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☆ 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.

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.

☆ Brain implant startup backed by Bezos and Gates is testing mind-controlled computing on humans
▼ + stars: | 2023-02-18 | by ( Ashley Capoot | ) www.cnbc.com time to read: +7 min

Philip O'Keefe, one of Synchron's patients in the SWITCH clinical trial, using his BCI. Philip O'Keefe, one of Synchron's patients in the SWITCH clinical trial, was the first person in the world to tweet using a BCI device. About 20 months earlier, O'Keefe was implanted with Synchron's BCI. Synchron's technology has caught the attention of its competitors. Source: SynchronIn January, the medical journal JAMA Neurology published the peer-reviewed, long-term safety results from a trial of Synchron's BCI system in Australia.

☆ I asked 30 health and wellness professionals how they avoid burnout—here are 4 things they all do
▼ + stars: | 2023-02-11 | by ( Renée Onque | ) www.cnbc.com time to read: +3 min

This can be extremely difficult for those in the healthcare industry, which is why I asked 30 health and wellness professionals the same question: "How do you manage your energy and not burn out in your profession?" In our day-to-day lives, we're constantly looking for ways to increase our energy and avoid burnout , especially in our jobs. Despite the large differences in their roles, there were several themes within their responses that stood out as ways to prevent burnout. "I don't think work feels like work when you feel like you're having an impact," says Gounder. "Look at your life as a whole, and make sure there's good things about it, and make sure you have time for them."

☆ Precision Neuroscience, co-founded by Neuralink alum, is creating a brain implant thinner than a human hair
▼ + stars: | 2023-01-25 | by ( Ashley Capoot | ) www.cnbc.com time to read: +5 min

Precision was co-founded by Benjamin Rapoport, who also co-founded Elon Musk's BCI company, Neuralink , and Michael Mager. But while Neuralink's BCI is designed to be implanted directly into the brain tissue, Precision relies on a surgical technique that is designed to be less invasive. A BCI is a system that deciphers brain signals and translates them into commands for external technologies, and several companies have successfully created devices with this capability. The device is called the Layer 7 Cortical Interface , and it's a brain implant that aims to help patients with paralysis operate digital devices using only neural signals. "I think that the brain is, in a lot of ways, the next frontier for modern medicine," he said.

☆ A new test for autism hopes to help doctors diagnose before symptoms show
▼ + stars: | 2023-01-05 | by ( Evan Bush | Evan Bush Is A Science Reporter For Nbc News. He Can Be Reached At Evan.Bush Nbcuni.Com. | ) www.nbcnews.com time to read: +8 min

Researchers have discovered myriad risk factors associated with autism, including infections during pregnancy, air pollution and maternal stress. “We can detect the clear rhythm of autism with just about one centimeter of hair,” Arora said. Autism diagnosis timingArora and his team hope their technology could help young children, even newborns, receive early interventions for autism sooner than they can now. “We want to enable early intervention.”There is not yet a biological test for autism spectrum disorder. Perhaps eventually, that information could open up new pathways for the development of drugs or therapies for autism, he said.

☆ Biotech investor Brad Loncar shares 10 predictions for 2023, including a hot new cancer target, Nobel Prize winners, and a biotech founder running for president
▼ + stars: | 2023-01-04 | by ( Andrew Dunn | ) www.businessinsider.com time to read: +14 min

Loncar shared his 2023 forecast, including new drugs, Nobel Prize winners, and more globalization. Brad Loncar isn't expecting a miraculous rebound for the biotech industry in 2023. In an interview with Insider, Loncar shared 10 predictions for biotech in 2023, ranging from Nobel Prize winners and presidential runs to hot cancer targets and bankruptcy worries. 2022 was a rough year for the biotech industry, which once again underperformed the stock market. The industry runs to the next super-hot cancer target: Claudin 18.2In cancer research, drug companies are always on the hunt for the next promising target.

☆ Final farewell: From Sidney Poitier to Pope Emeritus Benedict a look back at the influential figures who died in 2022
▼ + stars: | 2023-01-01 | by ( Associated Press | ) www.nbcnews.com time to read: +55 min

Other world leaders who died in 2022 include former Soviet leader Mikhail Gorbachev, who died in August. The final days of 2022 saw the loss of some exceptionally notable figures, including Pope Emeritus Benedict XVI. Here is a roll call of some influential figures who died in 2022 (cause of death cited for younger people, if available):___JANUARY___Dan Reeves, 77. A Cuban-born artist whose radiant color palette and geometric paintings were overlooked for decades before the art world took notice. A prolific character actor best known for playing villains and tough guys in “The Manchurian Candidate,” “Ocean’s Eleven” and other films.

