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While relying solely on your nonclinical laboratory can be tempting when conducting IND-enabling studies, it’s important to provide significant input and oversight to ensure regulatory compliance. Watch our on-demand webinar to learn how to prepare so that your studies meet FDA guidelines. Premier Consulting. Built for Biotech℠. _updated+(1).png)
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Today's Big NewsJun 12, 2023 |
| By Nick Paul Taylor Novartis wants to give a $3.2 billion lift to its kidney disease pipeline. While working to generate phase 3 data on its own IgA nephropathy candidate, the Swiss drugmaker has seized the chance to buy Chinook Therapeutics for a pair of late-stage programs targeting the rare, progressive chronic kidney disease. |
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By Annalee Armstrong Patients with the inflammatory disorder hereditary angioedema who took Intellia Therapeutics’ CRISPR medicine have been attack free for a year or more after receiving just one dose. |
By Nick Paul Taylor Coya Therapeutics’ plan to treat frontotemporal dementia by boosting the function of regulatory T cells is unraveling. Months after putting FTD at the heart of its IPO pitch, the biotech has decided it would be “premature” to continue to study its low-dose formulation of IL-2 in the indication. |
Sponsored by YPrime Michael Hughes, Chief Product Officer at YPrime discusses the benefits and challenges of eConsent implementation and how to circumvent the biggest barriers to adoption. |
By James Waldron A week after Oncorus shed pretty much all its staff, the board has decided that the game is up and moved to liquidate the RNA-focused company. |
Sponsored by Sanyou Biopharmaceuticals Co., Ltd. On June 12th, 2023 local time, Sanyou Biopharmaceuticals Co., Ltd. officially announced the launch of "Sanyou Super Trillion Common Light Chain Antibody Discovery Platform" (the "platform"). As one of the nine trillion antibody discovery platforms of Sanyou, the platform features a library capacity of up to 1.12E+12 CFU. For a single target, the platform can generate hundreds of lead antibodies with diverse sequences, which can be further designed into bispecific antibodies with good drug developability, providing a feasible solution for obtaining bispecific antibodies with structures similar to the natural monoclonal antibodies |
By Helen Floersh Scientists have come up with a new anti-Müllerian hormone gene therapy that could one day offer an alternative to surgical sterilization in female cats. Their findings help validate the notion of using AMH in human applications too. |
Sponsored by The Janssen Pharmaceutical Companies of Johnson & Johnson The creation of collaborative partnerships continues to be essential to delivering transformational therapies to address critical healthcare needs. |
By Ayla Ellison Francis deSouza has resigned as CEO and director of Illumina after recently surviving activist investor Carl Icahn’s proxy fight against the company, which involved demands to remove deSouza from the DNA sequencing company’s board and replace him as chief executive. |
By Zoey Becker After Merck's bombshell lawsuit contesting the Inflation Reduction Act, shareholders at the Interfaith Center on Corporate Responsibility are asking the company to reconsider. They're citing Merck's stated commitments to access and affordability as the rationale behind their plea. |
By Andrea Park No more beating around the bush here: With a newly bestowed FDA clearance, Huma’s disease-agnostic health management software can now be more direct in offering clinical recommendations to users and their doctors. |
By Eric Sagonowsky After a daylong discussion among experts on an FDA advisory committee, Eisai and Biogen's Leqembi is heading into the final stretch of its regulatory review on strong footing. |
By Frank Diamond Emerging Alzheimer’s medications come with high price tags, but researchers with the University of Chicago calculate that in the long run, it’s much less costly to cover these therapies for Medicare beneficiaries. |
Fierce podcasts Don't miss an episode |
| This week on "The Top Line," we discuss the the top news from this year's annual ASCO meeting, plus contesting the Inflation Reduction Act, an ADHD video game, and the rest of the week's headlines. |
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July 18-19, 2023 | Jersey City, NJ This is the only communications event for peer learning and networking exclusively for the life science community. Save $300 when you Register Today! .png)
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Whitepaper Autoantibody screening is promising for early cancer detection with the potential to improve the whole treatment decision tree, providing a less invasive, powerful approach. Sponsored by: Sengenics |
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 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 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 |
eBook See how clinical trial sponsors can build stronger strategies to address challenges across the patient enrollment funnel, starting with four necessary steps. Sponsored by: OneStudyTeam |
Whitepaper This paper outlines various market archetypes and key considerations leaders must address when prioritizing new potential markets for gene therapies. Sponsored by: Blue Matter, strategic consultants in the life sciences |
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 |
| July 18-19, 2023 | Jersey City, NJ |
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