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

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• FDA Advisory Committee Calendar

• 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)

• 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)

• Update - Notice: Introduction of the Regulatory Enrolment Process (REP) and the Use of the Common Electronic Submission Gateway (CESG) for Medical Devices (Health Canada)