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Patients treated with Bristol Myers Squibb’s Krazati in combination with cetuximab saw shorter median overall and progression-free survival than comparators on chemotherapy.
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Molecular glue degraders are gaining traction in the clinic as well as funding from Big Pharma, with their potential to treat previously “undruggable” cancers and immunological diseases. Here are five clinical programs worth keeping an eye on.
Last month, the FDA launched TrialBlazer, intended to streamline the IND path and bring early clinical trials and medical innovation home to the U.S. It’s a start, but new agency leadership must see it through.
Significant leadership instability at the FDA—compounded by continued workforce attrition—led to a slight slowdown in overall regulatory productivity in the first half of this year, but the agency has been catching up of late.
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Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
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While the regulator conducts another review into the supply of Eli Lilly’s tirzepatide, compounders will be able to continue selling their own remixed versions of the blockbuster drug.
The approval makes Pfizer’s Hympavzi the first once-weekly subcutaneous prophylactic injection for hemophilia B in the U.S., according to the company, which is currently embroiled in a row with activist investor Starboard Value.
While ex vivo genome editing results in highly effective cell therapies, it can lead to off-target effects. Caribou Biosciences has come up with a novel approach for potentially more precise gene editing compared to all-RNA guides.
The FDA is looking at four events for the remainder of October, one of which is an advisory committee meeting for a dual SGLT inhibitor for use alongside insulin in type 1 diabetes and chronic kidney disease.
Since its inception in 1992, the FDA’s accelerated approval pathway has helped shepherd nearly 300 new drugs to the market. However, recent years have seen a number of high-profile market withdrawals and failed confirmatory trials.
As companies roll out data showing the power and improved safety profile of antibodies that target two antigens, analysts say the class could overtake monoclonal antibody Keytruda as the “immunotherapy backbone” of solid tumor treatment.
Senator Elizabeth Warren told the Federal Trade Commission that the acquisition of contract manufacturer Catalent could increase Novo’s dominance over the hot GLP-1 market, reducing competition and increasing prices.
Turnstone is shifting resources to focus on clinical advancement of its selected tumor-infiltrating lymphocyte therapy as three C-suite members exit their roles.
Two biotechs set out for the public markets this week, with Upstream Bio raising $255 million for its inflammatory disease work, while CAMP4 Therapeutics picked up $75 million to develop RNA-targeting drugs.
Despite substantial variability in the presented data and no well-controlled trial, the FDA advisory committee voted in favor of Stealth BioTherapeutics’ Barth syndrome therapy elamipretide, citing the urgent unmet need.