Orexo AB enrolled the first patient in a pivotal trial of its digital therapeutic Modia plus sublingual buprenorphine/naloxone for treatment of opioid use disorder (OUD). Orexo’s Zubsolv, the combination of buprenorphine and naloxone used in the study, has been employed to help U.S. patients with OUD since 2013.
Members of the California Technology Assessment Forum (CTAF), an independent appraisal committee of the Institute for Clinical and Economic Review (ICER), discussed – and voted on – the safety vs. efficacy and other aspects of Biogen Inc.’s embattled Aduhelm (aducanumab), the amyloid beta-targeting therapy recently approved for Alzheimer’s disease. It didn’t go well for Biogen.
Paq Therapeutics Inc. closed a $30 million series A round to take forward a novel approach to the targeted degradation and removal of a wide range of molecular substrates and defective organelles by developing drug molecules that can tap into autophagy, the cell’s general waste disposal and recycling system.
LONDON – Neuvasq Biotechnologies has launched with a €20 million (US$23.7 million) series A to take forward a new approach to treating neurological disorders by reversing age- or injury-related damage to the blood-brain barrier.
LONDON – Another Novo Seeds start-up has graduated, with Muna Therapeutics ApS closing a $73 million series A to take forward small-molecule treatments for neurodegenerative diseases.
As rumblings continued about possible skulduggery between Biogen Inc. and the FDA related to Aduhelm (aducanumab), an already precedent-setting case took yet another turn: Acting FDA Commissioner Janet Woodcock asked acting U.S. Inspector General Christi Grimm’s office to conduct an independent review of goings-on that led to approval of the amyloid-beta-targeting drug in Alzheimer’s disease.
Following battles over its price and accelerated approval, Biogen Inc. and Eisai Co. Ltd.’s Aduhelm (aducanumab) now has newly approved prescribing information from the FDA that limits the patient population and sales along with it. The updated Indications and usage now reads that the anti-amyloid beta monoclonal antibody should be used only in patients with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s dementia. That’s the patient population in which treatment was initiated in clinical trials that led to approval. The company said the new wording “clarifies the indication.” The original FDA-approved language cleared the drug for much broader use in Alzheimer’s.
In search of new therapies for amyotrophic lateral sclerosis (ALS), Eli Lilly and Co. has agreed to pay Verge Genomics $25 million in up-front, equity and potential near-term payments, plus as much as $694 million in milestones, to discover and validate up to four new targets for treating the disease over the course of a three-year collaboration. Verge retained rights to its internal lead ALS program, poised to enter the clinic next year.
Compass Pathways Ltd. has joined with a U.K. hospital and an academic establishment to research the role of psychedelic medicine in new models of mental health care. The London-based company signed a memorandum of understanding with South London and Maudsley NHS Foundation Trust and the Institute of Psychiatry, Psychology and Neuroscience at King’s College London to launch the project.
Alector Inc. Chief Operating Officer Shehnaaz Suliman said her company’s deal with Glaxosmithkline plc (GSK) – worth as much as $2.2 billion – “allows us to expand into indications that we have been quite thoughtful about doing, but in a more expeditious manner. This is really an opportune time to continue to explore the biology of these programs across multiple indications.”
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