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☆ Musk's Neuralink brain implant company cited by FDA over animal lab issues
▼ + stars: | 2024-02-29 | by ( ) www.cnbc.com time to read: +2 min

The inspectors identified quality control lapses at the company's California animal research facility. Those visits took place last year from June 12-22, and represent the FDA's sole inspections of Neuralink facilities on record. The laboratory problems identified by FDA inspectors included missing calibration records for instruments such as a pH meter used in one of the studies. An animal welfare advocacy group, Physicians Committee for Responsible Medicine, submitted a formal complaint to both USDA and FDA over the alleged breaches. In July, the USDA said it did not find any violations of its animal research rules beyond a 2019 incident that Neuralink had already reported.

Persons: Elon Musk's, Jerry L, Chapman, Lou Gehrig's, Neuralink Organizations: Food, Drug Administration, Elon, Elon Musk's Neuralink, Reuters, Redica Systems, FDA, U.S . Department of Agriculture, Physicians, Responsible Medicine Locations: California, Neuralink's Texas

☆ Elon Musk claims the first human patient has received a Neuralink brain implant
▼ + stars: | 2024-01-30 | by ( Katherine Tangalakis-Lippert | ) www.businessinsider.com time to read: +5 min

Elon Musk claimed on X that Neuralink's first human patient received their brain implant. AdvertisementElon Musk on Monday claimed in a post on X that a Neuralink brain implant has, for the first time, been inserted into a human patient's brain. "The first human received an implant from @Neuralink yesterday and is recovering well," Musk wrote. AdvertisementMusk previously said the Neuralink device would record and stimulate brain activity, acting as a "Fitbit in your skull," and claimed the implant would eventually "solve" conditions including autism and schizophrenia . "However, any for-profit medical device company also has a vested interest in generating a consumer base, which is why they make the sometimes grandiose claims they do."

Persons: Elon Musk, Musk, —, Elon, Stephen Hawking, Hilary Brueck, Neuralink, Tesla, Lou Gehrig's, Insider's Brueck, Randy Bruno, Bruno, that's, Jason T, Eberl, Albert Gnaegi, Healthline Organizations: Service, Business, SpaceX, FDA, Reuters, Columbia University, Albert Gnaegi Center for Health, Saint Louis University

☆ These smaller stocks could see big gains in 2024, Bank of America says
▼ + stars: | 2024-01-30 | by ( Lisa Kailai Han | ) www.cnbc.com time to read: +5 min

Against this backdrop, Bank of America on Monday released a list of best small- and mid-cap ideas for 2024. Strategist Jill Carey Hall added that this year's basket of 31 stocks has average 12-month potential upside of 29%, and is slightly tilted towards value stocks over growth. Shares of Bath & Body Works have trailed the market, rising 2.4% in 2023 and 0.4% so far in 2024. Bank of America also named United Airlines one of its top SMID ideas for 2024. Other names on Bank of America's list of SMID picks included e-commerce retailer Wayfair and aircraft leasing company Air Lease .

Persons: That's, Russell, Jill Carey Hall, Lorraine Hutchinson, Hutchinson, BofA, Geoff Meacham, Lou Gehrig's, Meacham, CyberArk, Tal Liani, Liani, Max, Andrew Didora, UAL, Didora, — CNBC's Michael Bloom Organizations: Wall, Bank of America, Monday, Body, Pharmaceuticals, TAM, United Airlines, Boeing, Bank of, Air Lease Locations: U.S, Amylyx, cybersecurity, CY26, Chicago

☆ Meet the 23-year-old who's spreading awareness about ALS on TikTok and openly joking about being in her 'terminally ill era'
▼ + stars: | 2024-01-08 | by ( Kieran Press-Reynolds | ) www.businessinsider.com time to read: +5 min

Amanda Tam is documenting her journey with the disease neurodegenerative ALS on TikTok. Tam's videos often have a comedic bent, and her followers say she's an inspiration. AdvertisementAmanda Tam's TikTok channel is like many other 23-year-olds on the app. But most of Tam's videos also revolve around a much more serious topic: her diagnosis of ALS , also known as Lou Gehrig's disease. "It's important to be a realist and be aware of your situation, but it's equally important to still find joy and hope in life," Tam told BI.

Persons: Amanda Tam, —, Amanda Tam's, Lou Gehrig's, TikToker, Peter Frates, Tam, she's, I've, It's, She's, TikTok Organizations: Service, ALS Association Locations: Quebec

☆ FDA staff reviewers raise concerns over BrainStorm Cell's ALS therapy
▼ + stars: | 2023-09-25 | by ( ) www.reuters.com time to read: +2 min

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. Brainstrom's therapy, NurOwn, is being reviewed for the treatment of ALS, also known as Lou Gehrig's Disease, which affects nerve cells in the brain and spinal cord. The FDA had in November last year refused to accept the application for the therapy after BrainStorm failed to meet the main goal in a late-stage study. Over the last one year, the FDA has given accelerated approvals to Amylyx Pharmaceuticals' (AMLX.O) drug Relyvrio and Biogen's (BIIB.O) Qalsody for treatment of ALS. A panel of external advisors to the FDA is set to vote on the effectiveness of the therapy in ALS patients on Wednesday.

