DIRS.INFO The most relevant business & tech news

☆ FDA authorizes Prenosis software as first AI tool that can diagnose sepsis
▼ + stars: | 2024-04-03 | by ( Ashley Capoot | In | ) www.cnbc.com time to read: +4 min

Prenosis' tool, called Sepsis ImmunoScore, uses 22 different parameters like temperature, heart rate and cell counts to help clinicians assess a patient's risk of sepsis, the company told CNBC. While Prenosis is the first company to receive FDA approval for its AI diagnostic tool for sepsis, several organizations have built and released similar solutions. Epic's sepsis model is used in hundreds of hospitals across the U.S., according to a 2021 study published in JAMA Internal Medicine. Even so, Epic reportedly overhauled its sepsis model the following year in an attempt to improve its performance, according to Stat News. Prenosis said it worked to demonstrate the safety and efficacy of Sepsis ImmunoScore to the FDA for around 18 months.

Persons: ImmunoScore, Prenosis Organizations: U.S . Food, Drug Administration, Wednesday, Centers for Disease Control, CNBC, Johns Hopkins University, Nature Medicine, Systems, Stat News, FDA Locations: U.S, White Oak , Maryland, Chicago

☆ A key segment of the Treasury market is on a record losing streak ahead of the Fed meeting
▼ + stars: | 2024-03-19 | by ( Jesse Pound | In Jesse-Pound | ) www.cnbc.com time to read: +2 min

The price of bond funds like TLT move in the opposite direction of bond yields, meaning lower prices equal higher yields. TLT 1M mountain The iShares 20+ Year Treasury ETF has fallen for eight straight trading sessions. Only two of the trading sessions have seen a decline of more than 0.5%. One of the TLT's main competitors, the Vanguard Long-Term Treasury ETF (VGLT) , also fell for eight-straight trading sessions. The iShares 1-3 Year Treasury Bond ETF (SHY) has only fallen in five of the past eight sessions, for example.

Persons: Jason Goepfert Organizations: U.S . Treasury, Treasury Bond ETF, Treasury, Federal, White Oak Consultancy

☆ Here's how to play Japan stocks, finally hitting a new high after 34 long years
▼ + stars: | 2024-02-22 | by ( Bob Pisani | ) www.cnbc.com time to read: +5 min

Japan's Nikkei 225 index , a price-weighted index of 225 Japanese stocks, has also hit an historic high. A few months before that, on December 29, 1989, Japan's Nikkei 225 Index hit an historic high that stood until this week. That's about the amount the U.S. stock market dropped at the start of the Great Depression, from 1929 to 1932. .N225 5Y mountain Nikkei 225 Index in past five years. The Japanese stock market took 20 years.

Persons: it's, Japan's, Minoru Isutani, Arnold Palmer, Richard Ferris, Peter Ueberroth, Clint Eastwood, Nori, Bart Wakabayashi Organizations: Nikkei, CNBC, Japan's Nikkei, Mitsubishi, Rockefeller Center, Lone Cypress Company, Sumitomo Bank, Taiheiyo, Lone Cypress, Toyota, Honda, Sony, Hitachi, Nintendo, Sumitomo Mitsui, Japan Hedged Equity, Dow Jones, Tokyo Stock Exchange, Retailing, Softbank, Vision Fund, Foreign, Bank of Japan, White Oak Capital, Reuters Locations: Tokyo, New York, Japanese, California, Japan, U.S, Singapore

☆ US FDA says BD recalling infusion pumps due to compatibility issues
▼ + stars: | 2023-12-01 | by ( ) www.reuters.com time to read: +1 min

REUTERS/Andrew Kelly/File Photo Acquire Licensing RightsDec 1 (Reuters) - The U.S. Food and Drug Administration (FDA) said on Friday that Becton Dickinson (BDX.N) is recalling its Alaris infusion pumps due to compatibility issues with Cardinal Health's (CAH.N) Monoject syringes. However, the dimensions for Monoject syringes have recently changed while rebranding the syringes from Covidien Monoject to Cardinal Health Monoject. Last month, the FDA warned healthcare providers not to use Cardinal's Monoject syringes with patient-controlled pain management pumps and syringe pumps after the company initiated a recall due to compatibility problems. On Sept. 15, BD asked its customers to stop using Cardinal's Monoject syringes with BD's Alaris pumps. An infusion pump is a medical device that delivers fluids such as nutrients and medications into a patient's body in controlled amounts.

