Regulatory Focus™ > News Articles > 2019 > 6 > Recon: Merck to Acquire Tilos for $773; Roche Gets Accelerated Approval for Lymphoma Drug Polivy

Recon: Merck to Acquire Tilos for $773; Roche Gets Accelerated Approval for Lymphoma Drug Polivy

Posted 10 June 2019 | By Michael Mezher 

Recon: Merck to Acquire Tilos for $773; Roche Gets Accelerated Approval for Lymphoma Drug Polivy

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Merck to buy Tilos Therapeutics for up to $773 million (Reuters) (STAT) (Endpoints) (Press)
  •  Merck’s Baby Biotech Splurge Won’t Fix Its Reliance on Keytruda (Bloomberg)
  • In a boost to Rituxan franchise, Roche nabs quick approval for Polivy (Endpoints) (Press) (FDA)
  • Co-owner, ex-employee of pharmacy in U.S. meningitis outbreak acquitted (Reuters) (Law360-$)
  • Opioid maker Insys files for Chapter 11 bankruptcy (Financial Times) (STAT)
  • Sarepta CEO says he welcomes Vertex’s effort to develop muscular dystrophy drugs (Boston Globe)
  • Roche’s $5bn Spark acquisition delayed amid regulatory scrutiny (Financial Times) (Endpoints) (Press)
  • PTC scores new Emflaza approval in DMD patients 2 and older (Fierce) (Press)
  • Experimental drug delays type 1 diabetes onset in mid-stage trial (Reuters)
  • Lilly's Trulicity CV outcomes data underwhelm amid blockbuster diabetes rivalry with Novo (Endpoints) (Fierce) (BioPharmaDive) (Press)
  • Lilly plans phase 2b NASH trial of dual GIP, GLP-1 agonist (Fierce)
  • Supplements for Weight Loss, Sexual Function and Muscle Building May Be Deadly (NYTimes)
  • US measles outbreak spreads to Idaho and Virginia, hits 1,022 cases (Reuters)
In Focus: International
  • AZ says Farxiga cuts kidney disease in type 2 diabetes (PMLive) (Fierce)
  • NHS data is worth billions – but who should have access to it? (The Guardian)
  • New psoriasis drug study yields positive results: Dr Reddy's (Economic Times) (Press)
  • AI study in London offers hope for MS treatment (Financial Times)
  • Implementing “the safest medicines system in the world” (Pharmafile)
  • Swedish biotech Calliditas signs China licensing deal for autoimmune candidate (PMLive)
  • China to tighten rules on foreigners using genetic material (Reuters)
  • Ebola outbreak may last up to 2 years, WHO says (The Hill)
Pharmaceuticals & Biotechnology
  • FDA sends NovaVax back to the clinic; Stoke Therapeutics sets terms for upsized $101M IPO (Endpoints)
  • The gene therapy era has arrived. So have the challenges. (BioPharmaDive)
  • The top 20 highest-paid biopharma CEOs of 2018 (Fierce)
  • Understanding how microbiome bugs metabolize drugs (Nature)
  • KRAS’s undruggability cracks? (Nature)
  • Janssen inks nference AI research pact (Fierce)
  • Chickenpox Vaccine May Protect Against Shingles Years Later (NYTimes)
  • How early biomarkers and constant iteration fuel Vertex's R&D efficiency (BioCentury)
  • Evolution Or Extinction: Where Will The Gene Editing Revolution Take Us (Forbes)
  • Amid BMS R&D shuffle, F-star nabs its immuno-oncology executive (Fierce)
  • The $2.1 Million Question: What Are The Medical, Ethical Implications Of The World's Priciest Drug? (Forbes)
  • Keeping Track: First RMAT Approval On The Horizon; Big Weeks For Merck, Lilly And Celgene (Pink Sheet-$)
  • Sanofi's Soliqua proves superior to GLP-1 RA therapies in reducing blood sugar levels (Pharmafile) (Fierce)
  • ADA: NGM backs up case for once-monthly dosing of Merck-partnered NASH drug (Fierce)
  • Sticking to hottest trends in biopharma, Oncologie gathers $80M for next leg of trans-Pacific clinical journey (Endpoints)
