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☆ 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.

☆ NIH Top Job Still Empty as Candidates Back Out
▼ + stars: | 2023-03-13 | by ( Liz Essley Whyte | Stephanie Armour | ) www.wsj.com time to read: 1 min

Photo: Shuran Huang for The Wall Street JournalDiscoveries by National Institutes of Health scientists and grant recipients have been awarded more than 100 Nobel Prizes. The top job at the National Institutes of Health, a prestigious role that has attracted a Nobel Prize winner and other leading scientists, is going unfilled as candidates back out. At least two potential choices for the job have walked away, and the White House has struggled finding qualified candidates willing to fill a job that would probably force them to take a substantial pay cut and face popular attacks on scientists, people familiar with the search 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.

☆ 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.

☆ 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.

☆ Buy this little-known biotech stock set to rally nearly 60% as use of gene therapy grows, Goldman Sachs says
▼ + stars: | 2023-02-28 | by ( Samantha Subin | ) www.cnbc.com time to read: +1 min

Shares of Krystal Biotech can rally nearly 60% as use of its gene therapy to treat cases of herpes simplex virus mount, Goldman Sachs said. Given the promising outlook for the treatment, Kumar raised Goldman's peak global unadjusted sales expectations to $1.2 billion from $1.5 billion. He also expects a rapid launch of the therapy, anticipating 25% and 48% peak penetration in 2024 and 2025. Along with the upgrade, Kumar upped the Wall Street firm's price target to $124 from $79, suggesting that shares could potentially rally about 59%. KRYS YTD mountain Krystal Biotech shares so far this year — CNBC's Michael Bloom contributed reporting

☆ Shionogi sees COVID pill reaping $2 billion in annual sales upon U.S. approval
▼ + stars: | 2023-02-27 | by ( Rocky Swift | ) www.reuters.com time to read: +3 min

Xocova, a protease inhibitor like the COVID treatments developed by Pfizer Inc (PFE.N) and Merck & Co (MRK.N), was granted emergency approval by Japanese regulators in November, making it the nation's first domestically produced oral treatment for COVID. "If you kill the virus fast enough and sharp enough, the lower the probability of long COVID. According to one study by the Veterans Affairs St. Louis Health Care System, Pfizer's antiviral drug Paxlovid cuts the risk of developing many long COVID symptoms. Shionogi is hoping for Xocova sales of around $1 billion to $1.5 billion this year. "I have no regrets," Teshirogi said, adding that expectations among shareholders and the public had demanded that Shionogi devote its resources to fighting COVID.

☆ Moderna to make milestone payments to NIH for COVID vaccine
▼ + stars: | 2023-02-24 | by ( ) www.reuters.com time to read: 1 min

Companies Moderna Inc FollowFeb 24 (Reuters) - Moderna Inc (MRNA.O) will make certain contingent development, commercial and regulatory milestone payments to the U.S. National Institutes of Health (NIH) related to the development of COVID-19 vaccines, the company said in a filing on Friday. Moderna and the U.S. government agency had entered into a license agreement in December related to certain patents concerning the COVID vaccine products, the filing showed. The vaccine maker first disclosed the deal in its fourth-quarter earnings release stating it missed profit estimates hurt by the royalty payment to NIH. Moderna said under the agreement it would pay low single-digit royalties on future net sales and also minimum annual royalties. Reporting by Khushi Mandowara in Bengaluru; Editing by Shailesh KuberOur Standards: The Thomson Reuters Trust Principles.

☆ FDA says Guillain-Barre syndrome is possible risk of Pfizer's RSV vaccine for older adults
▼ + stars: | 2023-02-24 | by ( Spencer Kimball | ) www.cnbc.com time to read: +5 min

Guillain-Barre syndrome, or inflammatory neuropathy, is a rare disorder in which the body's immune system mistakenly attacks the nerves. There was also a possible case of Guillain-Barre syndrome in GSK 's RSV vaccine trials, but the company said there was insufficient evidence to confirm a diagnosis. They will also vote Wednesday on GSK's RSV vaccine for older adults. The Guillain-Barre casesIn Pfizer's trial, a 66-year-old man in the U.S. with a history of hypertension developed Guillain-Barre symptoms seven days after vaccination. He was hospitalized again after suffering a fall and was subsequently diagnosed with Guillain-Barre Syndrome.

