Recon: Trump to Announce Plans to Cut Medicare Drug Prices

• Trump to propose sweeping changes to Medicare drug prices (Politico) (Bloomberg)
• Comparison of US and International Prices for Top Medicare Part B Drugs by Total Expenditures (HHS)
• Gottlieb ‘extremely worried’ about how to pay for CAR-T therapies (STAT) (BioPharmaDive)
• The outrage over insulin prices (Axios)
• FDA approves a fast-acting flu drug that is taken in a single dose (STAT) (Endpoints) (Reuters) (NYTimes) (FDA) (Press)
• Merck posts global sales of $11B in third quarter (AP) (Financial Times)
• Bristol-Myers Squibb Reports Third Quarter Financial Results (Press)
• Biogen shares slip after Alzheimer's data fails to convince (Reuters) (STAT) (Endpoints)
• AbbVie is going for it in cystic fibrosis. But why are they buying the weak Galapagos portfolio in a $245M deal? (Endpoints) (Fierce)
• FDA declines to approve pre-filled syringe version of Regeneron's Eylea (Reuters) (Endpoints)
• Amgen cuts price of cholesterol drug Repatha by 60 percent (Reuters) (Endpoints)
• Trump to unveil proposal to reduce prices on doctor-administered drugs as midterms loom (Endpoints)
• Biogen Prevails In Fed. Circ. MS Drug Dispute With Forward (Law360-$) (PharmaTimes)
• Government expansion of health care is on the ballot in the most unlikely places (NBC)

• European Parliament passes law to restrict antibiotic use in food-producing livestock (STAT)
• A Chinese company unveils a powerful new sequencer. But can it compete in the US? (STAT)
• EU biosimilar embrace hits Roche’s Herceptin hard, but the pain is coming for AbbVie, J&J and more: report (Fierce)
• J&J steps up vaccines R&D—and preps for launches—with €72M plant (Fierce)
• A biotech unicorn prepares for a public offering, banking on gene therapy (STAT)
• West Africa's Ebola outbreak cost $53 billion – study (Reuters)
• Why Is This Ebola Outbreak Affecting So Many Children? (Medpage)
• Biosimilar Regulation Headaches From Morocco To Pakistan (Pink Sheet-$)
• Japan’s Conditional Approval System Passes Test With Global First Lorlatinib Nod (Pink Sheet-$)
• High drug prices due to unreasonable margins of companies: Competition Commission of India (Economic Times)
• UK medicines innovation must be supported post-Brexit, says RPS chief scientist (Pharmaceutical Journal)
• Another BeiGene NDA accepted in China (PharmaLetter)

• Milestone Pharma grabs an $80M round as it steams into pivotal trial work, starts outlining commercial structure (Endpoints) (Fierce)
• FDA generics approvals up 90% compared to 2014 (Pharmafile)
• Putting the “Complete” Back into Complete Response Letters (FDA Law Blog)
• Drug/Software Combo Platform Coming Soon To US FDA, Gottlieb Says (Pink Sheet-$)
• Bayer preps filings for new prostate cancer drug (PMLive)
• Do IBM Watson Health's Leadership Change And Layoffs Mean A.I. Is Bad Medicine? (Forbes)
• The Quality Lowdown: FDA's Enhanced Drug Recall Authority (Pink Sheet-$)
• US ‘unicorn’ Samumed on track with lead arthritis drug (PMLive) (Endpoints)
• Shire files for FDA approval of Georgia manufacturing facility (PharmaLetter-$)
• OrbiMed launches 89Bio with $60M Series A round to develop Teva’s NASH drug (MedCity)
• Express Scripts to expand network offerings to mail-order pharmacies in nod to changing consumer trends (MedCity)
• Follow the debate over Alkermes’ controversial new depression drug (STAT)
• Agency Information Collection Activities; Proposed Collection; Comment Request; Prescription Drug Product Labeling; Medication Guide Requirements (FDA)
• Product-Specific Guidance; Revised Draft Guidance for Industry on Sucralfate; Reopening of Comment Period (FDA)

