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Thursday, April 6, 2023 | 11am ET / 8am PT In this webinar, we show how we used Nunchuck to make LNPs in small-volume screening runs and bulk formulations. The complete workflow will be illustrated, from the testing of flow rates in initial formulations to the final assessment of mRNA expression in multiple cell types, showing successful transfection of cells by the LNPs. Register now.
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Today's Big NewsMar 27, 2023 |
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April 3 - 4, 2023 | San Diego, CA Be a part of a learning experience developed by our esteemed Advisory Board who are leaders in the life science communications space. Time is running out! Register Today
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| By Nick Paul Taylor The FDA is planning to shake up its approach to the accelerated approval of oncology drugs—and wants to know what you think of its proposals. In draft guidance, the agency outlined plans to move away from single-arm studies and instead favor randomized controlled trials that can potentially serve as the basis for both accelerated and full approval. |
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By Max Bayer Historically known for developing a handful of cystic fibrosis treatments, Vertex is now going deeper into diabetes and its work with CRISPR Therapeutics in a new $330 million deal. |
By Max Bayer The latest R&D budget rankings looks a lot like the 2021 list, but Sanofi cracked the list this year and shifts in positions occurred, like Merck reaching the podium after jumping Pfizer for third place. |
By James Waldron Only two weeks after crashing Redx Pharma’s planned reverse merger into Jounce Therapeutics, Concentra Biosciences’ unsubtle tactics appear to have paid off as it walks home with Jounce. |
By James Waldron More than a year after Gamida Cell slimmed down its workforce, the biotech has again resorted to laying off staff to keep the long-delayed plans for its blood cancer treatment omidubicel on the road. |
By James Waldron Another biotech bites the dust. This time it’s Codiak Biosciences, whose attempts to deliver exosome-based therapeutics have reached the end of the road. |
By Max Bayer Vaxxinity is on the hunt for a partner to press ahead with late-stage work of its Alzheimer's treatment vaccine. The acknowledgment comes as the company is looking to nab approval for its COVID booster shot. |
By Gabrielle Masson A year and a half after Agenus withdrew its accelerated approval request for cervical cancer drug balstilimab, the biotech has provided new combo data in ovarian cancer. |
By Nick Paul Taylor AstraZeneca and Ionis Pharmaceuticals have breezed past another marker on the route to approval of eplontersen, revealing that the challenger to Alnylam’s Amvuttra and Onpattro improved outcomes in a rare disease out to 66 weeks. |
By Max Bayer Bayer has elected to move away from early R&D work focused on women's health. The pharmaceutical company behind the birth control brand Yasmin says it will continue to work on clinical-stage assets in the field. |
By Annalee Armstrong A Parkinson’s disease treatment from Neuraly, a biotech spun out from the Johns Hopkins School of Medicine, did not improve motor experiences of daily living or movement in a midstage trial, but the investigators did flag a better result for younger patients. |
By Annalee Armstrong BrainStorm Cell Therapeutics has been determined to get a twice-rejected amyotrophic lateral sclerosis treatment through the FDA process. And now, the dogged New York biotech will get another chance. The FDA agreed to hold an advisory committee meeting after the company used an unusual regulatory Hail Mary. |
By Helen Floersh Though the work is only in the proof-of-concept stage, the “mini organs” could help develop patient-specific therapies for treating thymic dysfunction. |
By Andrea Park Seemingly undeterred by reports earlier this month that the FDA had rejected an early 2022 request from Neuralink to begin a clinical trial of its brain implant, Elon Musk's brain-computer interface company is reportedly plowing ahead with plans for human testing. |
By Paige Minemyer The NCAA basketball tournament is officially underway, and that means the Fierce Healthcare team is back with another bracket competition as well. |
By Angus Liu Novartis' highly anticipated NATALEE trial reported a positive readout, showing Kisqali could pare back disease recurrence in an early breast cancer population that's broader than Eli Lilly's Verzenio. |
By Heather Landi,Paige Minemyer,Dave Muoio Fierce Healthcare's editorial team brings you the latest news and trends from the ViVE 2023 conference in Nashville. |
By Conor Hale The FDA has laid down a path for the developers of COVID-19 tests and other pandemic-focused medical devices to finally make the transition to the foreseeable regulatory future, where the coronavirus will be treated as more endemic than emergency—and the agency is urging companies to get their paperwork in ASAP. |
Fierce podcastsDon't miss an episode |
| This week on "The Top Line," we discuss Fierce Medtech’s annual Fierce 15 report and startups that made the cut. We also cover Illumina and Carl Icahn's proxy battle and more of this week's top headlines. |
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May 1 - 3, 2023 | Jersey City, NJ Connect with senior executives in Medical Affairs, MSL and IIT to share best practices. Register Today & save $200 from now until April 7th!
