Biogen gets much-needed pipeline lift with speedy ALS drug review
Beleaguered Biogen has been handed some encouraging news from the FDA, after the regulator agreed to complete its review of amyotrophic lateral sclerosis (ALS) therapy […]
Beleaguered Biogen has been handed some encouraging news from the FDA, after the regulator agreed to complete its review of amyotrophic lateral sclerosis (ALS) therapy […]
The F.D.A. is also reviewing the treatment, Albrioza, but the agency’s scientists have raised questions about its effectiveness.
Amylyx Pharmaceuticals’ efforts to bring its amyotrophic lateral sclerosis therapy AMX0035 to market in the US have run into some roadblocks, so an approval by […]
The F.D.A. is also reviewing the treatment, Albrioza, but the agency’s scientists have raised questions about its effectiveness.
Cumulus Neuroscience has started a pair of clinical trials to gauge the value of a panel of physiological and digital biomarkers in tracking the course […]
By a narrow margin, an FDA advisory committee has voted against approval of Amylyx’ experimental medicine for amyotrophic lateral sclerosis until the company can provide […]
With a 6-4 vote, the group of independent advisers to the agency narrowly concluded that results from another clinical trial are needed to assess whether […]
Shares in Amylyx Pharma slid today after the FDA published a less-than-enthusiastic assessment of its amyotrophic lateral sclerosis (ALS) therapy ahead of an advisory committee […]
The FDA has accepted Amylyx Pharmaceuticals’ submission for amyotrophic lateral sclerosis drug AMX0035 and it expects to issue a regulatory decision by late June. A […]
Three life science companies unveiled Series B rounds of funding Thursday, early Christmas gifts that top $219 million combined. Along with Verge Genomics, the other […]
Amylyx Pharmaceuticals has submitted its amyotrophic lateral sclerosis (ALS) drug for FDA review based on positive Phase 2 data after discussions with the agency over […]
Biogen amyotrophic lateral sclerosis drug, tofersen, failed a Phase 3 clinical trial, but the drug showed improvement according to secondary and exploratory goals of the […]
Shots: The P-I clinical study evaluates the safety, PK, and PD of single & multiple ascending doses of DNL343 in 95 healthy volunteers with ALS […]
FDA’s Go-Ahead to Amylyx New Drug Application for ALS Drug Amylyx Pharmaceuticals has announced its plan to submit a New Drug Application (NDA) to the […]
Just a few months ago, Amylyx was talking about having to complete another clinical trial before it could file for FDA approval of its drug […]
AstraZeneca’s Newly Occupied Alexion Hits Rock Bottom After Ultomiris (Ravulizumab) Fails to Show Efficacy in Patients with Amyotrophic Lateral Sclerosis AstraZeneca’s 39 billion USD complete […]
Shots: The IDMC has recommended the discontinuation of the P-III CHAMPION-ALS trial for Ultomiris (IV, q8w) in adults with ALS. Additionally, enrolled patients will discontinue […]
It has only been a month since AstraZeneca’s $39 billion takeover of Alexion was completed, but the merger has already had a setback. Alexion has […]
Alexion Pharmaceuticals drug Ultomiris is already approved to treat a rare blood disorder, but the company hoped the antibody’s approach could also work in amyotrophic […]
An amyotrophic lateral sclerosis drug from Amylyx Pharmaceuticals is being prepared for Phase 3 clinical testing on track to begin later this quarter. To support […]
Eli Lilly is partnering with startup Verge Genomics in a move intended to add ALS drugs to its neuroscience pipeline. To date, Verge’s artificial intelligence […]
Shots: EMA’s COMP has granted ODD to SLS-005 for the treatment of amyotrophic lateral sclerosis Under ODD, Seelos will get benefit from several incentives such […]
Amylyx’s ALS drug met the goals of a mid-stage study, paving the way for regulatory submissions in Europe and Canada. But the FDA is requiring […]
A Brainstorm Cell Therapeutics therapy for Lou Gehrig’s disease failed a pivotal study, but the company points to better results in a subgroup. The FDA […]
CNS disorders are a wide-ranging set of disorders in which the brain loses its normal functioning, limiting everyday ability to function. These may arise from […]
Shots: Aquestive will receive upfront, milestones, royalties on net sales for Exservan (oral film formulation) in the US and will earn revenue pursuant to the […]
Biotech Clene Nanomedicine has gone public with a mission to use nanotherapeutics that will use gold to treat devastating neurological diseases including Parkinson’s disease. Over […]
Amyotrophic lateral sclerosis (ALS), commonly known as Lou Gehrig’s disease, is a group of rare neurological diseases that mainly involve the nerve cells (neurons), responsible […]
Eli Lilly is to buy the private biotech Disarm Therapeutics, which is working on a new class of disease-modifying drugs for neurological diseases, in a […]
Scribe Therapeutics, a start-up focusing on gene-editing using CRISPR/Cas9, has burst onto the biotech scene with a $415 million deal with Biogen. Jennifer Doudna Scribe […]
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