☆ Fact Check-Suramin is not a proven cure for autism
▼ + stars: | 2023-02-22 | by ( Reuters Fact Check | ) www.reuters.com time to read: +6 min

Examples of users sharing the claim that suramin is a “relatively cheap” autism “cure” can be seen (here) and (here)Some posts refer to the treatment having caused “non-verbal” children with autism to start speaking within hours, but without citing the source of that alleged result. NO CURE FOR ASDThe U.S. National Institutes of Health (NIH) and the Food & Drug Administration (FDA) websites say that there is no cure for ASD, and caution against using any non-approved medication to treat ASD (here), (here). Other drugs may improve ASD symptoms, according to the NIH (here). The study found small, temporary improvements in scores on a diagnostic assessment for autism known as the Autism Diagnostic Observation Schedule, 2nd edition (ADOS-2) examination (here). Suramin is not a proven cure or treatment for autism spectrum disorder (ASD), but preliminary research suggests it might have promise to improve symptoms associated with ASD.

☆ Senators call on Medicare to offer broad coverage of Alzheimer's treatments as public pressure grows
▼ + stars: | 2023-02-17 | by ( Spencer Kimball | ) www.cnbc.com time to read: +5 min

U.S. senators on Friday called for Medicare to offer broad coverage of Alzheimer's treatments approved by the Food and Drug Administration, warning that current restrictions cost patients precious time as their disease progresses. The 20 senators told CMS that Alzheimer's will cost the nation $1 trillion by 2050 if the U.S. does not take decisive action. As a consequence, Medicare coverage for the expensive drug is basically nonexistent. The Alzheimer's Association wrote CMS in December calling for the agency to provide unrestricted Medicare coverage for Leqembi. "We believe Medicare beneficiaries should have unimpeded access, broad and simple access to Leqembi because the data fulfill those criteria."

☆ Maker of promising Alzheimer's drug Leqembi expects full FDA approval this summer, expanded Medicare coverage
▼ + stars: | 2023-02-17 | by ( Spencer Kimball | ) www.cnbc.com time to read: +7 min

Early Alzheimer's typically hits people ages 65 and older, causing cognitive impairment and other issues. Medicare beneficiaries who agree to participate in CMS-backed research studies, which are broader than clinical trials, would get coverage if Leqembi receives full approval. Drug rollout will take yearsIf everything goes according to Eisai's expectations, the FDA would grant full approval and CMS would provide unrestricted coverage of Leqembi. In that scenario, Eisai anticipates that about 100,000 diagnosed early Alzheimer's patients will be eligible by year three of the drug's rollout. Private insurers are largely waiting for a CMS coverage decision though some may decide to make their coverage decisions earlier, he said.

☆ U.S. NIH starts trial for Shionogi's COVID-19 pill
▼ + stars: | 2023-02-15 | by ( ) www.reuters.com time to read: 1 min

Feb 15 (Reuters) - The U.S. National Institutes of Health (NIH) said on Wednesday that it had started a clinical trial to evaluate Japan's Shionogi & Co Ltd's (4507.T) experimental oral antiviral drug to treat COVID-19. The drug, S-217622 or ensitrelvir, will be tested in adult patients hospitalized with COVID-19. Ensitrelvir is an oral antiviral agent taken once daily for five days to suppress replication of the virus. The trial will enroll about 1,500 people from different sites across the world, the government health organization said in a statement. Reporting by Mariam E Sunny; Editing by Anil D'SilvaOur Standards: The Thomson Reuters Trust Principles.

☆ Moderna CEO Stephane Bancel will testify before Senate next month on Covid vaccine price hike
▼ + stars: | 2023-02-15 | by ( Spencer Kimball | ) www.cnbc.com time to read: +3 min

Moderna CEO, Stephane Bancel attends 2019 Forbes Healthcare Summit at the Jazz at Lincoln Center on December 05, 2019 in New York City. Moderna CEO Stephane Bancel will testify before the Senate health committee in March over the company's plans to hike the price of its Covid-19 vaccine. Sanders, in a letter to Bancel last month, slammed the proposed price hike as "outrageous" given that the vaccine was developed in cooperation with the National Institutes of Health using taxpayer money. When the federal supply runs out, uninsured adults may have to pay the full price for the shots. There is a federal free vaccine program for children whose families or caretakers can't afford the shots.

