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☆ J&J backs out of RSV vaccine race with rivals Pfizer and GSK
▼ + stars: | 2023-03-29 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

Johnson & Johnson on Wednesday said it's ducking out of the RSV vaccine race, weeks after competitors Pfizer and GSK inched closer to launching the world's first shot against the deadly virus. J&J will stop working on its investigational RSV adult vaccine program and discontinue a pivotal phase three trial testing the shot, the company announced in a press release. Since then, the race to create the world's first RSV vaccine has garnered more attention than ever. A phase two trial on the company's RSV shot found it provided 80% protection against severe RSV infections. Drugmaker Moderna also has its own potential RSV shot, which performed well in clinical trials.

March 27 (Reuters) - Elon Musk's brain implant company Neuralink has approached one of the biggest U.S. neurosurgery centers as a potential clinical trials partner as it prepares to test its devices on humans once regulators allow for it, according to six people familiar with the matter. Barrow has helped standardize brain implant surgeries in which the patient can remain asleep, a key step in making it more acceptable to a broad set of the population, Ponce said. This is in line with Musk's vision for Neuralink's brain chip. The billionaire CEO of Tesla Inc (TSLA.O) and majority owner of Twitter has said Neuralink's brain implants will become as ubiquitous as Lasik eye surgery. Neuralink's implant is a brain computer interface (BCI) device, which uses electrodes that penetrate the brain or sit on its surface to provide direct communication to computers.

☆ 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.

☆ 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.

☆ Another 55 amateur players join concussion lawsuit
▼ + stars: | 2023-03-14 | by ( Lori Ewing | ) www.reuters.com time to read: +4 min

MANCHESTER, England, March 14 (Reuters) - Another 55 amateur rugby players who are suffering from neurological impairments joined the growing list of claimants in a class-action concussion lawsuit on Monday, claiming that the sport's governing bodies failed to take reasonable action to protect them. "The players we represent love the game," Rylands Garth said in a statement. "(CTE) is a cruel and progressive degenerative disease of the brain found in many players of contact sports leading to repetitive brain trauma," they said. World Rugby pointed to studies in France and South Africa that showed positive advancements in terms of player safety and overall game experience. In 2019, the NHL paid $18.49 million to settle a concussion lawsuit brought by more than 100 players.

☆ Almost 30,000 Amazon employees have signed an internal petition to fight the company's return-to-office mandate. Read the full copy here.
▼ + stars: | 2023-03-10 | by ( Eugene Kim | ) www.businessinsider.com time to read: +15 min

New mandate requires most office workers to come into the office at least 3 times a week starting in May. About 3 weeks since the announcement of the new policy, more than 29,200 Amazon employees have signed an internal petition opposing the mandate. Roughly 30,000 Amazon employees have joined that Slack channel, which was created shortly after the RTO announcement. In the petition, Amazon employees added internal data supporting continued remote work and dozens of comments explaining why they oppose the change. A 2013 Stanford University study of Chinese workers found that remote workers are 13% more productive than their in-office counterparts.

☆ We tried a 4-day workweek for 6 months. Here's what we had to do to make it work and why we landed on something different.
▼ + stars: | 2023-03-07 | by ( Ella Hopkins | ) www.businessinsider.com time to read: +7 min

During the pilot, it went from 40 hours a week over five days to 32 over four days. The staff would work eight hours a day but only four days a week. On the senior-leadership team, we were used to handing over work, but for the creative team, it was harder to work across several briefs. Apart from that, working hours are fully flexible — and our office is still hybrid. Our working pattern might not work for larger organizations, and we might have to be more prescriptive about people's working hours if we grow.

☆ The quality of your clinical data drives everything, says Reata Pharma CEO Warren Huff
▼ + stars: | 2023-03-02 | by ( ) www.cnbc.com time to read: 1 min

In this videoShare Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailThe quality of your clinical data drives everything, says Reata Pharma CEO Warren HuffWarren Huff, CEO of Reata Pharmaceuticals, and CNBC's Meg Tirrell join 'Power Lunch' to discuss Reata's new drug for treating a rare neurological disorder receiving FDA approval.

