Regulatory Recon: Senate to Begin Cures Debate Tonight FDA Close to Finishing Combination Product Reporting Rule (5 December 2016)

Posted 05 December 2016 | By Michael Mezher 

Regulatory Recon: Senate to Begin Cures Debate Tonight FDA Close to Finishing Combination Product Reporting Rule (5 December 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Missed Friday's Recon? Read it here.

In Focus: US

  • FDA Presses Hospitals on Medical-Tool Problems (WSJ)
  • FDA's Office of New Drugs Director to Retite (Focus)
  • Immune System, Unleashed by Cancer Therapies, Can Attack Organs (NYTimes)
  • New data on risk vs benefit for potent CAR-T cancer drugs (Reuters)
  • Kite Files for First CAR-T therapy BLA with FDA (PharmaLetter-$) (Press)
  • Rivals Kite and Novartis post new CAR-T data as both plot FDA approval (Fierce) (SCRIP-$)
  • Novartis, Kite say 82 percent of leukemia patients in remission after CAR-T (Reuters) (Kite)
  • Pfizer blood cancer drug tops standard therapy for untreated patients (Reuters) (Press)
  • Study raises questions over benefit of Roche's Gazyva cancer drug (Reuters) (Press)
  • FDA approves Jardiance to reduce cardiovascular death in adults with type 2 diabetes (FDA) (Medpage) (PharmaTimes) (Press) (Reuters)
  • US Health Spending in 2015 Averaged Nearly $10,000 Per Person (NYTimes) (Reuters)
  • GOP Plans Immediate Repeal of Health Law, Then a Delay (NYTimes) (Washington Post)
  • In House Majority Leader's Home District, Many Depend On Health Law He Wants To Scrap (NPR)
  • FDA Finalizes Guidance on Clinical Pharmacology Labeling (Focus)
  • Combination Products Review Program: Progress and Potential (FDAVoice)
  • Combo Product Safety: US FDA Rule On Postmarket Reporting Nears Finalization (Pink Sheet-$)
  • Will US FDA Wind Up With More Political Positions Under Trump? (Pink Sheet-$)
  • Tom Price Is Eager to Lead H.H.S., and Reduce Its Clout (NYTimes)
  • Senate to Debate on Cures Act This Evening (Senate)
  • The 21st Century Cures Act: A Giant Piñata (In The Pipeline)
  • Winners and losers of the 21st Century Cures Act (STAT)
  • What is the Right Number of Unsafe, Ineffective Drugs for the FDA to Approve? (Harvard Bill of Health)
  • Novo Says it is Working on Sustainable Solutions to Drug Pricing, Affordability (Novo Nordisk)
  • Oral arguments in CRISPR patent case expected to be 'fight to the death' (STAT)

In Focus: International

  • Scientific advice from regulators, HTAs is key in quest for effective Alzheimer's drugs (BioWorld)
  • ReNeuron says stem cells improved motor function in stroke study (Reuters) (Fierce) (Press)
  • Government buys time to amend its petition on combo drugs ban (Economic Times) (PharmaLetter-$) (Pink Sheet-$)
  • No Delays Expected As Australian Bill On Faster Drug Approvals Goes To Parliament (Pink Sheet-$)
  • UniQure gene therapy delivers lasting efficacy in hemB, but Spark FIX comparisons continue to cast a shadow over data (Fierce) (EP Vantage) (The Street) (Poster)
  • GSK files triple combo for COPD in Europe (PharmaTimes)
  • Allergan, Amgen file first Avastin biosimilar in EU (PharmaTimes)
  • ICH Advances Three Guidance Documents (Focus)
  • NHS to launch three-year anti-HIV PrEP trial (Financial Times)
  • New Medical Device Classification Criteria from Malaysian MDA (Emergo)
  • Brexit Briefing: Britain's EU patent opt-in (Financial Times)
  • AstraZeneca to move some UK jobs to Poland, Costa Rica and Malaysia (The Guardian)
  • A Zika vaccine is being developed at warp speed, but will there be a market for it? (STAT)

