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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 15, 2023 |
| By Max Bayer Mersana Therapeutics' lead antibody-drug conjugate (ADC) has had the clamps put down by the FDA over bleeding events in patients that have included five fatalities. |
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By Nick Paul Taylor Eli Lilly is joining Amgen and Novartis in the pack of drugmakers aiming to treat cardiovascular disease by targeting lipoprotein(a) (Lp(a)). The Big Pharma landed a spot at the back of the bunch by handing Verve Therapeutics $60 million for rights to its once-and-done gene editing approach to the problem protein. |
By Gabrielle Masson After nearly 20 years away, pharma vet Paul Burton, M.D., Ph.D., is returning to Amgen. The leader will leave his chief medical officer spot at Moderna for the same role at Amgen. |
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 Syncona has blamed the “challenging market environment” for another quarter of falling valuations, as the life sciences investment firm pushes its portfolio of biotechs to trim back their pipelines. |
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 James Waldron Aldeyra Therapeutics has notched up another phase 3 win for its allergic conjunctivitis treatment, as the biotech awaits an FDA approval decision for dry eye disease. |
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 Nick Paul Taylor Astellas has found a biotech capable of enhancing its in-house protein degradation skills. Having used its internal capabilities to hustle a KRAS candidate into the clinic, the Japanese drugmaker has agreed to pay Cullgen $35 million upfront to access next-generation prospects. |
By Helen Floersh Brain aneurysms at risk of rupture can only be treated with surgery, and that may not be possible if the aneurysm is in a hard-to-access location. But a new study hints at another solution: the cancer drug sunitinib, commercialized by Pfizer as Sutent, which appears to prevent aneurysms in mice. |
By Kevin Dunleavy A vaccine manufacturing facility conceived as an example of the good that can come from a public/private partnership now sits empty in Scotland, with its fate yet to be determined. French biotech Valneva reportedly hired commercial real estate firm JLL to help determine what to do with the 75,000-square-foot plant in Livingston, West Lothian. |
By Nick Paul Taylor Pfizer has a new star on the telephone. After working with Khloe Kardashian to move Nurtec ODT to the edge of glory, the migraine therapy’s marketing team has signed up Lady Gaga to give patients a million reasons to take the treatment. |
By Annie Burky Paige is enhancing its suite of AI-powered tools designed to support pathologists in the diagnosis of breast cancer while decreasing subjectivity and the tedium of manual analysis. |
By Eric Sagonowsky While demand for COVID-19 vaccines has plummeted throughout 2023, healthcare officials remain focused on ensuring that the most effective shots are available for those who need them. Now, regulators are discussing strain selection for the next round of boosters. |
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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