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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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According to analysts at BMO Capital Markets, non-obstructive hypertrophic cardiomyopathy would have meant a $1.3 billion label expansion opportunity for Camzyos.
At the heart of the licensing deal is CUE-501, a bispecific molecule that can selectively deplete B cells to address autoimmune and inflammatory conditions.
Trump could use the findings of the probe to impose certain trade restrictions on pharma products, including tariffs.
In a Phase Ib trial, VERVE-102 showed it could lower bad cholesterol across doses, setting up an opt-in decision for Eli Lilly and a showdown with Novartis.
Viking Therapeutics enjoyed a nice share rally on the news that rival Pfizer is discontinuing obesity candidate danuglipron. But the biotech has a long way to go to recover after six straight months of decline.
Pfizer’s discontinuation of danuglipron brings the company down to a single molecule in its obesity pipeline.
Vanda is criticizing the FDA’s restrictions on information companies can provide regarding off-label use of approved medicines.
Future Pak—whose acquisition offer was rejected by Vanda Pharmaceuticals last summer—is offering to buy Theratechnologies for an unsolicited $255 million. The Canadian biotech is under an exclusivity agreement with another yet-to-be-disclosed potential purchaser.
Leerink analysts warned that Kennedy’s remarks to FDA staff would likely be a negative for the biotech industry.
At the GenScript Biotech Global Forum 2025, industry leaders celebrated CAR T cell therapy achievements while discussing ongoing challenges in manufacturing, distribution, treatment center capacity, and global payment structures for cell and gene therapies.