☆ House GOP asks Fauci and dozens of health officials to testify in investigation into Covid origins
▼ + stars: | 2023-02-14 | by ( Spencer Kimball | ) www.cnbc.com time to read: +4 min

House Republicans have asked former White House chief medical advisor Dr. Anthony to testify before Congress as they launch a new investigation into the origins of the Covid-19 pandemic. "If there are oversight hearings I absolutely will cooperate fully and testify before the Congress," Fauci told reporters during his final briefing at the White House. He stepped down from his posts at the White House and at the helm of the National Institute of Allergy and Infectious Diseases in December. EcoHealth Alliance provided funding, which originated at NIH, to the Wuhan Institute of Virology to study coronaviruses. About $600,000 of that money went directly to the Wuhan Institute of Virology to study the threat posed by bat coronaviruses.

SummarySummary Companies Number of cases totals 57, court records showFeb 6 (Reuters) - Nearly 60 lawsuits claiming hair relaxer products sold by L'Oreal USA Inc and other companies cause cancer and other health problems will be consolidated in Chicago federal court, according to a Monday order from the Judicial Panel on Multidistrict Litigation. At least 57 lawsuits have been filed in federal courts across the country over the products, which use chemicals to permanently straighten textured hair, court records show. The lawsuits allege the companies knew their products contained dangerous chemicals but marketed and sold them anyway. In a statement posted online after the first lawsuits were filed, L'Oreal said it is "confident in the safety of our products and believe the recent lawsuits filed against us have no legal merit." She estimates that thousands of women could end up suing over the products, which are typically marketed to women of color.

☆ Fact Check-Vaccine work before SARS-CoV-2 had a name does not prove pandemic was planned
▼ + stars: | 2023-01-30 | by ( Reuters Fact Check | ) www.reuters.com time to read: +4 min

Users online are circulating that widely-known fact to imply the COVID-19 pandemic was planned. At timestamp 0:17-0:42, Bancel says Moderna was working on a COVID-19 vaccine before the virus had an official name, saying “I think there was no name at that time” (here). On Jan. 23, 2020, the WHO-affiliated Coalition for Epidemic Preparedness Innovations (CEPI) announced funding for three separate research teams to work on potential vaccines against the novel coronavirus (here). One of the research teams included a partnership between drug and vaccine developer Moderna and the U.S. National Institute of Allergy and Infectious Diseases. Neither the disease nor the virus that causes it had formal names until February 2020.

☆ Risky Virus Research Needs Tougher Review, Government Advisers Say
▼ + stars: | 2023-01-28 | by ( Liz Essley Whyte | ) www.wsj.com time to read: 1 min

An advisory board at the Bethesda, Md.-based National Institutes of Health unanimously backed research-oversight proposals. Virus experts advising the federal government backed proposals to bolster oversight of research that could make pathogens more dangerous or contagious. The experts, members of the National Institutes of Health’s biosecurity advisory board, voted unanimously on Friday in favor of the proposals. The NIH helps to administer the board, which gives advice to the entire U.S. government.

An advisory committee to the Food and Drug Administration on Thursday raised doubts about shifting toward a yearly Covid booster for most adults and children, saying too many questions about the virus still remain unanswered. The FDA convened its Vaccine and Related Biology Products Advisory Committee to discuss how the Covid vaccines may change moving forward. On Monday, the agency published briefing documents proposing annual Covid shots that target the latest variants of the virus — an approach similar to the yearly flu shot. Some committee members said they would prefer to make multiple yearly meetings on the Covid vaccines the norm. In a unanimous vote, the committee recommended using the bivalent formula in all Covid vaccines moving forward, not just for booster shots.

