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Industry-wide accelerated approval review yields four withdrawals

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Since late December, four drugmakers have voluntarily withdrawn indications for their cancer drugs amid an industry-wide review of accelerated approvals by the US Food and Drug Administration’s (FDA) Oncology Center of Excellence.

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RAPS.org

Esmo 2020 preview – late-breaking immunotherapy

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Most of the presentation titles for the upcoming Esmo congress have now been made available, and judging by the late-breaking abstracts the meeting looks to be another one with a heavy focus on big pharma and immunotherapy.

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EP Vantage

Bristol Myers Pays Dragonfly $55M to Bring NK Cells to Neuro Diseases

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Bristol Myers Squibb likes what it sees from the immune cell research of Dragonfly Therapeutics so far—enough to pay $55 million to add multiple sclerosis and neuroinflammation to their ongoing partnership.

Source
Xconomy

I-O blockbusters from Merck, BMS and more linked to poor COVID-19 outcomes: study

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In the month ending April 7, 423 cancer patients at Memorial Sloan Kettering Cancer Center were diagnosed with COVID-19, 20% of whom developed serious respiratory symptoms. That in and of itself wasn’t surprising, given that cancer patients are immuno-compromised and therefore face a higher risk of struggling with the virus.

But one trend that emerged among those COVID victims did surprise their MSK oncologists: The risk of poor outcomes was higher among patients who had been treated with drugs that inhibit “checkpoints” such as PD-1 and CTLA-4 so the immune system can recognize and attack cancer, according to a study (PDF) published in Nature Medicine.

Source
Fierce Pharma

FDA accepts for priority review Bristol Myers Squibb’s application for CC-486 for maintenance treatment of adults in remission with AML

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Bristol Myers Squibb announced that the US Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for CC-486 for the maintenance treatment of adults in remission with acute myeloid leukemia (AML)

Source
Pharmaceutical Business Review

Motion denied: Gilead still on the hook for $1.5B in damages over CAR-T patent dispute with Bristol Myers Squibb

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Gilead’s bid to overturn a jury verdict that ordered it to pay Bristol Myers Squibb about $752 million for CAR-T patents owned by its subsidiary Juno Therapeutics has ended in vain.

Source
Endpoints

Just in time to assure a decision before CVR deadline, Bristol Myers Squibb files NDA for Celgene/bluebird CAR-T

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A new CAR-T therapy may be coming. And maybe $9 per share for Celgene investors, too.

Bristol Myers Squibb announced they submitted an NDA for the multiple myeloma “ide-cel” CAR-T therapy Celgene developed in partnership with bluebird. The therapy is one of the three that has to be approved to unlock the BMS-Celgene contingent value agreement that would give shareholders of the absorbed NJ company $9 per share. The first, ozanimod, was approved last week. The second, a CAR-T treatment for non-Hodgkin’s lymphoma called liso-cel, was submitted to the FDA in December.

Source
Endpoints

FDA Approves Bristol Myers MS Drug, But Pandemic Will Delay Launch

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A multiple sclerosis drug that came to Bristol Myers Squibb via its acquisition of Celgene last year was approved Thursday but don’t expect it to reach patients any time soon. The company says the drug’s launch will be delayed due to the coronavirus pandemic.

Source
Xconomy