Persons: Andrew Kelly, Becton Dickinson, Cardinal Health's, Monoject, Health Monoject, BD, Christy Santhosh, Maju Samuel Organizations: Food and Drug Administration, FDA, REUTERS, U.S . Food, Drug Administration, Health, Thomson Locations: White Oak , Maryland, U.S

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo Acquire Licensing RightsNov 27 (Reuters) - The U.S. health regulator on Monday approved SpringWorks Therapeutics' (SWTX.O) drug for treating adult patients with desmoid tumors, making it the first approved treatment for this type of non-cancerous soft-tissue growth. The brokerage estimates U.S. sales of $3 million in 2023 and $79 million in 2024 and peak sales of $544 million in 2032. Desmoid tumors are rare, abnormal non-cancerous growths that occur in connective tissues and are associated with a high rate of recurrence. An estimated 1,650 people in the U.S. are diagnosed with desmoid tumors each year, according to data from the National Institutes of Health.

Persons: Andrew Kelly, Saqib Islam, Ogsiveo, Cowen, Yaron, Islam, Pratik Jain, Christy Santhosh, Shilpi Majumdar, Shailesh Organizations: Food and Drug Administration, FDA, REUTERS, Therapeutics, Food, National Institutes of Health, Thomson Locations: White Oak , Maryland, U.S, United States, Bengaluru

☆ US FDA to delay decision on Bristol Myers-2seventy bio cancer therapy
▼ + stars: | 2023-11-20 | 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. The U.S. Food and Drug Administration (FDA) has not yet confirmed when the advisory panel would meet, they added. Shares of Bristol Myers Squibb fell more than 2% and those of 2seventy bio slid nearly 20% in early morning trade. The therapy was originally co-developed by bluebird bio (BLUE.O) but following its spin-off in 2021 became part of 2seventy's portfolio. Bristol Myers and 2seventy bio, however, have faced manufacturing constraints, and a month-long planned maintenance shutdown of one of Abecma's manufacturing facility in June had also negatively impacted sales.

Persons: Andrew Kelly, 2seventy bio's, Bristol Myers, Johnson, Biotech's, Khushi, Sriraj Kalluvila Organizations: Food and Drug Administration, FDA, REUTERS, Bristol Myers Squibb, U.S . Food, Drug Administration, Bristol, Johnson, Thomson Locations: White Oak , Maryland, U.S, Bengaluru

☆ US FDA approves CorMedix's drug for bloodstream infections
▼ + stars: | 2023-11-15 | by ( Christy Santhosh | ) 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. REUTERS/Andrew Kelly/File Photo Acquire Licensing RightsNov 15 (Reuters) - The U.S. health regulator on Wednesday approved CorMedix's (CRMD.O) antimicrobial drug for reduction of catheter-related bloodstream infections (CRBSIs) in patients with kidney disease, allowing the company to launch its first commercial product. The company plans to ready the drug for commercialization by end of the first quarter of 2024, CorMedix CEO Joe Todisco told Reuters. DefenCath, a combination of the antimicrobial active ingredient taurolidine and blood thinner heparin, has previously been rejected twice by the U.S. Food and Drug Administration (FDA) on manufacturing concerns. Ahead of the drug approval, CorMedix said it had changed its heparin supplier and the FDA had inspected its current manufacturing facility and was comfortable with it.

Persons: Andrew Kelly, Joe Todisco, CorMedix, Christy Santhosh, Shailesh Organizations: Food and Drug Administration, FDA, REUTERS, Reuters, U.S . Food, Drug Administration, RBC, DefenCath, Thomson Locations: White Oak , Maryland, U.S, New Jersey, DefenCath, Bengaluru

Many of the patents at issue in the Food and Drug Administration's Orange Book listing of approved products were for devices such as asthma inhalers and epinephrine autoinjectors, the FTC said. "Wrongfully listed Orange Book patents by pharma companies can raise drug prices for Americans, harm fair competition, and delay better drugs," FTC Chair Lina Khan said on X, formerly known as Twitter. The Orange Book identifies drugs and products that the FDA has deemed safe and effective. The FTC says companies sometimes improperly list patents in the Orange Book that can delay market entry of lower priced generics. AbbVie was informed the FTC would dispute four patents in the Orange Book having to do with Restasis Multidose, eye drops used for chronic dry eye.

