J&J is not the first name in Alzheimer's these days, but Janssen is charting the 'sweet spot' behind the scenes AstraZeneca's novel checkpoint inhibitor flunks first phase 3, denting partner's share price Fierce Biotech Fundraising Tracker: BigHat's supercharged $75M round, a $55M Replay Marengo's STAR shines as Ipsen hands over $45M for 2 preclinical T-cell activators Apollo lands inflammatory antibody from Avalo for $90M biobucks Quince hoping to sweeten its fruit with acquisitions, out-licensing of legacy Cortexyme assets Beam's light scatters as FDA blocks phase 1 study for lymphoma CAR-T Vivoryon's stock climbs as midphase Alzheimer's disease trial determines optimal dose Celyad's CAR-T cleared by FDA in phase 1 Keytruda combo trial, but nature of 2 deaths still unclear Hit by clinical holds for mystery eye inflammation, Nuvation drops tumor asset and reduces staff by a third Otonomy cuts lead asset loose after phase 2 failure, the latest in a string of pitfalls The top 10 Big Pharmas for their diversity, equity and inclusion efforts in 2022 We're looking for 2022's Fiercest Women in Life Sciences Featured Story | By James Waldron Neurodegeneration is one of the hottest areas of drug development at the moment. For Johnson & Johnson’s R&D arm Janssen, this involves a two-pronged strategy of precision medicines for diseases like Alzheimer’s while at the same time working on biomarkers that can identify patients who will benefit most. read more |
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Top Stories By Nick Paul Taylor AstraZeneca's first phase 3 bet on the anti-NKG2A antibody monalizumab has ended in failure. Adding the Innate Pharma-partnered molecule to Erbitux failed to improve outcomes in head and neck cancer patients at an interim analysis, prompting AstraZeneca to stop the study. read more By Max Bayer As venture capital pours into budding biotechs, we're launching the Fierce Biotech Fundraising Tracker to keep tabs on all things financing. read more By James Waldron Marengo has received further validation for its STAR platform for T-cell activators, with Ipsen paying $45 million upfront to take two cancer candidates into the clinic. read more By James Waldron Apollo Therapeutics has landed the rights to an immunology drug from Avalo Therapeutics to the tune of $15 million upfront and $74 million to potentially follow in milestone payments. read more By Annalee Armstrong Quince, the fruit, may not need a lot of maintenance to keep growing but Quince Therapeutics, the biotech, is undergoing quite a pruning to ensure future growth. read more By Annalee Armstrong Beam Therapeutics’ leukemia and lymphoma CAR-T therapy has been stopped in its tracks by the FDA after a clinical hold was placed on the new drug application. read more By Nick Paul Taylor Vivoryon Therapeutics has hit upon the right dose of its Alzheimer’s disease candidate. Having seen a 33% dropout rate at 800 mg, the biotech has dialed down the dose to improve tolerability without causing a steep drop in target engagement, clearing it to move into the second part of the study. read more By Annalee Armstrong Five months after Celyad Oncology voluntarily paused a phase 1b study of its cell therapy after two patient deaths, the trial has been cleared by the FDA to restart. read more By James Waldron After receiving a flurry of clinical hold letters from the FDA, Nuvation Bio has resorted to drastic action to try to stay afloat. The biotech will not only discontinue development of the tumor drug in question but will lay off over a third of its workforce in a bid to keep the money flowing for another five years. read more By Max Bayer Otonomy can’t seem to shake its clinical demons. A phase 2 trial for a tinnitus treatment has struck out, forcing the company to call it quits on the drug and shift focus once more. read more By Ben Adams Pharma’s reputation may have soared amid the pandemic, but that came with a brighter spotlight on DEI issues. In recent years, pharma has been trying to penetrate social issues of diversity, equity and inclusion more deeply into its corporate psyche. read more By Annalee Armstrong Each year at Fierce, we spotlight women who are leading the way in the life sciences, from industry professionals and academics to venture capitalists and regulatory officials. read more Resources Sponsored by: Thermo Fisher Scientific See how integration of innovative genetic analysis techniques into drug development is driving biopharma & biotech companies ahead. Sponsored by: Triangle Insights Group, LLC Discover how the new partnership between TrialCard and Triangle Insights Group can help you bridge the critical gap between strategy and execution, ensuring commercialization success of your product or therapy. Sponsored by: Nexelis Discover Nexelis’ first-hand perspective on how to develop innovative, agile solutions in vaccine efficacy testing in this exclusive e-book. Sponsored by: Catalent What is the most suitable dosage form technology for the Oral Delivery of Lipid-Based Formulations? Sponsored by: Catalent Learn how formulation development for a PFS affects manufacturing to drive the industry toward optimizing delivery of injectable products and, ultimately, improving patient care. Sponsored by: Catalent Did you know Catalent has newly expanded in-house capabilities spanning clinical and commercial scale manufacturing for DPIs, unit-dose, bi-dose and preserved multi-dose nasal sprays? Sponsored by: Catalent What are key considerations for intranasal delivery in the treatment of acute and chronic conditions? Sponsored by: Catalent Learn more about how the versatility of Softgel Technology helped a customer with a volatile compound. Sponsored by: Catalent How can Lipid-Based Drug Delivery System help bring poorly soluble drugs to market? Sponsored by: Catalent Carla Vozone discusses the significant trends in the OINDP segment including large molecules and novel indications, changes within CDMOs and various challenges facing the industry. Sponsored by: Catalent Ypsomed and Catalent Biologics experts discuss strategies for integrated PFS manufacturing and auto-injector assembly to accelerate timelines and more in this webinar. Fierce Biotech Cell & Gene Therapy Forum October 19, 2022 | Free Virtual Event Fierce Pharma Meeting Professionals Summit November 2-3, 2022 | Atlantic City, NJ | 