| Publisher’s Note: Join Fierce Biotech Editors and industry leaders at the Fierce Biotech Summit to network and gain exclusive insights. Don’t miss out — register now! |
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Drug development requires a delicate balance between innovation, speed, and regulatory compliance. The 505(b)(2) pathway offers a strategic avenue for developers to bring qualifying drugs to market more efficiently.
Learn how in our latest guide. 
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Today’s Big NewsSep 25, 2024 |
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Tuesday, October 1, 2024 | 11am ET / 8am PT The clinical trial landscape continues to evolve at a rapid pace. In this webinar, learn how new biomarker detection technologies drive key breakthroughs. With early detection, biomarker testing research can advance disease understanding and management in many care areas. Register now to join us. 
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| By Nick Paul Taylor An attempt by Merck & Co. to unlock the microsatellite stable metastatic colorectal cancer market has ended in failure. The drugmaker found a fixed-dose combination of Keytruda and an anti-LAG-3 antibody failed to improve overall survival, extending the wait for a checkpoint inhibitor that moves the needle in the indication. |
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By James Waldron BioAge Labs is eyeing about $180 million in initial proceeds from an IPO and a private placement, funds the metabolic-focused biotech will use to push its lead obesity prospect through the clinic. |
By Nick Paul Taylor Amgen has shared the first phase 3 data on its $400 million eczema drug, linking the anti-OX40 antibody to significant improvements in symptoms. But, while the trial met its primary endpoint, the biotech still needs to make the case that there is a role for rocatinlimab in a market served by Dupixent. |
Sponsored by MMC + RXMOSAIC Courtney Walker of MMC and RxMosaic discusses the future of communication roles, emphasizing AI's impact and the growing importance of human connection. She also highlights strategies for rebuilding pharma's reputation, effective leadership communication, and engaging diverse audiences. |
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Developing immunotherapeutic antibodies can be challenging, but potency shouldn’t stand in your way of clinical success. Learn more. 
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By James Waldron While Windtree Therapeutics has struggled to grow the financial roots needed to survive, a phase 2 win for the biotech’s lead asset will at least give the company encouragement to persevere. |
By Gabrielle Masson OncoC4 is taking AcroImmune—and its in-house clinical manufacturing capabilities—under its wing in an all-stock merger. |
By James Waldron Aitia’s so-called Gemini Digital Twins leverage multi-omic patient data, plus AI and simulations, to help identify potential new molecules and the patient groups most likely to benefit from them. |
By Gabrielle Masson,Annalee Armstrong,Darren Incorvaia,Max Bayer Welcome to Fierce Biotech's Fundraising Tracker, 2024's version. |
By Darren Incorvaia Health tech company PicnicHealth is launching a new program that lets researchers conduct clinical trials in cyberspace. Virtual Site is meant to help clinical trial sponsors conduct observational studies without the need for a physical location. |
By Darren Incorvaia Headlands Research, a clinical trial site network with locations across the United States and Canada, is launching its newest site on the U.S.-Mexico border in El Paso, Texas. |
By Angus Liu Bristol Myers Squibb’s CAR-T therapy Abecma has hit a major setback. Bristol and its partner 2seventy bio have decided to pull the plug on the phase 3 KarMMa-9 trial in first-line myeloma after struggling to enroll patients. |
By Fraiser Kansteiner While it was just last week that Zevra Therapeutics’ Miplyffa became the first FDA-approved treatment for the lysosomal storage disorder Niemann-Pick disease type C, IntraBio has already one-upped its rare disease rival. |
By Conor Hale Roche said its new tech can track as many as 15 pathogens with a single kit and be run on existing instruments without hardware or software upgrades. |
Fierce podcasts Don’t miss an episode |
| In this week's episode of "The Top Line," we’re recapping and discussing the major trends from Digitial Pharma East. |
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Whitepaper Unlock the Future of Biotherapeutics with Catalent Biologics! Sponsored by: Catalent Biologics |
Whitepaper Finding an effective epilepsy treatment can be arduous. Download this brochure to delve into how IQVIA's expertise and innovative strategic approach can streamline the clinical trial process, helping to get new therapies to patients who need them sooner. Sponsored by: IQVIA |
Whitepaper Unique Solutions for Drug Discovery and Development Sponsored by: Cell Signaling Technology |
Whitepaper When the fate of your company hangs in the balance, you need expert guidance to navigate the complexities of biotechnology development and to make informed decisions. Sponsored by: WCG |
Whitepaper Power non-invasive, self-sampling solutions using the Colli-Pee™️ first-void urine collection device. Learn more. Sponsored by: DNA Genotek |
Whitepaper Facing roadblocks in drug development? Uncover how phase-appropriate technology transfers can help you navigate challenges and speed up your journey to market. Sponsored by: Veranova |
Whitepaper We interviewed dozens of biopharma leaders on the critical success factors for building a Best Practice commercial organization. This report shares what we learned. Sponsored by: Blue Matter Consulting |
On Helix Date: 4 July 2024 - Location: Babraham Research Campus, Cambridge UK |
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