| Publisher’s Note: Break the silos. Spark the strategy. Fierce Pharma Engage brings every key function together to move brands forward. Learn how now! |
|
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. 
|
|
Today’s Big NewsApr 15, 2025 |
|
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. 
|
|
| 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 Nick Paul Taylor Boehringer Ingelheim has joined the surge of companies entering the B-cell depletion space. But while its peers have largely focused on CAR-Ts and bispecifics, the German drugmaker has paid Cue Biopharma $12 million for a novel preclinical program that could eliminate some of the risks of rival approaches. |
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. |
Sponsored by Ohio Discovery Corridor CTI grew from a Cincinnati startup to a global leader in clinical research. CEO Tim Schroder shares insights on its success and what’s next. |
|
Developing next-generation AI models capable of predicting disease progression and treatment response in multiple sclerosis. Learn more. 
|
|
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. |
Sponsored by TriNetX, Inc. Discover how AI and RWD are transforming drug development by optimizing clinical trial protocols, enhancing recruitment, and accelerating timelines. |
By Gabrielle Masson Amid an FDA overhaul and market volatility, one biotech executive says her public company still operates with the mentality of a private company, while urging the industry to work together with federal health agencies so drug developers can continue to transform cancer care. |
By James Waldron Having picked up a pipeline of oncology drugs as part of a merger last year, NAYA Biosciences is reverting back to its original focus of fertility and spinning off the cancer business. |
By Gabrielle Masson,Darren Incorvaia The Fierce Biotech Fundraising Tracker records venture capital rounds of $50 million or more secured by biotechs. |
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 Darren Incorvaia The U.K. is rolling out new regulations meant to reduce red tape for clinical studies and boost the nation’s role in international trials. |
By Zoey Becker In a Friday speech to FDA employees, the HHS secretary laid bare his belief that the agency hasn't acted in the best interest of Americans—going many steps further in his own colorful language. |
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. |
|
---|
|
|
|
Wednesday, April 23, 2025 | 11am ET / 8am PT Commissioning and qualification (C&Q) are critical processes within pharmaceutical manufacturing. Join us for this valuable webinar to learn about today’s top challenges and the key strategies for overcoming them. 
|
|
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 Is 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 |
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 |
| |
|