Persons: Andrew Kelly, Lina Khan, Boehringer Ingelheim, Mylan, AbbVie, Restasis, Diane Bartz, Patrick Wingrove, Bill Berkrot Organizations: Food and Drug Administration, FDA, REUTERS, AstraZeneca, GSK, U.S . Federal Trade Commission, Food, FTC, pharma, Thomson Locations: White Oak , Maryland, U.S, WASHINGTON, Israel, Viatris

☆ Eyedrops from CVS, Rite Aid and others carry possible infection risk, FDA says
▼ + stars: | 2023-10-30 | by ( ) www.cnbc.com time to read: +1 min

U.S. health regulators are warning consumers not to use more than two dozen varieties of over-the-counter eyedrops because of the risk of infections that could lead to blindness. The Food and Drug Administration advisory applies to lubricating drops sold by six companies, including CVS Health , Target , Rite Aid and Cardinal Health . The agency asked the companies to recall their products last week, because FDA inspectors found unsanitary conditions and bacteria at the facility producing the drops. Earlier this year, federal officials linked an outbreak of drug-resistant bacteria to eyedrops from two companies, EzriCare and Delsam Pharma. After the products were recalled in February, health inspectors visited the manufacturing plant in India that made the eyedrops and uncovered problems with how they were made and tested, including inadequate sterility measures.

Organizations: U.S . Food, Drug Administration, Drug, CVS Health, Target, Rite Aid, Cardinal Health, Consumers, FDA, Delsam Pharma, Centers for Disease Control Locations: U.S, White Oak , Maryland, India

Domestic equipment manufacturers, such as toolmaker Naura (002371.SZ) and etching equipment maker AMEC, are winning a much higher proportion of tenders from Chinese foundries than in previous years, as chipmakers race to replace foreign-made equipment with domestically made alternatives, research showed. "There is definitely huge progress happening in the Chinese semiconductor equipment space, as reflected in the strong revenue growth metrics," he said. The Huatai Securities report revealed that for the first eight months of 2023, only one tender for lithography equipment was awarded to a Chinese company, out of many bids. "Local players still lack capability to supply a full set of equipment, such as EUV," said Nori Chiou, investment director at White Oak Capital, saying Chinese manufacturers are focused on covering mature node equipment. "It’s a long way to go to see advanced semiconductor equipment made in China."

Persons: Florence Lo, Xi Jinping, Biden, Hua Hong, SMIC, Nori, Fanny Potkin, Yelin, Ellen Zhang, Brenda Goh, Sharon Singleton Organizations: REUTERS, Companies, Huatai Securities, Beijing, Reuters, HK, Hua Hong Semiconductor, CINNO Research, Analysts, Materials Inc, Lam Research Corp, U.S, Huawei Technologies, White Oak, Thomson Locations: China, SINGAPORE, BEIJING, Japan, Netherlands, U.S, ASML, Singapore, Yelin Mo, Beijing

☆ Alnylam gives up on expanded use of heart-disease drug in US after FDA declines approval
▼ + stars: | 2023-10-09 | by ( Mariam E Sunny | ) 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. The FDA, in 2019, approved Pfizer's (PFE.N) oral drug tafamidis, sold under the brand names Vyndaqel and Vyndamax, to treat transthyretin amyloid cardiomyopathy in the United States. Alnylam said it will focus on another drug candidate, vutrisiran, an under-the-skin injection in late-stage trials to treat ATTR amyloidosis-related cardiomyopathy. Branded as Amvuttra, vutrisiran is also approved in the U.S. to treat nerve damage in adult patients with hereditary ATTR amyloidosis. William Blair analyst Myles Minter estimates peak U.S. sales of $2.2 billion for vutrisiran as an ATTR cardiomyopathy treatment.

