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☆ 'Quiet vacationing' shows how sad America's work culture has become
▼ + stars: | 2024-06-20 | by ( Dan Defrancesco | ) www.businessinsider.com time to read: +7 min

download the appSign up to get the inside scoop on today’s biggest stories in markets, tech, and business — delivered daily. In today's big story, we're looking at why the rise of "quiet vacationing" shows the depressing state of America's work culture . If you're unfamiliar with the distinction, let me introduce you to a new workplace phrase: quiet vacationing . But Business Insider's Emily Stewart argues workers feeling too stressed to fully take time off is a sad example of America's work culture. The irony is that quiet vacationing could arguably put you in a worse position for your job these days.

Persons: —, Jenny Chang, Rodriguez, Slack, Emily Stewart, Martin Barraud, Wally Pipp, Pipp, Lou Gehrig, Wally Pipped, Alyssa Powell, Steve German, Arizona's, Mohamed El, Erian, China's, Brooks Kraft, They've, Dan DeFrancesco, Jordan Parker Erb, Hallam Bullock, George Glover, Annie Smith, Amanda Yen Organizations: Service, Business, New York Yankees, American League, Yankees, Getty, Partners, Alfa Bank, YouTube, Foo Fighters, BI, Amazon, Bain & Company, Brooks Kraft LLC, Harvard, Hollywood . Media, Dell Locations: Arizona, Miami, China, Beijing, Shanghai, Russia, Hollywood, New York, London

☆ Rob Burrow, Rugby Star and A.L.S. Campaigner, Dies at 41
▼ + stars: | 2024-06-04 | by ( Alex Williams | ) www.nytimes.com time to read: +1 min

Rob Burrow, a rugby standout who overcame his diminutive stature with fleetness and ferocity to become an eight-time champion of Britain’s Super League and who was later hailed for raising awareness of motor neuron disease after being diagnosed with it in 2019, died on Sunday. His death — from M.N.D., a group of neurological disorders that includes amyotrophic lateral sclerosis, or A.L.S., also known as Lou Gehrig’s disease — was announced by the Leeds Rhinos, the British club with which he spent his entire 17-year professional career. It did not say where he died. Doubted at every turn for his small stature — he was about 5-foot-5 and 150 pounds — Burrow nevertheless became a star, earning nicknames like Mighty Atom and Pocket Rocket in the British tabloids. He was sapped of his physical gifts, however, when he was diagnosed with his neurological disorder at 37, just two years after his retirement in 2017.

Persons: Rob Burrow, Lou Gehrig’s, —, Burrow Organizations: Britain’s Super League, Leeds Rhinos Locations: M.N.D, British

☆ As MLB changes its records, Josh Gibson, not Ty Cobb, is all-time batting leader
▼ + stars: | 2024-05-28 | by ( Tyler Kepner | ) www.nytimes.com time to read: +10 min

And as of Wednesday, Josh Gibson will replace Cobb as the leading hitter in the official records of the game. Thorn estimated that about 75 percent of all Negro Leagues box scores have been documented, and that MLB would update the records as more are uncovered. To some extent, Negro League numbers will always be a work in progress. Barnstorming games, essential as a financial lifeline to Negro League teams, are not included in the statistics. The scheduled games range from 26 (Negro American League, 1942) to 91 (Negro National League I, 1927).

Persons: Abner Doubleday, Tyrus Raymond Cobb, Doubleday, Josh Gibson, Cobb, ”, Larry Lester, “, Ty Cobb, Oscar Charleston, Rogers, Jud Wilson, Ed Delahanty, Buck Leonard, Ted Williams, John Thorn, Thorn, ” Lester, I’ve, Gibson, Chino Smith’s, Hugh Duffy’s, Chino Smith, Hugh Duffy, Charlie Blackwell, Ross Barnes, Willie Keeler, Rogers Hornsby, Tetelo Vargas, Vargas, — Lyman Bostock Sr, Bostock, Ted Williams ’, Sean Forman, Ty, Lester, Gary Ashwill, Kevin Johnson, Seamheads, ” Thorn, Elias, Babe Ruth, Lou Gehrig, Oscar, Barry Bonds, Jimmie Foxx, Ed Walsh, Addie Joss, Mordecai Brown, John Ward, Christy Mathewson, Rube Waddell, Walter Johnson, Dave Brown, Tommy Bond, White, Willie Mays, Mays, Bullet Rogan, Turkey Stearnes, ’ ” Lester, Simon Bruty Organizations: Major, Baseball, Negro Leagues, MLB, “, Negro League, Negro, Rogers Hornsby, Turkey Stearnes, Louis Cardinals, San Francisco Giants, Kansas City Monarchs, American, National Leagues, Negro American League, Negro National League I, Boston, New York Cubans, Twins, Red Sox, Sports, Birmingham Black Barons, Graphics, Retrosheet, Oscar Charleston, Barry, Major League Baseball, Birmingham, Giants, Mets Locations: Turkey, Birmingham, Ala, Chicago, Moline, Washington ,