Persons: Andrew Kelly, Lou Gehrig's Disease, Amylyx, Mariam Sunny, Leroy Leo, Krishna Chandra Organizations: Food and Drug Administration, FDA, REUTERS, U.S . Food, Drug, Cell Therapeutics, Amylyx Pharmaceuticals, ALS Association, Thomson Locations: White Oak , Maryland, U.S, Bengaluru

☆ Goldman upgrades this biotech, sees the shares doubling
▼ + stars: | 2023-07-24 | by ( Alex Harring | ) www.cnbc.com time to read: +2 min

It's a good time to buy into beat-down Amylyx Pharmaceuticals as investors could be underestimating one of its trials, according to Goldman Sachs. Analyst Corinne Jenkins upgraded the pharmaceutical stock to buy from neutral and increased her price target by $4 to $49. Her new price target implies shares can surge 117% from Friday's close. But investors have been concerned about the stock because of low expectations going into the phase 3 Phoenix study for Relyvrio. But Jenkins also said the approval would likely be a positive catalyst for the beat-down stock.

Persons: Goldman Sachs, Corinne Jenkins, Jenkins, Lou Gehrig's, — CNBC's Michael Bloom Organizations: Pharmaceuticals, PHOENIX Locations: Friday's, U.S

An expansion of the criteria for medically assisted death that comes into force in March 2024 will allow Canadians like Pauli, whose sole underlying condition is mental illness, to choose medically assisted death. In 2021, the most recent year available, 10,064 people died through medically assisted death, about 3.3% of deaths in Canada that year. Dembo served on an expert panel on assisted death and mental illness that presented a report to Canada's parliament last year. loadingThe reported cases of people resorting to medically assisted death in part due to lack of supports are "tragic," Lametti said. "It does in one sense [represent a slippery slope], doesn't it, because it started off with terminal illness and it's ended up with non-terminal illness and mental illness."

Persons: Lisa Pauli, Pauli, I've, David Lametti, Lametti, It's, Marie, Claude Lacasse, Georges L'Esperance, Sarah Dobec, Justine Dembo, Dembo, She's, Mary Heatley, …, Heatley, Sonu Gaind, Michelle Hewitt, Hewitt, Sean Tagert, Lou Gehrig's, Tagert's, Sean, Charles Falconer, it's, Anna Mehler Paperny, Denny Thomas, Suzanne Goldenberg Organizations: TORONTO, Reuters, Health, Quebec Association for, Canada, Health Sciences Centre, Labour, Thomson Locations: Canada, Netherlands, Belgium, Provinces, Quebec, British Columbia, Ontario, Health Canada, Canadian, Britain

☆ FDA grants accelerated approval for Biogen ALS drug that treats rare form of the disease
▼ + stars: | 2023-04-25 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

The Food and Drug Administration on Tuesday granted accelerated approval for Biogen 's drug tofersen, which treats a rare and aggressive form of the disease known as ALS. Accelerated approval is an FDA designation that clears drugs faster if they fill an unmet medical need for serious conditions. If a subsequent trial confirms those benefits, the FDA can grant traditional approval for the drug. An independent panel of advisors to the FDA last month similarly voted that tofersen's effect on neurofilament could produce a clinical benefit in ALS patients. Stephanie Fradette, Biogen's head of ALS development, said those SOD1 protein levels are "indirect evidence" that tofersen targets the rare form of ALS.

☆ FDA advisors reject Biogen's ALS drug for rare and aggressive form of the disease
▼ + stars: | 2023-03-22 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

The Food and Drug Administration's independent panel of advisors on Wednesday declined to endorse accelerated approval of Biogen's investigational ALS drug for a rare and aggressive form of the disease. The drug tofersen was developed to treat a rare genetic form of amyotrophic lateral sclerosis, or ALS. That number is even smaller in the U.S., with roughly 330 people affected by the SOD1 mutation. The median survival time from diagnosis with the rare form of ALS to death is 2.7 years, according to the company. The SOD1 mutation is associated with 20% of cases that occur within families.

☆ FDA advisors vote against effectiveness of Biogen's ALS drug for rare and aggressive form of the disease
▼ + stars: | 2023-03-22 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

The Food and Drug Administration's independent panel of advisors on Wednesday voted against the effectiveness of Biogen's investigational ALS drug for a rare and aggressive form of the disease. The drug tofersen was developed to treat a rare genetic form of amyotrophic lateral sclerosis, or ALS. That number is even smaller in the U.S., with roughly 330 people affected by the SOD1 mutation. The median survival time from diagnosis with the rare form of ALS to death is 2.7 years, according to the company. The SOD1 mutation is associated with 20% of cases that occur within families.

