Getting the Ensuring Pathways to Innovative Cures (EPIC) Act through the U.S. Congress to do away with the “pill penalty” in the Medicare drug price negotiations could require an epic effort, given the current politically fueled atmosphere on the Hill. With the Inflation Reduction Act (IRA), which created the negotiations, considered a signature achievement of the Biden administration, the negotiations have become, for many lawmakers, almost a sacred cow that can’t be touched. If anything, some of them want to expand the negotiations to more drugs and to the commercial market.
Yesterday’s first part of this two-part series surveyed bispecific antibodies for immunological and inflammatory (I&I) disease. Apart from bispecifics, Leerink analyst Thomas Smith lately has proven interested in I&I overall, unveiling his “five for 2025” in a January report that listed five indications with “potential for disruption” in the year ahead.
Positive 16-week extension data from Cervomed Inc.’s phase IIb in dementia with Lewy bodies followed a failure from December. New results from the Rewind-LB trial testing neflamapimod, a brain-penetrant, orally administered small molecule that inhibits the intracellular enzyme p38MAP kinase alpha, have encouraged the company to pursue a phase III study.
Mixed clinical results led shares of Arvinas Inc. (NASDAQ:ARVN) to close March 11 at $8.30, down $9.26, or 52%, after the company and Pfizer Inc. disclosed results from the phase III Veritac-2 study testing vepdegestrant monotherapy vs. fulvestrant in adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer. Enrolled were subjects whose disease progressed after treatment with CDK4/6 inhibitors and endocrine therapy.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Celltrion, Ionis, Vertex.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Agomab, Alumis, Arrowhead, Beam, BMS, Eli Lilly, Incyte, Innocare, Johnson & Johnson, Leo Pharma, Mineralys, Novo Nordisk, Organon, Regeneron, Sanofi, SFA, Trevi, Urogen.
Analysts were pleasantly surprised by the positive phase III data reported for Kyowa Kirin Co. Ltd./Amgen Inc.’s rocatinlimab, a T-cell rebalancing therapy, in moderate to severe atopic dermatitis.
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