Recon: Janssen’s Darzalex Combination Trials Halted

• Genmab takes a hit after J&J sounds retreat on cancer combos, as patient deaths force researches to scrap trials (Endpoints) (GEN) (Fierce) (PMLiVE) (PharmaTimes) (Labiotech.eu)
• FDA starts speedy review of Loxo’s site-agnostic cancer drug larotrectinib (Fierce) (Reuters)
• Roche, chasing Merck, notches another lung cancer win (Reuters) (Endpoints) (pharmaphorum)
• Juries Weigh Cases Over Alleged Harms of Johnson & Johnson Baby Powder (WSJ) (Reuters)
• Arcturus’ ex-CEO triumphs, ousting board that ousted him (Endpoints) Fierce)
• Axovant poaches Allergan CMO to lead R&D recovery (Fierce) (Endpoints)
• Allergan Recalls Taytulla Birth-Control Packs After Pills Placed Out of Order (WSJ) (STAT)
• Opioid recovery teams benefit from the addition of lawyers (STAT) (Forbes)

• Former Pfizer exec joins Nouscom as CMO (The Pharma Letter-$) (Fierce)
• Australian anti-trust watchdog loses appeal against Pfizer over Lipitor sales (Reuters) (The Sydney Morning Herald) (Bloomberg)
• Brazil Approves First Generic Sovaldi (Scrip-$)
• Alibaba Sells Assets to Healthcare Unit in $1.4 Billion Deal (Bloomberg) (Reuters) (WSJ)
• Sun Pharma shares jump over 7%, market cap rises Rs 7,951 crore (Press Trust of India) (Fierce)
• Taiwan cancer drugs developer seeks Hong Kong bond issue ahead of IPO after delisting from Taipei (South China Morning Post) (DealstreetAsia)
• Rare virus kills more than a dozen in India, health officials warn it could cause global epidemic (Fox News) (HuffPost) (FirstPost)
• WHO's Congo Ebola plan assumes 100-300 cases over three months (Reuters)
• WHO adopts resolution on digital health initiated by India (Economic Times)
• Multinationals lose ground in China’s medical devices (Financial Times)
• Vaccinations set to begin in Ebola outbreak epicenter (STAT)

• Origins of an Epidemic: Purdue Pharma Knew Its Opioids Were Widely Abused (NYT)
• ‘Paying Twice’: A Push for Affordable Prices for Taxpayer-Funded Drugs (NYT)
• Sanofi CEO Seeks ‘Bolt-On’ Acquisitions to Spur Sagging Growth (Bloomberg)
• With $460B in borrowing capacity, will any of the Big-20 biopharmas go after one of the top-5 takeover targets? (Endpoints)
• Roche CEO: US, China dominate healthcare innovation, EU lags ‘far behind’ (EURACTIV.com)
• Luye Pharma buys AstraZeneca's CNS products Seroquel & Seroquel XR (Pharmabiz)
• Takeda shareholders fear dilution, debt from Shire deal pose ‘high risks,’ demand shareholders vote on it (Fierce)
• Biologics Exclusivity: Key Questions Unlikely To Have Clear Answers From US FDA (Scrip-$)
• Revance Announces Departure of Chief Financial Officer (Press)