Persons: Andrew Kelly, patisiran, ATTR amyloidosis, Alnylam, Luca Issi, ATTR, William Blair, Myles Minter, Mariam Sunny, Pooja Desai Organizations: Food and Drug Administration, FDA, REUTERS, Alnylam Pharmaceuticals, RBC, Thomson Locations: White Oak , Maryland, U.S, Massachusetts, United States, Bengaluru

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. The concerns over the limited use of the drug, however, dragged the shares down to settle 8% lower. That makes the label narrower than that in Europe, which allows use in all adults with late-onset Pompe disease. At least one analyst said the drug's label, which restricts its use only to switch patients, weighed on the drugmaker's shares. Amicus said it would launch the therapy immediately in the U.S. with a list price of around $650,000 for a patient weighing about 70 kilograms.

Persons: Andrew Kelly, Needham, Gil Blum, Sriparna Roy, Shinjini Ganguli, Sriraj, Shweta Agarwal Organizations: Food and Drug Administration, FDA, REUTERS, Amicus Therapeutics, U.S . Food, Sanofi, Amicus, Thomson Locations: White Oak , Maryland, U.S, Europe, Sanofi, Bengaluru

☆ 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

☆ Inside the Elaborate, Enviable Design of Three New York Homes
▼ + stars: | 2023-09-21 | by ( ) www.nytimes.com time to read: +34 min

If You Can Make It Here Great design for a great city (New York, of course — where else?) In the oak-paneled living room of Justinian Kfoury’s apartment in a townhouse on Washington Square Park, an Audubon-style print and a Hans Wegner Papa Bear chair. “She was eccentric, grand, but not afraid of making weird decisions about design.” In the living room, a 1975 Leonid Berman painting of the Venice Lagoon hangs between the French doors. A view of the double-height living room from the curved balcony on the third floor. A sculpture by Huma Bhabha and a configuration of five Isamu Noguchi L7 pendants in the landing that separates the primary suite from the living room.

Persons: it’s, Mishan, there’s, —, Justinian, Hans Wegner Papa Bear, Paavo, Marc Hundley, that’s, Adriana Lara, Nicholas Krushenick, ”, Justinian Kfoury, downtowners, He’d, Trish Goff, Kfoury, “, Leonid Berman, Jelto ”, Tomma Abts, Paul Cadmus, Edith Wharton, Henry James, Paul van der, ” Kfoury, Joe Roberts, Mary Cameron Goodyear, Kfoury’s, He’s, Wolfgang Tillmans, they’d, It’s, Lorna Simpson, Mario Bellini, Misha Kahn, Michael Anastassiades, Glenn Ligon’s, Frank Bowling, Piet Hein Eek, Miriam Cahn, Paul Pfeiffer’s, Leah Panlilio, Tal Schori, Rustam Mehta, Adam Pogue, Constantino Buccolieri, Michael Kirkland, Alvar Aalto, Cy Twombly’s, Ho, Huma Bhabha, Isamu Noguchi, Nairy Baghramian, Coco Fusco, Robert Vinas Jr, Duro Olowu, Mark Ellison, Adam Marelli, Bob Chan, Isamu Noguchi Akari, Danh Vo, Nairy, ‘, Laura Mac Donald, Theaster Gates, Frank Lloyd, Kirkland, Ettore, Parsons, Jasper Johns, Merce Cunningham, Julianne Moore, Bart Freundlich’s Montauk, Bart Freundlich’s, Moore, Tom Volk, Oliver Freundlich, Anne’s, Pierre Jeanneret, Willy Van Der, Ori Gersht, she’s, ” It’s, Bart Freundlich, Tomas Maier, Bottega, Andrew Geller, Norman Jaffe, Freundlich, ” Moore, Moore’s, Liv, Caleb, Robert Gurr, Pierre, Noguchi, Alma Allen, Joseph Dirand, Oliver, “ I’m, ” Oliver, grins, MOORE, Anne Love Smith, Massimiliano Locatelli, Daniel Romualdez, Vincent Van Duysen, Charlotte Perriand, Pierre Chapo, Willy Van Der Meeren, Friedrich Kunath, Mark Wilson, Donald Judd, Wilson, Karl Springer, Rogan Gregory, Nancy Pearce, Oscar, Alice ”, Alexander Calder, Andrea Zittel, JB Blunk, AFTRA, Hope, ‘ You’re, ’ ” Organizations: Manhattan’s, Yorkers, that’s, Audubon, Washington, East Village, brac, AS, Fifth, Fort Standard, GRT Architects, Architects, Walt Disney Concert Hall, Soane Britain, Hamptons, WHO, Writers Guild of America, SAG, “ Locations: New York, Paris, London, Rome , New York, It’s, Washington, Manhattan, Harlem, Montauk, American, Chinatown, York, New York’s Washington, Kennebunkport, England, East, Boston, Lebanon, Maine, Vermont, Venice, Moroccan, North, Kfoury’s, New York’s Harlem, Westchester County, N.Y, Brooklyn, Italian, Finnish, Rome, Los Angeles, Korean, Berlin, Iranian, Chicago, North Carolina, California, Summerhill, Long, Fort Pond, New York City, Pond, Morentz, Scottish, Japanese American, Belgian, East Hampton, Japan, “, Swiss

