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Tuesday, December 19, 2023 | 12pm ET / 9am PT Either you want to implement a CLM, or you don’t know how to fix the processes of the one you have in place. Either is a tough place to be in. Join us in this webinar to learn from a CLM solution implementation expert in the highly regulated field of pharmaceuticals. Register now.
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Today’s Big NewsDec 12, 2023 |
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Explore new possibilities with Fortrea. Oncology drug development informed by years of insights and powered by our agile approach to clinical trials. Explore Agility.
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| By Nick Paul Taylor The Federal Trade Commission has scuttled Sanofi’s licensing deal with Maze Therapeutics. With the FTC moving to block the deal, the Big Pharma is pulling out rather than working through the antitrust maze that has sprung up between it and the asset. |
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By Nick Paul Taylor Bristol Myers Squibb has filled the antibody-drug conjugate-shaped hole in its pipeline by following the increasingly well-trodden path to China, handing SystImmune $800 million upfront for a phase 1/2 solid tumor candidate as part of a deal worth up to $8.4 billion. |
By James Waldron It looked for a while like AstraZeneca was planning to back out of the vaccines business for good, but the acquisition of respiratory syncytial virus (RSV) shot developer Icosavax suggests the British Big Pharma plans to be a player for a while longer. |
Sponsored by SAP America Aparna Seksaria and Kevin Brophy sit down with Fierce Biotech’s Rebecca Williamson to talk about the importance of levelling the playing field by offering leading-edge software solutions to the smaller businesses in the pharma sphere. |
By Gabrielle Masson On the heels of Friday’s FDA approval of not one but two gene therapies to treat sickle cell disease, Editas Medicine is sharing another slice of early data for its gene-edited candidate designed to tackle the same condition. |
By Max Bayer If you can raise more in a tough financing environment, then why not? Such was the calculus for Bicara Therapeutics, which raised its second nine-digit financing in 2023 after building momentum off new data. |
By Max Bayer Merck & Co. is paying $10 million upfront with $600 million in potential biobucks for a targeted protein degradation med from C4 Therapeutics. The Big Pharma has the option to license three additional targets. |
By Gabrielle Masson A few weeks after selling off certain regional rights to monoclonal antibody (mAb) rademikibart, Connect Biopharma is back to share that an asthma trial assessing the candidate has hit its main goal, demonstrating significantly improved lung function in a mid-stage trial. |
By James Waldron Athira had clung to the hope that its drug fosgonimeton could overcome a phase 2 failure in Alzheimer’s to demonstrate success in Parkinson’s and dementia. Unfortunately, a mid-stage trial in those indications has been no kinder. |
By Gabrielle Masson As SQZ Biotechnologies slips away, the biotech’s founder and former CEO Armon Sharei, Ph.D., is launching a new cell engineering platform company dubbed Portal Biotechnologies. |
By James Waldron ISA Pharmaceuticals' cancer vaccine may have failed to sufficiently improve the overall response rate in a phase 2 trial, but the Netheralands-based biotech is insistent that honing in on a subgroup of patients could reap rewards in phase 3. |
By Gabrielle Masson,Max Bayer,Annalee Armstrong Alongside the new year, we've launched a new Fierce Biotech Fundraising Tracker to keep the pulse on the industry's financing. |
By Helen Floersh A collaboration between the Allen Institute, the Chan Zuckerberg Initiative and the University of Washington aims to build new technologies that let scientists measure changes in single cells in real time. |
By Helen Floersh Tune Therapeutics' epigenetic editor represses HBV genes in cell lines in mice almost completely, setting the stage for clinical trials in humans. |
By Ben Adams Less than two years after snapping up the chief commercial role at Moderna, Arpa Garay is stepping aside amid a shake-up in the Big Biotech’s commercial unit. |
By Andrea Park In the study, patients with Alzheimer’s were tasked with using Cognito’s neuromodulation headset for an hour each day for the entire six-month study period. |
By Eric Sagonowsky Evofem has struggled to gain commercial traction after a 2020 approval for Phexxi. Now, it's selling itself after shares crashed dramatically over the last few years. |
By Noah Tong Members on both sides of the aisle are celebrating successful efforts to codify price transparency requirements and establish site-neutral payments in the Lower Costs, More Transparency Act passed by the House of Representatives on Monday. |
Fierce podcasts Don’t miss an episode |
| Amphotericin B, an effective antifungal with rare resistance, is associated with significant kidney damage, prompting the search for a potential alternative. This week on "The Top Line," Fierce Biotech Research’s Helen Floersh spoke with Martin Burke, M.D., Ph.D., founder of antifungal startup Sfunga Therapeutics, to discuss the design and path to clinic of a promising new drug that could shape the future of antimicrobials. |
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