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☆ Neuralink, Elon Musk’s brain implant startup, set to begin human trials
▼ + stars: | 2023-09-20 | by ( Jennifer Korn | ) edition.cnn.com time to read: +3 min

New York CNN —Elon Musk’s controversial biotechnology startup Neuralink opened up recruitment for its first human clinical trial Tuesday, according to a company blog. After receiving approval from an independent review board, Neuralink is set to begin offering brain implants to paralysis patients as part of the PRIME Study, the company said. In May, Neuralink tweeted that it had received FDA clearance for human clinical trials, with the approval acknowledged by the agency in a statement. Musk has forecast human trials at the startup at least four times since 2019, yet the company didn’t seek FDA approval until 2022. Before Neuralink’s brain implants hit the broader market, they’ll need regulatory approval.

Persons: New York CNN — Elon, Musk, Neuralink, Peter Thiel, ” Organizations: New, New York CNN, Founders Fund, PayPal, Twitter, Reuters, Food and Drug Administration, FDA Locations: New York, San Francisco, Neuralink

☆ Elon Musk's Neuralink is now recruiting people with serious disabilities like ALS to test if his brain chips are safe
▼ + stars: | 2023-09-20 | by ( Kwan Wei Kevin Tan | ) www.businessinsider.com time to read: +3 min

Elon Musk's Neuralink is seeking candidates for its first human trials. Neuralink wants to test their brain chips on people with cervical spinal cord injuries or ALS. The company is under federal investigation for animal welfare abuses while conducting animal tests. At a company event last year, Musk said he would test Neuralink's brain chips on himself when human trials begin. AdvertisementAdvertisementNeuralink received approval from the Food and Drug Administration in May to embark on human trials.

Persons: Elon Musk's Neuralink, Neuralink, Musk, — Organizations: Service, Food and Drug Administration, Reuters Locations: Wall, Silicon

☆ PrEPVacc: HIV vaccine trial that could be ‘the last roll of the dice’ this decade is underway
▼ + stars: | 2023-08-28 | by ( Tom Page | Thomas Page | ) edition.cnn.com time to read: +24 min

CNN —A novel trial that has been described as “the last roll of the dice” for a generation of HIV vaccines has entered its latter stages. Nearly 40 years since HIV was identified as the cause of AIDS, and 36 years since the first HIV vaccine trial, the medical community still does not have a working vaccine. But that is not necessarily why they were chosen to participate, said Eugene Ruzagira, PrEPVacc trial director. Evaluating the combination of a trial HIV vaccine and PrEP is a first, say organizers. “I did my very first HIV vaccine trial in 1991,” recalled Weber.

Persons: PrEPVacc, ”, Jonathan Weber, Frank, Helena Herholdt, Eugene Ruzagira, Ruzagira, “, Weber, ” Ruzagira, “ We’ve, Mark Runnacles, Edward Jenner, Louis Pasteur, Galileo, Win McNamee, Humphry Davy, JEAN, SEBASTIEN EVRARD, Haydn West, Joe Raedle, ANNE, CHRISTINE POUJOULAT, Alexander Fleming, Fleming, wasn't, Louise Joy Brown, Sandy Huffaker, Daniel Acker, James Watson, Francis Crick, Rosalind Franklin, Watson, Crick, Raphael GAILLARDE, Sean Gallup, Wilhelm Conrad Röntgen, Thomas Edison's, INDRANIL MUKHERJEE, Descovy, Luwano Geofrey, Dr, Luke Dray, Geofrey, Nishanta Singh, Sharon Lewin, Lewin, “ it’s, it’s, ” Lewin, ” Geofrey Organizations: CNN, Imperial College Academic Health Science Centre, PrEPVacc, Medical Research, Uganda Virus Research Institute, European Union, Smithsonian National Museum of, Cleveland Clinic, Volvo, Bayer, U.S . Food, Drug Administration, Getty, Keystone, — Farmers, Food and Drug Administration, FDA, Bloomberg, PANTHAKY, PrEP, US Centers for Disease Control, Independent, The University of Melbourne, International AIDS Society, Muhimbili University of Health, Allied Sciences, Dar Locations: Entebbe, Uganda, Thailand, London, Mbeya, Tanzania, South Africa, Ugandan, Durban, Masaka, Salam, African, Africa, China, FPG, AFP, United States, America, U.S, Peoria , Illinois, Europe, “, Dar es Salaam, Rwanda

