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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 11, 2025 |
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Access this resource for key insights from industry leaders on the use of in-country liquid biopsy testing for global clinical trials. Country-specific regulations often prevent or delay access to testing results, decreasing population sizes and increasing timing and costs. Download now to see how to overcome these challenges. 
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| By James Waldron The market turbulence unleashed by President Donald Trump’s tariff policies will likely dry up the trickle of biotech IPOs that were expected in 2025, a capital markets expert has told Fierce. |
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By Angus Liu Bristol Myers Squibb has received the FDA’s green light to compete with Roche's and AstraZeneca's immunotherapy-based treatments in first-line liver cancer. |
By Darren Incorvaia The FDA announced on April 10 that the agency plans to end the requirement for new monoclonal antibodies and some other drugs to be tested in animals. Animal testing will be replaced with a suite of techniques, including computational models and human cell lines and organoids, the agency said. |
By Darren Incorvaia The White House has ordered the National Institutes of Health (NIH) to study regret and detransition in people who have transitioned genders, according to multiple reports. |
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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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By Fraiser Kansteiner As concerns around President Donald Trump's import tariffs mount, Novartis has announced it will spend $23 billion to build and expand 10 U.S. facilities over the next five years. The project, expected to create 1,000 new jobs at the company, includes several new manufacturing facilities for biologics, oral drugs and radiopharmaceuticals, as well as a new R&D hub in San Diego. |
By Zoey Becker The company is moving its oncology R&D digs in San Diego to a nearby site, but 56 employees won't take part in the move. A spokesperson said the layoffs are "not connected" to the site sale. |
By Conor Hale Currently under FDA review, Microbot’s miniaturized, disposable Liberty system is designed to control guidewires and catheters as they move through the body. |
By Andrea Park After years of back-and-forth with the FDA over Hetlioz's potential use as a jet lag disorder treatment, Vanda Pharmaceuticals is pursuing a new route to establish the drug in the space. |
By Zoey Becker PhRMA's latest ad highlights the double trouble that can come from pharmacy benefit managers and insurance companies that are owned by the same big healthcare conglomerate. |
By Angus Liu After Pfizer let limited patient interest get the best of its hemophilia B gene therapy ambitions and discontinued Beqvez, CSL Behring naturally faced the question of whether it can hold its ground with Hemgenix. |
By Kevin Dunleavy Already thriving with a successful launch of infused Vyvgart and its subcutaneous follow-on Vyvgart Hytrulo to the tune of $2.2 billion in sales last year, argenx has scored FDA approval for a new formulation of the treatment, which gives patients the option of administering it at home. |
By Darren Incorvaia,Zoey Becker After more than 13 years at Johnson & Johnson, including most recently serving as new ventures lead for Italy within J&J Innovation, Marcella Origgi is stepping away from the Big Pharma to take on the CEO role at Valo Therapeutics. |
Fierce podcasts Don’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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eBook Typical 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 |
Whitepaper Avoid costly mistakes and ensure your clinical development program meets the highest standards by reading WCG’s whitepaper on Imaging Core Labs, Endpoint Adjudication Committees (EAC), and other safety reviews. Sponsored by: WCG |
Research We 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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