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| Whitepaper Preparation of critical process liquids and buffer components shifts resources away from core activities and can be filled with inefficiencies and risks that can increase time and costs across your workflow. Learn about the framework to help reduce your total costs beyond capital and operational expenditures and set a solid foundation for successful scale-up of buffer preparation. Sponsored by: Thermo Scientific Production Chemicals and Services |
| WhitepaperThis paper describes the key elements of good US/EU corporate governance for US-based biopharma companies in operating Europe. Sponsored by: Blue Matter, strategic consultants in the life sciences |
| Executive SummaryRead about the latest survey results from over 200 biopharma executives and the changing approaches to building biologic drug development pipelines. Sponsored by: Twist Bioscience |
| WhitepaperHave you had your questions about mRNA/saRNA manufacturing unanswered during a webinar; have no fear, we have you covered here. Sponsored by: Aldevron |
| Whitepaper Download Herspiegel Consulting’s Go-To-Market Model, based on 100+ launches, to learn the critical components, and timelines for commercial success. Sponsored by: Herspiegel Consulting |
| WhitepaperWhat are key considerations for intranasal delivery in the treatment of acute and chronic conditions? Sponsored By: Catalent |
| Research Learn more on Catalent’s step-wise approach for the definition and execution of Process Characterization for the production of a monoclonal antibody for late phase process characterization and development. Sponsored by: Catalent |
| WhitepaperExplore how clinical supply can be scaled up as decentralized programs progress, and how technological solutions can accelerate trial deployment. Sponsored by: Catalent Clinical Supply |
| Whitepaper As sponsors increasingly look to CROs to support their clinical studies, making and addressing certain clinical supply considerations at the outset of the relationship can reduce the risk of potentially unforeseen impact to budget and time later. Discover key issues sponsors should consider to help their CRO or partner of choice better understand their clinical supply needs. Sponsored by: Catalent |
| WhitepaperFor sponsors, cost is a key concern when it comes to managing the supply of their clinical trials. A financial project analyst (FPA) is a specialized expert who can help control clinical supply costs and keep the project within budget. Explore the critical role that a Financial Project Analyst plays in clinical trial supply and budget management. Sponsored by: Catalent |
| WhitepaperLearn how Catalent’s extensive network across APAC can meet a wide range of clinical supply needs for sponsors conducting trials within the region. Sponsored by: Catalent |
| WhitepaperDiscover key considerations that every trial sponsor should know when navigating the complex clinical supply distribution landscape across Asia-Pacific. Sponsored by: Catalent |
| WhitepaperHow can specialized expertise help you optimize your clinical supply chain? Learn about the roles and responsibilities of unique experts such as clinical supply management, project management, and financial project analysis. Sponsored by: Catalent Clinical Supply |
| Research Learn more on an approach for process characterization for the production of a monoclonal antibody, which will improve the efficiency and effectiveness of the process by targeting the right design and number of experiments. Sponsored by: Catalent |
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| WhitepaperPlanning on using a CRO to support your next clinical study? This infographic outlines critical areas to address at the start of the relationship in order to ensure that budget and timelines keep on track for the duration of the trial. Sponsored by: Catalent |
| Case Study Learn more on an approach for process characterization for the production of a monoclonal antibody, which will improve the efficiency and effectiveness of the process by targeting the right design and number of experiments. Sponsored by: Catalent |
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