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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 23, 2023 |
| By Kevin Dunleavy With demand for vaccines and other COVID-19 products plummeting, drugmakers who thrived during the pandemic have seen their sales decline significantly. The effects of the COVID cliff were apparent over the last few weeks as companies reported their first-quarter results. Of 20 leading biopharma companies, just six saw their revenues increase in the first quarter of 2023 compared with the same period last year. |
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By Andrea Park When Abbott reeled in FDA approval for its first leadless pacemaker last spring, it was playing catch-up with Medtronic, whose Micra implant became the first such device greenlighted by the regulator in 2016. Now, however, Abbott is hoping to leap ahead of the competition by being the first to earn the FDA’s blessing for a dual-chamber version of the technology. |
By Max Bayer ReNAgade Therapeutics is unveiling after closing a $300 million series A in the largest private fundraising round of the year to date. The new company's joint venture with Orna Therapeutics has already spawned a collaboration with Merck & Co. |
By Kevin Dunleavy Diabetes and weight loss juggernaut Novo Nordisk has presented data from a phase 3 trial that show an oral version of its obesity drug Wegovy performs comparably to its original injected therapy. In the study, patients who received a 50 mg daily dose lost an average of 15.1% of their weight over 68 weeks compared to 2.4% for those on placebo. |
By Nick Paul Taylor Wave Life Sciences’ antisense oligonucleotide WVE-004 has come up short in an early-phase trial. A year after Biogen and Ionis killed off a similar asset, the biotech is waving goodbye to WVE-004 after getting a look at early-phase clinical trial data in amyotrophic lateral sclerosis and frontotemporal dementia. |
By Andrea Park A recall of nearly 62,800 replacement batteries used in several of ICU Medical’s infusion pumps has received the FDA’s Class I rating—the agency’s most serious, denoting a higher risk of serious injuries or death linked to use of the affected devices. |
By Zoey Becker Blueprint's Ayvakit is now approved to treat the indolent form of systemic mastocytosis. The nod follows the drug's 2021 green light for the advanced form of the disease. |
By Zoey Becker As the opioid epidemic rages on in the U.S., a new overdose reversal option has arrived in Opiant's Opvee. The nalmefene hydrochloride nasal spray is a new tool to combat rising overdose rates. |
By Andrea Park After an attempt to expand its business fell apart earlier this year, Bioventus is downsizing instead. |
By James Waldron April was a tricky month for Affimed. We already knew that a phase 2 fail prompted the end of plans to develop a bispecific antibody as a monotherapy in lymphoma. Now, Affimed has revealed that the resulting reorganization also meant a quarter of its employees were shown the exit. |
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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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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