Regulatory Focus™ > News Articles > 6 > Recon: Merck Seen as Top Developer of Immunotherapies

Recon: Merck Seen as Top Developer of Immunotherapies

Posted 04 June 2018 | By Ana Mulero 

Recon: Merck Seen as Top Developer of Immunotherapies

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In Focus: International Pharmaceuticals & Biotechnology
  • Opinion: Boston: the best city in the world to fail in biotech (STAT)
  • Prices Keep Rising for Drugs Treating Painful Sex in Women (NYT)
  • Astrazeneca to lift lid on payments to doctors (The Times)
  • FDA Chief Expects Agency to Play Role in Overseeing Requests for Unproven Drugs (The Washington Post)
  • FDA wants to shorten new drug monopolies to cut costs (Reuters)
  • Celgene CEO: There's nothing like pipeline success to reverse sentiment (CNBC)
  • After Aravive’s CEO exits, Fierce 15 winner reveals near-death Versartis merger deal (Fierce)
  • Theranos Indirect Investors Denied Class Cert. For Fraud Suit (Law360-$)
  • Shkreli Deals Saved Retrophin Millions, Ex-Katten Atty Argues (Law360-$)
  • Cescaa Therapeutics Announces Reduction in Operating Expense (Press)
  • Allogene Therapeutics Appoints Alison Moore, Ph.D. as Chief Technical Officer (Press)
  • CytRx Corporation Launches Centurion BioPharma Corporation to Advance LADR™ Albumin Binding Ultra-High Potency Oncology Drug Candidates (Press)
  • Clovis Oncology and Immunomedics Announce Planned Clinical Collaboration to Study Combination Therapies in Metastatic Triple-Negative Breast and Urothelial Cancers (Press)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • Winners And Losers From Cancer Research's Biggest Event (Forbes)
  • Five key takeaways from ASCO, the world's largest cancer research conference (CNBC)
  • ASCO Soundbites, 2018 edition: Comments candid—and not so much—from industry executives (FIerce)
  • ASCO: Novartis makes a case for earlier Kisqali use. Will 'conservative' docs run with it? (Fierce)
  • ASCO: Adaptimmune builds case for GlaxoSmithKline-partnered T-cell therapy (Fierce)
  • ASCO18: Celgene makes its case as CAR-T rival in lymphoma (BioPharma Dive)
  • Vaxart reports PhII defeat for a legacy antiviral from Aviragen — shares slide (Endpoints)
  • From one breast cancer patient’s turnaround, clues to a new immunotherapy (STAT-$)
  • Billions of T-Cells Clear Woman's Breast Cancer in Study (Bloomberg)
  • HIV vaccine elicits antibodies in animals that neutralize dozens of HIV strains (NIH)
  • New approach to immunotherapy leads to complete response in breast cancer patient unresponsive to other treatments (NIH)
  • NCI-MATCH precision medicine clinical trial releases new findings, strengthens path forward for targeted cancer therapies (NIH)
  • Alnylam Receives Orphan Drug Designation from the United States Food & Drug Administration for ALN-TTRsc02, a Subcutaneously Delivered Investigational RNAi Therapeutic for the Treatment of Transthyretin-Mediated Amyloidosis (Press)
  • Palatin Technologies Announces FDA Acceptance for Review of Bremelanotide NDA (Press)
  • New IMCgp100-102 Data Show Durable Response and Robust Overall Survival Rate in Patients with Metastatic Uveal Melanoma (Press)
  • Synlogic Presents New Preclinical Data from Synthetic Biotic Medicine, SYNB1020, Highlighting Beneficial Activity in Animal Model of Liver Disease at Digestive Disease Week (Press)
  • Celldex Presents Promising Data from Phase 1/2 Study of Varlilumab and Opdivo at 2018 ASCO Annual Meeting (Press)
  • MiNA Therapeutics Presents Initial Results from First-in-Human MTL-CEBPA Study in Advanced Liver Cancer Patients (Press)
  • New Data from Phase 1 Study of Ivosidenib or Enasidenib in Combination with Azacitidine Demonstrate Robust Responses and a Well Tolerated Safety Profile in Newly Diagnosed IDHm AML Patients (Press)
  • Corcept Therapeutics Announces Positive Relacorilant Data at the 2018 American Society of Clinical Oncology Meeting (Press)
