Biogen and Ionis Pharmaceuticals have decided to discontinue research testing the investigational drug BIIB078 after a phase 1 clinical trial did not meet any secondary endpoints on efficacy and did not demonstrate clinical benefit.
“The Lawrence and Isabel Barnett Drug Development Program has fostered critical relationships between academia and industry and helped move the science forward. We are proud of the fact that projects supported by this program have leveraged that support to attract 6 more dollars for every $1 we initially invested,” said Dr. Kuldip Dave, vice president of research at The ALS Association.
The ALS Association announced today that it has awarded a $620,000 grant to the Packard Center for ALS Research at Johns Hopkins to support the Answer ALS Data Portal. Launched in January this year, the Data Portal provides open access to the world’s most comprehensive collection of ALS data.
Today, more than 230 organizations sent a letter to all 50 state governors urging them to maintain and expand licensure flexibilities enacted at the start of the pandemic for the duration of the federal public health emergency, to better address patient needs during the ongoing pandemic.
The ALS Association has created a new diagnostic guide, thinkALS, that will help neurologists more quickly diagnose ALS. Earlier diagnoses allow patients to participate in clinical trials and access treatments and benefits sooner, as well as receive care services support.
Following Amylyx’s announcement that it intends to submit a New Drug Application (NDA) for AMX0035, The ALS Association today urges the Food and Drug Administration to approve the treatment for all people with ALS as soon as possible.
The ALS Association today announced that California’s legislature, in conjunction with the California Department of Public Health has approved $15 million over the next five years for the wraparound model of care and treatment of ALS in the state.
Following the lack of action by the FDA to expedite approval of AMX0035, an experimental treatment for ALS, The ALS Association today called on the agency to follow its own guidance and move with the urgency of its Canadian and European Union counterparts. Health Canada and the European Medicines Agency (EMA) are working with Amylyx, the company that makes AMX0035, to move the treatment toward approval.
The ALS Association, Muscular Dystrophy Association (MDA) and ALS Finding a Cure® (ALSFAC), provided an additional $1.1 million in supplementary funding to leading investigators at the Houston Methodist Neurological Institute and Massachusetts General Hospital for promising research into cell therapy that could slow the progression of amyotrophic lateral sclerosis (ALS).
A press release outlining the certification that Holy Cross Health received as The ALS Association Florida Chapter's fifth multidisciplinary ALS clinic recognized as a Certified Treatment Center of Excellence
The ALS Association endorses the strengthened Accelerating Access to Critical Therapies for ALS Act (ACT) for ALS Act (H.R.8662/ S. 4867) as an important step in bringing promising new treatments to people with ALS as quickly as possible. The bill accelerates the fight against ALS by authorizing $100 million for ALS research and creating the first federal entity explicitly charged with developing treatments for neurodegenerative diseases.
Today, in response to the New England Journal of Medicine publication of encouraging clinical trial results showing that Amylyx Pharmaceuticals’ AMX0035 brought statistically significant benefit to people living with ALS, The ALS Association and I AM ALS immediately called on the drug company and the FDA to make the treatment widely available as soon as possible.
Historic changes in telehealth were made in response to COVID-19 that marked a big step forward in the use of digital technology to deliver health care. We need Congress to pass legislation to ensure expanded use of this vital health care tool is permanent. Send a letter to your members of Congress today urging them to support permanent access to telehealth.
The ALS Association strongly supports initiatives to enable people with ALS to access promising treatments as soon as possible, including prior to FDA approval. Our primary goal is to facilitate the development of effective treatments and help support delivery to everyone with ALS as soon as possible.
The ALS Association and I AM ALS announced today that the organizations have awarded a combined grant of $500,000 to BrainStorm Cell Therapeutics (NASDAQ: BCLI), a biotechnology company, to support an amyotrophic lateral sclerosis (ALS) biomarker research study. The grant will be used to draw insights from data and samples collected from patients enrolled in BrainStorm’s ongoing phase 3 clinical trial of its NurOwn® treatment, to further understanding of critical biomarkers associated with treatment response for people with ALS.
The ALS Association, in partnership with the American Brain Foundation and the American Academy of Neurology, has awarded the 2020 Sheila Essey Award for ALS research to Guy Rouleau, M.D., Ph.D., director of the Montreal Neurological Institute and Hospital and chair of the Department of Neurology and Neurosurgery at McGill University. The award recognizes significant research contributions in the search for the cause, prevention of and cure for amyotrophic lateral sclerosis (ALS). Since 1996, The ALS Association and the American Academy of Neurology have jointly chosen recipients of the award.
The ALS Association today announced a three-year, $652,543 commitment to support new collaborative initiatives that will encourage therapeutic pipeline development, improve ALS trial efficiency and quality, and enhance the patient experience with trial access, recruitment, and retention efforts. Activities will take place at the Sean M. Healey & AMG Center for ALS at Mass General in collaboration with the Barrow Neurological Institute and the Northeast ALS Consortium (NEALS).