The U.S. Centers for Medicare & Medicaid Services’ (CMS) decision last month restricting coverage of a class of Alzheimer’s drugs to clinical trials meeting the agency’s standards still isn’t sitting well with some lawmakers.
A quartet of companies on May 2 announced three complete response letters (CRLs) that left them scrambling to get back on the path to approval. Hutchmed Ltd.'s surufatinib met with word from the U.S. FDA that two positive phase III studies in China and a bridging study in the U.S. would not support approval of the drug for pancreatic and extra-pancreatic neuroendocrine tumors. A multi-regional clinical trial in the U.S. is needed, the regulator said, brushing aside China-only studies when seeking a U.S. approval.
Targeted protein degradation (TPD) specialist Plexium Inc.’s potential $565 million deal with Abbvie Inc. came on the heels of a tie-up with Amgen Inc. in February worth as much as $500 million-plus, as well as an oversubscribed $102 million financing the same month – all of which translates into “optionality, moving forward, to keep our heads down, do the work we’re really good at and continue to watch the market,” said CEO Percival Barretto-Ko.
Ashvattha Therapeutics Inc. secured $69 million in a series B financing that it said will strengthen its ability to develop hydroxyl dendrimer-based medicines and accelerate efforts to advance its candidates to the clinic.
Mitorx Therapeutics Ltd. is poised to develop small molecules that reverse impaired sulphide signaling underlying degenerative diseases ranging from Duchenne muscular dystrophy to Alzheimer’s disease. The company was formed some time ago as a spinout from Exeter University, where the founding scientist Matt Whiteman is professor of experimental therapeutics. It is showing its colors for the first time after closing a seed funding round.
Shares of Eliem Therapeutics Inc. fell 56% on the company’s announcement that it would end development of its non-opioid palmitoylethanolamide prodrug, ETX-810, in diabetic peripheral neuropathic pain following a phase IIa failure. It was part of a double dose of bad news reported by Seattle-based Eliem, which also is delaying phase II development of depression candidate ETX-155 to resolve issues of lower-than-expected drug exposure in a phase I study of the neuroactive steroid GABAA receptor positive allosteric modulator in photosensitive epilepsy.
After August 2021 news from the U.S. FDA of deficiencies in the NDA that Axsome Therapeutics Inc. submitted for AXS-05 in major depressive disorder (MDD), word was especially welcome April 19 that the firm has come to an agreement with the agency with regard to post-marketing requirements. Meanwhile, another player in MDD, Relmada Therapeutics Inc., is due to report phase III data with REL-1017 (esmethadone) around the middle of this year.
Biogen Inc. has given up on its attempt to get its Alzheimer’s disease drug Aduhelm (aducanumab) approved by regulators in Europe, deciding to withdraw its filing midway through a review of a previous rejection. The company had asked the European Medicines Agency’s CHMP to reconsider its negative opinion for Aduhelm in December 2021. But its subsidiary in the Netherlands wrote to the EMA this week saying that it had decided to withdraw its marketing authorization application after all.
After failing to meet primary safety and efficacy endpoints in a phase I/II trial for stroke, Teijin Ltd. and JCR Pharmaceuticals Co. Ltd. have terminated a co-development and Japan licensing agreement to develop JTR-161, an allogeneic regenerative candidate containing dental pulp stem cells.
Shares in Medincell SA dropped 29.1% Apr. 20 on news that the U.S. FDA slapped a complete response letter (CRL) on an NDA for an extended release, long-acting formulation of risperidone, which it is co-developing with Teva Pharmaceuticals Industries Ltd. as a maintenance treatment for schizophrenia.
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