• Vertex halts phase 2b spinal injury trial for futility (Fierce)
• FDA Grants Priority Review for Ruxolitinib (Jakafi®) as a Treatment for Patients with Acute Graft-Versus-Host Disease (Press)
• Nordic Nanovector's Betalutin® Receives Promising Innovative Medicine (PIM) Designation in the UK for the Treatment of Follicular Lymphoma (Press)
• Aerpio Pharmaceuticals Announces Presentation of Renal Function Data from TIME-2 Study of AKB-9778 in Diabetic Retinopathy Patients at American Society of Nephrology Kidney Week 2018 (Press)
• Acerus Announces Initiation of a Phase 1 Clinical Trial with a Proprietary Intranasal Formulation of a Tetrahydrocannabinol-Rich Cannabis Oil (Press)
• SpinalCyte Announces Positive 12 Month Pain Data From Phase 1/Phase 2 Clinical Trial for Degenerative Disc Disease (Press)
• Scarless Laboratories Receives FDA Clearance to Initiate Phase I/IIa Trial of SLI-F06 Peptide for Scar Reduction (Press)

• Accreditation Scheme for Conformity Assessment (ASCA) (FDA)
• FDA permits marketing of a diagnostic test to aid in the determination of menopausal status (FDA)
• Medtronic wins FDA nod for SynchroMedII myPTM drug therapy manager (Drug Delivery)
• FDA warns on corneal haze with recalled Raindrop inlay (MassDevice)
• Boston Scientific CEO talks pricing pressure for drug-eluting stents (MassDevice)
• Philips wins FDA nod for IntelliVue GuardianSoftware mobile app (MassDevice)
• ICU Medical warns about leaks in Thermoset drug-delivery systems (Drug Delivery)
• Masimo Announces FDA Clearance for Masimo RD Sensors with Improved Accuracy Specifications for SET® Pulse Oximetry (Press)
• NeuroBlate Optic Laser Probe with Fiber Optic Temperature Control FDA Cleared (medGadget)
• Baxter Announces U.S. Regulatory Filing for PrisMax Acute Care System and Presentation of 15 Abstracts to Start ASN: Kidney Week 2018 (Press)
• Novarad’s OpenSight Augmented Reality System is the First Solution for Microsoft HoloLens 510(k) Cleared by the FDA for Medical Use (Press)

• Cleveland, Akron Will Try To Prove Opioid Cases Without A Single Bogus Prescription (Forbes)
• J.P.M.L. Denies Request for New Gadolinium MDL (Drug & Device Law)
• A Closer Look At CMS' Drug Price Disclosure Proposal (Law360-$)
• J&J Unit Snags Win Over Glucose Test Strips Patent (Law360-$)
• Women's Expert Witnesses Axed In Bayer Mirena MDL (Law360-$)
• Justices Told $200M Merck IP Award Should Be Reinstated (Law360-$)
• Teva Asks FTC To Tweak Watson-Actavis Merger Fix (Law360-$)
• Shkreli, Ex-Firm Hit With Antitrust Suit Over Kidney Drug (Law360-$)

• FDA Advisory Committee Calendar

• UK Probes Thermo Fisher's Buy Of Electron Microscope Co. (Law360-$)
• Europe’s Shiny New X-Ray Laser Starts Showing Its Worth (IEEE)
• Antibiotic consumption in England has fallen by 6% in past five years, report shows (Pharmaceutical Journal)
• Dementia Discovery Fund, Uk Dementia Research Institute Partner To Fund Dementia Research (BioCentury)
• Decide if your product is a medicine or a medical device (MHRA)

• CDSCO tightens fluoroquinolone labelling norms to add warnings about mental health problems, hypoglycaemia (PharmaBiz)

• NMC Health, Hassana Investment sign agreement to build Saudi healthcare network (Reuters)

• Cold, Windy, Gray Day? Heart Attack Risk Is High (NYTimes) (Reuters)