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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 21, 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 Annalee Armstrong $100 million for Rapport Therapeutics. $112 million for Noema Pharma. $108 million for Bicara Therapeutics. The megaround has come roaring back in the past few weeks, but is biotech really healing? |
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By Fraiser Kansteiner The recent decision by CMS to uphold its coverage restrictions on Leqembi and other anti-amyloid drugs didn’t come as a shock to Eisai. The company is “not so nervous” about Leqembi’s ultimate access prospects, U.S. CEO Ivan Cheung said in an interview. |
By Andrea Park During a hearing that lasted just under 90 minutes on Friday, Judge Edward Davila stopped short of offering a definitive ruling on Elizabeth Holmes' dual bids to stay out of prison while awaiting an appeal and to avoid paying restitution for her four felony convictions. |
By Max Bayer For a moment there, it seemed as though a reverse merger between Carisma Therapeutics and Sesen Bio was on thin ice. Activist investors at the latter were holding up the marriage, largely to maximize the amount of cash that would be dispersed to Sesen shareholders. But after months of negotiating, the final assuaging came from Carisma’s head honcho. |
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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 Fraiser Kansteiner Gilead's Yescarta has helped patients with large B-cell lymphoma live longer when used as a second-line treatment. The phase 3 update comes after a historic approval based on disease progression data. |
By Andrea Park The letter follows an early November inspection of one of Olympus’ Tokyo facilities, during which the FDA concluded that some of the company's endoscopes and endoscope accessories are “adulterated” due to improper manufacturing practices. |
By Nick Paul Taylor Evofem Biosciences is making top-to-bottom cuts in a bid to slash its costs. Months after laying off 39 people, the women’s health biotech has pushed more employees, including its chief commercial officer, out the door and cut the salary of its CEO by 40%. |
By Kevin Dunleavy Biopharma industry lobbying group PhRMA is angling for tax breaks that would encourage more drug manufacturing in the United States. The measures would strengthen the supply chain, reduce the potential for drug shortages and cut prices, PhRMA says. |
By Andrea Park The FDA clearance makes Viz’s AI tool the first to be given the agency’s green light to detect and triage suspected cases of abdominal aortic aneurysm, according to the company, which was named to Fierce Medtech’s annual Fierce 15 list this week. |
By Zoey Becker Six months after its first regulatory nod in Indonesia, Takeda's dengue vaccine is on an approval roll. After a recent nod in Brazil, the company detailed its pricing outlook for the key launch. |
Fierce podcastsDon't miss an episode |
| This week on "The Top Line," we discuss the SVB failure, what to expect next and what it all meant for the biotech industry. We also cover Pfizer's big acquisition, insulin prices 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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| WhitepaperPreparation 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 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 |
| 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 |
| 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 |
| WhitepaperDiscover 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 |
| 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 |
| 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 |
| 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 |
| WhitepaperExplore 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 |
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