The 44-year-old man was surfing near Lighthouse Beach, Port Macquarie when a shark launched a “sustained and prolonged attack,” New South Wales (NSW) police said in a statement. Police said a bystander applied a tourniquet before paramedics transferred the surfer to Port Macquarie Hospital in critical condition. “[He is in] a serious condition with life threatening injuries, sustained from the lower leg injuries, and also significant blood loss,” NSW Police Chief Inspector Martin Burke said. Australia ranked behind only the United States in the number of unprovoked shark encounters with humans last year, according to the Florida Museum’s International Shark Attack File. According to the Australian Shark Incident Database, there were 10 shark encounters in New South Wales in 2022, resulting in seven injuries and one death.

Persons: Martin Burke, “ Organizations: CNN, 9News, Police, Port Macquarie Hospital, ” NSW Police, Port Macquarie, Facebook, Department of Primary Industries, Fisheries, Life, NSW, Australia, Florida, Australian, Incident Locations: Lighthouse Beach, Port Macquarie, New South Wales, NSW, United States

☆ The CEO of Verge Genomics shares how she's overcome gender and age biases in biotech by showing people 'there can be a new way of doing things'
▼ + stars: | 2023-08-17 | by ( Josée Rose | ) www.businessinsider.com time to read: +15 min

In the latest Equity Talk, she shares how she's overcoming biases in the VC and biotech fields. Verge Genomics works with data derived from brains and spinal cords donated by people after they die. That's really been helpful because they don't necessarily see the same kind of questions. But I think part of that is just showing them that there can be a new way of doing things. I think that's an area where naivete can be a benefit, when you have big technological hurdles to overcome.

Persons: Alice Zhang, Zhang, it's, It's, That's, I've, we're, I'm, who's, There's, Alice, aren't, they're, that's unarguable, — Organizations: Genomics, Morning, Verge Genomics, Eff, pharma, Tech

☆ Sandra Bullock's sister mourns death of actress's longtime partner Bryan Randall
▼ + stars: | 2023-08-08 | by ( Lisa Respers France | ) edition.cnn.com time to read: +2 min

CNN —Gesine Bullock-Prado, the sister of Sandra Bullock, paid tribute Monday to the actress’s longtime partner, photographer Bryan Randall. Randall “passed away peacefully” following a private three-year battle with ALS, his family said in a statement to People magazine. “Bryan chose early to keep his journey with ALS private and those of us who cared for him did our best to honor his request,” his family said in their statement. We share two beautiful children – three children, [Randall’s] older daughter,” Bullock said. “It’s the best thing ever.”Bullock is mother to a 13-year-old son, Louis, and a 10-year-old daughter, Laila.

Persons: CNN — Gesine Bullock, Sandra Bullock, Bryan Randall, Randall “, Bullock, Prado, Randall, “ I’m, Bry, Gesine Bullock, Emma McIntyre, ”, Bryan, ” Randall, “ Bryan, ” Bullock, “, Louis, Laila, Skylar Organizations: CNN, Prado, ALS, Los Angeles, Regency Village Theatre, ALS Association, Massachusetts General Hospital Locations: Los Angeles

☆ Biogen to cut 1,000 jobs to save costs as company prepares for Leqembi launch
▼ + stars: | 2023-07-25 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

Biogen on Tuesday said it expects to cut approximately 1,000 jobs, or about 11% of its workforce, to save costs as the biotech company prepares to launch its newly approved Alzheimer's drug Leqembi. It's the latest round of layoffs after Biogen slashed nearly 900 jobs last year. The larger plan is expected to generate approximately $1 billion in gross operating expense savings by 2025, according to Biogen. About $300 million of those savings will be reinvested into product launches and R&D programs. "There's a need, obviously, to have a strong investment in our new product launches.

