Recon: Highlights From EMSO 2018; GSK’s RA Prospect Misses in Phase II

• What Big Pharma Fears Most: A Trump Alliance With Democrats to Cut Drug Prices (NYTimes)
• Head of IBM Watson Health leaving post after company stumbles, growing criticism (STAT) (MassDevice)
• AcelRx shares fall as Sen. Markey calls on FDA to reject opioid painkiller (Drug Delivery) (Medpage) (Markey)
• Tegaserod, Prucalopride Win FDA Panel's Backing for Constipation (Medpage)
• Not So Fast With Immune Therapy For Breast Cancer (Forbes)
• Eight midterm races putting pharma — and its influence — front and center (STAT)
• A Billionaire Pledges to Fight High Drug Prices, and the Industry Is Rattled (WSJ)
• Sanofi drug Dupixent wins FDA approval to treat asthma (Reuters) (Press)
• FDA Approves Label Update for Genentech’s Rituxan (Rituximab) in Two Rare Forms of Vasculitis (Press)
• US filing for ViiV’s two-drug, single pill HIV treatment (PharmaTimes)
• Saving Mila: How a tailor-made therapy, developed in a flash, may have halted a young girl’s rare disease (STAT) (Science)
• Attorney General Frosh appeals to U.S. Supreme Court to uphold Maryland's law curbing drug price-gouging (Baltimore Sun)
• The Viral Obituary Of An Opioid Addict: 'She's Just One Face' Of The Epidemic (NPR)
• Scientific Misconduct and Medical Journals (JAMA)

• Winners and losers at #ESMO18 (Endpoints)
• GlaxoSmithKline’s rheumatoid arthritis prospect misses phase 2 endpoint (Fierce) (Endpoints) (Press)
• Roche scores win in slowing aggressive type of breast cancer (Reuters) (AP) (NYTimes) (Fierce) (Press)
• Novartis drug cut death risk by 35 percent in gene mutation breast cancer (Reuters) (Endpoints)
• #ESMO18: Cardio dreams blighted, Novartis showcases its “blockbuster” ambitions for radiopharmaceuticals (Endpoints)
• Roche lands Tecentriq trial win, still trails Merck in lung cancer (Reuters) (Press)
• Roche takes on Loxo, Bayer in gene-defined cancer class (Reuters) (Press)
• Loxo's targeted therapy holds up to Roche challenge (BioPharmaDive) (Fierce) (Press)
• Merck KGaA says might strike partnership deal this year (Reuters)
• ESMO: Merck's Keytruda, alone and in combo, makes its case for earlier use in head and neck cancer (Fierce) (Press)
• Is ‘STING’ a new and promising cancer target? Don’t look at Merck’s study results for a definitive answer (STAT) (Press)
• ESMO: Bristol-Myers Squibb eyes lead in rare colorectal cancer with new Opdivo results (Press)
• AstraZeneca's Lynparza shown to put brakes on ovarian cancer (Reuters) (Financial Times)
• NICE rejects Lilly’s breast cancer drug Verzenios (PharmaTimes)
• Faster approvals for clinical trial applications - what our robots have taught us so far (MHRA)
• Is China ready for a revolution in cancer therapy? Progress may hinge on access and screening (STAT)
• Cancer Of The Voice Box Declining Worldwide, But Not In Developing Countries (Forbes)
• Congo Rebels Kill 15, Threaten Ebola Containment Efforts Again (NPR)

• Opioid Blister-Pack Mandate Tops Gottlieb's Agenda With New Authority (Pink Sheet-$)
• Flooding the world with psychiatric drugs could boost the burden of mental disorders (STAT)
• Seres lures Kevin Horgan from AstraZeneca to fill CMO post (Fierce)
• Medicines Co execs grab a $33M A round to spin out an infectious disease outfit with a pipeline (Endpoints) (Xconomy)
• Cipla Handed Form 483 During September Inspection (FDA)
• In key endorsement, Deerfield reserves $65M for drug venture with UNC-Chapel Hill (Endpoints)
• Logicbio Marks Week’s Third IPO To Miss Price Target (BioCentury)
• Intellia's gene-editing ATTR treatment cuts abnormal proteins in monkeys (Fierce)
• FDA, EMA Delay Review Of Opdivo/Yervoy For First-Line NSCLC (BioCentury)
• Fidelity, Valor pool $71.8M for Jeff Aronin’s plan to reformulate a generic for butterfly skin disease at Castle Creek Pharma (Endpoints)