Amylyx said Friday it would discuss its plans for Relyvrio with patients and the FDA, which “may include voluntarily withdrawing” the drug. The latest company study showed that the drug did not slow the disease compared with a dummy treatment. Amylyx’s medication is part of a string of drugs for deadly, degenerative diseases that have won FDA approval in recent years despite questionable proof that they work. That commitment seemed to reassure FDA's advisers who voted in favor of the drug's approval, despite the questionable data. In the months before the decision the FDA faced intense pressure from ALS patients, advocates and members of Congress.

Persons: Lou Gehrig’s, Amylyx, ”, “, Relyvrio Organizations: WASHINGTON, Drug Administration, Amylyx Pharmaceuticals, Relyvrio, FDA, Cambridge, Amylyx Pharmaceuticals Inc, Associated Press Health, Science Department, Howard Hughes Medical Institute’s Science, Educational Media Group, AP Locations: U.S

☆ 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

Without ever clicking a mouse or touching a screen, Mark selected this command on his computer simply using signals from his brain. “I figured I had two choices: I could wallow in self-pity, or I could pick myself up by the bootstraps and do what I could to help,” Mark said. Synchron’s brain implant, the one Mark has, is called a Stentrode and consists of a stent with electrode sensors that can detect electrical brain activity. That external transmitter sits right above the internal transmitter and carries the signal from Mark’s brain to the computer almost instantaneously. Earlier this month, Musk also said Neuralink’s first human trial participant can control a computer mouse with their brain.

Persons: Sanjay Gupta’s, Erin Burnett OutFront, CNN —, Mark, Lou Gehrig’s, ” Mark, Elon Musk, ”, “, Sanjay Gupta, Synchron, Tom Oxley, hardwired, he’s, Mark didn’t, “ We’d, Maria Nardozzi, ” Oxley, CNN Mark, Musk’s Neuralink, Oxley, António Guterres, ” Elon Musk, Gonzalo Fuentes, Neuralink, Musk, Hope Organizations: CNN, BCI, US Food and Drug Administration, Netflix, US Securities and Exchange Commission, United Nations, Reuters, SpaceX Locations: Neuralink, UNESCO’s, Pennsylvania

Washington CNN —President Joe Biden is fit for duty, his doctor reported Wednesday following the president’s annual physical, in what is expected to be the last update on Biden’s health before November’s election. Dr. Kevin O’Connor said in a memo there are “no new concerns” with the president’s health revealed by this year’s physical. The White House said earlier Wednesday that no cognitive test was administered as O’Connor did not find it necessary. The procedure was “successfully completed” at the White House by a team from Walter Reed, O’Connor said. Reports from the White House physician over the last several decades have consistently described the office-holder as fit to serve.

Persons: Joe Biden, Kevin O’Connor, ” O’Connor, Biden, ”, SSRS, Karine Jean, Pierre, “ doesn’t, Donald Trump, Jonathan Reiner, ” Reiner, that’s, O’Connor, “, Biden’s, ” Biden, Lou Gehrig’s, Robert Hur, I’ve, –, seething Biden, “ I’ve, NBC’s, Seth Meyers, ” Wednesday’s Walter Reed, Walter Reed, CNN’s Kevin Liptak, Mira Cheng Organizations: Washington CNN, O’Connor, “, State, CNN, Quinnipiac University, White, US Preventive Services, Force, Medical Unit, American Medical Association, National Institutes of Health, White House Locations: Beverly Hills , California, United States

☆ 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

NEW YORK (AP) — According to Elon Musk, the first human received an implant from his computer-brain interface company Neuralink over the weekend. Neuralink reposted Musk's Monday post on X, but did not publish any additional statements acknowledging the human implant. In its September announcement, Neuralink said the wires would be surgically placed in a region of the brain that controls movement intention. The initial goal of the so-called brain computer interface is to give people the ability to control a computer cursor or keyboard using their thoughts alone. There are more than 40 brain computer interface trials underway, according to clinicaltrials.gov.

