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IND-enabling nonclinical studies play a crucial role in bringing new medications to market. But these tests require careful coordination & meticulous execution. Read our 5-step checklist to help make sure the data is accepted by regulatory agencies. Attending ACT Nov 12-15? Schedule a meeting with our experts!
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Today’s Big NewsSep 28, 2023 |
| By Max Bayer FDA advisers voted down BrainStorm's cell therapy for ALS, saying that there was not enough evidence to demonstrate the treatment's potential efficacy. The committee also raised issues with the lack of data on the company's manufacturing and delivery process. |
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By Nick Paul Taylor Bionomics’ bid to bounce back from its stock-crushing anxiety trial failure has gained a little momentum, with investors sending the share price up over 180% on the strength of phase 2 data in post-traumatic stress disorder. |
By Max Bayer Karuna has formally submitted a new drug application to the FDA for its schizophrenia treatment. The company expects to launch in the second half of 2024 if approved. |
Sponsored by IPM.ai IPM.ai helps brands assess a unique patient population, accelerate clinical trial recruitment, and optimize commercial outcomes |
By James Waldron Gritstone Oncology is the latest drug developer to be tapped for BARDA’s Project NextGen, with the biotech in line for over $400 million to conduct an 10,000-person phase 2 study of its COVID-19 vaccine. |
Sponsored by Emulate An introduction to Organ-on-a-Chip technology and how it can improve the quality of drugs entering the clinic. |
By Nick Paul Taylor The artificial intelligence deals keep coming at Merck KGaA. Days after the Merck put out news of two new AI pacts, Quris-AI has shared details of the expansion of the drug toxicity prediction project it is working on with the German drugmaker. |
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 Fraiser Kansteiner Bluebird and Lonza recently amended their production contract for the second time since the deal was announced in summer of 2016. Under the updated deal, Lonza has agreed to increase manufacturing capacity for bluebird’s therapies Zynteglo and Skysona, according to a SEC filing published Wednesday. |
By Joseph Keenan Clinical trial tech firm Clario has joined forces with CellCarta to improve the way tissue and other samples are handled during trials. |
By Heather Landi Amazon announced this week that it would invest up to $4 billion in artificial intelligence company Anthropic as the AI arms race heats up. The collaboration introduces more competition and more options for healthcare teams looking to innovate using different approaches or to get more tactical with their AI strategy, one health IT expert said. |
By Joseph Keenan Maryland-based CRO Emmes has added telehealth capabilities to its Advantage eClinical platform, allowing for virtual video calls for trial participants and sites. |
By Heather Landi As new primary care models, including retail health clinics, continue to scale, the national supply of clinical providers will become even more constrained. For health systems, hospitals and medical groups, competition for the shrinking pool of nurses and doctors will intensify, according to a new analysis. |
Fierce podcastsDon’t miss an episode |
| | In this week's episode of "Podnosis," Heather Landi from Fierce Healthcare engages in a conversation with Othman Laraki, co-founder and CEO of Color Health. They delve into strategies for boosting screenings and explore the partnership between Color Health and the American Cancer Society, aimed at making convenient cancer screenings more accessible. |
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October 16-18, 2023 | Boston, MA Hear from leading experts as they share their experiences and insights covering drug development from the earliest stage of research to FDA approval. Time is running out, be left out! Register today
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| eBookLearn how to get better results from suboptimal biospecimens for NGS and protein analysis. Sponsored by: Covaris |
| Whitepaper As the field of real-world data and evidence is constantly evolving, it can be hard to keep-up with best practices. Do you know the definitive characteristics of a high-quality dataset? What questions to ask if you decide to outsource your research to consultants? Here’s everything you need to know in one, must-have guide. Sponsored by: MarketScan by Merative |
| Whitepaper As the field of real-world data and evidence is constantly evolving, it can be hard to keep-up with best practices. Do you know the definitive characteristics of a high-quality dataset? What questions to ask if you decide to outsource your research to consultants? Here’s everything you need to know in one, must-have guide. Sponsored by: MarketScan by Merative |
| eBookEmulate in vivo biology with next-generation in vitro technology. Sponsored by: Emulate |
| Whitepaper Learn more about how you can improve the productivity of your research and manufacturing operations and accelerate the journey from laboratory to saving lives. Sponsored by: JLL |
| WhitepaperLearn how outsourcing the buffer preparation can reallocate resources to support core activities of your bioprocess production. Sponsored by: Thermo Fisher Scientific |
| WhitepaperFrom trial site feasibility and patient populations to data analysis, generative AI has the potential to revolutionize drug discovery and clinical trial recruitment at both the therapeutic area and indication level. Sponsored by: H1 |
| 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 |
| Whitepaper By 2030, the global demand for biologics is projected to grow at a CAGR of 8.7% and the challenges, risks, and costs of bringing large molecule products to market are growing exponentially. Sponsored by: ThermoFisher Scientific |
| Whitepaper15 biotech executives from the Cambridge area discuss the current biotech landscape, as well as challenges, opportunities, and best practices for emerging biotech companies seeking success in the UK and beyond. Sponsored by: Blue Matter, strategic consultants in the life sciences |
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