Regulatory Focus™ > News Articles > 5 > Recon: Janssen’s Darzalex Combination Trials Halted

Recon: Janssen’s Darzalex Combination Trials Halted

Posted 29 May 2018 | By Ana Mulero 

Recon: Janssen’s Darzalex Combination Trials Halted

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US
  • 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)
In Focus: International Pharmaceuticals & Biotechnology
  • 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)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • 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)
Medical Devices
  • 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)
US: Assorted & Government
  • 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)
Upcoming Meetings & Events Europe
  • 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)
Asia
  • 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)
India
  • 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
  • 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)
Canada
  • 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)
Brazil
  • Fewer babies were born in Brazil amid Zika outbreak, study says (CNN)
  • Tactio and BR HomMed Expand Brazil Digital Health Partnership (Press)
General Health & Other Interesting Articles  
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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