| T cell therapies may be a breakthrough, but dangerous side effects—like the cascading immune symptoms of a cytokine storm—demand caution. Case in point: the FDA recently held up Unum Therapeutics’ trial after a patient showed severe side effects. But what if you could pause the therapy? German researchers temporarily halted a CAR-T therapy’s effect in mice using Bristol-Myers’ chemo drug Sprycel, creating an “on-off” switch to fend off potentially fatal cytokine reactions. After they lifted the Sprycel brake, the CAR-T cells went back to their cancer-fighting work. Those stories are below, plus our most-read and widely shared articles of the month so far. | |
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Featured Story | | | Wednesday, July 3, 2019 Only about one-third of the top 30 U.S. insurance companies have decided how to cover Novartis’ new $2.1 million gene therapy, Zolgensma, but analysts at one influential Wall Street firm are already worried. One reason? Their payer survey showed insurers are "very unhappy" with Zolgensma's record-setting price. |
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| This week's sponsor is ExL Events. | |  | |
Top Stories Of The Week Wednesday, July 10, 2019 Michael Becker, the former biotech CEO who spent his life working on new drugs and then turned to raising awareness of the cancer that would eventually kill him, has died of head and neck cancer that had spread to his lungs. Wednesday, July 3, 2019 Cytokine release syndrome (CRS), the most common acute side effect associated with CAR-T cancer therapies, can be difficult to combat. A team of researchers in Germany has now found a possible solution in Bristol-Myers Squibb’s leukemia drug Sprycel. Tuesday, July 9, 2019 Bayer’s for-sale animal health unit has been stirring up interest among private equity players—but the German pharma may have another buyer in mind. Monday, July 1, 2019 Versant Ventures’ Century Therapeutics has exited stealth with $250 million to take allogeneic cell therapies into the clinic. Bayer’s VC wing led the investment with the support of Versant and Fujifilm Cellular Dynamics. Wednesday, July 3, 2019 The FDA has put Unum Therapeutics’ phase 1 ACTR087-Rituxan trial on clinical hold for the second time. Unum suffered the setback after a patient experienced grade 3 and 4 adverse events including neurotoxicity and respiratory distress. Wednesday, July 10, 2019 It’s been a troubled few years for Canadian generics maker Apotex after the unsolved murder of founder Barry Sherman and a possible sale in the works. Now, after multiple warnings from the FDA, Apotex faces a future without a big slice of its portfolio. Tuesday, July 9, 2019 BioNTech has raised $325 million (€289 million) in a private fundraising round. The series B positions the immuno-oncology player to advance its multidrug clinical pipeline and grow its manufacturing footprint. Monday, July 8, 2019 Key to Pfizer's paying $11 billion for Array BioPharma were the positive early readouts from its triplet therapy for colorectal cancer. Now, the biotech has shown exactly how attractive that data are. But not all analysts agree it's good enough. Wednesday, July 10, 2019 23andMe’s chief scientific officer and former therapeutics foreman Richard Scheller has left the sequencing company and landed on the boards of at least two biotechs—namely, two of the biggest money raisers of the year so far. Monday, July 8, 2019 There are only three manufacturing sites in the world approved by the FDA to make nicotine gum and Teva has sold one, along with its U.S. portfolio of OTC products, to a company that is all about store brands. Monday, July 8, 2019 Arming the immune system so it can recognize and attack solid tumors has proven to be an illusive goal. Scientists at Columbia University hope to change that with an engineered form of the bacterium E. coli that's designed to colonize solid tumors. In mouse models, the treatment cleared primary tumors and reduced metastasis. | This week's sponsor is Medrio. | |  | [Webinar] Accelerating Site and Patient Enrollment for Phase 1 Trials
Tuesday, July 23 | 2pm ET / 11am PT
This Fierce webinar will feature clinical trial site leaders and R&D executives, who will pass along the latest strategies for boosting site and patient enrollment in phase 1 trials. They will discuss best practices for communicating with both investigators and patients. Register Now! |
Resources Sponsored by: Almac Group Innovative Just in Time Manufacturing solution enables sponsors full late stage customisation of clinical trial materials Sponsored by: PwC How are employer activism strategies beginning to replace the cost-sharing of the past, and improve the health of the workforce? Sponsored by: United Cargo and SAVSU Technologies The combination of SAVSU technology with United Airlines’ global network has made it easier than ever to bring cell and gene therapies to destinations beyond major markets. Sponsored by: XiltriX North America Find out in this article how your pharmaceutical organization can leverage IoT technologies and informatics integration to innovate and improve overall operational efficiencies. Sponsored by: Patheon, by Thermo Fisher Scientific When a biologics company prepares to launch a new product, it must forecast the manufacturing capacity it will need. Learn more here. Sponsored by: Veradigm Patient demand for more information on their care is driving new e-prescribing regulations, and technology is evolving to help providers meet them. This report provides an overview of key areas where such regulation has emerged, and what it could mean for providers and healthcare IT companies. Sponsored by: Patheon, by Thermo Fisher Scientific Anticipate challenges in formulation early. Sponsored by: Veradigm Patients living with diabetes deserve better – Real-World Evidence for effecting/realizing change in the management of type 2 diabetes and cardiovascular/renal comorbidities. Sponsored by: Catalent Download the case study to learn about the clinical supply management tools that helped a small sized pharma company during phase III of a multi-arm oncology study. Sponsored by: Catalent Watch a short video on demand led supply model. It is designed to meet the needs of patients, clinical sites, clinical team and sponsors and results in shorter lead time, less waste, less stock out risk and no booklet labels. Sponsored by: Catalent Download the eBook to explore a proactive approach for clinical supply management. |
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