Abbvie Inc.’s much-hyped emraclidine, the centerpiece of its $8.7 billion buyout of Cerevel Therapeutics Inc., failed to hit its endpoints in two phase II trials in schizophrenia, sending company shares (NYSE:ABBV) down more than 12.6%, to close at 174.43, catching industry watchers by surprise and removing a potentially near-term competitor for Bristol Myers Squibb Co.’s recently approved antipsychotic, Cobenfy (xanomeline-trospium).
Autolus Therapuetics plc has been granted FDA approval for Aucatzyl (obecabtagene autoleucel) for the treatment of acute lymphoblastic leukemia in adults, becoming the first marketed CAR T therapy that does not have a risk evaluation and mitigation strategy attached to its label. The approval of Aucatzyl was based on results of the Felix clinical trial in relapsing/remitting ALL, which showed a strong safety profile compared to existing CAR T-cell therapies. The conduct of the trial was dogged by the COVID-19 pandemic, but of the 65 patients from an initial dosed cohort of 95 for whom efficacy was evaluated by the FDA, 63% achieved overall complete remission.
Zap Surgical Systems Inc. reported closing a $78 million series E funding round led by Qingdao Baheal Medical Inc., with participation from other strategic investors. The new funds will be used to commercialize the company’s Zap-X gyroscopic radiosurgery platform for the non-invasive treatment of brain tumors.
The U.S. Government Accountability Office has rejected an appeal by MCI Diagnostics Inc. regarding a contract bid with the Department of Veterans Affairs despite the company’s assertion that the VA pricing mechanism is flawed.
Early-stage breast cancer patients in the U.S. may soon be able to access another treatment regime based on the result of a Nov. 7 FDA advisory committee for the Prosense cryoablation system by Icecure Medical Ltd. The advisory committee voted 9-5 that the benefits of Prosense outweigh the risks, although the FDA has yet to decide on the application.
Allovir Inc., which has struggled since late last December, will merge with privately held Kalaris Therapeutics Inc. to develop therapies for treating neovascular and exudative retinal diseases. Kalaris already has an anti-VEGF treatment in a phase I study with a data readout set for the third quarter of 2025. Once the deal closes, the combined company name will be Kalaris Therapeutics Inc. and shares will trade on Nasdaq as KLRS. The new company said it plans to drive development of TH-103 for treating neovascular age-related macular degeneration (nAMD), diabetic macular edema and retinal vein occlusion. The phase I study is for treatment of nAMD.
The U.S. FDA has had its sights on artificial intelligence (AI) for some time, but an upcoming advisory hearing will review questions such as the regulatory status of a generative AI (GenAI) algorithm. This is just one of several AI-related dilemmas facing the agency in the next few years.
With the U.S. Congress sitting on its hands on reforms to the 340B drug discount program, states are stepping into the gap. While most state efforts have been aimed at forcing biopharma companies to give the federally mandated drug discounts to an increasing number of contract pharmacies, California is looking in a different direction. According to unofficial election results, a slim majority of the state’s voters said yes to Proposition 34, which would require certain providers that benefit from the drug discounts to spend at least 98% of their 340B revenues on direct patient care.
Eli Lilly and Co.’s chief scientific officer, Daniel Skovronsky, called peresolimab, the PD-1 agonist previously in the works by the firm for rheumatoid arthritis (RA), a “really interesting mechanism” – but not interesting enough.
Positive findings from a phase III trial of semaglutide in metabolic dysfunction-associated steatohepatitis (MASH) is moving Novo Nordisk A/S to expand the glucagon-like peptide-1 (GLP-1) agonist’s indications in the U.S. and Europe, the Danish pharma said, as the MASH field sights more novel therapies.
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