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September 26, 2023 | 1:00 PM ET Planning to commercialize a gene therapy product? Learn how you can maximize revenue potential and navigate the market’s unique challenges with Trinity Life Sciences. Ready to tackle the elephant? Register Now.
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Today’s Big NewsAug 31, 2023 |
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Understand how to navigate EU regulations to launch rare disease medicines in European markets. Download guide.
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Thank you to Bridge Bankfor sponsoring our editorial feature: Fierce 15 |
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| By Nick Paul Taylor Bristol Myers Squibb has reported full phase 1 data on one of its successors to Revlimid and Pomalyst. An outside expert called the multiple myeloma survival data “modest,” but the potential for the therapy, mezigdomide, to find a place in combination therapies is spurring hopes heading into phase 3 readouts. |
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By James Waldron Sage Therapeutics will jettison 40% of its workforce as the company navigates a future for its Biogen-partnered drug after the therapy was rejected as a treatment for major depressive disorder. |
By Max Bayer ADC Therapeutics is stepping away from a 2019 licensing pact with Adagene following a refocused clinical development plan. Adagene received an undisclosed upfront payment and research reimbursement when the deal was first signed. |
Sponsored by Novartis Global Biotech Cooperations With the rapid increase in cell and gene manufacturing, companies need support from experienced, reliable, and global, CDMO's with a deep and rich technology network. |
By James Waldron Mesoblast’s CEO will “lead by example” and take a 30% pay cut as the biotech continues to reel from another FDA rejection of its off-the-shelf cell therapy. |
Sponsored by IPM.ai Using artificial intelligence to predict and uncover de-identified rare disease patients shortens the time to diagnosis, benefiting both patients and life science companies. |
By Nick Paul Taylor Genexine’s once-weekly growth hormone has matched daily injections in a pivotal trial in China, teeing it and its partners I-Mab and Jumpcan up to file for approval next year and prepare to launch the medicine. |
By Helen Floersh A molecule developed by researchers at the Massachusetts Institute of Technology appears to improve cognitive function in mouse models of Alzheimer’s disease, setting the stage for a new drug that could one day complement existing therapies. |
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. |
By Joseph Keenan Lokavant, a unit of Roivant Sciences, has debuted a study planning platform to help sponsors and CROs determine the best sites and other goals for their clinical studies. |
By Fraiser Kansteiner After FDA Commissioner Robert Califf, M.D., recently made comments about the untenable nature of generic drug production in the U.S., a clutch of governors has raised its own set of concerns about shortages. |
By Andy Miller and Sam Whitehead, KFF Health News Artificial intelligence is working its way into more parts of American life. As AI spreads within the health care landscape, it brings familiar concerns of bias and accuracy and whether government regulation can keep up with rapidly advancing technology. |
By Nick Paul Taylor Emergent BioSolutions has launched an over-the-counter version of its opioid overdose treatment Narcan, putting the emphasis on the potential for the product to keep loved ones safe with the tagline “anyone can save a life.” |
By Noah Tong As more Medicaid beneficiaries are wrongly kicked off the program, CMS is requiring states to reevaluate its eligibility systems and auto-renewal process. |
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| WebinarDownload this webinar to learn how to avoid pitfalls when characterizing CAR-T cells in your development workflow, how to save time by using one antibody to examine your entire panel of CARs, and more. Sponsored by: Cell Signaling Technology |
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