• Opdivo (nivolumab) in Combination with Yervoy (ipilimumab) Results in Significantly Longer Treatment-Free Survival in Patients with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (Press)
• Opdivo (nivolumab) in Combination with Yervoy (ipilimumab) Demonstrates Durable Four-Year Survival Benefits in Patients with Advanced Melanoma (Press)
• Opdivo (nivolumab) in Combination with Yervoy (ipilimumab) Shows Promising Results in Patients with Advanced Form of Bladder Cancer (Press)
• Opdivo (nivolumab) Plus Low-Dose Yervoy (ipilimumab) Demonstrates Durable Clinical Benefit in Previously Untreated Patients with MSI-H or dMMR Metastatic Colorectal Cancer (Press)
• Bristol-Myers Squibb Provides Update on the Ongoing Regulatory Review of Opdivo Plus Low-Dose Yervoy in First-Line Lung Cancer Patients with Tumor Mutational Burden ≥10 mut/Mb (Press)
• Pfizer Presents Overall Survival Data From PALOMA-3 Trial of IBRANCE® (palbociclib) in Patients With HR+, HER2- Metastatic Breast Cancer (Press)
• First Results of New Data of ABRAXANE in Combination with Atezolizumab Presented at ESMO 2018 (Press)
• amcure Presents First Clinical Data for Lead Compound AMC303 at ESMO 2018 Congress (Press)
• Ipsen Presents Real-World Pancreatic Cancer Data on ONIVYDE® at the European Society for Medical Oncology (ESMO) 2018 Annual Congress (Press)
• Mirati Therapeutics Announces Updated Data From Ongoing Clinical Trial Of Single Agent Sitravatinib At The 2018 ESMO Congress (Press)
• SOLO-1 Phase 3 Trial Demonstrates LYNPARZA® (olaparib) Maintenance Therapy Cut the Risk of Disease Progression or Death by 70 Percent in Patients with Newly-Diagnosed, Advanced BRCA-Mutated Ovarian Cancer (Press)
• Epizyme Reports Positive Data on Tazemetostat in Epithelioid Sarcoma from its Phase 2 Trial Cohort at ESMO (Press)
• BioLineRx Discloses Additional Data from Phase 2a COMBAT/KEYNOTE-202 Study in Pancreatic Cancer at ESMO 2018 Congress (Press)
• Phase 3 Data on Filgotinib in Biologic-Experienced Rheumatoid Arthritis to Be Presented at 2018 ACR/ARHP Annual Meeting (Press)
• Servier and Taiho Oncology Announce Phase III LONSURF® Study Has Met Primary and Secondary Endpoints Demonstrating Prolonged Overall Survival and Progression-Free Survival in Patients with Refractory Metastatic Gastric Cancer (Press)
• Incyte Announces Positive Interim Data from Phase 2 Trial of Pemigatinib, Its Selective FGFR Inhibitor, in Patients with Cholangiocarcinoma (Press)
• ImmunoGen Presents Initial Data from FORWARD II Expansion Cohort Assessing Mirvetuximab Soravtansine in Combination with KEYTRUDA at ESMO 2018 Congress (Press)
• FDA Grants Breakthrough Device Status for MediBeacon's Transdermal GFR Measurement System (Press)
• Exelixis Announces Results from the Dose-Escalation Stage of the Phase 1b COSMIC-021 Study of Cabozantinib in Combination with Atezolizumab in Previously Untreated Advanced Renal Cell Carcinoma (Press)
• AVEO Oncology and EUSA Pharma Announce Updated Interim Results from Phase 2 Portion of the TiNivo Study in Renal Cell Carcinoma (Press)
• Pancreatology Publishes Results of the PANOVA Phase 2 Pilot Trial in Advanced Pancreatic Cancer Suggesting Improved Survival of Patients Treated with Tumor Treating Fields (Press)
• Biohaven Receives Authorization to Proceed from FDA and Doses First Subject with BHV-3500, Third-Generation, Small Molecule CGRP-Receptor Antagonist (Press)
• Moffitt Cancer Center and Anixa Biosciences Announce Completion of Pre-IND Meeting with FDA for CAR-T Therapy (Press)

• FDA Pre-Cert participants share early experiences (mobihealthnews)
• Medtronic Co-Founder Earl Bakken Passes Away at Age 94 (Medtronic)
• Report: Abbott CEO White selects possible successor (MassDevice)
• Stryker extends deadline on $1.4B K2M buy as shareholders sue (MassDevice)
• FDA approves Abbott’s HeartMate 3 as a destination therapy (MassDevice)
• FDA Grants Breakthrough Device Status for MediBeacon's Transdermal GFR Measurement System (Press)
• OssDsign Announces FDA 510(k) Clearance of OSSDSIGN® Cranioplug (Press)
• Levita® Magnetics Announces FDA Clearance of Expanded Indication for Magnetic Surgical System for Use in Bariatric Procedures (Press)

• Long and Strong for 10 Years: FDA Determines that 2007 Teva ANDA for Generic CIALIS Escapes 180-Day Exclusivity Forfeiture (FDA Law Blog)
• Medical Device Maker Sued Over 'Dangerous' Walking Boot (Law360-$)
• Extracting a Toll from Litigation Tourists (Drug & Device Law)

• FDA Advisory Committee Calendar
• EFPIA: Value Based Health Care (VBH) Outcomes Workshop: A Health Systems Approach – 15 November 2018

• Mylan Launches Hulio in the European Union (Center for Biosimilars)
• CAR-T Therapies Should Impress EU Reimbursement Bodies (Pink Sheet-$)
• GSK named third best UK workplace (Pharmafile)

• Reistone Biopharma, a new Chinese biotech company ready to initiate its Ulcerative Colitis phase II clinical trial globally (Press)

• J&J hip implants: Affected patients seek clarity on report on compensation amount (Economic Times)
• Lupin Gears For Europe Specialty Push With Orphan NaMuscla (SCRIP-$)
• Dengue claimed 80 lives, affected 40,000 people till September '18: Health ministry (Economic Times)

• A Centennial of Death: The Great Influenza Pandemic of 1918 (NYTimes)
• The Tuberculosis That Afflicts Much Of The World Was Likely Spread By Europeans (NPR)
• Report says the UN's global 'war on drugs' has been a failure (CNN) (Report)