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With the emergence of precision medicine and its focus on customizing treatment to individual patients, it may be possible to reduce the time to diagnosis for rare conditions, enabling identification and intervention at earlier stages of the disease – a hope that is new for rare disease patients. Explore this and more in our latest blog. Premier Research. Built for Biotech℠.
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Today's Big NewsMar 23, 2023 |
| 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 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. |
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. |
Sponsored by DrugBank Data rich but quality poor. Massive amounts of disorganized data might be the final roadblock to unlocking the potential of data-centric AI. |
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 Nick Paul Taylor Biotech’s backburner is getting even busier. The latest set of earnings reports brought news of more drug programs that are being stopped or deprioritized, with Assembly Biosciences, Context Therapeutics and Innate Pharma all rethinking where to allocate their R&D budgets. |
By Max Bayer VistaGen's social anxiety nasal spray passed an open-label phase 3 test, showing it was safe and effective. The company said treated patients also showed improvement in a measurement of social anxiety. |
By Joseph Keenan The U.K.’s Medicines and Healthcare products Regulatory Agency has introduced several new measures to make it easier to run clinical trials in the country, marking the first time in 20 years the regulatory body has made such an overhaul. |
By Fraiser Kansteiner Genentech is winding down operations at its production facility in South San Francisco, the company told Fierce Pharma. The site wrapped up its final production runs several weeks ago and is now in the decommissioning phase, which will take some six to 12 months. |
By Andrea Park As Eli Lilly inches ever closer to the finish line in its yearslong mission to bring an Alzheimer’s disease drug to the market, the company has picked up a side quest. |
By Zoey Becker Second time's the charm. After the FDA shot down Incyte's bid to treat front-line squamous cell anal carcinoma, Zynyz scored a green light for the rare cancer Merkel cell carcinoma. |
By Joseph Keenan TFS HealthScience, a Sweden-based CRO, continued its march of global growth by inking a deal to acquire parts of GCP Clinical Studies, a CRO based in Israel. |
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 Kevin Dunleavy After an unsuccessful bid to get its appeal reheard in the Third Circuit Court on Wednesday, Johnson & Johnson said it will make one last appeal to the U.S. Supreme Court to legitimize its strategy to funnel more than 38,000 talc lawsuits into a company it created with the intent to declare it bankrupt. |
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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May 1 - 3, 2023 | Jersey City, NJ Don’t miss the opportunity to gain best practices in medical affairs strategy development and ensuring scientific materials are created and shared in a regulatory compliant manner to internal/external stakeholders and thought leaders. 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 |
| 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 |
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| 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 |
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