Recon: FDA Approves SK Life Science’s Seizure Drug Xcopri; Rewrite Coming for Grassley-Wyden Drug Pricing Bill – Regulatory Focus

Posted 22 November 2019 | By Michael Mezher 

Recon: FDA Approves SK Life Science’s Seizure Drug Xcopri; Rewrite Coming for Grassley-Wyden Drug Pricing Bill
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US

  • Changes coming to Grassley-Wyden drug bill (Politico) (Senate Finance)
  • FDA approves new epilepsy therapy, a first for Korea's SK Life Science (BioPharmaDive) (FDA) (Press)
  • AstraZeneca wins FDA approval for Calquence in chronic lymphoma (PMLive) (Endpoints) (Press)
  • ViiV inks bNAb deal with National Institutes of Health (PharmaTimes) (Endpoints)
  • US vaping-related deaths rise to 47, cases of illness to 2,290 (Reuters)
  • Having gobbled up Celgene, the Bristol-Myers CEO ducks questions about his key rival (STAT)
  • Biogen’s top scientist nearly dares FDA not to approve Alzheimer’s drug (STAT) (BioPharmaDive) (Endpoints)

In Focus: International

  • Bayer AG discussed plans to give not-for-profit funding for influence (The Guardian)
  • Sanofi's strategy boss to leave as CEO readies revamp (Reuters) (Endpoints)
  • Pakistan grapples with drug-resistant typhoid outbreak (Reuters)
  • Health Canada Creates New Medical Devices Directorate (Focus)
  • Brexit Costs EMA Almost €60M in 2019 (Focus)
  • Italy’s plan to create €300-million research agency draws fire (Nature)
  • WHO Forges Ahead With New Framework To List Regulatory Authorities (Pink Sheet-$)
  • UK is a leader in early clinical research but falls in later study stages, says ABPI (PMLive)
  • Roche extends offer deadline for Spark Therapeutics again (Reuters) (Endpoints)
  • Across several continents, infecting mosquitoes with bacteria results in dramatic drops in dengue illness, trials show (STAT)

Pharmaceuticals & Biotechnology

  • A bold prediction: Machine learning will yield new drug candidates within three years (STAT)
  • AI's impact in drug discovery is coming fast, predicts GSK's Hal Barron (BioPharmaDive)
  • NASEM Committee Calls to Expand Agreements Between Drug Regulators (Focus)
  • FDA Releases 81 Product-Specific Guidances (Focus)
  • Alexandria is thinking big as it lays out plans for 1.6M square foot Bay Area biotech campus (Endpoints)
  • Azeria raises £32M to take breast cancer drug into humans (Fierce)
  • A study showed RWE can replicate only 15% of RCTs – is this accurate? (MedCity)
  • Generic Drug Approvals In US Off To Slow Start In FY 2020 (Pink Sheet-$)
  • Cancer cells’ loss is T cells’ gain (Nature)
  • Compound nestled in parasitic worm offers promise as antibiotic against obstinate superbugs (Endpoints)
  • Novel Clinical Trial Designs for Gene Therapies: An Exploration of Challenges by the National Academies’ Forum on Regenerative Medicine (FDA Law Blog)
  • Teva to Resume Production of Critical Pediatric Oncology Drug: Too Little, Too Late (Harvard Bill of Health)
  • International Reference Pricing Under H.R.3 Would Devastate the Emerging Biotechnology Sector, Leading to 56 Fewer New Medicines Coming to Market Over 10 Years (Vital Transformation) (PhRMA)
  • Vaccine Development Challenges Include Extensive Quality Control, Sanofi's Loew Notes (Pink Sheet-$)