Persons: Elon Musk, Musk, Neuralink, Gehrig’s Disease, ___ Laura Ungar Organizations: Twitter, Associated Press, Drug Administration Locations: Columbia , Missouri

☆ Hochul to Propose $25 Million in State Funding for A.L.S. Research
▼ + stars: | 2024-01-15 | by ( Claire Fahy | ) www.nytimes.com time to read: +1 min

Kathy Hochul is set to propose an appropriation on Tuesday that would provide one of the largest sums ever invested by a state into research of amyotrophic lateral sclerosis, the neurodegenerative disease known as A.L.S. The appropriation, part of Ms. Hochul’s overall budget proposal, would commit $25 million to A.L.S. The governor said she hoped the program could serve as an outline for tackling other rare diseases as well. Ms. Hochul’s mother, Patricia Courtney, died from A.L.S., also known as Lou Gehrig’s disease, in 2014. She never saw her daughter become lieutenant governor or governor.

Persons: Kathy Hochul, Hochul’s, Patricia Courtney, Lou Gehrig’s, Hochul, ” Organizations: State Assembly Locations: A.L.S, State

☆ 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

☆ Chris Snow, Calgary Flames executive, dead at 42 following battle with ALS
▼ + stars: | 2023-10-01 | by ( Homero De La Fuente | ) edition.cnn.com time to read: +3 min

CNN —Calgary Flames assistant general manager Chris Snow died on Saturday following his battle with ALS, his wife Kelsie Snow announced. “The National Hockey League family is deeply saddened by the passing of Calgary Flames Assistant General Manager Chris Snow, a remarkable man whose courageous and relentless battle with ALS has been an inspiration to so many,” NHL commissioner Gary Bettman said in a statement. Prior to his time with the Flames, Snow was a sports reporter for the Boston Globe, where he covered the Boston Red Sox, and the Minneapolis Star-Tribune, where he covered the Minnesota Wild. Following his time as a journalist, Snow worked as a director of hockey operations for the Wild from 2006 through 2010. He is survived by his wife Kelsie, his son Cohen, and his daughter Willa.

Persons: Chris Snow, Kelsie Snow, Chris, ” Snow, Lou Gehrig’s, “ Chris, Craig Conroy, Kelsie, Cohen, Willa, ”, Gary Bettman, Snow Organizations: CNN — Calgary Flames, ALS, Flames, ” Flames, National Hockey League, Calgary Flames, NHL, Club’s Hockey, Boston Globe, Boston Red Sox, Minneapolis Star, Tribune Locations: Minnesota

☆ 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

Those advocates still face one giant hurdle: FDA regulators say the treatment hasn't been shown to work. But with the backing of thousands of ALS patients, Brainstorm took the rare step of “filing over protest,” essentially forcing the agency to render a decision. Still, ALS patients see reasons for optimism. At Wednesday’s meeting, people with such reservations are certain to be outnumbered by appeals from ALS patients and their families. That compromise would be similar to FDA's approach to Relyvrio last year, another ALS drug with questionable data.

Persons: Lou Gehrig’s, drugmaker, they’re, ”, Marc Scheineson, Brian Wallach, Wallach, “, Brainstorm’s, NurOwn, Patricia Manhardt, Anthony Windebank, reanalyzing, weren’t, Terry Heiman, Patterson, it’s, Holly Fernandez Lynch, Matthew Perrone Organizations: WASHINGTON, Drug Administration, FDA, drugmakers, Congress, Obama White House, ALS Association, Mayo Clinic, Physicians, Temple University, University of Pennsylvania, Twitter, Associated Press Health, Science Department, Howard Hughes Medical Institute’s Science, Educational Media Group, AP

NEW YORK (AP) — Aaron Judge became the first New York Yankees player to hit three home runs in a game twice in one season when he connected in the seventh inning Friday night against the Arizona Diamondbacks. “Greatness doing special things,” Yankees manager Aaron Boone said. It was the 35th time a Yankees player hit three homers in a game. “A lot of missed time, a lot of missed opportunities, that’s how I look at it,” Judge said. The five-time All-Star hit 62 home runs last season, breaking the previous American League record of 61 set by former Yankees slugger Roger Maris in 1961.

