Recon: Merck Seen as Top Developer of Immunotherapies

• Merck cements its position as dominant developer of immunotherapy (Financial Times) (Forbes) (Endpoints) (Reuters) (Fierce) (The Pharma Letter-$)
• Roche dumps its PhIII PI3K effort on taselisib after researchers track poor survival edge, harsh side effects for breast cancer (Endpoints) (Fierce)
• Roche drugs show limited benefit in lung, breast cancer trials (Reuters) (BioPharma Dive)
• A controversial ASCO presentation underscores risk Bristol, Nektar carry with experimental cancer drug (STAT) (Reuters) (Fierce) (Endpoints) (Forbes)
• #ASCO18: Grail’s first data shows 38%-51% detection of early-stage lung cancer (Fierce) (STAT)
• FDA labels Medtronic Heartware recall as Class I (MassDevice) (Medscape) (Star Tribune)
• HHS finalizes 340B ceiling-price rule delay (Modern Healthcare) (Fierce) (FDA Law Blog)
• Thousands of women with breast cancer may not need chemo, study says (USA Today) (Chicago Tribune) (NYT) (Forbes) (NPR) (Reuters) (NIH)
• When it's appropriate to use the C-word: A conversation with the director of the National Cancer Institute (CNBC)
• New Immunotherapy Treatment Removes All Tumors In Woman With Advanced Metastatic Breast Cancer (Forbes) (STAT-$)

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• First Major Trial Of Keytruda For Prostate Cancer Shows It Works, But Only For A Minority Of Men (Forbes) (The Institute of Cancer Research) (The Independent) (The Guardian) (BBC News)
• Roche’s Perjeta combo approved in Europe for early breast cancer (pharmaphorum) (Reuters)
• Teladoc expands globally with $352M acquisition of Advance Medical (Fierce) (Forbes) (MedCity News) (MobiHealthNews)
• Nipah Virus, Dangerous and Little Known, Spreads in India (NYT) (Khaleej Times) (Times of India)
• Govt may bring in new curbs on drug prices this month (Times of India) (Pharmabiz)
• India to make a case with the US for speedy renewal of tariff preference scheme (Business Line)
• Epidemiological situation of the Ebola Virus Disease dated 02 June 2018 (Democratic Republic of the Congo Ministry of Public Health)

• 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)

• 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)

• 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)

• 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)

• FDA Advisory Committee Calendar

• 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)

• 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)

• 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 to create a connected health service through the National Health Interoperability Roadmap (OpenGov)

• 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)

• 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)