Regulatory Focus™ > News Articles > 10 > Recon: Highlights From EMSO 2018; GSK’s RA Prospect Misses in Phase II

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

Posted 22 October 2018 | By Michael Mezher 

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

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • 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)
Sponsored Content: A breakthrough in regulatory intelligence management.
Discover how much more cost effective and efficient the process of registering and commercializing medical devices can be with the Magellan Device Compliance Platform. Magellan is designed specifically to address the challenges faced by regulatory professionals when registering devices in multiple country jurisdictions. Magellan combines a central repository for all documentation and license requirements, at the same time providing robust management and analytic tools.
In Focus: International
  • 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)
Pharmaceuticals & Biotechnology
  • 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)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • 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)
Medical Devices
  • 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 $1.4B K2M buy as shareholders sue (MassDevice)
  • FDA approves Abbott’s HeartMate 3 as a destination therapy (MassDevice)
  • FDA Grants Breakthrough Device Status for MediBeacon's Transdermal GFR Measurement System (Press)
  • OssDsign Announces FDA 510(k) Clearance of OSSDSIGN® Cranioplug (Press)
  • Levita® Magnetics Announces FDA Clearance of Expanded Indication for Magnetic Surgical System for Use in Bariatric Procedures (Press)
US: Assorted & Government
  • Long and Strong for 10 Years: FDA Determines that 2007 Teva ANDA for Generic CIALIS Escapes 180-Day Exclusivity Forfeiture (FDA Law Blog)
  • Medical Device Maker Sued Over 'Dangerous' Walking Boot (Law360-$)
  • Extracting a Toll from Litigation Tourists (Drug & Device Law)
Upcoming Meetings & Events Europe Asia
  • 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)
General Health & Other Interesting Articles
  • 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)
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? Email us at
A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.