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As protein engineering and manufacturing technologies evolve, small biotech and major pharma companies alike need flexible, customized strategies that balance cost, speed and risk to accelerate drug development and approval of biotherapeutics that could address unmet medical needs. Download white paper. 
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Today's Big NewsMar 24, 2023 |
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Puerto Rico is the perfect location for reshoring & securing operations. Benefit from unmatched tax incentives, USA legal framework, & world-class talent. Plus, made in Puerto Rico is made in the USA. Learn more. 
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| 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. |
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By Andrea Park In an all-too-familiar echo of fellow digital therapeutics maker Pear Therapeutics’ recent desperate attempts to cut costs, Better Therapeutics has begun making its own money-saving moves. |
By Kevin Dunleavy Analysts at Evercore ISI believe a label expansion for Sanofi and Regeneron’s Dupixent in COPD would add $3.5 billion in sales, expanding the drug’s peak sales potential to more than $20 billion. |
By Fraiser Kansteiner After a California judge said a plaintiff's expert witnesses can testify in an upcoming trial over cancer risks on heartburn med Zantac, GSK has hit back. The British drugmaker stressed that litigation is still at an “early stage." |
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Thursday, Apr 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. 
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By James Waldron After a number of high-profile SPAC announcements toward the end of last year, these deals once again dropped off in 2023. But that doesn’t mean the low-key revival of this reverse merger model has died. |
By Andrea Park Post-traumatic stress disorder treatment typically takes a two-pronged approach: talk therapy and medications combined to help manage symptoms. And now, a newly FDA-cleared device adds a third option in the form of self-guided neuromodulation. |
By Angus Liu The FDA has rejected an extended-release formulation of Incyte’s Jakafi in a serious blow to the company’s broader pipeline ambitions. |
By Nick Paul Taylor Bioasis Technologies and Celyad Oncology are still waiting for better days. In separate updates, the two biotechs revealed that their respective turnaround strategies remain works in progress—and constraints on cash are still defining what can and cannot be achieved. |
Fierce podcasts Don'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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Thursday, March 30, 2023 | 1pm ET/ 10am PT Enzymes have long demonstrated their utility as a green alternative to metal-based catalysts, but the evolution time required can be significant. Join this webinar to learn about an extracellular strategy that reduces the evolution cycle and enables biocatalysis to be used much earlier in development. Register now. 
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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 |
Executive Summary Read about the latest survey results from over 200 biopharma executives and the changing approaches to building biologic drug development pipelines. Sponsored by: Twist Bioscience |
Whitepaper Have 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 |
Whitepaper What are key considerations for intranasal delivery in the treatment of acute and chronic conditions? Sponsored By: Catalent |
Whitepaper Explore how clinical supply can be scaled up as decentralized programs progress, and how technological solutions can accelerate trial deployment. Sponsored by: Catalent Clinical Supply |
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 |
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 |
Whitepaper Discover key considerations that every trial sponsor should know when navigating the complex clinical supply distribution landscape across Asia-Pacific. Sponsored by: Catalent |
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 |
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 |
Whitepaper For 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 |
Whitepaper Learn 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 |
Whitepaper How 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 |
Whitepaper Planning 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 |
Whitepaper Explore Catalent’s newest clinical supply facility in Japan, including the comprehensive services & solutions it offers to help support trials both in-country & around the world. Sponsored by: Catalent |
| May 1-3, 2023 | Jersey City, NJ |
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