  • Dova Pharmaceuticals Announces Publication of Pivotal Phase 3 Data and Upcoming Congress Presentations for DOPTELET (avatrombopag) (Press)
  • Neuralstem’s NSI-566 stem cell therapy confers neurological improvement in spinal cord injury patients with complete paraplegia (Press)
  • Idera Pharmaceuticals Presents Clinical Data from the ILLUMINATE-204 Trial of the Combination of tilsotolimod and ipilimumab for Anti-PD-1 Refractory Metastatic Melanoma at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting (Press)
  • Kite Announces Initial Results From a Phase 1 Study of T Cell Receptor (TCR) Cell Therapy in HPV-16-Positive Solid Tumors (Press)
  • Eisai and Merck Announce Data at 2018 ASCO Annual Meeting from Investigational Studies of LENVIMA (lenvatinib) and KEYTRUDA (pembrolizumab) Combination Therapy in Four Different Tumor Types (Press)
Medical Devices
  • CMS considers paying for medical device that treats depression (Modern Healthcare)
  • Mount Sinai, RenalytixAI ally to use AI to spot kidney disease (Fierce)
  • CMR raises $100M to commercialize surgical robot (Fierce)
  • 3T Medical Systems buys product line from Stryker, to move production to Canton (Crain's Detroit Business)
  • Abbott is developing a dual-chamber leadless pacer (Medical Design & Outsourcing)
  • Widespread failures threaten billion-dollar medical mesh market (Verdict Medical Devices)
  • FDA In Brief: FDA alerts health care providers about 5 additional deaths associated with the use of liquid-filled intragastric balloon devices for obesity treatment (FDA)
  • Hospira Issues a Voluntary Nationwide Recall for Two Lots of Naloxone Hydrochloride Injection, USP, in the Carpuject Syringe System due to the Potential Presence of Particulate Matter (FDA)
  • Update to the Required Prior Authorization List of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies Items that Require Prior Authorization as a Condition of Payment (CMS)
  • BD, Helmer Scientific Collaborate to Introduce First Fully Integrated Refrigerated Automated Dispensing Solution (Press)
  • Insulet’s Omnipod DASH Insulin Management System Receives FDA 510(k) Clearance (Press)
  • Camber Spine Announces 510(k) Approval Of ENZA-A Titanium ALIF (Press)
  • New Study Investigates the Utility of Continuous Noninvasive Hemoglobin Measurement With Masimo SpHb for Reflecting Real-time Iatrogenic Hemodilution During Incremental Fluid Administration (Press)
  • LabCorp and Unilabs Collaborate to Expand Global Reach of Precision Medicine Capabilities to Serve Patients, Physicians and Pharma (Press)
  • Materialise Announces Partnership with HCL Technologies on Platform for Hybrid Manufacturing (Press)
  • Apollo Endosurgery Announces Presentation of Intragastric Balloon Comparison Study at Digestive Disease Week 2018 titled: “Fluid-Filled Intragastric Balloons are Superior to Gas-Filled Balloon” (Press)
  • Survey Confirms Patients Find Greater Comfort, Improved Safety and Enhanced Personal Appearance with Uni-flo2 Single-Nasal Cannula System, Significant Impact for COPD (Press)
  • Motus GI Presents Cost Analysis Data Demonstrating Pure-Vu System Has the Potential to Reduce Costs and Incidence of Colorectal Cancer at Digestive Disease Week 2018 (Press)
  • Castle Biosciences Presents Data at ASCO 2018 Supporting Accuracy and Performance of the DecisionDx-Melanoma Test in Predicting Risk of Melanoma Recurrence (Press)
  • Virpax Pharmaceuticals Licenses Liposome Drug Delivery Technology From LipoCure (Press)
  • Ichor Medical Systems Announces First in Human Administration with Its Next Generation TriGrid System of a DNA Vaccine for Chronic Hepatitis B in Development (Press)
  • OncoSec Presents Update on PISCES/KEYNOTE-695 Phase 2b Registration-Directed Clinical Trial in Combination with Merck's KEYTRUDA for Metastatic Melanoma at the ASCO 2018 Annual Meeting (Press)
US: Assorted & Government
