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Monday, April 21, 2025 | 12pm ET / 9am PT Join us for an exclusive webinar exploring groundbreaking findings from the DUTRENEO trial, which evaluated the role of predictive biomarkers in guiding neoadjuvant therapy for muscle-invasive bladder cancer (MIBC). Register today.
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Today’s Big NewsApr 15, 2025 |
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Thursday, April 22, 2025 | 11am ET / 8am PT Digital transformation is the way of the future, but knowing where and how to start the journey toward digital evolution can be challenging. Join us for key insights on digital strategies that can help you overcome the inefficiencies in traditional methods of process development and biomanufacturing. Register now.
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| By Conor Hale During its quarterly earnings report, executives at Johnson & Johnson said they expect escalating worldwide tariffs to put a $400 million dent in the company’s financial forecasts—largely from its exports of medical devices from the U.S. into China. |
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By Zoey Becker Merck will create oral versions of its peptides using Cyprumed's drug delivery technology through a nonexclusive license and option agreement that puts Cyprumed in line for up to $493 million. |
By Andrea Park After several weeks and thousands of votes, TV drug ads from Apellis Pharmaceuticals and AstraZeneca found themselves in the final round of the annual #FierceMadness bracket competition. The trophy ultimately went to Apellis, but both companies’ commercials racked up plenty of fans on the road to their championship matchup. |
By Darren Incorvaia The Trump administration is freezing more than $2.2 billion in funding to Harvard University after the school defied the administration’s demands for radical change. |
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Tuesday, May 6, 2025 | 9am ET / 6am PT This webinar will explore how to use AI-driven tools for timely data-driven decisions that are critical to securing approvals, expediting market entry and sustaining competitive strength. Register now.
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By James Waldron Sanofi’s blockbuster ambitions for amlitelimab hit a bump in the road this morning with the news that the highest dose of the anti-OX40-ligand monoclonal antibody missed the main goal of a phase 2 asthma study. |
By Angus Liu An investigation into the national security implications of pharma imports has been underway for two weeks, the Trump administration disclosed Monday. |
By Nick Paul Taylor The writing is on the wall at Mural Oncology. Responding to clinical data, the biotech is laying off 90% of its employees and stopping clinical development of its lead program to hunker down and seek a strategic alternative. |
By Zoey Becker Camzyos came up short in a phase 3 trial weighing its use in patients with non-obstructive hypertrophic cardiomyopathy (nHCM). In 2022, the drug won FDA approval to treat certain patients with obstructive HCM. |
By Kevin Dunleavy A two-day meeting of the Advisory Committee on Immunization Practices (ACIP), which was postponed by new HHS Secretary Robert F. Kennedy Jr., is underway today in Atlanta and will conclude with panel votes on several vaccines on Wednesday afternoon. |
By Conor Hale The companies said they will work together to train artificial intelligence algorithms on genomic data, while also collecting evidence on the clinical benefits of molecular diagnostics and comprehensive genomic profiling in everyday healthcare. |
By Nick Paul Taylor Spruce Biosciences has put out new shoots, snapping up rights to a former BioMarin rare disease candidate and outlining plans to seek accelerated FDA approval in the first half of next year. |
By Nick Paul Taylor Sanofi has said “deal” to Chrissy Teigen. The model, cookbook author and “Deal or No Deal” banker has signed on as a celebrity spokesperson for Sanofi’s push to encourage people to screen early for Type 1 diabetes. |
By Conor Hale After acquiring its developer last year, Edwards Lifesciences has now obtained a European approval for what it described as the world’s first transfemoral transcatheter mitral valve replacement implant. |
Fierce podcastsDon’t miss an episode |
| | In this week’s episode of "The Top Line," Fierce Deputy Editor Andrea Park and Fierce Biotech Senior Editor Gabrielle Masson discuss how workforce reductions impacted the biopharma industry in the first quarter. |
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Scaling advanced biotherapeutics is becoming more complex due to the rise of therapies like cell and gene treatments, RNA therapeutics and monoclonal antibody variants. Access this report to discover key strategies to optimize production, ensure compliance and accelerate commercialization. Download now.
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| eBookTypical vaccine development timelines have averaged 10 years, but the time from the SARS-CoV-2 genetic sequence’s release to the submission of the first vaccine clinical trial data for regulatory review was a mere 314 days. In IQVIA Laboratories’ Vaccine eBook we focus on how contract research organizations (CROs) can best leverage strategic partnerships with sponsors to prepare for the next pandemic. Sponsored by: IQVIA |
| WhitepaperIs your clinical trial data truly reliable? Learn how a combined approach using Imaging Core Labs and Endpoint Adjudication Committees (EAC) can minimize risk, control costs, and strengthen your study from the ground up. Don’t leave success to chance—arm yourself with the insights to stay ahead. Sponsored by: WCG |
| ResearchWe interviewed 15 biopharma leaders on the critical success factors for building a Best Practice customer-facing organization. This report shares what we learned. Presented by Blue Matter, strategic consultants in the life sciences |
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