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July 8-9, 2024 | Jersey City, NJ Hear the latest industry trends from leaders in the field, and developed with input from our esteemed advisory board, to ensure you have a sound plan for your company, brands, and yourself.
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| By Gabrielle Masson New data presented at 2024’s European Hematology Association meeting show how Gilead's bet on its now-abandoned CD47 drug magrolimab failed to deliver left and right. |
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By Zoey Becker Following a similar move by Texas, Kansas Attorney General is accusing Pfizer of "misrepresenting" its vaccine's safety and efficacy in a 179-page civil suit seeking unspecified damages. |
By Fraiser Kansteiner,Eric Sagonowsky,Angus Liu,Kevin Dunleavy,Zoey Becker After a period of leadership transition for many of the world's top drugmakers in recent years, the industry's CEO pay rankings appear to be returning to a state of equilibrium. |
By James Waldron The FDA has slammed the brakes on MediLink Therapeutics’ trial of a BioNTech-partnered antibody-drug conjugate over the risk of “unreasonable and significant risk of illness or injuries.” |
By Helen Floersh The “remarkable” success of chimeric antigen receptor T-cell therapy in lupus has led to a gold rush as cell therapy companies shift their focus from oncology to immunology. But a new relapse in a clinical trial may dim the strategy’s glow, at least in the eyes of investors. |
By Kevin Dunleavy The FDA has approved the world’s first pneumococcal disease vaccine designed for adults, signing off on Merck’s Capvaxive (formerly V116) and positioning it to become the primary shot used by seniors to protect against the bacterial infection. |
By Conor Hale The FDA is joining hands with regulators in Canada and the U.K. on policies to ensure transparency in the development of medical devices powered by machine learning. |
By Zoey Becker In deal potentially worth up to $1.3 billion, Takeda has gained an option to license Ascentage's third-generation tyrosine kinase inhibitor, which could go up against Novartis' Scemblix in chronic myeloid leukemia. |
By Helen Floersh Everyone knows that mice aren’t men. Yet animal studies still form the basis of most biomedical research, even as their value is hotly debated. But exactly how often do therapies that start in animals ultimately translate to new drugs for humans? |
By Zoey Becker A New Jersey jury determined that the company caused submissions of almost 160,000 false claims across state and federal governments due to off-label marketing of its HIV meds Prezista and Intelence. |
By Fraiser Kansteiner From vitamin maker to pharmaceutical specialist and now, contract manufacturer, India’s Lupin is embarking on a new phase of its corporate journey. |
Fierce podcasts Don’t miss an episode |
| In this week's episode of "The Top Line," journalists from Fierce Biotech and Fierce Pharma discuss the most talked-about data drops at ASCO and share on-the-ground details, including their experience with Gilead’s virtual reality Trodelvy ride. |
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Whitepaper This study delved into the manufacturing costs of the three mRNA capping methods. It involved discussions with 30 subject matter experts engaged in mRNA therapeutic development across various companies in the US and the EU. Sponsored by: TriLink |
Whitepaper An insider’s workbook filled with practical tips and tools for designing and scaling a global patient support program. Sponsored by: Harte Hanks |
Webinar Watch our on-demand webinar video to learn more about the challenges in pDNA manufacturing for gene and cell therapy and how to resolve many of these barriers by partnering with our experts through the adoption of vital manufacturing technologies and strategies. Sponsored by: Aldevron |
Research Learn how a Top-10 Pharma company automated the extraction of oncology efficacy endpoints from scientific literature with high precision and recall using a combination of AI technologies. Sponsored by: IQVIA |
eBook This eBook offers insights for business leaders looking to do more with reduced budgets by using the power of SmartIQ’s true forms automation to eliminate the need to print, sign, and scan/mail physical documents, increase operational efficiency, and reduce disparate systems. Sponsored by: SmartComms LLC |
Whitepaper Virtual care programs represent a compelling opportunity for decision makers in life sciences companies to drive growth, innovation, and value creation. Download now to learn more. Sponsored by: Wheel |
Whitepaper Small molecule active pharmaceutical ingredients (APIs) continue to grow more complex. Download the white paper to learn more about using synthesis and route design technology to approach API complexity. Sponsored by: Lonza |
Whitepaper This paper outlines the challenges, pitfalls, & solutions associated with adding rare disease therapies to a biopharma company’s portfolio. Sponsored by: AIM, the strategic leader in life science supply chains |
On Helix Date: 4 July 2024 - Location: Babraham Research Campus, Cambridge UK |
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