CNS

CMS said Medicare will cover anti-amyloid antibodies for early Alzheimer’s disease upon traditional approval from the US FDA if prescribed by doctors participating in a patient registry. 

Much of the focus on the French major’s MS pipeline has been on the BTK inhibitor tolebrutinib but promising Phase II data on frexalimab have caught the eye.

The US firm’s drug for schizophrenia- and bipolar-related agitation Igalmi has failed part one of a pivotal trial in at-home patients, but the option for higher dosing in part two combined with placebo-like safety could offer hope.

Apellis’s pegcetacoplan – approved for two other indications – will not go forward in amyotrophic lateral sclerosis after a Phase II failure, two days after Wave Life made a similar call in the neurodegenerative disease.

Pointing to data showing benefit in patients who completed 72 weeks of therapy, PTC thinks vatiquinone still could be viable for pediatric FA patients. Restructuring won’t affect Upstaza.

In a little over two years, the Korean bio-digital healthcare platform company Emocog has moved its digital therapeutic for mild cognitive impairment into pivotal clinical trials and is discussing possible collaborations with big pharma firms, CEO Yoo Hun Noh tells Scrip.

New CEO Richard Francis outlined the company’s new focus on innovative brands, funded by a portion of capital reallocated from Teva’s generics business.

In this week's podcast edition of Five Must-Know Things: J&J’s Duarto on the importance of diversity; Teva’s views on its new risperidone launch; Almirall’s hopes for lebrikizumab; Biogen’s Viehbacher questions the need for spending on weight loss drugs; and Citeline’s annual R&D review looks at the current state of the global biopharma pipeline.

Company’s prediction that Duchenne muscular dystrophy patients likely would not be able to access SRP-9001 until four months after accelerated approval eased some US FDA panelists’ concerns about interference with the ongoing confirmatory trial.

The rare disease drug launch continues to outperform expectations, though questions remain about demand and how long patients will remain on the treatment.

The US FDA approved Rexulti as the first drug for agitation in Alzheimer’s disease, a multibillion-dollar market where Lundbeck estimates it could bring in $1bn in annual sales.

After recent landmark approvals in other neurodegenerative diseases such as Alzheimer’s and amyotrophic lateral sclerosis, hopes are rising that Huntington’s disease could be next to reach a breakthrough.