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Eisai/Biogen’s Leqembi Gets Some Medicare Coverage Certainty In CMS Update

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. 

Government Payers Market Access

Sanofi Moves Up In MS With Frexalimab Success

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.

Neurology Clinical Trials

Part One Disappointment For BioXcel’s Igalmi In Pivotal Agitation Trial

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.

Clinical Trials Neurology

Apellis Follows Wave Life By Shelving ALS Candidate After Trial Miss

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.

Clinical Trials Drug Approval Standards

PTC Misses Phase III In Friedrich Ataxia, But Isn’t Giving Up

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.

Business Strategies Clinical Trials

Emocog Setting The Standard For Cognitive Decline DTx in Korea

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.

South Korea Digital Health

Teva Establishes Four Pillars To Prop Up Its Return-To-Growth Strategy

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.

Strategy Growth

Quick Listen: Scrip's Five Must-Know Things

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.

Leadership Diversity & Inclusion

Gene Therapy: Four-Month Lag In Commercial Access Protects EMBARK Study, Sarepta Says

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.

Advisory Committees Gene Therapy

Amylyx’s ALS Treatment Relyvrio Beats Expectations Again

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

Neurology Commercial

Otsuka/Lundbeck’s Rexulti Has Time To Build A Lead In The Alzheimer’s Agitation Market

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.

Approvals Business Strategies

UniQure Looks For Clear Signal From Huntington’s Disease Gene Therapy

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.

Neurology Clinical Trials
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