  • Trump Plan to Lower Drug Prices Could Increase Costs for Some Patients (NYT)
  • Mylan CEO: You can't build a company in a quarter (CNN)
  • NJ Enacts Law Targeting 'Surprise' Medical Bills (Law360-$)
  • Drug prices soar in Medicare despite fewer prescriptions (Axios)
  • Vulnerable Democrats campaign on opioids, drug prices (Axios)
  • Supreme Court throws out immigrant teen abortion ruling (Reuters)
  • This New NIH Study Could Finally Pave the Way for HIV-Positive Organ Transplants (Fortune)
  • Medicare wants insurers to monitor suspicious prescribing of laughing drug Nuedexta (Fierce)
  • Athenahealth CEO Bush Faces New Allegations as Video Emerges (Bloomberg)
Upcoming Meetings & Events Europe
  • Enyo Pharma raises $47M to bring hepatitis B, NASH drug to phase 2 (Fierce)
  • Planar cell polarity signalling coordinates heart tube remodelling through tissue-scale polarisation of actomyosin activity (Nature) (Press)
  • Cogstate Announces European Approval for Healthcare Offering (Press)
  • TILT Biotherapeutics Wins a Grant from European Commission for a Phase 1 Clinical Trial (Press)
  • Clovis Oncology Submits Application to EMA to Expand Use of Rubraca (rucaparib) to Include Maintenance Treatment for Women with Recurrent Ovarian Cancer (Press)
  • Sangamo Announces U.K. Authorization Of Clinical Trials Evaluating Zinc Finger Nuclease In Vivo Genome Editing Treatments SB-318 For MPS I And SB-913 For MPS II (Press)
Asia
  • Saudi Food and Drug Authority preparing e-system to track pharmaceuticals (Arab News)
  • Shionogi inks deal with Hsiri Therapeutics (The Pharma Letter)
  • Cigna Error Revealed Customer Bank and Claims Data in Asia (Bloomberg)
  • My mother was lucky to survive giving birth to me in Papua New Guinea (The Guardian)
  • BioMarker Strategies Announces Chinese Patent for PathMAP Functional Signaling Profile Technology (Press)
  • With competition on its heels, Blueprint takes three cancer drugs to China (Endpoints) (Press)
India
  • Maha FDA launches prosecution in 87 cases, cancels 51 retail licenses & 26 mfg licenses for violation of norms (Pharmabiz)
  • DoP orders NPPA to refix ceiling price of Zydus' rosuvastatin 20mg + clopidogrel 75mg capsule and Sun Pharma's ranixime plus (Pharmabiz)
  • Health ministry to make it mandatory to set up MDR TB centres at all govt hospitals as patient numbers surge (Pharmabiz)
  • Medical device manufacturers are facing a lot of challenges (BioSpectrum)
  • Curing India's import-driven $5 bn medtech industry with niche devices (Business Standard)
  • Why India is finding it difficult to handle Nipah (Hindustan Times)
  • Can this Mumbai NGO be a game changer for women’s health in India? (Qrius)
  • India slashes heatwave death toll with series of low-cost measures (The Guardian)
Australia
  • Australia to create a connected health service through the National Health Interoperability Roadmap (OpenGov)
Canada
  • Hepatitis C screening now recommended for Canadian baby boomers (CTV News)
  • Report card on mental health care in Canada: greater improvement needed (iPolitics)
  • Demulen 30 birth control packages may contain broken pills, Health Canada warns (CBC News)
  • New questions about old Canadian study foreshadowing opioid crisis (CBC News)
  • Medical Devices Bureau Performance Quarterly Report for Q4 2017-18 (Health Canada)
  • Genome Canada launches national initiative to bring precision health to patients (Press)
  • Innovus Pharma Announces the Approval of Its Product ProstaGorx in Canada for Benign Prostatic Hyperplasia (“BPH”) (Press)
General Health & Other Interesting Articles
  • The preventable tragedy of D’ashon Morris (Dallas Morning News)
  • A new cancer care dilemma: Patients want immunotherapy even when evidence is lacking (STAT)
  • 3 Ways To Stand Up To The Health Care System And Control Costs (Forbes)
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 news@raps.org.

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