☆ U.S. regulators rejected Elon Musk’s bid to test brain chips in humans
▼ + stars: | 2023-03-02 | by ( ) www.reuters.com time to read: +23 min

Musk’s missed deadlines for FDA approval of Neuralink July 2019:Musk says Neuralink is aiming to receive regulatory approval for human trials of brain implants by the end of 2020. “Everybody in the industry was saying: ‘Oh my God, they’re going to run straight into a brick wall,’” Ludwig said of Musk’s bid for FDA approval. For example, NeuroPace, which makes the brain implant to treat epilepsy, received final FDA approval in 2013 – 16 years after the company’s launch. The FDA’s concerns about the battery are also potentially serious, experts in brain devices said. Still, that proposal disappointed Neuralink because it could delay progress toward final FDA approval, one of the sources said.

☆ U.S. regulators rejected Elon Musk’s bid to test brain chips in humans, citing safety risks
▼ + stars: | 2023-03-02 | by ( Rachael Levy | Marisa Taylor | ) www.cnbc.com time to read: +19 min

Companies that do secure human-testing approval typically conduct at least two rounds of trials before applying for FDA approval to commercially market a device. "Everybody in the industry was saying: 'Oh my God, they're going to run straight into a brick wall,'" Ludwig said of Musk's bid for FDA approval. For example, NeuroPace, which makes the brain implant to treat epilepsy, received final FDA approval in 2013 – 16 years after the company's launch. Beyond grants, it provides access to government experts who advise on how to gain FDA approval and commercialize a device. Musk's emails to Neuralink staffers often come from his SpaceX address, said two people who reviewed them.

☆ Reata shares triple after surprise FDA nod for rare disease drug
▼ + stars: | 2023-03-01 | by ( ) www.reuters.com time to read: +2 min

March 1 (Reuters) - Shares of Reata Pharmaceuticals Inc (RETA.O) tripled in value on Wednesday after the U.S. Food and Drug Administration (FDA) approved its rare disease drug, ending years of uncertainty over its future. The U.S. biotech firm's shares jumped to $93, the highest since late 2021, on more than 16 million shares traded, a record one-day volume for the stock. Reata's drug Skyclarys is the first approved treatment for Friedreich's Ataxia, a rare genetic disorder that causes progressive damage to the nervous system and can lead to premature death. The nod follows years of back and forth between Reata and the FDA. Reata's shares had tumbled 30% following Dunn's resignation as investors fretted about the possibility of approval under a new division head.

☆ Reata shares hit 1-year high after surprise FDA nod for rare disease drug
▼ + stars: | 2023-03-01 | by ( ) www.reuters.com time to read: +2 min

March 1 (Reuters) - Shares of Reata Pharmaceuticals Inc (RETA.O) soared 175% to hit a one-year high in early trading on Wednesday, after the U.S. Food and Drug Administration (FDA) approved its rare disease drug and ended years of uncertainty over its future. The U.S. biotech firm's shares jumped to $86, their highest since December 2021. The nod follows years of back and forth between Reata and the FDA. Reata's shares had tumbled 30% following Dunn's resignation as investors had fretted about the possibility of approval under a new division head. "We've followed some pretty dramatic stories in the past, but the Reata odyssey is in the Hall of Fame," said Baird analyst Brian Skorney.

☆ Reata shares surge after surprise FDA nod for rare disease drug
▼ + stars: | 2023-03-01 | by ( ) www.reuters.com time to read: +1 min

March 1 (Reuters) - Shares of U.S. biotech firm Reata Pharmaceuticals Inc (RETA.O) more than doubled in premarket trading on Wednesday, a day after the Food and Drug Administration (FDA) approved its rare disease drug and ended years of uncertainty over its future. The drug Skyclarys is the first approved treatment for Friedreich's Ataxia, a rare genetic disorder that causes progressive damage to the nervous system and can lead to premature death. The approval follows years of back and forth between Reata and the FDA, which in 2020 said the data from a mid-stage trial was not enough to support an approval. The FDA has previously approved drugs for neurological conditions based on limited data such as for Biogen Inc's Alzheimer's drug Aduhelm and Amylyx's (AMLX.O) ALS drug. Reata's shares were up 174.2% to $85.47 before the bell.

☆ FDA advisors recommend GSK's RSV vaccine for older adults, but flag potential safety risks
▼ + stars: | 2023-03-01 | by ( Spencer Kimball | ) www.cnbc.com time to read: +6 min

Ten of the FDA advisors said the safety data on GSK's vaccine was adequate, while two said it was not. The panel reached a similar conclusion in a narrow 7 to 4 vote Tuesday on Pfizer's application to clear its RSV vaccine. While the advisors erred toward recommending approval, they also raised concern over a possible link to Guillain-Barre syndrome. Both companies have asked the FDA to approve their RSV shot for adults ages 60 and older. The FDA said the cases are possibly related to either GSK's RSV vaccine or the flu shot that was administered with it.

