Alzamend Neuro Inc.’s positive preclinical data for AL-002 sent the company’s stock (NADAQ:ALZN) more than 70% higher before the market opened July 23. The Tampa, Fla.-based biopharma is researching a mutant-peptide sensitized cell for treating Alzheimer’s disease. The positive data came from a GLP toxicology study using a transgenic mouse model.
Regardless of the controversy swirling around the FDA’s accelerated approval of Biogen Inc.’s Alzheimer’s drug, Aduhelm, that U.S. approval is expected to open the door to more opportunities for Alzheimer’s treatments and diagnostics.
Regardless of the controversy swirling around the FDA’s accelerated approval of Biogen Inc.’s Alzheimer’s drug, Aduhelm, that U.S. approval is expected to open the door to more opportunities for Alzheimer’s treatments and diagnostics.
A sometimes contentious policy roundtable on how to handle Alzheimer’s disease therapies followed the July 15 meeting of the California Technology Assessment Forum, an independent evidence appraisal committee of the Institute for Clinical and Economic Review (ICER). CTAF’s 15 panelists voted unanimously that the evidence was not adequate to prove Biogen Inc.’s recently approved Aduhelm (aducanumab) superior to supportive care alone.
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.
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.
A five-minute artificial intelligence (AI)-based system from Cognetivity Neurosciences Ltd. that can detect common symptoms of Alzheimer’s disease years before they become visible using a tablet or smartphone is poised to change how this devastating disease is diagnosed.
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.
