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Home » ALS

Articles Tagged with ''ALS''

FDA Approved stamp

Amylyx prices newly approved ALS drug, Relyvrio

Sep. 30, 2022
By Lee Landenberger
The wholesale acquisition cost for Amylyx Pharmaceuticals Inc.'s new U.S. FDA-approved amyotrophic lateral sclerosis (ALS) treatment, Relyvrio, has been set at about $158,000 for the first year’s treatment. It jumps to about $163,000 in the second year, the company said, a change that would move it closer to the cost of competitor Mitsubishi Tanabe Pharma Corp.'s Radicava (edaravone), which costs about $165,000 annually. A 28-day prescription will cost $12,504.
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Drug capsule spilling onto brain
Neurology/Psychiatric

NEK6 identified as a novel therapeutic target in ALS and FTD

Sep. 20, 2022
Frontotemporal dementia (FTD) and amyotrophic lateral sclerosis (ALS) are two devastating neurodegenerative diseases, with clinical, pathological and genetic overlap, without effective therapy.
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Antibodies
Neurology/Psychiatric

Novel antibody protects from HML-2 Env-mediated neurotoxicity

Sep. 15, 2022
Human endogenous retrovirus-K (HERV-K) belongs to the β-retrovirus-like supergroup of viruses, and it has been previously demonstrated that the expression of HERV-K subtype HML-2 envelope (Env) in human neuronal cultures or in transgenic mice resulted in neurotoxicity and neurodegeneration.
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US drug pricing caught between the proverbial ‘rock and a hard place’

Sep. 13, 2022
By Mari Serebrov
Pricing new drugs for the U.S. market, especially those treating rare diseases, is getting a lot more complex now that the Medicare inflation rebate is in play. The rebate provision in the newly enacted Inflation Reduction Act incentivizes companies to set higher launch prices for drugs that will be used by Medicare beneficiaries since their future price increases will be limited to the rate of inflation. Although some of the other drug pricing measures included in the new law won’t kick in for a few years, the Medicare inflation rebate is to become effective next year.
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Neurology/Psychiatric

Targeting ApoB100 rescues motor neuron degeneration in ALS

Sep. 13, 2022
Amyotrophic lateral sclerosis (ALS) is a progressive disease characterized by upper and lower motor neuron degeneration.
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Person in wheelchair

Amylyx, ALS community look to US FDA to follow adcom lead

Sep. 8, 2022
By Mari Serebrov
What a difference a U.S. FDA advisory committee meeting can make. In the wake of the Peripheral and Central Nervous System Drugs Advisory Committee voting 7-2 Sept. 7 to recommend approval of Amylyx Pharmaceuticals Inc.’s amyotrophic lateral sclerosis (ALS) candidate, shares of the Cambridge, Mass.-based company (NASDAQ:AMLX) more than regained the value they lost in March when the same committee voted against approval of AMX-0035.
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Person using walker

Amylyx counts on new analyses as it heads into second US adcom

Sep. 6, 2022
By Mari Serebrov
Amylyx Pharmaceuticals Inc.’s amyotrophic lateral sclerosis candidate, AMX-0035, will get a rare second bite at the adcom apple Sept. 7. This time around, the Cambridge, Mass.-based company is looking to improve on its first performance by stressing the survival benefit of its drug.
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Silhouette of person walking with a cane

Kringle Pharma’s phase II ALS study falls short

Aug. 16, 2022
By Tamra Sami
Kringle Pharma Inc.’s phase II trial evaluating its recombinant human hepatocyte growth factor ligand, oremepermin alfa, failed to meet both primary and secondary endpoints in a study of its potential to help people with amyotrophic lateral sclerosis (ALS).
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Kringle Pharma’s phase II ALS study falls short

Aug. 15, 2022
By Tamra Sami
Kringle Pharma Inc.’s phase II trial evaluating its recombinant human hepatocyte growth factor ligand, oremepermin alfa, failed to meet both primary and secondary endpoints in a study of its potential to help people with amyotrophic lateral sclerosis (ALS).
Read More

Good news for Amylyx as it prepares for adcom redux

Aug. 4, 2022
By Mari Serebrov
Amylyx Pharmaceuticals Inc. got good news when the Institute for Clinical and Economic Review posted a revised evidence report Aug. 4 that assessed the comparative clinical effectiveness and value of the company’s AMX-0035 and Mitsubishi Tanabe Pharma America Inc.’s Radicava (edaravone) in treating amyotrophic lateral sclerosis.
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