☆ Julianne Moore’s Montauk Sanctuary
▼ + stars: | 2023-09-21 | by ( Nick Haramis | ) www.nytimes.com time to read: +34 min

— HANYA YANAGIHARASpeak Softly In a wild meadow by the sea, Julianne Moore and Bart Freundlich’s Montauk house uses just a few materials to say many things. In Moore’s office, a Pierre Jeanneret desk and chair, an Alvar Aalto stool and a Willy Van Der Meeren cabinet. In the oak-paneled living room of Justinian Kfoury’s apartment in a townhouse on Washington Square Park, an Audubon-style print and a Hans Wegner Papa Bear chair. A view of the double-height living room from the curved balcony on the third floor. A sculpture by Huma Bhabha and a configuration of five Isamu Noguchi L7 pendants in the landing that separates the primary suite from the living room.

Persons: it’s, Mishan, there’s, —, Julianne Moore, Bart Freundlich’s Montauk, Bart Freundlich’s, Moore, Tom Volk, Oliver Freundlich, Anne’s, Pierre Jeanneret, Alvar Aalto, Willy Van Der, Ori Gersht, she’s, ” It’s, ”, “, Bart Freundlich, Tomas Maier, Bottega, Andrew Geller, Norman Jaffe, Freundlich, ” Moore, Moore’s, Liv, Caleb, Robert Gurr, Isamu Noguchi, Pierre, Noguchi, Alma Allen, Joseph Dirand, Oliver, “ I’m, ” Oliver, grins, MOORE, Anne Love Smith, Massimiliano Locatelli, Daniel Romualdez, Vincent Van Duysen, Charlotte Perriand, Pierre Chapo, Willy Van Der Meeren, Friedrich Kunath, Mark Wilson, Donald Judd, Wilson, Mario Bellini, Karl Springer, Rogan Gregory, Nancy Pearce, Oscar, Alice ”, Alexander Calder, Andrea Zittel, JB Blunk, AFTRA, Hope, It’s, ‘ You’re, ’ ”, Justinian, Hans Wegner Papa Bear, Paavo, Marc Hundley, that’s, Adriana Lara, Nicholas Krushenick, Justinian Kfoury, downtowners, He’d, Trish Goff, Kfoury, Leonid Berman, Jelto ”, Tomma Abts, Paul Cadmus, Edith Wharton, Henry James, Paul van der, ” Kfoury, Joe Roberts, Mary Cameron Goodyear, Kfoury’s, He’s, Wolfgang Tillmans, they’d, Lorna Simpson, Misha Kahn, Michael Anastassiades, Glenn Ligon’s, Frank Bowling, Piet Hein Eek, Miriam Cahn, Paul Pfeiffer’s, Leah Panlilio, Tal Schori, Rustam Mehta, Adam Pogue, Constantino Buccolieri, Michael Kirkland, Cy Twombly’s, Ho, Huma Bhabha, Nairy Baghramian, Coco Fusco, Robert Vinas Jr, Duro Olowu, Mark Ellison, Adam Marelli, Bob Chan, Isamu Noguchi Akari, Danh Vo, Nairy, ‘, Laura Mac Donald, Theaster Gates, Frank Lloyd, Kirkland, Ettore, Parsons, Jasper Johns, Merce Cunningham Organizations: Manhattan’s, Yorkers, that’s, Hamptons, WHO, Writers Guild of America, SAG, “, Audubon, Washington, East Village, brac, AS, Fifth, Fort Standard, GRT Architects, Architects, Walt Disney Concert Hall, Soane Britain Locations: New York, Paris, London, Rome , New York, It’s, Washington, Manhattan, Harlem, Montauk, American, Chinatown, York, N.Y, Summerhill, Long, Fort Pond, New York City, Pond, North Carolina, Morentz, Scottish, Japanese American, Belgian, East Hampton, Japan, “, California, Swiss, New York’s Washington, Kennebunkport, England, East, Boston, Lebanon, Maine, Vermont, Venice, Moroccan, North, Kfoury’s, New York’s Harlem, Westchester County, Brooklyn, Italian, Finnish, Rome, Los Angeles, Korean, Berlin, Iranian, Chicago

