Neurology

The European Medicines Agency is set to adopt opinions on whether marketing approval should be granted to five new products, including three orphans. A decision is also due on a previously-rejected Alzheimer’s drug that was under re-examination.

According to the health technology assessment institute, NICE, new cost-effectiveness thresholds – which are higher than those that applied when the original decisions were made – will apply when its committee reconsiders the appraisals for Eisai and Eli Lilly’s Alzheimer’s disease drugs.

Cognito Therapeutics has revealed data from its OVERTURE feasibility study backing up the ability of its non-invasive Spectris headset to treat Alzheimer’s via the stimulation of gamma oscillations. The company is hoping to launch the device in 2027

Teva’s R&D chief Eric Hughes discusses the company’s long-acting injectable olanzapine program, how it could address adherence challenges in schizophrenia, and why the therapy forms a key pillar of the firm’s growing injectables franchise.

So far this year, four drug candidates have secured a place on the European Medicines Agency’s priority medicines scheme for promising treatments for unmet medical needs.

The company remains blinded to data on functional gains, holding that for future US FDA accelerated approval discussions, but Phase I/II results show microdystrophin production without liver toxicity seen with Sarepta’s Elevidys.

As Spinraza’s sales have slumped, Biogen is developing the once-yearly salanersen, showing efficacy in patients with suboptimal responses to Novartis’s Zolgensma.

Phase III results for azetukalner in focal onset seizures bested the impressive placebo-adjusted Phase IIb data for the first-in-class drug, which Xenon designed to overcome challenges of other anti-seizure medications.

The Phase III anti-alpha-synuclein antibody has the potential to become a first-in-class therapy for multiple system atrophy.

At BIO’s Investor and Growth Summit, investors acknowledged the tough funding environment for early stage neuroscience, but said there are signs of increasing interest in the space.

While several drugs are already approved in the EU for treating myasthenia gravis, the European Medicines Agency says that the therapeutic area represents a “dynamic landscape” and “justifies the need for an up-to-date and comprehensive regulatory guidance.”

As biopharma continues to push the boundaries of innovation, the most powerful breakthroughs are coming from the discovery of new drug modalities, the reinvention of old ones and a strategic application of multi-modality treatment regimens.