US: Pharmaceuticals & Biotechnology

  • Celgene acquiring Acetylon after spinout of newco (BioCentury) (MedCityNews)
  • Life Sciences Researchers Win $15M in Breakthrough Prizes (GEN)
  • Crizanlizumab for the Prevention of Pain Crises in Sickle Cell Disease (NEJM)
  • Breaking Zen: FDA Denies Vanda's Petition on FANAPT 3-Year Exclusivity; Approves Generic (FDA Law Blog)
  • Arrowhead fires CSO & Co-inventor of delivery tech responsible for clinical trial abandonment (BioPharmaReporter)
  • Human Blood Substitutes, Once Dead, Now Resuscitated (The Street)
  • Higher blood clot risk after starting testosterone treatment (Reuters)
  • Are DTC ads tipping the balance in psoriasis battle between Lilly's Taltz and Novartis' Cosentyx? (Fierce)

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

  • Encouraging Survival Observed With Opdivo (nivolumab) Plus Yervoy (ipilimumab) With Longer Follow-up in First-line Advanced Non-small Cell Lung Cancer, in Updated Phase 1b CheckMate -012 Study (Press)
  • Agios' PK deficiency data tees up decision on pivotal trial (Fierce) (Press)
  • Noveome Initiates Phase 2 Clinical Trial of ST266 for the Treatment of Allergic Conjunctivitis (Press)
  • Seattle Genetics Highlights Phase 1 Vadastuximab Talirine (SGN-CD33A; 33A) Data Presentations, Including Combination Therapy with HMAs, in Patients with Acute Myeloid Leukemia at ASH Annual Meeting (Press)
  • Seattle Genetics Presents Phase 1b Data from Vadastuximab Talirine (SGN-CD33A; 33A) in Combination with Standard of Care in Frontline Acute Myeloid Leukemia at ASH Annual Meeting (Press)
  • Seattle Genetics Presents Data from Phase 2 Study Evaluating ADCETRIS® (Brentuximab Vedotin) in Frontline Diffuse Large B-cell Lymphoma at ASH Annual Meeting (Press)
  • True North Presents Additional Data from an Ongoing Clinical Study Showing Normalization of Hemoglobin Levels with TNT009 in Severely Anemic Cold Agglutinin Disease (CAD) Patients (Press)
  • Takeda and Seattle Genetics Report Positive Phase 3 ALCANZA Clinical Trial Data of ADCETRIS® (Brentuximab Vedotin) for CD30-Expressing Cutaneous T-Cell Lymphoma (Press)
  • New Phase 2 Results Show Investigational Compound Glasdegib Improved Overall Survival in Acute Myeloid Leukemia and High-Risk Myelodysplastic Syndrome (Press)
  • AmpliPhi Biosciences Reports Favorable Final Results From Phase 1 Trial of AB-SA01 (Press)
  • Juno Therapeutics Announces Complete Response and Corresponding Early Survival Data for JCAR014 in Patients with Ibrutinib-Refractory CLL (Press)
  • Nordic Nanovector: Single-dose Betalutin® Shows Promising Efficacy, Improved Duration of Response and Favourable Safety in Relapsed NHL Patients (Press)
  • Preclinical Data on Proprietary AKT Inhibitor, ARQ 092, Demonstrating Effectiveness in the Treatment of Sickle Cell Disease Presented at the American Society of Hematology Annual Meeting (Press)
  • Unum Therapeutics to Present on its Antibody-Coupled T-Cell Receptor (ACTR) Platform at the Upcoming 58th American Society of Hematology (ASH) Annual Meeting (Press)
  • Data at ASH 2016 Show Strong, Lasting Efficacy of Imbruvica®▼ (ibrutinib) Through Five Years of Treatment for Chronic Lymphocytic Leukaemia (CLL) (Press)
  • Alnylam Reports Positive Interim Clinical Results for Fitusiran from Ongoing Phase 2 Open Label Extension Study in Patients with Hemophilia A or B without Inhibitors (Press)
  • Sunovion to Initiate Recruitment for Aptiom® (eslicarbazepine acetate) Clinical Study with Integrated Digital Health Technology to Aid Seizure Detection (Press)
  • New Data from ALXN1210 Dose-Escalation Study Presented at ASH Show Rapid and Sustained Reductions in LDH in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) (Press)
  • Acetylon Presents Early Phase 1a/1b Results for Citarinostat (ACY-241) in Combination with Pomalyst® and Dexamethasone Showing Promising Treatment Responses in Relapsed or Relapsed-and-Refractory Multiple Myeloma (Press)
  • Acetylon Presents Preclinical Data Demonstrating the Utility of Selective HDAC1,2 Inhibition by ACY-957 to Induce Gamma Globin (HBG) Protein Expression for the Treatment of Sickle Cell Disease and Beta-Thalassemia (Press)
  • Pooled Analysis of Five-Year Data from Two Phase 3 Studies Further Supports Overall Survival Advantage Observed in Patients with Myelofibrosis Treated With Jakafi® (ruxolitinib) (Press)
  • Syros Pharmaceuticals Presents Data at ASH Annual Meeting Further Supporting Clinical Potential of Its First-in-Class Selective RARα Agonist for Genomically Defined Subsets of AML and MDS Patients (Press)
  • Imara Presents Results for IMR-687, a PDE9 Inhibitor, in Sickle Cell Disease at ASH (Press)