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. The rejection and request for additional testing sharply contrasts the backing from the U.S. Food and Drug Administration's (FDA) independent experts for the spray, neffy, in May. EpiPen-maker Viatris (VTRS.O) had in June petitioned the FDA to require that ARS conduct more trials that closely mimic real-world conditions. It did not test neffy in anaphylaxis, a severe, life-threatening allergic reaction, due to ethical concerns. ARS expects to re-submit its application in the first half of 2024, with an FDA decision likely in the second half.

Persons: Andrew Kelly, William Blair, Tim Lugo, Stacey Saiontz, anaphylaxis, James Tarbox, Christy Santhosh, Sriparna Roy, Jahnavi, Varun Organizations: Food and Drug Administration, FDA, REUTERS, ARS Pharmaceuticals, U.S . Food, Pharma, Regulators, ARS, Texas Tech University Health Sciences Center, Thomson Locations: White Oak , Maryland, U.S, anaphylaxis, Bengaluru

☆ Exclusive: U.S. FDA found lapses at Novo's main U.S. factory in May 2022 -report
▼ + stars: | 2023-09-20 | by ( Maggie Fick | ) www.reuters.com time to read: +4 min

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. A Form 483 is a type of agency report containing "observations" that FDA inspectors "deem to be objectionable". The FDA did not immediately respond to a request for comment on the report, but usually does not comment on inspections. The report from the May 2022 inspection shows that FDA officials found the factory had failed to include one type of bacteria, abbreviated as B. cepacia, on its list of "objectionable organisms". Analysts at Barclays and Jefferies said in notes this week that, although investors may be concerned by news of potential manufacturing issues, they saw minimal impact on Novo's production of semaglutide.

Persons: Andrew Kelly, Clayton, Jefferies, Steven Lynn, Maggie Fick, Josephine Mason, Mark Potter Organizations: Food and Drug Administration, FDA, REUTERS, Novo Nordisk, Reuters, U.S . Food, Drug Administration, Barclays, Manufacturing, Thomson Locations: White Oak , Maryland, U.S, North America, Clayton , North Carolina

☆ I moved to Seattle for a high-paying tech job. It turned out to be the loneliest time of my life.
▼ + stars: | 2023-09-13 | by ( Aria Yang | ) www.businessinsider.com time to read: +9 min

This as-told-to essay is based on a conversation with Alexander Nguyen, a software engineer who moved from New York City to Seattle for a job at Amazon. It was his first job out of college, and he says it was the loneliest time of his life. Finally, after a three-month job search, things started looking up: I received a software-development-engineering job offer from Amazon in 2020. Back when I got the job at Amazon, all I was thinking about was my tech career and the $150,000 salary. Looking back now, I realize perhaps I should have looked a little bit harder for opportunities in New York before taking the first tech job that came my way.

