| Publisher’s Note: Break the silos. Spark the strategy. Fierce Pharma Engage brings every key function together to move brands forward. Learn how now! |
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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 14, 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 Nick Paul Taylor Pfizer has axed its oral GLP-1 asset danuglipron after one patient had potential drug-induced liver injury in a phase 1 trial. The setback blows a hole in the Big Pharma’s plans to challenge for the obesity market. |
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By James Waldron Third Harmonic Bio has abandoned plans to take its chronic spontaneous urticaria (CSU) drug into phase 2, instead preparing to sell the asset while liquidating the business. |
By Nick Paul Taylor Verve Therapeutics has generated evidence its PCSK9 pivot could pay off. One year after dropping a base editing candidate over a safety signal, the biotech has shown its Eli Lilly-partnered successor can achieve similar cholesterol reductions without raising any red flags. |
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. |
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Developing next-generation AI models capable of predicting disease progression and treatment response in multiple sclerosis. Learn more. 
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By James Waldron Ironwood Pharmaceuticals has been left considering its options after the FDA demanded another phase 3 trial before it will consider the biopharma’s long-acting GLP-2 analog for approval. |
Sponsored by TriNetX, Inc. Discover how AI and RWD are transforming drug development by optimizing clinical trial protocols, enhancing recruitment, and accelerating timelines. |
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 to study regret and detransition in people who have transitioned genders, according to multiple reports. |
By Angus Liu Despite President Donald Trump’s threat last week that tariffs on pharmaceuticals will come “very shortly,” the biopharma industry may have a brief reprieve after all—that’s if a new comment from Commerce Secretary Howard Lutnick holds up. |
By James Waldron The HIV-focused biopharma has received its latest bid from CDMO Future Pak for a cool $255 million, but the drugmaker had to disclose it is currently in negotiations with another suitor. |
By Noah Tong In a letter sent to states, designated state health program requests with a healthcare-adjacent focus are unlikely to be approved, CMS announced. Here's what that means. |
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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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. 
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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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