Anavex Life Sciences Corp (AVXL)

[sokol]

This (ALS) act also establishes the first federal entity explicitly charged with the responsibility to speed the development and approval of therapies for rare neurodegenerative diseases. Below is a summary of the act and an article about speeding up development and approval for therapies to treat ALS and other severely debilitating and rare neurodegenerative diseases. Anavex is focused on treating rare and debilitating neurological diseases. If Anavex reports strong data for Rett, it should speed up fast track approval and entry of AVXL 2-73 to treat Rett plus open the door for Anavex's development of its drugs for several other indications Anavex is currently investigating. Anavex is uniquely situated to benefit from passage of this legislation.

S.1813. Bill summary:
Shown Here:
Introduced in Senate (05/25/2021)
Accelerating Access to Critical Therapies for ALS Act

This bill establishes grant programs to address neurodegenerative diseases, such as amyotrophic lateral sclerosis (also known as ALS or Lou Gehrig's disease), and contains other related provisions.

The Department of Health and Human Services (HHS) shall award grants to eligible entities to facilitate patients' access to investigational drugs that diagnose or treat ALS. The Food and Drug Administration (FDA) shall award grants to public and private entities to cover the costs of research and development of drugs that diagnose or treat ALS and other severely debilitating neurodegenerative diseases.

HHS shall also establish the Public-Private Partnership for Neurodegenerative Diseases between the National Institutes of Health, the FDA, and at least one eligible entity (generally, an institution of higher education or a nonprofit organization). The partnership shall support the development and regulatory review of drugs that address ALS and other rare neurodegenerative diseases.

The FDA shall publish on its website a five-year action plan for fostering the development of drugs that improve or extend the lives of people living with rare neurodegenerative diseases.

https://www.congress.gov/bill/117th-congress/senate-bill/1813?s=1&r=97

With today’s signing into law, ACT for ALS will create a new grant program that funds access to investigational ALS treatments for people living with ALS who cannot participate in clinical trials, while also supporting research on treatment safety and ALS progression.

This law invests in neurodegenerative disease research through a brand-new Food and Drug Administration (FDA) Rare Neurodegenerative Disease Grant Program. This program will be critically important to keep the FDA and other federal agencies moving urgently to find treatments and cures that can be approved by the FDA, covered by health insurance and made available to all.

Finally, ACT for ALS will establish a Health and Human Services (HHS) Public-Private Partnership for Rare Neurodegenerative Diseases jointly led by the FDA and the National Institutes of Health (NIH), the first federal entity explicitly charged with the responsibility to speed the development and approval of therapies for rare neurodegenerative diseases.

https://www.mda.org/press-releases/three-leading-als-organizations-celebrate-president-biden-signing-the-act-for-als-into-law