Here are the latest stories being discussed in biopharma today:
Industry News Roundup
AstraZeneca’s Truqap Combo Falters in Phase 3 Triple-Negative Breast Cancer Trial
AstraZeneca’s quest to broaden the indications for its AKT inhibitor Truqap has hit a setback. The Phase 3 CAPItello-290 trial, aimed at assessing the combination of Truqap with chemotherapy paclitaxel in 923 triple-negative breast cancer patients, failed to meet its primary endpoints. The study did not show improvement in overall survival for either the entire patient group or a specific subgroup with alterations in the PI3K/AKT pathway. Despite this, no new safety concerns were identified.
FDA Eases Reporting Protocols for Certain CAR-T Therapies
In an effort to alleviate some of the regulatory burdens on healthcare providers, the FDA has decided to loosen the side effect reporting requirements for some CAR-T therapies. The two side effects in question, cytokine release syndrome (CRS) and neurological toxicities, are commonly associated with these treatments. The regulatory adjustment applies to Gilead’s Yescarta and Tecartus, as well as Bristol-Myers Squibb’s Breyanzi and Abecma, among others.
FTC Supports Measures to Scrutinize Patent Settlements
The Federal Trade Commission (FTC) has endorsed a proposal from the US Patent and Trademark Office intended to increase transparency around patent settlements that could hinder competition. The proposed rule would mandate the disclosure of all patent settlements, enabling the FTC to identify and investigate potentially anticompetitive agreements, particularly those involving reverse payments that delay the entry of generic drugs into the market.
Intra-Cellular Therapeutics Achieves Success in Depression Treatment
Intra-Cellular Therapeutics reported positive results from a second Phase 3 trial for its antipsychotic drug Caplyta as an adjunctive treatment for major depressive disorder. Patients taking Caplyta showed a significant improvement in their Montgomery-Asberg Depression Rating Scale (MADRS) scores compared to those on a placebo. With this success, Intra-Cellular plans to seek FDA approval to expand Caplyta’s label to include this new indication later in the year.
Hikma Acquires Assets from Xellia Pharmaceuticals
Hikma Pharmaceuticals is set to bolster its US portfolio by acquiring several assets from Xellia Pharmaceuticals for $135 million, with an additional $50 million tied to future regulatory and commercial milestones. The deal includes a manufacturing site, sales and marketing resources, and an R&D center in Croatia. This acquisition will enhance Hikma’s injectable manufacturing capabilities and expand its complex technologies portfolio.
Teva in Settlement Talks Over Alleged Copaxone Kickback Scheme
Teva Pharmaceuticals is negotiating with the US government to settle a lawsuit that accuses the company of engaging in a kickback scheme for its multiple sclerosis drug Copaxone. According to court documents, Teva allegedly paid over $300 million to two foundations to cover Medicare copayments for Copaxone, thereby generating false claims to Medicare and increasing revenue for itself. Discussions are ongoing, and Teva remains optimistic about reaching a resolution.
International Society Challenges Utah’s Stem Cell Therapy Law
A prominent international research society has strongly criticized recently passed legislation in Utah that allows for the use of unapproved stem cell therapies. The law has sparked significant controversy, raising concerns about patient safety and the undermining of rigorous scientific processes.
Day One Pharmaceuticals Ventures into ADCs
Day One Pharmaceuticals is stepping into the field of antibody-drug conjugates (ADCs) by targeting a molecule that has previously attracted interest from big players like AbbVie and Genmab. This new move underscores Day One’s ambitions to expand its oncology pipeline by leveraging the potential of targeted treatments.