| Editor's Note: The Fierce PM Tracker will not publish on Monday, May 29, due to the Memorial Day holiday. We'll be back in your inboxes on Tuesday, May 30. Enjoy your long weekend! |
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Explore the current environment of cell therapies in solid and hematologic cancer. Discover lessons learned from the front lines of cell therapy trial conduct. Decode the nuances and strategies of oncology cell therapy research and development. Equip yourself with the knowledge to amplify your program. Precision for Medicine – Realize More.
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Today's Big NewsMay 26, 2023 |
| By James Waldron Roche's faith in TIGIT may have finally been rewarded, as tiragolumab shows signs of efficacy in liver cancer. |
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By Zoey Becker After Novartis’ sickle cell disease medicine Adakveo flopped in a phase 3 trial, European regulators promised to take a closer look at its prior approval. Now, the re-examination has come back with a recommendation to revoke authorization. |
By Andrea Park In spite of a wave of news reports suggesting that more delays were on the horizon, almost exactly six months after Elon Musk said his neurotech company Neuralink was half a year away from beginning human trials of its flagship brain implant, the company has achieved that goal. |
By Gabrielle Masson Regeneron believes its LAG-3 inhibitor and PD-1 inhibitor combo for patients with advanced melanoma could serve as a rival to Bristol Myer Squibb’s Opdualag, although a significant portion of patients discontinued treatment in a phase 1 study. |
By Angus Liu Bristol Myers Squibb's Breyanzi is the first CAR-T drug to deliver a positive readout in chronic lymphocytic leukemia in a pivotal multicenter study. But the study's small size and its single-arm nature might raise uncertainties for drug regulators. |
By Helen Floersh After a motorbike accident left him paralyzed from the waist down, Gert-Jan wished to walk again. Now, with the help of a "digital bridge" that connects his brain to his spinal cord, he can. |
By Kevin Dunleavy Pfizer and BioNTech have agreed to reduce their supply of COVID-19 vaccines to the EU by 35%, according to a report from Bloomberg. Meanwhile, Moderna is looking to boost its vaccine sales in China, establishing a unit based in Shanghai. |
By James Waldron The U.K. government has pledged that a chunk of the 650 million pound sterling ($803 million) funding package assigned to boost the country’s life sciences industry will go toward reversing the slowdown in clinical trial uptake. |
Fierce podcastsDon't miss an episode |
| This week on "The Top Line," we discuss the 20 most influential people in biopharma, plus a topical gene therapy, a new opioid overdose medication, and the rest of the week's headlines. |
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Friday, June 9, 2023 | 9am ET / 6am PT Plasmid DNA plays a very important role in cell and gene therapy, yet often manufacturing at large scale can present challenges for organizations looking to focus their efforts on therapeutic outcomes rather than bioprocessing roadblocks. Join this discussion to explore the latest opportunities, challenges, innovations, lessons learned and more. Register now.
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WhitepaperChatGPT shows promise in drug discovery for information extraction, scientific text authoring, hypothesis prediction, and chemical entity prediction. This whitepaper explores its potential to streamline research, delving into its technology, applications, and limitations. Sponsored by: Elucidata Corp., Cloud SAAS in Life Sciences R&D |
WhitepaperLearn how a GPCR-focused library with a cell-based biopanning strategy led to the discovery of 13 high-affinity and selective anti-GLP-1R antibodies with highly developable therapeutic properties. Sponsored by: Twist Bioscience |
eBookDiscover a game-changing approach to clinical research with Hybrid and Decentralized Clinical Trials (DCTs). Learn about the benefits, challenges, and key elements for success. Sponsored by: EvidentIQ |
ResearchWhat role do the Library and Legal teams play in the drug development pipeline at Lilly? An import one – find out how. Sponsored by: CCC |
WhitepaperThis paper focuses on stakeholder engagement and how Medical Affairs teams’ responsibilities, goals, tools, and techniques are changing. Sponsored by: Blue Matter, strategic consultants in the life sciences |
ResearchStrategies for Optimal Site Selection and Feasibility Research in Novel Therapies and Geographies Sponsored by: H1 |
WhitepaperExplore how clinical supply can be scaled up as decentralized programs progress, and how technological solutions can accelerate trial deployment. Sponsored by: Catalent Clinical Supply |
WhitepaperDiscover key considerations that every trial sponsor should know when navigating the complex clinical supply distribution landscape across Asia-Pacific. Sponsored by: Catalent |
Whitepaper As sponsors increasingly look to CROs to support their clinical studies, making and addressing certain clinical supply considerations at the outset of the relationship can reduce the risk of potentially unforeseen impact to budget and time later. Discover key issues sponsors should consider to help their CRO or partner of choice better understand their clinical supply needs. Sponsored by: Catalent |
WhitepaperFor sponsors, cost is a key concern when it comes to managing the supply of their clinical trials. A financial project analyst (FPA) is a specialized expert who can help control clinical supply costs and keep the project within budget. Explore the critical role that a Financial Project Analyst plays in clinical trial supply and budget management. Sponsored by: Catalent |
WhitepaperLearn how Catalent’s extensive network across APAC can meet a wide range of clinical supply needs for sponsors conducting trials within the region. Sponsored by: Catalent |
WhitepaperHow can specialized expertise help you optimize your clinical supply chain? Learn about the roles and responsibilities of unique experts such as clinical supply management, project management, and financial project analysis. Sponsored by: Catalent Clinical Supply |
WhitepaperPlanning on using a CRO to support your next clinical study? This infographic outlines critical areas to address at the start of the relationship in order to ensure that budget and timelines keep on track for the duration of the trial. Sponsored by: Catalent |
WhitepaperExplore Catalent’s newest clinical supply facility in Japan, including the comprehensive services & solutions it offers to help support trials both in-country & around the world. Sponsored by: Catalent |
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