| 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 24, 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 Gabrielle Masson Novartis has inked a deal potentially worth more than $1 billion with Flagship-founded Generate:Biomedicines to develop protein therapeutics across multiple indications. |
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By Gabrielle Masson After a few years in biotech, Mike Quigley, Ph.D., is returning to the pharma fold, taking up the top science spot at Sanofi. |
By Nick Paul Taylor Biogen and UCB’s gamble on advancing into phase 3 on the back of a failed study looks to have paid off, with the partners reporting positive top-line results in systemic lupus erythematosus and outlining plans to start a second pivotal trial. |
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 Gabrielle Masson While the biotech has yet to unveil a more detailed data set, the injection, dubbed MET-097, was tied to “significant and durable” weight loss. |
By Nick Paul Taylor Wave Life Sciences has met its goal in a Duchenne muscular dystrophy study, positioning it to talk to regulators about accelerated approval while continuing to track patients through to the completion of the trial. |
By Darren Incorvaia To help clinical trial sponsors who are planning global cancer trials best position themselves for FDA approval, the agency has released draft guidance for conducting multiregional clinical trials in oncology. Once finalized, the guidance will provide recommendations for how industry can use data from global trials to support FDA approval in the U.S. |
By James Waldron Italian biotech Aptadir Therapeutics has launched with the promise that its pipeline of preclinical RNA inhibitors could crack intractable cancers. |
By Angus Liu Black Diamond Therapeutics and Ideaya Biosciences are mulling over registrational trials for their lead assets after receiving encouraging phase 2 data in lung and eye cancers, respectively. |
By Angus Liu After bluebird bio acknowledged troubles keeping its business operational, the gene therapy biotech is launching a restructuring that will reduce the size of its workforce by about 25%, or nearly 100 employees. |
By Zoey Becker Ahead of a hearing on Ozempic and Wegovy prices, prepared remarks from Novo CEO Lars Fruergaard Jørgensen shine a light on the larger U.S. healthcare system. |
By Fraiser Kansteiner After several years spent building partnerships to hone its robotic cell therapy manufacturing system, Multiply Labs has snared its first collaboration with a major cell therapy developer: Legend Biotech. |
By Fraiser Kansteiner As part of the new restructuring push, AGC will lay off 68 employees at its cell and gene therapy plant in Longmont, Colorado, 17 employees at its commercial mammalian plant in Boulder, Colorado, and 10 employees in Bothell, Washington, according to a Worker Adjustment and Retraining Notification alert. |
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 |
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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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