  • Research on HIV cure: Mapping the ethics landscape (PLOS)
  • Kimberly Blackwell, M.D., to become Vice President of Early Phase Development and Immuno-oncology at Lilly Oncology (Press)
  • US FDA Readies For Assessment Of IND Communications With Sponsors (Pink Sheet-$)
  • Liposomal Drugs Should Not Be Compounded – Until Technology Catches Up (Pink Sheet-$)
  • FDA Endocrinology Division To Be Led By Thanh Hai On Interim Basis; Guettier Leaving For Private Sector (Pink Sheet-$)
  • AstraZeneca taps Biggest Loser host Bob Harper for heart attack survivors push (Fierce)
  • Specialty pharmacy scrutiny hits again with state's focus on Horizon meds (Fierce)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • Alnylam Announces Expansion of U.S. Orphan Drug Designation for Patisiran to Treatment of Transthyretin-Mediated Amyloidosis (Press)
  • FDA Accepts Biologics License Application (BLA) to Review Galcanezumab for the Prevention of Migraine in Adults (Press)
  • ARMO BioSciences Presents Data from its Phase 1b Trial in Non-Small Cell Lung Cancer at ESMO Immuno Oncology Congress 2017 (Press)
  • Rhizen receives USFDA fast track designation for cancer drug (Economic Times)
  • 'Ground-breaking' new drug gives hope on Huntingdon's disease (Reuters) (Press)
  • Regeneron Announces FDA Acceptance of sBLA Filing for 12-Week Dosing of EYLEA® (aflibercept) Injection for Patients with Wet AMD (Press)

Medical Devices

  • FDA Plans New Medical-Device Approval Processes (WSJ)
  • Boston Scientific Spinal Cord Stimulation System (FDA)
  • FDA Approves Investigational Device Exemption for SetPoint Bioelectronic Therapy Clinical Study in Rheumatoid Arthritis (Press)
  • Spirosure Makes FDA 510(k) Submission for Clearance to Sell Fenom PRO Point-of-Care Breathalyzer in the U.S. (Press)
  • Intersect ENT Announces FDA Approval of SINUVA™ Sinus Implant, a New In-Office Treatment Option for Recurrent Nasal Polyps (Press)

US: Assorted & Government

  • Hospital Giants in Talks to Merge to Create Nation's Largest Operator (WSJ) (Reuters)
  • The way over-the-counter drugs are regulated is a mess — and Congress is ready to step in (STAT)
  • McKesson Records Show Failed Opioid Oversight, Lawsuit Says (Bloomberg)
  • Patheon Says Rival Can't Recover $135M Over Softgel Pact (Law360-$)
  • Innovator Liability – A Word to the Wise (Drug & Device Law)

Upcoming Meetings & Events


  • Russia's pharma imports resume growth for the first time since 2014 (PharmaLetter-$)
  • Questions and answers on monoclonal antibodies for veterinary use (EMA)


  • Asahi Kasei Pharma gains rights to Kevzara in Japan (PharmaLetter-$)
  • MHRA finds evidence of data integrity issues at Acme Lab's plant (InPharma)


Other International

  • Biocad bringing biosimilars to North Africa through fill/finish plant (BiopharmaReporter)

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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