Persons: Alexander Nguyen, Boba Guys, —, Alexander Nguyen Nobody, it'd, I've, It's, I'm, it's, you've, Aria Yang Organizations: New York University, White Oaks, Amazon, Facebook, University District, NYU, CS, Netflix, Microsoft, Google Locations: New York City, Seattle, Greenwich Village, University, San Francisco, New York, ayang@insider.com

☆ US FDA panel says popular decongestant used in cold medicines ineffective
▼ + stars: | 2023-09-12 | by ( ) www.reuters.com time to read: +1 min

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo Acquire Licensing RightsSept 12 (Reuters) - An outside panel of experts to the U.S. Food and Drug Administration on Tuesday refused to back the effectiveness of oral over-the-counter (OTC) medicines made with phenylephrine, an ingredient widely used in cold and cough syrups. The panel unanimously voted against the effectiveness of orally administered phenylephrine as a nasal decongestant, adding that no more trials were required to prove otherwise. The FDA usually follows the recommendations of its expert panel but is not obligated to do so. Phenylephrine was substituted for pseudoephedrine in many non-prescription cold and allergy medicines after the latter was restricted amid reports of abuse.

Persons: Andrew Kelly, Jennifer Schwartzott, Phenylephrine, Mariam Sunny, Devika Organizations: Food and Drug Administration, FDA, REUTERS, U.S . Food, Drug Administration, GSK, Thomson Locations: White Oak , Maryland, U.S, United States, Bengaluru

☆ US FDA authorizes Pfizer-BioNTech and Moderna's updated COVID shots
▼ + stars: | 2023-09-11 | by ( ) www.reuters.com time to read: +2 min

[1/3] Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. A third shot, made by Novavax (NVAX.O), is still under review by the FDA. But obviously that requires that FDA have decided the data supports it," said Jesse Goodman, a professor at Georgetown and former FDA chief scientist. Moderna and Pfizer, which is partnered with German biotech firm BioNTech SE (22UAy.DE), said the updated vaccines were expected to be available the United States in the coming days. An endorsement by CDC Director Mandy Cohen, expected shortly, should clear the way for the new shots.

Persons: Andrew Kelly, Novavax, Jesse Goodman, —, Mandy Cohen, Cohen, Sriparna Roy, Mariam Sunny, Michael Erman, Shinjini Organizations: Food and Drug Administration, FDA, REUTERS, Pfizer, Moderna, U.S . Food, Drug Administration, for Disease Control, Prevention, Georgetown, EG, CDC, Thomson Locations: White Oak , Maryland, U.S, United States, Bengaluru, New York

☆ US FDA warns 3 baby formula makers to correct manufacturing process controls
▼ + stars: | 2023-08-30 | 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. The FDA pulled up these companies for failing to establish processes to ensure infant formula does not become contaminated during manufacturing. The recalls were meant to remove products potentially contaminated with the bacteria cronobacter sakazakii, the FDA added. "The agency... believes that the recalls were effective in removing the potentially contaminated batches of product from the market," the FDA said. Infant formula manufacturing is under greater scrutiny following the shortage of the product last year due to a shutdown of Abbott Laboratories' (ABT.N) unit in Michigan.

Persons: Andrew Kelly, Benckiser, Mead Johnson, Perrigo, ByHeart, Leroy Leo, Krishna Chandra Organizations: Food and Drug Administration, FDA, REUTERS, U.S . Food, Drug Administration, ByHeart Inc, Mead Johnson Nutrition, Abbott Laboratories, Thomson Locations: White Oak , Maryland, U.S, PRGO.N, Wisconsin, Michigan, Bengaluru

☆ US FDA panel votes against use of Medtronic's blood pressure treatment device
▼ + stars: | 2023-08-23 | by ( ) www.reuters.com time to read: +2 min

The same panel on Tuesday voted in favor of rival ReCor's device for use in a surgery called renal denervation in patients whose high blood pressure cannot be controlled by drugs. Separately, while all panel members voted the device was safe to use, 6 of 13 voted against its effectiveness. Japan-based Otsuka Holdings' (4578.T) unit ReCor's device was shown to provide a benefit in lowering blood pressure in clinical trials. Medtronic's device helped to lower blood pressure at the doctor's clinic but not at home, which is considered a more accurate measure of blood pressure monitoring. The company was seeking the health regulator's nod for the device indicated for patients whose hypertension, or high blood pressure, cannot be controlled with drugs.