☆ A 24-year-old says she 'ignored' her bloating and stomach pain until it got so bad she went to the ER. Doctors diagnosed her with ovarian cancer.
▼ + stars: | 2023-01-27 | by ( Catherine Schuster-Bruce | ) www.businessinsider.com time to read: +4 min

A woman, 24, found out she had ovarian cancer after her stomach pain got so bad she went to the ER. Etheridge told SWNS that she "ignored" her pain for months because she didn't know cancer could cause it. Generally, people are diagnosed with ovarian cancer after menopause and it's rare in people younger than 40 to develop the disease, according to the American Cancer Society. "I don't think young women know the symptoms of ovarian cancer," she said. Chemotherapy was 'brutal'Treatment of ovarian cancer depends on the type of cancer and how far it has spread, but includes chemotherapy, hormone therapy, and surgery.

☆ A cosmetic dermatologist says he's seeing 'Ozempic face,' or gaunt cheeks from taking the buzzy weight loss drug
▼ + stars: | 2023-01-26 | by ( Allana Akhtar | ) www.businessinsider.com time to read: +4 min

A cosmetic dermatologist explained why he coined the term "Ozempic face," named after the buzzy weight loss drug. He treats "Ozempic face" by inserting fillers to revolumize the face, but said too many injections can create an unnatural look. Rapid weight loss causes skin saggingDr. Rocio Salas-Whalen, a board-certified endocrinologist, said "Ozempic face" is a result of rapid weight loss, not the drug itself. The weight-loss drug causes overall fat loss, so every part of the face loses fat, like around the temple or jaw line. Treating "Ozempic face" requires injecting fillers to add volume to the whole face, not just the cheeks.

☆ A plastic surgeon says he's seeing 'Ozempic face,' or gaunt cheeks from taking the buzzy weight loss drug
▼ + stars: | 2023-01-26 | by ( Allana Akhtar | ) www.businessinsider.com time to read: +4 min

A plastic surgeon explained why he coined the term "Ozempic face," named after the buzzy weight loss drug. He treats "Ozempic face" by inserting fillers to revolumize the face, but said too many injections can create an unnatural look. Rapid weight loss causes skin saggingDr. Rocio Salas-Whalen, a board-certified endocrinologist, said "Ozempic face" is a result of rapid weight loss, not the drug itself. The weight-loss drug causes overall fat loss, so every part of the face loses fat, like around the temple or jaw line. Treating "Ozempic face" requires injecting fillers to add volume to the whole face, not just the cheeks.

☆ Fact Check-Online claims about nutritional table lack context
▼ + stars: | 2023-01-20 | by ( Reuters Fact Check | ) www.reuters.com time to read: +6 min

Food Compass has not been endorsed or promoted by the NHLBI or the government departments responsible for developing nutrition guidelines. TUFTS’ FOOD COMPASSThe Food Compass was developed by researchers at the Friedman School of Nutrition Science and Policy at Tufts University (bit.ly/3ZSHEUC). The Tufts team addressed claims about the graphic shared online in the Frequently Asked Questions section of its Food Compass website (here). “These graphs were created by others to show these exceptions, rather than to show the overall performance of Food Compass and the many other foods for which Food Compass works well. But, as objective scientists, we accept constructive criticism and are using this to further improve Food Compass,” the statement added.

☆ NIH Advisers Propose Strengthening Oversight of Virus Research
▼ + stars: | 2023-01-20 | by ( Liz Essley Whyte | ) www.wsj.com time to read: 1 min

National Institutes of Health advisers proposed measures to enhance security of pathogen research, as House Republicans prepared to investigate the agency’s funding of virus experiments and handling of the Covid-19 pandemic. The NIH group recommended on Friday that federal officials expand their reviews of risky research to include any experiments altering a virus in a way that could make it so transmissible or virulent that it would pose a threat to public health or national security.

☆ NIH Faces GOP Scrutiny Over Handling of Covid-19 Pandemic
▼ + stars: | 2023-01-20 | by ( Liz Essley Whyte | ) www.wsj.com time to read: 1 min

House Republicans plan to put the National Institutes of Health under the microscope, conducting investigations into its funding of research on viruses and handling of the Covid-19 pandemic. The lawmakers, now in charge of the House, said they aim to probe the NIH’s oversight of research that involves modifying viruses to identify potential threats to humans and develop ways to fight them. The Republicans also want to probe the agency’s links to an institute in Wuhan, China, that conducts the pathogen research.

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