US: Medical Devices

  • 10 Biggest Medical Device Recalls of 2016 (MDDI)
  • Boston Scientific to Buy Neovasc Heart Valve Assets in $75M Deal (Xconomy)
  • Class 1 Device Recall Centurion (FDA)
  • J&J's Evarrest fibrin sealant patch wins expanded indication for hemostasis (Drug Delivery)
  • KYOCERA Medical Corporation Receives FDA 510(k) Clearance for Initia® Total Hip System, Featuring BIOCERAM AZUL® Ceramic Femoral Head (Press)
  • FDA clears BrightWater Medical's ConvertX nephroureteral stent (MassDevice)

US: Assorted & Government

  • Insurers' Flawed Directories Leave Patients Scrambling for In-Network Doctors (NYTimes)
  • Health Industry Lobbies To Keep Obamacare Customers (Forbes)
  • Retractable Technologies plummets after appeals court tosses $352m win over Becton Dickinson (MassDevice)
  • PTAB tosses out Covidien patent in surgical shears spat with J&J's Ethicon (MassDevice)

Upcoming Meetings & Events

  • FDA Advisory Committee Calendar
  • CDER Small Business and Industry Assistance (CDER SBIA) Webinar - What's New with Forms FDA 3542a and 3542? (FDA)
  • Twelfth joint EMA/EUnetHTA dialogue meeting – 7 December 2016
  • Workshop on measuring the impact of pharmacovigilance activities – 5-6 December 2016
  • ENVI meeting will discuss Pediatric Regulation, EU Options for Improving Access to Medicines – 8 December 2016


  • Pharma companies are upping their U.K. social media marketing game with country-specific accounts (Fierce)
  • Ita-leave? Italian referendum may impact European API supply chain (InPharmaTechnologist)


  • CASI Pharmaceuticals' Import Drug Registration Application For EVOMELA® Accepted For Review By CFDA (Press)


  • Strides Shasun R&D unit gets USFDA inspection closure report (Economic Times)
  • Bomaby High Court denies promoters of Mumbai-based Taj Pharmaceuticals Limited anticipatory bail (Economic Times)
  • Lupin gets USFDA's final nod for pain relief tablets (Economic Times)
  • Dr Reddy's launches anti-fungal ointment in the US (Economic Times)
  • Alembic Pharma gets US FDA nod for anti-migraine drug (Economic Times)


  • Medtronic SynchroMed II implantable infusion pump (TGA)

Other International

  • Senseonics and Roche expand distribution partnership into Europe, Middle East, Africa (MobiHealthNews)

General Health & Other Interesting Articles

  • Does Gene Testing Spur Healthier Habits? Maybe Not (NYTimes)
  • On a scale of 1-10: Earth gets a 3 for infectious disease readiness (BioWorld)

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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