Persons: Andrew Kelly, Jason Weidman, Sriparna Roy, Krishna Chandra Eluri Organizations: Food and Drug Administration, FDA, REUTERS, U.S . Food, Wednesday, Otsuka Holdings, Thomson Locations: White Oak , Maryland, U.S, Japan, Europe, Bengaluru

☆ US FDA approves higher dose of Regeneron's eye disease drug Eylea
▼ + stars: | 2023-08-18 | by ( ) www.reuters.com time to read: +1 min

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo Acquire Licensing RightsCompanies Regeneron Pharmaceuticals Inc FollowAug 18 (Reuters) - The U.S. Food and Drug Administration approved a higher dose version of Regeneron Pharmaceuticals' (REGN.O) drug Eylea for treatment of a disease that is a leading cause of blindness among the elderly, the company said in a statement on Friday. Eylea is normally given in doses of 2 mg every eight weeks. Two late-stage trials had shown Eylea was as effective as the lower dose version when given at 8 mg at longer intervals without any additional safety issues. In June, the FDA declined to approve the higher dose version of Eylea and said it had outstanding questions, citing an ongoing review of inspection findings at a third-party filler of the higher dose.

Persons: Andrew Kelly, retinopathy, Regeneron, Eylea, Jahnavi, Sandra Maler, Rosalba O'Brien Organizations: Food and Drug Administration, FDA, REUTERS, Regeneron Pharmaceuticals, U.S . Food, Drug Administration, Thomson Locations: White Oak , Maryland, U.S, Bengaluru

☆ U.S. FDA approves Johnson & Johnson's blood cancer therapy
▼ + stars: | 2023-08-10 | by ( ) www.cnbc.com time to read: +2 min

Johnson & Johnson said on Thursday the U.S. Food and Drug Administration had approved its antibody-based therapy for patients with a difficult-to-treat type of blood cancer. The therapy, Talvey, belongs to a class of treatments called bispecific antibodies designed to bring a cancer cell and an immune cell together so the body's immune system can kill the cancer. Around 35,730 people in the U.S. are expected to be diagnosed with multiple myeloma this year. The cancer starts in the bone marrow and disrupts production of normal blood cells. The accelerated approval is based on mid-stage trial data, which showed 73.6% patients achieved either partial or complete disappearance of cancer from their body.

Persons: Johnson, Talvey, J's Tecvayli, Michael Andreini Organizations: U.S . Food, Drug Administration, Reuters, FDA Locations: U.S, White Oak , Maryland

REUTERS/Andrew Kelly/File PhotoAug 7 (Reuters) - The U.S. drug regulator's approval of Biogen (BIIB.O) and Sage Therapeutics' (SAGE.O) first-of-its-kind postpartum depression (PPD) pill is unlikely to allay the drugmakers' growth concerns, analysts said on Monday. Adverse commentary after their PPD drug was approved by the U.S. Food and Drug Administration (FDA) on Friday sent Sage shares tumbling 40%, while Biogen dropped 3% in premarket trading. Zurzuvae's use as a clinical depression treatment represents a more than $1 billion sales opportunity compared with $250 million to $500 million potential for postpartum depression, said Jefferies analyst Michael Yee. "Postpartum depression is not necessarily where a big commercial opportunity is," Biogen CEO Christopher Viehbacher said last month. The U.S. FDA said last week that additional studies might be required to support the drug's approval for major depressive disorder (MDD), or clinical depression.

Persons: Andrew Kelly, Sage, Biogen, Baird, Brian Skorney, Skorney, Zurzuvae, Jefferies, Michael Yee, Christopher Viehbacher, Yee, Mariam Sunny, Bhanvi, Manas Mishra, Vinay Dwivedi Organizations: Food and Drug Administration, FDA, REUTERS, Sage Therapeutics, U.S . Food, Drug Administration, U.S, Thomson Locations: White Oak , Maryland, U.S, Bengaluru

Search resuls for: "White Oak"

25 mentions found