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

• 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)

• 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)

• 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-$)
• Cancer cells’ loss is T cells’ gain (Nature)
• Compound nestled in parasitic worm offers promise as antibiotic against obstinate superbugs (Endpoints)
• Novel Clinical Trial Designs for Gene Therapies: An Exploration of Challenges by the National Academies’ Forum on Regenerative Medicine (FDA Law Blog)
• Teva to Resume Production of Critical Pediatric Oncology Drug: Too Little, Too Late (Harvard Bill of Health)
• International Reference Pricing Under H.R.3 Would Devastate the Emerging Biotechnology Sector, Leading to 56 Fewer New Medicines Coming to Market Over 10 Years (Vital Transformation) (PhRMA)
• Vaccine Development Challenges Include Extensive Quality Control, Sanofi's Loew Notes (Pink Sheet-$)

• 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)

• 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)

• 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)

• FDA Advisory Committee Calendar

• 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)

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

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

• List of Drugs for an Urgent Public Health Need (Health Canada)

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

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