The pressure on U.S. drug prices continues, with the CMS lining up the drugs for round 3 of negotiations, which will set maximum fair prices to go into effect in 2028. The slate includes 15 drugs and, for the first time, opens the negotiations to Part B drugs, as well as Part D. Consequently, seven of the 15 selected drugs are biologics.
Suzhou Alphamab Co. Ltd.’s HER2 bispecific antibody, anbenitamab (KN-026), combined with chemotherapy has the potential to become a new standard of care for patients with HER2-positive gastric cancer who failed at least one prior line of therapy, according to newly released phase III results that show the combo cut disease progression risk by 75%.
Cardiff Oncology Inc. welcomed Mani Mohindru as interim CEO and simultaneously provided what the company dubbed a “positive” but stock-denting clinical update. The firm rolled out data from the 113-patient phase II trial called CRDF-004, designed to test the oral Polo-like kinase 1 (PLK1) inhibitor onvansertib in first-line, RAS-mutated metastatic colorectal cancer (mCRC). Shares (NASDAQ:CRDF) closed Jan. 27 at $2, down 94 cents, or 32%, as Wall Street took in the results.
1st Biotherapeutics Inc. announced the closing of a ₩31.7 billion series D funding round Jan. 26 to advance its lead phase I oncology asset, FB-849, and portfolio of candidates for neurodegenerative diseases.
Shionogi & Co. Ltd. and Fosun Pharmaceutical (Group) Co. Ltd. were involved in separate divestment transactions this week, with Shionogi buying out Pfizer Inc.’s stake in Viiv Healthcare Ltd. to lift its holding to 21.7%.
Cancer cells expand through mutations – but not just through mutations. They also change their behavior in the absence of underlying genetic alterations. Such plasticity helps the cells both adapt to the cellular stress fueled by out-of-control growth and resist targeted and chemotherapies alike. Investigators from Memorial Sloan Kettering Cancer Center and Huazhong Agricultural University have gained new insights into the underlying mechanisms of plasticity.
On the heels of more positive early data from the lead program derived from its tumor-activated T-cell engager (TRACTr) platform, Janux Therapeutics Inc. inked a collaboration with Bristol Myers Squibb Co. that comes with $50 million in up-front and near-term milestone payments, with the possibility of up to $800 million more tied to development, regulatory and commercial milestones.
Erasca Inc. priced an upsized public offering to raise $225 million to fund development of its therapies for patients with RAS/MAPK pathway-driven cancers.
In a move that could dramatically shorten some clinical development timelines for drugs targeting multiple myeloma, the U.S. FDA issued a draft guidance on the potential use of minimal residual disease and complete response to support accelerated approvals, following the recommendation of the agency’s Oncologic Drugs Advisory Committee, which voted 12-0 in favor of the change in April 2024.
Another day, another insider trading settlement involving a biopharma company employee. This time the U.S. SEC settlement is with Mohit Verma, who was a researcher and associate director of immunology at the San Diego-based Infinitybio Inc. at the time of the alleged violative trading activity.
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