Biohaven Pharmaceuticals

The first platform trial for amyotrophic lateral sclerosis (ALS), designed to assess multiple treatment candidates simultaneously with a goal of accelerating the development of ALS therapies, has enrolled its first patients. The HEALEY ALS Platform Trial (NCT04297683) will start by evaluating UCB’s…

Much work is ongoing in amyotrophic lateral sclerosis (ALS), as researchers look for better ways of treating people with a disease that progressively cripples and kills motor neurons — and possibly finding a first therapy addressing the root cause of ALS rather than its symptoms. “ALS is always…

The U.S. Food and Drug Administration (FDA) has authorized the evaluation of the first three candidate therapies for amyotrophic lateral sclerosis (ALS) in the HEALEY ALS Platform Trial. This trial model, designed to accelerate the development of ALS therapies by assessing multiple treatment candidates simultaneously, is the first of…

To help accelerate development of effective treatments for amyotrophic lateral sclerosis (ALS), the ALS Association is investing $3 million in the disease’s first platform trial. The award is $1 million annually for three years to support the platform investigation, a type of clinical study that evaluates the…

Concerns over an active pharmaceutical ingredient used in a 2017 study of Nurtec (riluzole) as a bioequivalent medicine were voiced by the U.S. Food and Drug Administration (FDA) in its response to a request for the treatment’s approval for  amyotrophic lateral sclerosis (ALS), its developer, Biohaven Pharmaceuticals,…

The U.S. Food and Drug Administration (FDA) has accepted for review the new drug application (NDA) of Biohaven Pharmaceuticals’ BHV-0223, a sublingual (dissolved under the tongue) form of riluzole, as a treatment for amyotrophic lateral sclerosis (ALS). Biohaven has begun enrollment of ALS patients for its Phase 2/3…

Biohaven Pharmaceuticals has established an expanded access program (EAP) for patients with amyotrophic lateral sclerosis (ALS) for its investigational treatment candidate, BHV-0223, the company recently announced. The United States Food and Drug Administration regulates the expanded access program to help provide access to therapies that are currently in development and have…