☆ Why tech billionaires like Elon Musk, Bill Gates, and Jeff Bezos are all investing in biotech startups that want to link your computer directly to your brain
▼ + stars: | 2022-12-21 | by ( Andrew Dunn | Hilary Brueck | ) www.businessinsider.com time to read: +8 min

Tech moguls like Elon Musk, Jeff Bezos, and Bill Gates are investing in brain-implant startups. Through their venture-capital funds, Jeff Bezos and Bill Gates both recently backed the Brooklyn, New York, startup Synchron, which has tested its brain stent in seven humans. Peter Thiel, a billionaire cofounder of PayPal, invested last year in Utah's Blackrock Neurotech, an older BCI startup that has said it hopes to apply for Food and Drug Administration approval soon. That long-term potential has caught the attention of tech billionaires like Musk, Gates, and Bezos. No BCI startup has gone public, and most of their fundraising rounds have been modest compared with larger and more-mature biotechs.

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☆ Singer Roberta Flack Has ALS, Finds It ‘Impossible to Sing’
▼ + stars: | 2022-11-15 | by ( Ginger Adams Otis | ) www.wsj.com time to read: 1 min

Roberta Flack won back-to-back Grammy awards for record of the year in 1973 and 1974. Grammy award-winning artist Roberta Flack has ALS, commonly known as Lou Gehrig ‘s disease, and can no longer sing, her representative said Monday. Ms. Flack, 85, had hoped to attend Thursday’s premiere of “Roberta,” a feature-length documentary about her that’s being screened at DOC NYC, an annual documentary film festival in New York.

☆ Roberta Flack has ALS, now ‘impossible to sing,’ rep says
▼ + stars: | 2022-11-14 | by ( Associated Press | ) www.nbcnews.com time to read: +3 min

A representative for Roberta Flack announced Monday that the Grammy-winning musician has ALS, commonly known as Lou Gehrig’s disease, and can no longer sing. The progressive disease “has made it impossible to sing and not easy to speak,” Flack’s manager Suzanne Koga said in a release. Flack also plans to publish a children’s book co-written with Tonya Bolden, “The Green Piano: How Little Me Found Music,” that month. Flack had a stroke in 2016 and spoke to The Associated Press a little over two years later about returning to performing. “I could sing any number of songs that I’ve recorded through the years, easily, I could sing them, but I’m going to pick those songs that move me,” Flack said.

☆ This gene-editing company that went public last month could rally 20%, Jefferies says
▼ + stars: | 2022-11-14 | by ( Alex Harring | ) www.cnbc.com time to read: +2 min

Prime Medicine shares could pop the company works toward a gene therapy that could address nine out of every 10 genetic mutations, Jefferies said Monday. The company went public Oct. 20 through an initial public offering. "PRME believes that key advantages of Prime Editing technology lie in its versatility, precision, effectiveness and breadth." Yang said Prime Medicine has a unique focus on search-and-replace genome editing, which can theoretically use one-time therapies to address 90% of the approximately 75,000 known genetic mutations. Search-and-replace can do more gene conversions without off-target editing or breaking double-strands of DNA, which allows it to have broader impact, Yang said.

☆ Roberta Flack can no longer sing after ALS diagnosis
▼ + stars: | 2022-11-14 | by ( Story Reuters | ) edition.cnn.com time to read: +1 min

Grammy-winning musician Roberta Flack, whose hits include “Killing Me Softly with His Song,” has been diagnosed with ALS, also known as Lou Gehrig’s disease, and can no longer sing, her representatives said on Monday. Amyotrophic lateral sclerosis, a progressive disease, “has made it impossible to sing and not easy to speak,” a statement from her publicists said. “But it will take a lot more than ALS to silence this icon.”A documentary about Flack’s life is set to debut at a film festival in New York next week. Flack, 85, also is releasing a children’s book in January. ALS breaks down nerve cells in the brain and spinal cord that make muscles work, leading to progressive paralysis and death.