• Clinical Trials in Alzheimer’s Disease Are Failing: What Can Be Done? (Labiotech.eu)
• Common Serious Side-Effect Of CAR T-Cell Therapy May Be Preventable (Forbes)
• Octapharma presents new data on personalized use of hemophilia A therapy (The Pharma Letter) (Press)
• US approves UCB’s Cimzia for psoriasis (PharmaTimes) (Press)
• Once quickly lethal and still humbling, multiple myeloma may be in a ‘golden age’ of treatment (STAT)
• Pfizer’s Xalkori (crizotinib) Receives FDA Breakthrough Therapy Designation in Two New Indications (Press)
• FDA Clears Development Pathway for NexoBrid for Sulfur Mustard Injuries (Press)
• CENTOGENE Announces Agreement with Aldeyra Therapeutics for the Advancement of Novel Therapeutics for Patients with Sjögren-Larsson Syndrome (Press)
• Mesoblast Partners With Cartherics to Develop ’off-the-shelf’ Cell-based Immunotherapies for Solid Cancers (Press)
• Algomedix Inc. Announces Issuance of U.S. Patent for Novel TRPA1 Modulators Designed to Treat Chronic Pain as Alternatives to Addictive Opioids (Press)
• Foundation Medicine and Collaborators to Present New Data at ASCO 2018 Supporting Comprehensive Genomic Profiling to Inform Personalized Approaches in Cancer Care (Press)
• NanOlogy to Unveil Positive Preclinical Data for Inhaled NanoPac in Treatment of Lung Cancer at 2018 ASCO Annual Meeting (Press)
• Large-Scale Study Provides First-Ever Insights into the Genetic Causes of Bedwetting (Press)
• NWBio Announces Scientific Publication of Interim Survival Data From Phase 3 Trial of DCVax®-L for Glioblastoma Brain Cancer (Press)
• KalVista Pharmaceuticals Presents Data at European Academy of Allergy and Clinical Immunology (EAACI) Congress 2018 (Press)
• Savara Provides Update on Case Reports of Inhaled Granulocyte-Macrophage Colony Stimulating Factor for the Treatment of Nontuberculous Mycobacteria Infection (Press)
• AnaptysBio Presents Updated ANB020 and ANB019 Clinical Data at the 2018 EAACI Congress (Press)
• GENETIC-AF Phase 2B Clinical Trial Results Presented in Late Breaking Presentation at European Society of Cardiology Heart Failure 2018 World Congress (Press)

• Robotic Surgery Pioneer Cuts It Close (Forbes)
• How Accurate Is Direct-To-Consumer Genetic Testing? From Gold(ish) To Garbage (Forbes)
• A Future Regulatory Paradigm with Potential Broader Implications (FDA Law Blog)
• Neural network bests dermatologists in lesion classification test (Fierce)
• Schizophrenia ‘risk genes’ are not so risky if the mother’s pregnancy was healthy (STAT)
• LuxCath eyes the atrial fibrillation market (MassDevice)
• How digital technologies will reshape musculoskeletal healthcare (MedTech Views)
• Belgian Diagnostic Device Detects Lung Cancer Mutations Where NGS Fails (Labiotech.eu)
• Weak oversight of medical devices jeopardizes patient safety (The Atlanta Journal-Constitution)
• Waiver documents posted for June 18, 2018 Circulatory System Devices Panel meeting (FDA)
• Adaptive Biotechnologies Announces a Collaboration with Sanofi to Use Adaptive’s clonoSEQ Assay to Measure Minimal Residual Disease in Active and Future Isatuximab Multiple Myeloma Trials (Press)
• CERENIS Therapeutics and University of North Texas Health Science Center Announce a Strategic Initiative to Develop New HDL-Based Pharmaceutical Products (Press)
• Lumendi Receives FDA 510(k) Clearance for DiLumen Is  Endolumenal Interventional Scissors (Press)
• TransEnterix Announces FDA Clearance for Expanded Indications for Senhance Surgical System (Press)
• European Medical Device Firm BrainCool AB Receives New 510(k) Clearance from FDA for IQool Warm System for Temperature Modulation (Press)
• Freyr’s 510 (k) Compilation Receives the USFDA Approval For an Indian Wound Care Company (Press)
• Akers Biosciences Withdraws FDA 510(k) Submission for PIFA Chlamydia Rapid Assay Pending Further Evaluation (Press)
• New Study Demonstrates Feasibility of Using RenalGuard-Guided Diuretic Therapy for Acute Heart Failure Patients (Press)
• Ra Medical Systems Announces Confidential Submission of Draft Registration Statement for Proposed Initial Public Offering (Press)