Pharmaceutical & Biotechnology: Study Results, Filings & Designations

  • BioMarin Submits Marketing Authorization Application to European Medicines Agency for Valoctocogene Roxaparvovec to Treat Severe Hemophilia A (Press)
  • Endo's (ENDP) BLA for Cellulite Treatment Accepted by FDA (Press)
  • Genentech Presents Pivotal Data Demonstrating Tecentriq in Combination With Avastin Improves Overall Survival in People With the Most Common Form of Liver Cancer (Press)
  • Zymeworks Highlights Advancing Clinical Collaboration with BeiGene and Updated ZW25 Phase 1 Data in HER2-Expressing Cancers at ESMO Asia Congress (Press)
  • Sunovion Resubmits New Drug Application for Apomorphine Sublingual Film (Press)
  • Immunomic Therapeutics’ Collaborator, University of Florida Presents New Clinical Data from ATTAC-II Study in GBM at the 2019 Society for Neurology (SNO) Annual Meeting (Press)
  • VBI Vaccines Presents Early GBM Tumor Response and Immunologic Data from Part B of Ongoing Phase 1/2a Study of VBI-1901 at the 2019 SNO Annual Meeting (Press)
  • Clover Biopharmaceuticals Doses First Patient in Phase I Study of SCB-313 in Australia for Malignant Pleural Effusions (MPE) (Press)

Medical Devices

  • FDA approves Medtronic balloon to treat lesions hindering dialysis (MassDevice)
  • Medtronic warns patients of MiniMed insulin pump safety issue (MassDevice)
  • Genedrive Receives CE Mark for Hearing Loss Assay (GenomeWeb)
  • Myriad Genetics BRACAnalysis Approved by Japanese Regulators (GenomeWeb)
  • Life Spine Announces FDA 510(k) Clearance of the Award-winning LONGBOW® Titanium Lateral Expandable Spacer System (Press)

US: Assorted & Government

  • FEDERAL RESEARCH: Additional Actions Needed to Improve Public Access to Research Results (GAO)
  • As FDA toils over how to regulate CBD, frustration builds on all sides (STAT)
  • Fed. Circ. Ruling May Affect Eligibility Of Life Sciences Patents (Law360-$)
  • House Advances Bills Targeting Pharma IP Practices (Law360-$)
  • Teva Gets PTAB To Review Cushing's Syndrome Drug Patent (Law360-$)
  • Democratic Candidates Advocate For Busting Drug Patents (Law360-$)
  • Insys Reaches Creditor Deal For Tiered Ch. 11 Recoveries (Law360-$)
  • PTAB Probes Authenticity Of Prior Art In Pain Treatment Case (Law360-$)
  • Ex-FDA chief says Trump got ‘spooked by the politics and pushback’ on banning flavored vapes (CNBC)
  • Trump set to meet with tobacco executives, vaping advocates and public health groups (CNBC) (Politico)
  • Walgreens Closes Nearly 160 Walk-In Clinics – What It Means for Retail Healthcare (Forbes)
  • Medicare’s new primary care payment rule is good news for patients (STAT)

Upcoming Meetings & Events Europe

  • EU-Singapore trade agreement enters into force (EC)
  • Potential nitrosamine contamination: request to perform a risk evaluation (Swissmedic)
  • Contamination Potential Leads UK to Fifth Recall of Ranitidine Drugs (Focus)
  • UK Labour Govt Would Boost Health Spending, Put Pressure On Drug Prices (Pink Sheet-$)
  • EU Regulatory Roundup: Swissmedic Creates Signal Notification Form in Change to 2020 Requirements (Focus)

India

  • Indian excipient industry to approach DCGI to curb irrational usage of excipients in domestic market (Pharmabiz)

Australia

  • Medicines: Suspensions from the ARTG (TGA)
  • Consultation: Review of the regulation of certain self-testing IVDs in Australia (TGA)

Canada Other International

  • Drone firm in talks in Uganda on medical supply delivery deal (Reuters)

General Health & Other Interesting Articles

  • Sedentary teens risk health, hearts and minds: WHO study (Reuters)

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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Source: https://www.raps.org/news-and-articles/news-articles/2019/11/recon-fda-approves-sk-life-sciences-seizure-drug