Weird Al, known for taking famous pop and rock songs and sending them up by rewriting the lyrics. It began as a fake movie trailer that director Eric Appel made in 2013 as a sketch for Funny or Die. It featured Aaron Paul, Olivia Wilde, Gary Cole, Mary Steenburgen, Patton Oswalt and yes, Weird Al. Yankovic noted that the day after the trailer came out, “if you did a Google search for Weird Al, the first thing is, ‘Did Weird Al date Madonna?’ Everybody wanted to know. Weird Al Yankovic during a photo shoot in Los Angeles in 1984.

☆ Sam Shields: Super Bowl champion regrets playing in NFL; says his head is 'all mushed together' with concussions
▼ + stars: | 2022-11-03 | by ( Ben Morse | ) edition.cnn.com time to read: +7 min

CNN —Former Green Bay Packers cornerback Sam Shields has said he regrets playing in the NFL, pointing to the effects concussions and head injuries had on his career and his later life. The spotters “serve as another set of eyes, watching for possible injuries at every NFL game,” according to NFL Football Operations. Concussions and their prevention have become an important issue in recent years due to their connection to brain disease later in life. The neurodegenerative brain disease can be found in individuals who have been exposed to repeated head trauma. The researchers hypothesized about a relationship between head trauma and ALS because of a similar link detected between football and the neurodegenerative disease CTE.

☆ Jim Obergefell's Supreme Court case helped legalize same-sex marriage 7 years ago. Now, he could become the only openly gay member of Ohio's state House.
▼ + stars: | 2022-11-02 | by ( Bryan Metzger | ) www.businessinsider.com time to read: +13 min

Now, Jim Obergefell — the man for which that case was named — is running for Ohio state House. "But you know, the nice thing is, everything I went through with the court case — a lot of that really prepared me for something like this." The "court case" in question was Obergefell v. Hodges, the landmark 2015 civil rights case in which the Supreme Court ruled five to four that same-sex couples were guaranteed the right to marry. "I don't start with it, and I don't focus on it," he said of his association with the 2015 Supreme Court case. "Very, very few of them have a Supreme Court case that happened because of that relationship."

☆ 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.

☆ Why a $158,000 Drug With Unclear Benefits Hurts Whole Health System
▼ + stars: | 2022-10-10 | by ( David Wainer | ) www.wsj.com time to read: 1 min

Like many patients suffering from amyotrophic lateral sclerosis, or ALS—also known as Lou Gehrig’s disease—Layne Oliff didn’t have any time to waste. Even before the drug Relyvrio was approved late last month by the Food and Drug Administration, he has had his own do-it-yourself method: he gets sodium phenylbutyrate in liquid form from a New Jersey pharmacy and taurursodiol online from Amazon. That costs him over $7,000 a year, but he says it has been well worth it because he feels the combination has helped stabilize a disease that often causes death within a few years.

☆ William Shatner describes space travel in new book "Boldly Go"
▼ + stars: | 2022-10-10 | by ( Jackie Wattles | ) edition.cnn.com time to read: +8 min

CNN interviewed him in June about the book, his trip to space with the Jeff Bezos-backed space tourism company Blue Origin, and what’s next for the 91-year-old. William Shatner: Fifty-five or 60 years ago I read a book called “Silent Spring” by Rachel Carson. Shatner: The whole idea here is to get people accustomed to going to space, as if it’s like going to the Riviera. The song “So Fragile, So Blue,” is very much about my experience in space. And then I have my book, called “Boldly Go,” coming out in the fall.

☆ 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.

☆ These startups are beating Elon Musk in the race to let you mind meld with your computer
▼ + stars: | 2022-08-17 | by ( Adam Rogers | ) www.businessinsider.com time to read: +21 min

That's when I started reporting on them, and like any good nerd I was compelled by what scientists could learn with these "brain computer interfaces." The race for implantable brain chips has been a long, deliberate marathon. Graham Felstead, who has severe paralysis, was the first person to have a BCI inserted via the blood vessels. Brain chips will enable them to perform simple actions on their own and reduce the need for round-the-clock care. "When we started in 2015 and I was pitching venture capitalists on brain computer interfaces, no one knew what a brain computer interface was," says Matt Angle, the CEO of Paradromics.

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