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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 23, 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 Nick Paul Taylor A FDA advisory committee has boosted Biogen and Ionis’ prospects of winning accelerated approval for their amyotrophic lateral sclerosis drug. The experts unanimously voted that biomarker evidence supports conditional approval—but a failed clinical trial proved a barrier to support for a full approval. |
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By Andrea Park Amid plans to trim off a few of its business units to give higher-priority areas room to grow, Medtronic is also undergoing some smaller-scale internal pruning. |
By Kevin Dunleavy A phase 3 study of Regeneron and Sanofi's Dupixent in COPD patients met its primary and secondary endpoints, setting it up to become the first biologic treatment for the disorder. COPD has seen few advancements over the last decade and is the world’s third leading cause of death. |
By Max Bayer Former Seagen CEO Clay Siegall will head up a new biotech spun out of Purdue University, less than a year after he stood down from the biotech giant in the wake of an arrest for alleged domestic violence. |
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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 Angus Liu AbbVie’s Skyrizi, which is already making inroads in Crohn’s disease, has clinched a win in another inflammatory bowel disease. But the clock’s ticking on a rival’s U.S. patent cliff, meaning pricing pressure could soon come. |
By Andrea Park A pair of implanted devices from Abbott and Ancora Heart both designed to improve outcomes for heart failure were proven successful in longer-term studies presented this week. |
By Zoey Becker The first treatment for aromatic L-amino acid decarboxylase (AADC) deficiency will soon be available to patients in England. The ultra-rare, fatal disease only affects an estimated 10 children in the U.K. |
By Sharon Klahr Coey GSK’s HIV-focused ViiV Healthcare knows how to speak to its audience, and usually that audience is men who have sex with men. However, with Black women accounting for nearly 60% of new HIV infections of US, ViiV convened a group of Black women advocates, the Black Women’s Working Group, to find a better way to reach this audience. |
By James Waldron Moderna is keeping its foot on the gas in 2023 when it comes to expanding beyond mRNA. After signing a gene-editing pact in January and scooping up a DNA manufacturer in February, this month sees the biotech giant hand over $76 million in cash and equity as part of a multifaceted lipid nanoparticle collaboration. |
By Fraiser Kansteiner As the era of over-the-counter naloxone looms, non-profit pharma company Harm Reduction Therapeutics is teaming up with contract manufacturing juggernaut Catalent to make its dream of easily accessible overdose reversal drugs a reality. |
By James Waldron A potential game changer. “The first new mechanism for treating schizophrenia in more than 50 years.” As the hype continues to build ahead of the expected launch of Karuna Therapeutics’ KarXT next year, it’s no surprise that Royalty Pharma wants a piece of the pie. |
By Ben Adams A new survey out from the American Gastroenterological Association has shown the need for better emotional and mental health support when it comes to treating inflammatory bowel disease. |
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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