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Trinity Life Sciences can partner with you to assess, benchmark, plan and implement. LET’S GO.
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Today's Big NewsMay 19, 2023 |
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Learn how modern software development is driving the future of clinical research and technology, specifically how it is impacting the next generation of IRT. Learn more.
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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. |
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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. |
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. |
Sponsored by Bridge Bank Venture debt is a type of debt financing obtained by early and growth-stage companies and typically used as a complementary method to equity financing. |
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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 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. |
Sponsored by Cytel Developing a new life-saving drug or medical device is fraught with challenges. But while challenges often vary from program to program, one in particular is guaranteed: uncertainty. In this article, Dr Kim, CMO at Cytel, discusses the nature and consequences of the uncertainty challenge, as well as the options available to help pharmaceutical and biotechnology companies navigate it. |
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 Annalee Armstrong Fierce Biotech's M&A Tracker, your one-stop shop for dealmaking in the biopharma universe. |
By Fraiser Kansteiner After numerous twists and turns, a highly divisive patent infringement case between Amgen and partners Sanofi and Regeneron has come to an end at the U.S. Supreme Court. |
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 Paige Minemyer A key House panel advanced a slew of healthcare bills during a busy Wednesday on the Hill for health policy. |
By Teresa Carey 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. |
By Max Bayer,Gabrielle Masson,Andrea Park Gilead taps longtime Roche exec to lead Kite. Billy Dunn exits FDA's revolving door. Recursion names a new CMO. |
By Angus Liu Takeda is bracing for two important patent expirations this year. AstraZeneca has in-licensed an antibody-drug conjugate from Chinese company LaNova Medicines. Astellas' menopause drug fezolinetant has won a delayed FDA approval. And more. |
Fierce podcastsDon'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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| 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 |
| 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 |
| 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 |
| 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 |
| WhitepaperDiscover key considerations that every trial sponsor should know when navigating the complex clinical supply distribution landscape across Asia-Pacific. 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 |
| 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 |
| 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 |
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