Persons: Chris Viehbacher, Wells, Mohit Bansal

☆ 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

☆ Here are Monday's biggest analyst calls: Apple, Tesla, Meta, Nvidia, Shopify, Netflix, Disney & more
▼ + stars: | 2023-07-24 | by ( Michael Bloom | ) www.cnbc.com time to read: +9 min

Goldman Sachs initiates Amylyx Pharmaceuticals as buy Goldman said it sees an attractive entry point for shares of the biotech company. " Goldman Sachs reiterates Nvidia as buy Goldman said it's standing by its buy rating on Nvidia and that it likes stocks with "room for meaningful positive EPS revisions." UBS downgrades Tesla to neutral from buy UBS said in its downgrade of Tesla that strong growth is already priced in. Goldman Sachs initiates Savers Value Village as buy Goldman said the thrift store operator is a share gainer. Goldman Sachs reiterates ServiceNow as buy Goldman said it sees more upside in shares of ServiceNow as the stock remains a key beneficiary.

Persons: Piper downgrades Estee Lauder, Piper, Baird, Goldman Sachs, Goldman, Wells, Evercore, it's, Stifel, Lam, Tesla, Moffett, Rosenblatt, Raymond James, Becton Dickinson, SLB, Horton, BTIG, Needham, ServiceNow Organizations: Express, Netflix, Amylyx Pharmaceuticals, Bank of America, NTR, RBC, Research, Nvidia, MU, UBS, Semiconductor, Deutsche Bank, Apple, Deutsche, Mac, Med Tech, Schlumberger, Disney, DIS, American Express Locations: China, underperform, ServiceNow

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

☆ Neuralink competitor Precision Neuroscience conducts its first clinical study to map human brain signals
▼ + stars: | 2023-06-23 | by ( Ashley Capoot | ) www.cnbc.com time to read: +3 min

He was standing in a busy operating room in West Virginia, waiting for a surgeon to place Precision Neuroscience's neural implant system onto a conscious patient's brain for the first time. In seconds, a real-time, high-resolution rendering of the patient's brain activity washed over a screen. According to Precision, the system had provided the highest resolution picture of human thought ever recorded. The company's flagship BCI system, the Layer 7 Cortical Interface, is an electrode array resembling a piece of scotch tape. Since the technology worked as expected, future studies will explore further applications in clinical and behavioral contexts, Mermel said.

Persons: Craig Mermel, Mermel, Elon, Blackrock Neurotech Organizations: Precision, CNBC, Neuralink, Neuroscience, BCI, Blackrock Locations: West Virginia, Paradromics

☆ Elon Musk's brain implant company Neuralink announces FDA approval of in-human clinical study
▼ + stars: | 2023-05-25 | by ( Ashley Capoot | ) www.cnbc.com time to read: +4 min

Neuralink, the neurotech startup co-founded by Elon Musk, announced Thursday it has received approval from the Food and Drug Administration to conduct its first in-human clinical study. A BCI is a system that deciphers brain signals and translates them into commands for external technologies. But receiving FDA approval for a commercial medical device is no small task — it requires companies to successfully conduct several extremely thorough rounds of testing and data safety collection. But by receiving the go-ahead for a study with human patients, Neuralink is one step closer to market. The FDA's approval for an in-human study is a significant win for Neuralink after a series of recent hurdles at the company.

☆ Citi names its top biotech and pharma stock picks, giving one nearly 90% upside
▼ + stars: | 2023-05-17 | by ( Weizhen Tan | ) www.cnbc.com time to read: +2 min

The healthcare sector outperformed in Europe, India and China last month, according to Citi, which named its top picks worldwide. It gave Amylyx a price target of $53, giving it upside of around 88% from current levels. It gave Beam a price target of $60, implying upside of around 67%. Other European picks from Citi include Swiss healthcare company Roche and British pharma and biotech firm AstraZeneca . Asia stocks In Asia, Citi named Japanese pharmaceutical company Daiichi Sankyo , South Korean biotech firm Samsung Biologics and China's Wuxi Biologics as top picks.