Persons: — Aaron Judge, “, ” Judge, ”, Brandon Pfaadt, Slade Cecconi, Aaron Boone, Gleyber Torres, Lou Gehrig, Joe DiMaggio, Alex Rodríguez, Tony Lazzeri, Bobby Murcer, Judge, Judge’s, Pfaadt, misplaying Oswald, spraining, Roger Maris, ___ Organizations: New York Yankees, Arizona Diamondbacks, New, ” Yankees, Yankee, Philadelphia, Yankees, New York, Yankees ’, Dodger, American League Locations: Washington

☆ Developers threaten Tokyo's historic Jingu baseball park, UNESCO panel says
▼ + stars: | 2023-09-08 | by ( ) www.reuters.com time to read: +2 min

[1/2] An aerial view shows Meiji Jingu Stadium and Chichibunomiya Rugby Stadium in Tokyo, Japan December 3, 2022. The U.N. cultural agency's panel, the International Council on Monuments and Sites (ICOMOS), urged the government to review the plan. Rallies and petition drives have also voiced opposition to the plan, which includes the demolition and replacement of the Meiji Jingu Stadium, built in 1926, and now home to the Yakult Swallows team. Ruth, Gehrig and five other baseball Hall of Fame inductees were part of an All American team that played at Meiji Jingu Stadium during their barnstorming Japanese tour. In June, the Mitsui Fudosan-led group of developers launched a website for queries from the public, aiming to build "understanding and empathy" for the project.

Persons: Babe Ruth, Lou Gehrig, Mitsui Fudosan, Ryuichi Sakamoto, Haruki Murakami, Yuriko Koike, ICOMOS, Ruth, Gehrig, Rocky Swift, Clarence Fernandez, Robert Birsel Organizations: Chichibunomiya Rugby, Kyodo, REUTERS, Rights, UNESCO, International Council, Mitsui Fudosan, Mitsui, Meiji, of Fame, Thomson Locations: Meiji, Tokyo, Japan, Jingu

☆ Developers threaten Tokyo's historic Jingu ball park, UNESCO panel says
▼ + stars: | 2023-09-08 | by ( ) www.reuters.com time to read: +1 min

[1/2] An aerial view shows Meiji Jingu Stadium and Chichibunomiya Rugby Stadium in Tokyo, Japan December 3, 2022. Rallies and petition drives have protested against the plan that will also tear down and replace the Meiji Jingu Stadium, built in 1926, which is now home to the Yakult Swallows team. The council and its national panel for Japan also called on Mitsui Fudosan and other developers to withdraw immediately. In June, the Mitsui Fudosan-led group launched a website for queries from the public, aiming to build "understanding and empathy" for the project. Reporting by Rocky Swift; Editing by Clarence FernandezOur Standards: The Thomson Reuters Trust Principles.

Persons: Babe Ruth, Lou Gehrig, Ryuichi Sakamoto, Haruki Murakami, Rocky Swift, Clarence Fernandez Organizations: Chichibunomiya Rugby, Kyodo, REUTERS, Rights, UNESCO, International Council, Mitsui Fudosan, Mitsui, Thomson Locations: Meiji, Tokyo, Japan, Jingu

☆ 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

☆ Born of Grief, a Couple’s Off Broadway Incubator Marks 20 Years
▼ + stars: | 2023-05-08 | by ( Robin Pogrebin | ) www.nytimes.com time to read: +1 min

In 2002, Jenny and Jon Steingart founded the Off Broadway incubator Ars Nova as a way of honoring Jenny’s brother, Gabriel Wiener, who in 1997 died of a brain aneurysm at the age of 26. Now, as the nonprofit theater is marking its 20th anniversary, the couple is facing another wrenching struggle: Jon has A.L.S., the severe neurological disorder also known as Lou Gehrig’s disease. “Every painful experience in my life — if I have to live through it, I am going to come out on the other side with a lesson and a way to give back in some way,” Jenny Steingart said in a recent interview at their home on the Upper West Side. “Because a loss without some meaning behind it is really hard to live with.”So this anniversary, to be celebrated with a gala on Monday, also finds the Steingarts feeling great satisfaction, having created an institution that — in the wake of the 9/11 attacks — has played a crucial role in the professional development of so many artists. Among those who have worked at Ars Nova are Lin-Manuel Miranda, Thomas Kail, Christopher Jackson and Phillipa Soo of “Hamilton” fame; Bridget Everett, the actress and cabaret performer of the acclaimed HBO series “Somebody Somewhere”; and Dave Malloy, who created “Natasha, Pierre & the Great Comet of 1812” at Ars Nova.

☆ 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.

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