☆ FDA staff says safety issues with Biogen's ALS drug to not prevent approval
▼ + stars: | 2023-03-21 | by ( Bhanvi Satija | ) www.reuters.com time to read: +2 min

March 20 (Reuters) - The U.S. health regulator's staff said on Monday safety issues with Biogen Inc's (BIIB.O) drug to treat an ultra-rare form of amyotrophic lateral sclerosis or ALS, also known as Lou Gehrig's disease, should not prevent its accelerated approval. The drug, tofersen, failed to meet its main goal of reducing symptoms but reduced protein neurofilament levels during a late-stage study. The risks related to Biogen's drug, such as spinal cord inflammation and optic nerve swelling, observed in trial patients "are acceptable to the patient population", the staff said. They added that a majority of these risks may be related to the way in which the drug is administered, rather than the drug itself. The company is seeking approval for the drug in ALS patients with mutation in a gene known as superoxide dismutase 1.

☆ US FDA staff flags no new safety concerns for Biogen's ALS drug
▼ + stars: | 2023-03-20 | by ( ) www.reuters.com time to read: +1 min

March 20 (Reuters) - Staff reviewers of U.S. drug regulator on Monday did not raise any new safety concerns about Biogen Inc's (BIIB.O) experimental drug for treating a rare type of amyotrophic lateral sclerosis, also known as Lou Gehrig's disease. The risks related to Biogen's drug, tofersen, "are acceptable to the patient population" and would not "preclude approval", staff reviewers said in briefing documents published on the agency's website. The agency has asked advisers to weigh in on approving the use of the drug based on available data, which shows it reduces a key protein related to the disease, and not disease symptoms. In October 2021, tofersen failed to meet the main goal of a late-stage study, but the company said trends of reduced disease progression were observed. Reporting by Raghav Mahobe and Bhanvi Satija in Bengaluru; Editing by Krishna Chandra Eluri and Shinjini GanguliOur Standards: The Thomson Reuters Trust Principles.

☆ FDA staff says Biogen's ALS drug may have a 'clinical benefit' on a rare form of the disease
▼ + stars: | 2023-03-20 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +6 min

U.S. Food and Drug Administration staff on Monday said Biogen's investigational ALS drug may have a "clinical benefit" on a rare and aggressive form of the disease, despite failing a broader late-stage clinical trial last year. A separate exploratory analysis of the drug suggests "a clinical benefit with a longer duration of treatment," the staff wrote. It also found that tofersen reduced levels of a protein called neurofilament light (NfL,) which is "correlated with disease severity, disease progression rate, and survival in patients with ALS," according to the FDA staff. The first is to move forward with recommending accelerated approval based on tofersen's reduction of NfL in ALS patients. "SOD1-linked ALS is a particularly rare and aggressive form of an already rare and devastating disease," said Dr. Neil Thakur, The ALS Association's chief mission officer.

☆ Startup Parrots is using 5G to develop a bird-shaped, AI-powered machine that helps people with disabilities communicate
▼ + stars: | 2022-10-27 | by ( Karen Fischer | ) www.businessinsider.com time to read: +6 min

Polly, a hardware and software service, helps people with disabilities live more independently. Parrots' founder is in talks with the VA to give Polly to veterans with neurological disorders. This article is part of "How 5G Is Changing Everything," a series about transformational 5G tech across industries. Hojah acknowledged that Parrots could have taken flight without 5G but said the timeline would have been much slower: "5G is expanding our growth rapidly." In 2019, Parrots won Verizon's Built on 5G Challenge, and Hojah got mentorship and technological assistance from the wireless-telecommunications giant.

☆ A controversial ALS drug potentially worth $1 billion is on the cusp of FDA approval. It could change Amylyx's fortunes and be a much-needed treatment for the rare disease.
▼ + stars: | 2022-09-26 | by ( Yeji Jesse Lee | ) www.businessinsider.com time to read: +7 min

The FDA may soon approve a new treatment for ALS, also known as Lou Gehrig's disease. If approved, Amylyx Pharmaceuticals's drug, AMX0035, will be a new treatment option for patients. A new drug for amyotrophic lateral sclerosis, more commonly known as ALS or Lou Gehrig's disease, is on the cusp of approval from the US Food and Drug Administration. The association said that treatment has the support of the larger ALS community and urged the FDA to "swiftly approve" AMX0035. By comparison, there are around 30,000 ALS patients in the US, meaning reimbursing AMX0035 would pose a much lighter burden on the CMS.

☆ Biogen says ALS drug shows clinical benefit in new data analysis
▼ + stars: | 2022-09-21 | by ( Mrinalika Roy | ) www.reuters.com time to read: +2 min

The Biogen drug, tofersen, is currently under priority review by the U.S. Food and Drug Administration with an approval decision expected by Jan. 25. Biogen last October had said the drug missed the main goal of the late-stage study, failing to show statistically significant improvement in the functional status of patients with fast-progressing ALS at six months. Biogen is seeking approval of tofersen for ALS patients with mutations in a specific gene that leads to accumulation of toxic levels of a protein called SOD1. Most side effects in both the late-stage study and the follow-on portion were mild to moderate, including headache and back pain, the company said. Nearly 7% of patients who received tofersen experienced serious neurological events, including spinal cord inflammation and swelling of the optic nerve.

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