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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 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. |
By Conor Hale J&J received a thumbs-up from the FDA last fall to launch human trials of the system, which is designed for both laparoscopic and open surgeries of soft tissue, as well as hybrid combinations of the two approaches. |
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. |
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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 Andrea Park If you ever find yourself doing outdoor hobbies in slow motion or bursting into a full-blown musical theater scene at the office, beware: You might be in a pharmaceutical ad. |
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. |
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 Kevin Dunleavy Sandoz has filed an antitrust lawsuit in federal court in Virginia claiming that Amgen has blocked competition to “unlawfully extend its monopoly” on Enbrel. It is the second time the generics and biosimilars specialist has challenged Enbrel's patents in federal court. |
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. |
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 |
| WhitepaperAvoid 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 |
| 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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