| Today's Big NewsApr 24, 2023 |
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May 1 - 3, 2023 | Jersey City, NJ Explore In-Depth Discussions Across 3 Tracks Dedicated to Medical Affairs Professionals. Last chance to register! Don’t miss out, register today.
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| By Max Bayer Ionis and AstraZeneca are providing the first detailed look at phase 3 data of eplontersen, a treatment for ATTR polyneuropathy that's going toe-to-toe against Alnylam's franchise. AstraZeneca signed a collaboration deal worth up to $3.5 billion to co-develop and commercialize the drug. |
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By James Waldron As Foghorn Therapeutics battles to free a trial from an FDA clinical hold, the biotech is now facing a partial hold for another program—meaning the company's two clinical assets are now tied up in red tape. |
By Nick Paul Taylor Applied Therapeutics’ phase 3 pediatric rare disease clinical trial has failed. But the biotech, which buried that news more than 500 words into its press release, framed the study as positive and outlined plans to meet with the FDA to discuss a filing for approval. |
By Nick Paul Taylor Twenty months after being rocked by a clinical hold, MaaT Pharma has finally received the green light from the FDA to run a phase 3 trial of its pooled fecal therapy in gastrointestinal acute graft-versus-host disease patients in the U.S. |
By Max Bayer Unity's eye disease med has passed an extended phase 2 test, setting the state for a head-to-head battle with Regeneron's industry mainstay Eylea. |
By Angus Liu Eli Lilly quietly registered a new phase 3b trial pitting its Mounjaro against Novo Nordisk’s Wegovy in overweight or obese patients with with certain health conditions, teeing up an epic fight in a multibillion-dollar market. |
By Conor Hale Billed as complete upgrades over the simple, ice-packed coolers that have been relied upon to move donor tissue for decades, the company’s heart-focused SherpaPak and its LUNGguard system are both cleared by the FDA and CE marked for use in Europe. |
By Dave Muoio The top court voted 7-2 to stay the lower courts' decision, with Justices Alito and Thomas opposing. |
By Conor Hale Activist investor Carl Icahn lodged a public proxy fight against the DNA sequencing giant in early March—largely over the company’s $8 billion acquisition of Grail and its resulting legal quarrels with antitrust regulators. |
By Fraiser Kansteiner Eli Lilly is selling Baqsimi to California’s Amphastar for $500 million in cash upfront. Amphastar is on the hook for an additional $125 million upon the one-year anniversary of the deal’s close, expected in the third quarter. Further, Lilly is in line to receive sales-based milestones worth up to $450 million, the companies said Monday. |
By Dave Muoio Limited slots for foreign-educated nurses introduce an international labor logjam even as hospitals clamor for clinicians. |
Fierce podcasts Don't miss an episode |
| This week on "The Top Line," we talk about how Pfizer became the first company in Big Pharma history with $100 billion in sales. We also dive into a J&J data leak, Eli Lilly's manufacturing spending plan and more of this week's top headlines. |
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July 18-19, 2023 | Jersey City, NJ
Hear the latest industry trends from leaders in the field, and developed with input from our esteemed advisory board, to ensure you have a sound plan for your company, brands, and yourself. Save $500 when you Register Today!
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Research Strategies for Optimal Site Selection and Feasibility Research in Novel Therapies and Geographies Sponsored by: H1 |
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Whitepaper How advanced medicines commercial readiness differs and the resources needed to maximize potential. Sponsored by: Herspiegel Consulting |
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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 |
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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 |
| May 1-3, 2023 | Jersey City, NJ |
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