Regulatory Focus™ > News Articles > 7 > Recon: Merck Leapfrogs Bristol-Myers to Take the Lead on PD-1/L1 market

Recon: Merck Leapfrogs Bristol-Myers to Take the Lead on PD-1/L1 market

Posted 27 July 2018 | By Ana Mulero 

Recon: Merck Leapfrogs Bristol-Myers to Take the Lead on PD-1/L1 market

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US In Focus: International Pharmaceuticals & Biotechnology
  • Several of the Biggest Pharma Giants Are Freezing Drug Prices. Here's How It Will Affect You (TIME)
  • CRISPR Chaos: 3 Shorts And A Buy In Gene Editing (Forbes)
  • Right To Try For Some Raises False Hopes For Many (Forbes)
  • Apotex acquisition likely to reduce Aurobindo's dependence on US market (Business Standard)
  • Judge's order keeps opioid pill numbers under wraps (Charleston Gazette)
  • When modest is actually excessive: AstraZeneca spins its price hikes (STAT-$)
  • FDA Chief Wants to Break Down Rare Disease Drug Monopolies (Bloomberg-$)
  • McKesson Sales Growth at Risk as Drugmakers Curb Price Increases (Bloomberg-$)
  • Horizon Pharma Vimovo Suit Won’t Wait for Patent Board (Bloomberg-$)
  • Pharma AI Requires a New Approach to Governance (PharmExec)
  • GlaxoSmithKline's Shingrix beats expectations again in Q2 despite supply constraint (Fierce)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • Alzheimer's research yields some promising results (Axios)
  • Here’s why Biogen lost $7 billion overnight despite ‘positive’ Alzheimer’s data (STAT-$)
  • Alzheimer’s Study Lacks `Shock and Awe’ Biogen Investors Sought (Bloomberg-$)
  • Tonix crashes on PhIII PTSD failure, sending stock to the gutter (Endpoints)
  • Sunovion drug cuts binge eating days at higher dose (BioPharma Dive)
  • Tonix Pharmaceuticals Announces Outcome of Interim Analysis for Phase 3 HONOR Study of Tonmya in Military-Related PTSD (Press)
Medical Devices
  • Bayer's Removal Of Contraceptive Device Essure Praised By Activists (Forbes)
  • Warning Claims Axed In Bard Blood Vessel Filter Bellwether (Law360-$)
  • Artificial hip maker demands retraction of a paper calling its research ‘grave fraudulence’ (STAT)
  • Flexible electronics are the key to a human ‘check engine’ light (STAT)
  • MilliporeSigma, InnoCore team up on extended-release platform for large biologics (Fierce)
  • Pharmacokinetic study of Proteus' ingestible sensor paves way for clinical trials of HIV prevention drug (MobiHealthNews)
  • FDA Regulation of Mobile Medical Apps (JAMA)
  • Improving Access To Medical Devices: The Use And Evolution Of Objective Performance Criteria (Health Affairs)
  • NuVasive Unveils Spine's First Integrated Surgical Automation Platform (Press)
  • Adherium Receives Additional U.S. FDA 510(k) Clearance, Setting in Motion a Full U.S. Consumer Launch of the Hailie Solution (Press)
  • Mighty Oak Medical Receives FDA 510K Clearance for S2AI (Press)
  • New Study Investigates Impact of General Ward Clinical Monitoring Using Masimo Root, Radius-7, and Patient SafetyNet on Clinical Workflow and Patient Care (Press)
  • BD Drives the Future of Immunology Research with Expanded Offerings for Simultaneous RNA and Protein Expression Analysis (Press)
US: Assorted & Government
  • Switch to electronic health records tied to fewer hospital deaths (Reuters)
  • FDA’s Exploration of Innovation vs. Access Continues with Public Hearing on the Biosimilar Marketplace (FDA Law Blog)
  • States sue Trump administration over expansion of skimpy group insurance plans (The Hill)
  • Why Medicare is going after hospital outpatient rates (Axios)
  • Proposed site-neutral payment policy sets the stage for battle royale between CMS, hospitals (Modern Healthcare)
  • Doctors Hold the Key to Lower Drug Prices (Bloomberg)
  • NIH Nixes Ethics Review of Human Research Grant Proposals (Bloomberg-$)
  • Dozens of patient and provider groups ask state insurance officials to probe a cost-shifting tool (STAT-$)
  • Ciitizen raises $3M for personal health records, soon to open private beta (MobiHealthNews)
  • Mammography Facility Adverse Event and Action Report – July 26, 2018: Palm Beach Broward Medical Imaging Center (FDA)
Upcoming Meetings & Events Europe
  • Protecting innovation in pharma is in Ireland’s interests (Irish Times)
  • Congenica aims to turn data into information (EP Vantage)
  • Nanobiotix signs €40m deal with the EIB (PMLiVE)
  • Bristol-Myers Drops After Cancer Drug Combo Rejected in Europe (Bloomberg-$)
  • NHS test drones for blood and medical test delivery between London hospitals (Healthcare IT News)
  • PharmaMar Reaches an Agreement With Impilo Pharma, a Part of Immedica Group, for the Promotion and Distribution of Yondelis in the Nordic Countries and Eastern Europe (Press)
  • Philips and Oxford University Hospitals NHS Foundation Trust team up to deploy innovative digital pathology network (Press)
Asia
  • In for the China biotech gold rush, BeiGene eyes monster $800M-plus Hong Kong IPO (Endpoints)
  • Pfizer gets additional indication for kidney cancer drug Sutent (Korea Biomedical Review)
  • China FDA Adds to List of Medical Devices, IVDs Exempt from Clinical Trials (Emergo Group)
  • Final Guidance on Saudi Arabia’s Medical Device National Registry (MDNR) Route Published (Emergo Group)
  • China's New Medical Device Regulations Bring Big Changes (Lexology-$)
  • Solasia wins Chinese approval for transdermal anti-emetic patch (The Pharma Letter-$)
  • AstraZeneca CEO champions China’s Internet of Things tech (pharmaphorum)
India
  • KAPL to be sole manufacturer & supplier of Oxytocin injection for domestic use from Sept 1 (Pharmabiz)
  • Companies drag J&K and central government to court over rolling back tax sops (Economic Times)
  • TPG Capital to buy into Sai Life Sciences (Economic Times)
Australia
  • Australian regulatory guidelines for biologicals (ARGB) (TGA)
  • General dossier requirements (TGA)
  • Syphilis: How deadly disease has spread in Australia (BBC News)
  • Aussie biotech firm wins 'fast track' US review for rare cancer drug (The Sydney Morning Herald)
  • GPs and social service providers demand My Health Record protections (The Guardian)
  • Access to My Health records too easy, police say (The Australian)
Canada
  • Codeine tops list of pharmaceutical drugs reported missing in Manitoba (CBC News)
General Health & Other Interesting Articles
  • The Real Future Of Artificial Intelligence And Cancer (Forbes)
  • Effect of a Lay Health Worker Intervention on Goals-of-Care Documentation and on Health Care Use, Costs, and Satisfaction Among Patients With Cancer (JAMA)
  • Hospitals know how to protect mothers. They just aren’t doing it.  (USA Today)
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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A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.
 

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