| Today's Big NewsMay 19, 2023 |
| By Nick Paul Taylor Moderna has early clinical evidence that its mRNA technology can treat a rare disease by replacing intracellular proteins. Participants in the phase 1/2 trial experienced a 66% overall relative risk reduction in the frequency of life-threatening events, encouraging the biotech to keep studying the candidate. |
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By Angus Liu AbbVie and Genmab's CD20-targeted bispecific epcoritamab has won an FDA blessing in diffuse large B-cell lymphoma. The drug boasts what analysts view as a best-in-class profile against potential competition from Roche and Regeneron. |
By Andrea Park Less than two years after Pear Therapeutics went public in a SPAC deal worth $1.6 billion—which in turn came after the digital therapeutics maker had raised more than $400 million in venture capital—its assets were sold in an auction this week for just over $6 million. |
By Andrea Park A pair of newly FDA-cleared blood tests from Thermo Fisher Scientific could be a major boon in the early detection and treatment of preeclampsia, a pregnancy complication that can endanger both the mother and fetus—and one that’s risen in prevalence in the U.S. in recent years. |
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Tuesday, May 23, 2023 | 12pm ET / 9am PT Join us for this insightful webinar to explore why analytical development is often underestimated, and should go hand-in-hand with process development when addressing clinical and commercial manufacturing requirements, advantages of using integrated analytical services within the areas of process development and technology transfer, and more. Register now. 
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By Gabrielle Masson Pfizer’s RSV shot has won the support of an FDA advisory committee for use in pregnant people to protect infants, but lingering concerns remain from a few members that couldn’t back the vaccine’s safety. |
By Kevin Dunleavy Amgen has complied with an FTC request for a temporary restraining order, agreeing not to close its proposed $27.8 billion deal to acquire Horizon Therapeutics right away. The move comes in response to the FTC filing an antitrust lawsuit earlier this week which is attempting to block the deal. |
By Andrea Park Though the current conversation about brain-computer interfaces is largely dominated by two companies—Synchron, with a minimally invasive implant already in human trials, and Elon Musk’s Neuralink, which has faced a series of setbacks in its own race to the clinic—they’re not the only ones developing implants aimed at decoding neurological signals. |
By Nick Paul Taylor Cure Rare Disease has shared a deep dive into the death of the only participant in a gene therapy trial. The nonprofit and its collaborators tied the death of the Duchenne muscular dystrophy patient to their immune reaction to the viral vector, raising concerns about dosing older, more advanced people. |
By Kevin Dunleavy AbbVie scored its seventh FDA approval for Rinvoq in a span of less than four years, getting the JAK inhibitor across the FDA finish line as a treatment for Crohn’s disease. |
By Andrea Park Many insertable cardiac monitors, known as ICMs or loop recorders, are already able to stay in place under the skin for several years at a time, enabling long-term tracking of irregular heartbeats—but Abbott has upped the ante. |
By Max Bayer As the American Society of Gene & Cell Therapy annual meeting draws to a close, Rocket Pharmaceuticals spotlighted three ongoing clinical programs for patients with blood disorders, two of which are nearing regulators’ desk. |
Fierce podcasts Don't miss an episode |
| This week on "The Top Line," we''ll discuss the recent biopharma layoff trends, plus Elizabeth Holmes, Sarepta Therapeutics, Abbott's FDA approval, and the rest of the week's headlines. |
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Thursday, May 25, 2023 | 10:00am ET / 7:00am PT Join the webinar and discover our MVA technology platform and explore the advantages for development and manufacturing of multiple vaccines and cell and gene therapeutics. Register now. 
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Whitepaper ChatGPT 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 |
Whitepaper Learn 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 |
eBook Discover 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 |
Research What role do the Library and Legal teams play in the drug development pipeline at Lilly? An import one – find out how. Sponsored by: CCC |
Whitepaper This 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 |
Research Strategies for Optimal Site Selection and Feasibility Research in Novel Therapies and Geographies Sponsored by: H1 |
Whitepaper Explore how clinical supply can be scaled up as decentralized programs progress, and how technological solutions can accelerate trial deployment. Sponsored by: Catalent Clinical Supply |
Whitepaper Discover 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 |
Whitepaper For 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 |
Whitepaper Learn 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 |
Whitepaper How 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 |
Whitepaper Planning 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 |
Whitepaper Explore 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 |
| July 18-19, 2023 | Jersey City, NJ |
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