☆ FDA Widens Path for Rare-Disease Treatments With New Approval
▼ + stars: | 2023-02-28 | by ( Amy Dockser Marcus | ) www.wsj.com time to read: 1 min

Photo: Eric Lee for The Wall Street JournalThe Food and Drug Administration, headquartered in Silver Spring, Md., has said it is willing to approve a drug based on results from one trial and “confirmatory evidence.”Federal regulators approved a drug to treat a debilitating disease using data collected about patients over decades, creating an opening for researchers of other rare conditions who often struggle to prove their treatments work. The Food and Drug Administration on Tuesday approved Reata Pharmaceuticals Inc.’s drug Skyclarys, or omaveloxolone, for treating the neurological disorder Friedreich’s ataxia in adults and adolescents age 16 and older.

Feb 28 (Reuters) - The U.S. Food and Drug Administration on Tuesday approved Reata Pharmaceuticals Inc's (RETA.O) drug for the treatment of a rare genetic disorder that causes progressive damage to the nervous system, sending shares up nearly 160% after the bell. The drug, Skyclarys, is Reata's first product to gain approval, and Jefferies analyst Maury Raycroft projected that U.S. sales of the drug could reach $400 million by 2030. Reata estimates the disorder, called Friedreich's ataxia, affects about 5,000 patients in the United States. Raycroft, before the FDA decision, estimated the drug could be priced at about $425,000 per patient annually. The FDA has previously approved drugs for neurological conditions based on limited data such as for Biogen Inc's (BIIB.O) Alzheimer's drug Aduhelm and Amylyx's ALS drug.

☆ FDA neurosciences chief Billy Dunn to leave immediately, analysts raise concern
▼ + stars: | 2023-02-28 | by ( ) www.reuters.com time to read: +2 min

Feb 28 (Reuters) - The U.S. Food and Drug Administration neurosciences head Billy Dunn will retire from his role effective immediately, the health regulator told Reuters on Tuesday. Wall Street analysts said Dunn's departure could impact the regulator's stance on neurological drug decisions in the near term, sending down shares of Reata Pharmaceuticals Inc (RETA.O) 30% on Monday when media reports on the exit surfaced. Texas-based Reata is expecting FDA's decision by Tuesday on its drug to treat a rare neuromuscular disorder called Friedreich's ataxia. The departure of Dunn, 53, was announced in an internal message to the agency's employees on Monday. Newly appointed deputy director Teresa Buracchio will also serve in Dunn's role on an interim basis at the Office of Neuroscience, the agency told Reuters.

☆ FDA advisors recommend Pfizer RSV vaccine for older adults, despite possible Guillain-Barre risks
▼ + stars: | 2023-02-28 | by ( Spencer Kimball | ) www.cnbc.com time to read: +5 min

The vote followed concerns at the FDA and among advisory committee members about two cases of Guillain-Barre syndrome among about 20,000 vaccine recipients. The FDA has asked Pfizer to conduct a safety study on Guillain-Barre syndrome, which the company has agreed to do. There currently is no approved RSV vaccine for the elderly. Pfizer's vaccine contains both strains of RSV, which circulate at the same time during fall and winter. Dr. David Kaslow, a senior official in the FDA's vaccine division, said safety monitoring will be "critically important" if Pfizer's RSV vaccine is approved.

☆ Long Covid disabled them. Then they met a ‘broken’ Social Security disability process
▼ + stars: | 2023-02-25 | by ( Morgan Stephens | ) edition.cnn.com time to read: +12 min

And two Congressional bills addressing the long Covid crisis — The “Covid-19 Long Haulers Act,” which would’ve collected data on long Covid patients with the goal of creating better care and treatment, and “The Care For Long Covid Act” would’ve improved research, centralized data and resources for people with Long Covid — died without making it out of committee. Disabled by long Covid since March 2020, she lives with her spouse and their 7-year-old son in Portland, Ore. “We didn’t design our life to be a single-income household.”Other long Covid patients have rearranged their finances, too. His company’s private long-term disability insurance pays a smaller percentage of the monthly benefit payout when federal disability pays a portion. “They’re not only dealing with long Covid complications, but they’re dealing with financial complications,” she said of her clients.

