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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℠.
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Today's Big NewsJun 13, 2023 |
| By Nick Paul Taylor Turnstone Biologics is about to show whether public investors have regained their appetite for high-risk, high-reward programs. Having lost deals with AbbVie and Takeda, and shrunk its head count, the biotech has filed for an IPO to fund early-phase development of tumor-infiltrating lymphocytes (TILs). |
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By James Waldron The war of words between Erytech and an activist investor trying to stall the long-planned merger with Pherecydes has reignited this week, with both sides firing off stinging press releases. |
By Nick Paul Taylor Alladapt Immunotherapeutics has delivered early clinical evidence that it can desensitize multiple food allergies with a single oral immunotherapy. The phase 1/2 clinical trial reported dose-dependent changes in recipients of the multi-allergen candidate, encouraging Alladapt to plot a late-stage program. |
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 Annalee Armstrong,Gabrielle Masson,Max Bayer We had hoped that our Layoff Tracker would stay retired for a while, but 2023 is starting to look a lot like our old friend 2022 when it comes to layoffs in biotech. |
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 Angus Liu Biogen has taken a step to “significantly refresh” its board of directors, departing chair Stelios Papadopoulos, Ph.D., said. But the reported romantic relationship between a new nominee and a departing member raises questions about one appointment. |
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 Phil Taylor Merit Medical Systems has spent $132.5 million in the last few days to ramp up its presence in the hemodialysis device market, adding a range of catheter and sealant products it reckons will add around $33 million a year to its top line. |
By Anastassia Gliadkovskaya The designation identifies providers committed to providing affirming care to the LGBTQ+ community by integrating OutCare’s “OutList,” which is the largest international directory of such providers according to the company. |
By Joseph Keenan AstraZeneca signed on with renewable natural gas producer Vanguard Renewables as part of a pledge to reduce its environmental footprint by using organic-produced fuel in all of its U.S. manufacturing facilities by the end of 2026. |
By Anastassia Gliadkovskaya The program includes at-home screenings, care navigation services, care advocacy and educational resources. The partnership will also give employers and unions data on their employee or member screening rates. |
Fierce podcastsDon'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!
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| WhitepaperAutoantibody 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 |
| WhitepaperDiscover key considerations that every trial sponsor should know when navigating the complex clinical supply distribution landscape across Asia-Pacific. Sponsored by: Catalent |
| 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 |
| 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 |
| eBookSee how clinical trial sponsors can build stronger strategies to address challenges across the patient enrollment funnel, starting with four necessary steps. Sponsored by: OneStudyTeam |
| WhitepaperThis 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 |
| 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 |
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