• U.S. top court rejects challenge to strict Arkansas abortion law (Reuters)
• The VA's history of setbacks and missteps (CNBC)
• Meet the six Trump administration officials who will oversee the next moves on drug pricing (STAT-$)
• FDA Commissioner Scott Gottlieb, M.D., Invites Internet Stakeholders to Opioid Summit June 27, 2018 (FDA)
• Recommendations to Reduce Surgical Fires and Related Patient Injury: FDA Safety Communication (FDA)

• FDA Advisory Committee Calendar

• AB Sciences decides against re-examination of masitinib filing (PharmaTimes)
• Health and pharma link to tackle dementia in Greater Manchester  (PharmaTimes)
• One year of new EU Medical Device Regulation: many problems remain (AG MPG)
• Acorda Announces EMA Validation of the MAA Submission for INBRIJA (levodopa inhalation powder) (Press)
• Clovis Oncology Announces European Commission Authorization of Rubraca (rucaparib) for Women with Recurrent Ovarian Cancer (Press)
• DxTerity Diagnostics Receives CE Mark for the REDI-Dx Radiation Biodosimetry Test (Press)
• EU budget: Regional Development and Cohesion Policy beyond 2020 (EC)
• Construction of new EMA building in Amsterdam on track: Foundation stone-laying ceremony takes place at Zuidas (EMA)
• Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 23–25 May 2018: New vaccine to reduce the incidence of intramammary infections in cows/heifers recommended for approval (EMA)
• Workshop: how European Reference Networks can add value to clinical research (EMA)

• China's Drugmaker Shares Are Red Hot, But So Are Valuations (Bloomberg)
• GSK submits first filing for triple COPD therapy in Japan (The Pharma Letter) (Press)
• ‘Electronic consent will transform patient experience in clinical trials’ (Korea Biomedical Review)
• Stick-on fever indicators to be available at supermarkets (Korea Biomedical Review)
• Pfizer strives to save blockbuster anti-smoking drug (Korea Biomedical Review)
• The Clinical Innovation Network: a policy for promoting development of drugs and medical devices in Japan (Elsevier)
• UK Based Halma Partners with OurCrowd to Catalyze Life Protection Technologies (Press)

• Nepal reports outbreak of highly pathogenic H5N1 bird flu (Reuters)
• IHH Healthcare in talks to expand in North India (Nikkei Asian Review)
• DCGI soon to be empowered to issue drug-specific labelling requirements for new drugs even after completion of 4 years (Pharmabiz)
• National digital drug database to be a reality soon as DTAB backs D&C Rules amendment to make submission mandatory (Pharmabiz)
• Meeting of the DTAB sub Committee: 28 May 2018 (CDSCO)

• Australia's doctors elect GP president to 'send a message' to Greg Hunt (The Guardian)
• Pregnant women 35 times more likely to die just 160km north of Australia (SBS News)
• Ensure that you have optimised your Class I medical device ARTG entries (TGA)

• Gonorrhea, other sexually transmitted infections on the rise in Canada (The Canadian Press)
• Opinion: Want health-care revenue? Make Canada a medical tourism destination (The Chronicle Herald)
• Acerus Acquires Canadian Rights to Novel Pain Relief Product for Gynecological Procedures from Pharmanest (Press)

• Fewer babies were born in Brazil amid Zika outbreak, study says (CNN)
• Tactio and BR HomMed Expand Brazil Digital Health Partnership (Press)

• The Operating Room of the Future (WSJ)
• The War on Gluten (Science Magazine)
• Scientists Discover Traces Of Opioids In Seattle Mussels (Fortune)
• The U.S. lost track of 1,475 immigrant children last year. Here’s why people are outraged (The Washington Post) (CNN) (The Hill) (Newsweek) (Quartz) (Axios)
• Are Social Determinants The Missing Key To Improving Health? (Forbes)