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Top biopharma companies are accelerating early-phase programs with integrated study designs that save time and reduce cost. Precision experts share best practices for regulatory planning, adaptive design, and protocol optimization. Download the Free eBook. +(002)+140w+(4).png)
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Today’s Big NewsApr 10, 2025 |
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Home to industry leaders like Amgen and AbbVie, Puerto Rico has over 70 years of pharmaceutical and biotech expertise. With a skilled workforce and world-class infrastructure, it remains a top destination for bioscience innovation. Find out how your company can thrive here. +(1)+(1).png)
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| By Nick Paul Taylor Opthea’s staff are paying for its clinical failures. Days after back-to-back flops sank an eye disease asset, the biotech revealed plans to lay off 65% of its staff and operate with a skeleton crew to save money. |
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By James Waldron Keros Therapeutics is considering whether it needs to find a buyer, while strengthening its stockholder rights as activist investors circle. |
By James Waldron Unable to secure additional financing amid a stormy market, Tempest Therapeutics has put out a call for partners as it seeks to take its liver cancer drug into phase 3. |
Sponsored by Allucent Project Optimus is changing the landscape of oncology drug development by redefining dose optimization standards. Learn how sponsors can align with FDA expectations and implement more precise dose-finding strategies. Watch the full interview with Alex MacDonald now! |
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BioIVT is the leading provider of quality, highly characterized, ethically procured ADME research products featuring extensive ready-to-ship inventory, large lot sizes & expert support. View Options >> 
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By Nick Paul Taylor Alzheon’s attempt to rescue a once-failed idea for treating Alzheimer’s disease has flopped. Sixteen years after tramiprosate flunked a phase 3 trial, Alzheon’s prodrug form of the molecule has joined the lengthy list of pivotal Alzheimer’s failures. |
By Darren Incorvaia Big Pharma-backed Atalanta Therapeutics is ramping up for the clinical debut of the company’s lead epilepsy asset with new data showing the RNA therapy suppressed seizures in mice. |
By Gabrielle Masson,Darren Incorvaia The Fierce Biotech Fundraising Tracker records venture capital rounds of $50 million or more secured by biotechs. |
By Dave Muoio A baseline of 10% will remain in effect during the delay, the president said, though the immediate and upcoming fate of healthcare-specific goods like pharmaceuticals is still unclear. |
By Fraiser Kansteiner After Sun Pharma appealed an injunction handed down in New Jersey federal court in November that blocked the U.S. launch of its alopecia med Leqselvi, the U.S. Court of Appeals for the Federal Circuit on Wednesday ruled in favor of the Indian drugmaker. Sun is no longer under any court order delaying or restricting Leqselvi’s market debut. |
By Zoey Becker The company settled with several purchaser plaintiffs in an antitrust case that involved Jazz and generic Xyrem maker Hikma Pharmaceuticals. |
By Fraiser Kansteiner,Eric Sagonowsky,Angus Liu,Zoey Becker,Kevin Dunleavy In this tracker, Fierce Pharma is recording the regulatory progress of in-market products, including expansions into key geographies and new indications. Some of these updates may not meet the bar for standalone stories, but we think they are still worth mentioning. |
By Nick Paul Taylor Ask a healthcare professional to name a psychiatric medicine and chances are they’ll say a brand approved at least 10 years ago. That finding, which comes from a ZoomRx survey, points to the challenge facing new market entrants as they try to wrestle mindshare from incumbents through marketing. |
Fierce podcasts Don’t miss an episode |
| This week on "Podnosis," Senior Writer Paige Minemyer chats with Jason Oberfest, vice president of healthcare at Oura, to discuss how the company is approaching its push into healthcare. |
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NashBio is transforming life sciences by making complex genomic and real-world data accessible for pharmaceutical R&D. Learn how their innovative Totem platform and groundbreaking Alliance for Genomic Discovery are accelerating research and improving outcomes. By NashBio |
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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