  • Artizan completes microbiome starter package with Brii deal, CSO hire and some money to dash for the clinic (Endpoints)
  • 'We kept at it': Jeffrey Bluestone plots late-stage comeback after teplizumab shown to delay type 1 diabetes (Endpoints)
  • Tergus Pharma to become full-fledged CDMO with new manufacturing facility (Fierce)
  • Vectura CEO to step down at end of June (Pharmafile)
  • FDA Closeout Letter - Sovereign Pharmaceuticals, LLC (FDA)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • Aptinyx's lead drug makes cut in small fibromyalgia trial, setting the stage for larger chronic pain study (Endpoints)
  • Aerpio Initiates Phase 1b Clinical Trial of Topical Ocular Formulation of AKB-9778 for Primary Open Angle Glaucoma (Press)
Medical Devices
  • Abbott device helps in cutting blood sugar in type 2 diabetics: study (Reuters)
  • Medtronic, Tidepool ink deal for interoperable, automated insulin pump (MassDevice) (Press)
  • Roche launches first in vitro lung cancer diagnostic test (PharmaTimes)
  • Will Medtech Be on High Alert after Quest and LabCorp Patient Data Exposure? (MDDI)
  • Masimo wins FDA clearance for neonatal O3 regional oximetry indication (MassDevice)
  • FDA Gives First-Ever Indication for Device to Be Used for Patients With Functional Abdominal Pain Associated With Irritable Bowel Syndrome (IBS) (Press)
  • Dance Biopharm Presents Encouraging Data from Phase 2 Clinical Trial of Dance 501 Inhaled Insulin Therapy at American Diabetes Association Meeting (Press)
  • Medtronic Initiates Pivotal Trial for Next-Generation Guardian(TM) Continuous Glucose Monitoring Sensor (Press)
  • GMED Reinstates CE Mark for Endologix Nellix System (MDDI)
  • Acucela Receives Orphan Designation From the EMA for Emixustat for the Treatment of Stargardt Disease (Press)
  • Medtronic Initiates Pivotal Trial for Bluetooth Enabled MiniMed(TM) 780G Advanced Hybrid Closed Loop System Designed to Automate Correction Bolusing (Press)
  • Medtronic Announces Its Forthcoming Robotic Assisted Surgical Platform to Feature Three-Dimensional Vision System from KARL STORZ (Press)
US: Assorted & Government
  • California set to expand Medicaid to some undocumented adults (Politico)
  • Issues To Watch In Fed. Circ. Hep C Drug Patent Case (Law360-$)
  • Drug Cos. Hit Back In High Court 'Blocking Patent' Fight (Law360-$)
  • States Call For Unredacting Of Their Generic-Drug Pricing Suit (Law360-$)
  • UnitedHealthcare Coverage Policy Undercutting Neulasta Biosimilars Draws Concerns (Pink Sheet-$)
  • International Trade Commission, Meet Buckman (Drug & Device Law)
Upcoming Meetings & Events Europe
  • UK Govt Must Prioritize Services And Staff In Post-Brexit Trade Deals, Says ABPI (Pink Sheet-$)
  • Early access to medicines scheme (EAMS) scientific opinion: Atezolizumab in the first line treatment of adult patients with extensive-stage small cell lung cancer, in combination with carboplatin and etoposide (MHRA)
India
  • World needs generic drugs but their quality must be guaranteed: Journalist Katherine Eban (Economic Times)
  • Telangana govt allocates 250 acres of land for Medical Device Park at Sultanpur (PharmaBiz)
  • CDSCO needs to take on onus to approve, permit drug brand names in India: Dr BR Jagashetty (PharmaBiz)
Canada
  • Update - Notice: Introduction of the Regulatory Enrolment Process (REP) and the Use of the Common Electronic Submission Gateway (CESG) for Medical Devices (Health Canada)
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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