☆ Biden, 80, to have closely watched physical exam
▼ + stars: | 2023-02-16 | by ( Steve Holland | ) www.reuters.com time to read: +2 min

[1/2] U.S. President Joe Biden delivers remarks on the economy at the IBEW Local 26 in Lanham, Maryland, U.S., February 15, 2023. REUTERS/Evelyn HocksteinWASHINGTON, Feb 16 (Reuters) - President Joe Biden, 80, will undergo a closely watched physical examination on Thursday, ahead of an expected announcement that he is seeking a second four-year term. His last physical and colonoscopy, in November 2021, showed the president to be a "healthy, vigorous, 78-year-old male," his doctors said. At his last exam, Biden's White House physician, Kevin O'Connor, declared him fit for duty and able to execute his responsibilities. Biden told Judy Woodruff in a PBS interview last week that any Americans concerned about his age should "watch me" perform the duties of the presidency.

President Joe Biden jogs across the South Lawn of the White House to speak with visitors before boarding Marine One, Friday, March 18, 2022, in Washington. President Joe Biden remains "fit" to conduct his duties as president, according to a medical memo released by the White House following a routine physical exam on Thursday. "President Biden remains a healthy, vigorous 80-year-old male, who is fit to successfully execute the duties of the Presidency," White House physician Kevin O'Connor said in a five-page memo. Biden was expected to have his exam in January, but it was postponed due to schedule conflicts, White House press secretary Karine Jean-Pierre said earlier this month. In 2021, Biden's exam included a colonoscopy, which required sedation.

☆ U.S. investigating Elon Musk's Neuralink over hazardous pathogens
▼ + stars: | 2023-02-09 | by ( Rachael Levy | Thomson Reuters | Award-Winning Journalist Covering Corporate Governance. Her Reporting Has Prompted Federal Investigations | ) www.reuters.com time to read: +5 min

Feb 9 (Reuters) - The U.S. Department of Transportation said on Thursday it is investigating Elon Musk's brain-implant company Neuralink over the potentially illegal movement of hazardous pathogens. The Department of Transportation spokesperson said the agency took PCRM's allegations "very seriously." Reuters reviewed the UC Davis records cited by PCRM in its letter. Neuralink messages and records not shared with UC Davis are not subject to such information requests. A UC Davis spokesperson would only say that the university abides by all biohazard and lab safety regulations.

☆ Elon Musk's Neuralink may have illegally transported pathogens, animal advocates say
▼ + stars: | 2023-02-09 | by ( Rachael Levy | Thomson Reuters | Award-Winning Journalist Covering Corporate Governance. Her Reporting Has Prompted Federal Investigations | ) www.reuters.com time to read: +5 min

Reuters reviewed the UC Davis records cited by PCRM in its letter. PCRM obtained the records from UC Davis through public information requests. Neuralink messages and records not shared with UC Davis are not subject to such information requests. A UC Davis spokesperson would only say that the university abides by all biohazard and lab safety regulations. During its partnership with UC Davis, Neuralink grew frustrated with what it regarded as the slow pace of testing on primates, current and former company employees told Reuters, and has since built out extensive in-house animal testing facilities.

Feb 8 (Reuters) - A Texas man accused of targeting Latinos during a 2019 massacre that left 23 people dead at an El Paso Walmart store is expected to plead guilty on Wednesday to federal hate crimes. Lawyers for alleged shooter Patrick Crusius said in a court filing last month that Crusius would change his plea to guilty. That decision came just days after federal prosecutors said they would not seek the death penalty against him. He faces the death penalty on state charges. The Texas court issued a gag order that prevents prosecutors, defense lawyers, victims and family members from discussing the case.

☆ A supportive and educational online community exists for people with chronic illnesses. They call themselves "spoonies."
▼ + stars: | 2023-01-27 | by ( Laura Wallis | ) www.businessinsider.com time to read: +6 min

The online spoonie community offers social connection, support, and education. From there, spoon theory was born, and today, the idea has grown in popularity, sparking a supportive online community around those living with chronic illnesses or who are disabled. The online community is made up of spoonies who self-identify and may have a range of diagnoses, such as Crohn's disease or endometriosis. The online community also represents neurological identities and divergences including autism and ADHD. Those who are disabled or have chronic illnesses may find that doctors and those around them don't take any pains or symptoms they experience seriously.

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