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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 15, 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 Max Bayer FDA advisers have narrowly voted in favor of Sarepta’s gene therapy for patients with Duchenne muscular dystrophy, a stunning decision that runs counter to regulators who expressed skepticism heading into the meeting. |
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By Max Bayer Sarepta was handsomely rewarded by investors early Monday after FDA advisers surprisingly voted in favor of the accelerated approval path for the company’s Duchenne muscular dystrophy gene therapy on Friday evening. |
By James Waldron Whether it’s returning to CAR-Ts, swooping in to pick up a Parkinson’s asset from a sinking biotech or setting up a spinout company to pursue its neuroscience ambitions, Janssen has been busy in recent months. |
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 Gabrielle Masson Gilead is paying $35 million cash to expand an existing oncology partnership with Arcus Biosciences into inflammatory diseases, giving the biotech the chance to make up to $1 billion in biobucks. |
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 Nick Paul Taylor AstraZeneca’s search for antibody-drug conjugates has again led to Asia. This time around, the Anglo-Swedish drugmaker is committing up to $55 million in upfront and near-term payments to secure global rights and join an intensifying race to offer options to patients who relapse after BCMA therapy. |
By Gabrielle Masson Nido Biosciences is exiting stealth mode with $109 million in hand to develop new precision medicines for neurological diseases, with a lead asset that takes aim at Kennedy’s disease, a rare degenerative disorder. |
By Nick Paul Taylor Athenex has run out of road. With programs stumbling and cash running out, the drug developer has filed for bankruptcy and begun seeking buyers for its three businesses. |
By Helen Floersh Scientists have once again implanted human-derived organoids into mouse brains, in this case to study the brain’s immune cells in-depth for the first time. |
By Zoey Becker The decision came nearly three months after the drug's original FDA decision date. |
By Frank Diamond Employers who self-insure are being hit by more million-dollar claims, according to a new report. Pricey injectables are a major factor. |
By Andrea Park For the second time in a decade, Philips has agreed to settle with the U.S. Securities and Exchange Commission over alleged misconduct in its international operations. |
By Angus Liu Pfizer's $43 billion Seagen deal is now up for its high-stakes review at the FTC. The review comes after the agency said it would take a tougher stance toward biopharma megamergers. |
Fierce podcastsDon't miss an episode |
| | This week on "The Top Line," we're concluding our miniseries on Narcan the nasal spray. It is the first naloxone product to be approved for use without a prescription. |
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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 |
| Whitepaper How can eConsent provide a more flexible approach to informed consent? Sponsored by: YPrime |
| 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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