☆ Apple says your iPhone will soon be able to speak in your voice with 15 minutes of training
▼ + stars: | 2023-05-17 | by ( Pete Syme | ) www.businessinsider.com time to read: +2 min

That includes "Personal Voice," which will replicate your voice through AI in 15 minutes. If you have an iPhone or iPad, you'll soon be able to hear it speak in your own voice, Apple announced Tuesday. The Personal Voice feature in use. It's not the first time Apple has ventured into the AI voice market, as iPhone users will be familiar with Siri. It's not clear exactly when Personal Voice will be available, but Apple says it'll be before the end of the year.

☆ Your iPhone will soon be able to replicate your voice after 15 minutes of training
▼ + stars: | 2023-05-16 | by ( Samantha Murphy Kelly | ) edition.cnn.com time to read: +3 min

CNN —Apple on Tuesday announced a series of new accessibility tools for the iPhone and iPad, including a feature that promises to replicate a user’s voice for phone calls after only 15 minutes of training. With an upcoming tool called Personal Voice, users will be able to read text prompts to record audio and have the technology learn their voice. A related feature called Live Speech will then use the “synthesized voice” to read the user’s typed text aloud during phone calls, FaceTime conversations and in-person conversations. In the blog post, Apple said the Personal Voice feature uses “on-device machine learning to keep users’ information private and secure.”Other tech companies have experimented with using AI to replicate a voice. In addition to the voice features, Apple announced Assistive Access, which combines some of the most popular iOS apps, such as FaceTime, Messages, Camera, Photos, Music and Phone, into one Calls app.

☆ Stocks making the biggest moves premarket: Starbucks, AMD, Pearson, PacWest & more
▼ + stars: | 2023-05-03 | by ( Brian Evans | ) www.cnbc.com time to read: +3 min

Check out the companies making headlines in premarket trading. AMD — The semiconductor stock fell more than 7% in premarket trading after quarterly results a day earlier. PacWest's shares fell 4.6% in premarket trading after sliding nearly 28% on Tuesday. Biogen reported earnings last week, notching an adjusted $3.40 per share while analysts polled by StreetAccount forecasted $3.28. The online dating company reported first-quarter earnings that topped analysts estimates from Refinitiv after the bell Tuesday.

☆ Biogen isn't concerned about competing with Eli Lilly in the Alzheimer’s drug space, CEO says
▼ + stars: | 2023-04-25 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

Biogen isn't worried about competing with Eli Lilly as they both attempt to bring an Alzheimer's drug to the market, Biogen's CEO said Tuesday. Researchers argue that the accumulation of amyloid plaque is a crucial first step toward the cognitive decline observed in Alzheimer's disease. Eli Lilly didn't immediately respond to a request for comment. He said that will likely require Eli Lilly and Biogen to roll out maintenance doses that will keep plaque levels low. Biogen is banking on the success of its drug leqembi after the disastrous approval and rollout of its old Alzheimer's drug aduhelm last year.

☆ 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.

☆ Grimes said she got a brain gadget for her birthday from a company competing with Elon Musk's Neuralink
▼ + stars: | 2023-03-22 | by ( Grace Kay | Hilary Brueck | ) www.businessinsider.com time to read: +5 min

Neurosity's device is designed to help people focus, but some developers are using it as a BCI. "Getting a non invasive brain computer interface for my birthday (!!!!? Grimes' birthday 'Crown' measures brain activity, and is designed to help people focusNeurosity's headset uses electroencephalogram technology, or EEG, to measure brain activity by placing small metal electrodes on a person's scalp. In a now-deleted tweet, the singer said Neurosity's device allowed her to use her mind to move a cursor. Meanwhile, Neurosity's device is already on the market.

☆ 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.

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