Johnson & Johnson's D.C. incubator opens for business with diversity at its core AstraZeneca and Sanofi's antibody prevents RSV in phase 3, accelerating path to market FDA lifts clinical hold on uniQure's gene therapy amid cancer concerns; shares jump Sponsored: Look before you leap: How a joined-up development strategy pays off for early-stage biotechs Vertex picks a horse in race for opioid painkiller replacement I-Mab's IL-6 drug hits goal in ulcerative colitis phase 2 FDA says Voyager can trek on as it removes trial hold for Huntington's gene therapy test Medtronic taps virtual reality 'flight simulators' for brain surgery, built from 3D patient scans ADC Therapeutics scores FDA approval for anti-CD19 blood cancer med Zynlonta Featured Story | By Amirah Al Idrus The pandemic wasn’t going to slow JLABS down. Two years after announcing a new location, Johnson & Johnson’s incubator arm opened its doors in the nation’s capital on Monday, right on time. read more |
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Top Stories By Nick Paul Taylor AstraZeneca and Sanofi’s nirsevimab has protected healthy babies against respiratory syncytial virus disease in a phase 3 clinical trial. The earlier-than-expected readout will enable a 2022 filing for a monoclonal antibody Sanofi CEO Paul Hudson has hailed as a “massive opportunity.” read more By Ben Adams After four months of hand-wringing and a deep investigation into how a patient was diagnosed with cancer after getting uniQure’s hemophilia gene therapy, the FDA is allowing the trial to continue. read more Sponsored By: Parexel Biotech A well-thought-out strategic development plan that brings together nonclinical, clinical, regulatory and commercial experts can improve efficiencies, cut costs, shorten timelines, and increase the chances of success for a new drug program. read more By Annalee Armstrong Boston-based Vertex says its NaV1.8 inhibitor VX-548 will advance to a phase 2 clinical trial after a successful phase 1 safety trial. read more By Nick Paul Taylor A phase 2 trial of I-Mab’s olamkicept in ulcerative colitis patients has met its primary endpoint. The study provides early evidence that the IL-6 inhibitor improves outcomes including rectal bleeding. read more By Ben Adams The FDA is in a forgiving mood: After clearing uniQure’s gene therapy to restart trials today, it’s handing the same reprieve to Voyager Therapeutics. read more By Conor Hale Using virtual reality tech described as a fighter-jet flight simulator for the human body, Medtronic hopes to put brain surgeons in the pilot’s seat—giving them patient-specific maps of blood vessels and tissue to explore as they prep for the real thing. read more By Eric Sagonowsky Multiple new CAR-T medicines against diffuse large B-cell lymphoma have hit the market in recent years, improving prospects for patients and extending the array of available options for doctors. Now, with an FDA approval Friday afternoon, ADC Therapeutics is getting ready to launch the first single-agent CD19-targeted antibody-drug conjugate therapy against the disease. read more Resources Sponsored By: AmerisourceBergen Developing a quality product and getting it approved for distribution is not enough to guarantee commercial success. Sponsored By: WCG Trifecta The new standards in study training help sponsors and CROs reduce costs by 60%, cut training time by 50%, and start enrollment 55 days faster – learn more today. Sponsored By: Oracle Health Sciences New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19. Sponsored by: Cytiva A one-stop hub for Cytiva resources to support process intesification Sponsored By: August Bioservices How has COVID-19 impacted CRO/CDMO customer (dis)satisfaction and outsourcing decisions for pharma and biotech companies in 2021 and beyond? Sponsored by: Cytiva A one-stop hub for Cytiva resources to support process development and manufacturing of your novel molecule Sponsored by: PerkinElmer Informatics Discover the benefits of a cloud-native ELN that delivers better performance, security, connectivity, total cost of ownership PLUS sub-second search results through even the largest data volumes. Sponsored by: PulsePoint Access this guide for the latest insights into how marketers can use data, technology, and personalized messaging to build vaccine confidence and drive successful immunization efforts. Sponsored By: Within3 We enable virtual work — offering over-time sessions where participants are more focused, insights are more diverse and business goals are met. Sponsored by: TAC Roche has inked a $1.8 billion, all-cash deal for GenMark Diagnostics, to acquire its molecular tests designed to screen patient samples for multiple infections simultaneously. Sponsored By: Remarque Systems Remarque Systems consolidates data, then layers on visualization and automated metrics to generate consistent, actionable data insights in real-time. Click here for more info. Sponsored By: Culture Biosciences Find out how upstream bioprocess scientists can use Culture Biosciences’ bioreactor system and real-time data visualizations to get faster insights and get their product to market more quickly. Sponsored By: BC Platforms Those wishing to unlock RWD’s true value must have access to a variety of data sources/types and the technological capabilities to use the data to uncover meaningful insights. Sponsored By: Oracle Health Sciences New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19. Sponsored by: Catalent Autologous cell therapies have seen propelled growth since 2017, with the spotlight on the first FDA approval of a chimeric antigen receptor (CAR) T cell immunotherapy, Kymriah® (tisagenlecleucel), for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia. Sponsored by: Catalent Learn about drug product process development challenges and risks, the difference between innovator and biosimilar drug product process development, and more during the drug product process development phase. Sponsored by: Catalent Get insights on key considerations for a successful tech transfer process for manufacturing a biologic drug product, including a case study on overcoming challenges in a process transfer for a sterile diluent. Sponsored by: Catalent In a BioPharma Dive industry survey, planning and forecasting were identified as top concerns for trial sponsors. In response to this need, the CSM team at Catalent has developed a methodology for identifying, evaluating, and proactively managing the inherent risks involved in clinical trial supply chain management. Sponsored by: Catalent Learn how to drive excellence within the forecasting process and utilize forecasting throughout the clinical study to better plan clinical supply budgets and project timelines. Explore how to identify potential supply-related issues before they can negatively impact your study. Drug Development Boot Camp® 2021 Onsite and VIRTUAL in real time November 17-18, 2021 | Register now! Pre-Boot Camp preparation is now available. Medical Affairs Strategic Summit (MASS) Virtual May 5-7, 2021 | Virtual Event TMF Virtual Summit May 18-20, 2021 | Virtual Event Vaccines, cell and gene therapy, therapeutic antibodies and RNA drugs May 20-21, 2021 | 12 p.m. EST / 9 a.m. PST Vaccines, cell and gene therapy, antibodies, and RNA-based drugs June 10-11, 2021 | 9 a.m. EST / 6 a.m. PST Biopharma Supply Chain June 29-30, 2021 | Virtual Event | 