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Nov 7 (Reuters) - The number of newborns with syphilis in the United States surged more than 10-fold in the last decade, the U.S. Centers for Disease Control and Prevention (CDC) reported on Tuesday. The agency said 3,761 cases were recorded in 2022, the highest in over 30 years, up from 334 cases in 2012. The 2022 cases included 231 stillbirths and 51 infant deaths. Congenital syphilis occurs when a mother with syphilis passes the infection to her baby during pregnancy. The CDC recommends screening for syphilis at the first prenatal care visit to reduce perinatal transmission.

Persons: Laura Bachmann, Bachmann, Sriparna Roy, Nancy Lapid Organizations: U.S . Centers for Disease Control, Prevention, CDC's, CDC, Thomson Locations: United, Bengaluru

A vial labelled "Novavax COVID-19 Vaccine" is seen in this illustration taken January 16, 2022. The Maryland-based company, whose COVID vaccine is its lone marketed product, has adopted cost-cutting measures and is counting on commercial sales of its updated shot to help it stay afloat. The CDC's Advisory Committee on Immunization Practices (ACIP) will not meet again to discuss the Novavax shot, a spokesperson said. Novavax's original COVID shot received U.S. authorization in July 2022, long after Pfizer and Moderna vaccines were in use. All three of the updated shots target the XBB.1.5 variant of the coronavirus.

Persons: Dado Ruvic, BioNTech, COVID, John Jacobs, Jacobs, Sriparna Roy, Bill Berkrot Organizations: REUTERS, U.S . Food, Drug Administration, U.S . Centers for Disease Control, Prevention, Pfizer Inc, Moderna, FDA, Pfizer, Moderna's, Thomson Locations: U.S, Maryland, 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

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

A general view of the drug product manufacturing laboratory in biologics and sterile injectables, Catalent, in Brussels, Belgium June 27, 2023. Catalent named three pharma industry executives and a senior Elliott executive to its board and said John Greisch, who has served on the board since 2018, will become executive chairman. Elliott, whose stake in Catalent became public last month, has been engaging with the company behind the scenes for months. Two of the directors were picked by Elliott, while two were mutually agreed by Elliott and Catalent. Catalent is also forming a new strategic and operational review committee which Greisch will chair.

Persons: Yves Herman, Elliott, Catalent, Alessandro Maselli, John Greisch, Max, William Blair, Maselli, Steven Barg, Goldman Sachs, Frank D'Amelio, Stephanie Okey, Michelle Ryan, Greisch, Merck KGaA, Svea Herbst, Bayliss, Maggie Fick, Sriparna Roy, Shinjini Ganguli, Catherine Evans, Mike Harrison Organizations: REUTERS, Catalent Inc, Elliott Investment Management, Reuters, Novo, pharma, U.S . Food, Drug Administration, Pfizer, Johnson, Catalent, Svea, Thomson Locations: Brussels, Belgium, ., Danish, Novo, United States, Catalent, GLP, Boston, London, Bengaluru

Companies Gilead Sciences Inc FollowJuly 21 (Reuters) - Gilead Sciences Inc (GILD.O) said on Friday it was stopping a late-stage trial of its blood cancer combination treatment following an analysis that showed it would not be effective. Gilead, whose shares dropped over 1% in after-market trading, recommended that treatment with magrolimab in patients with MDS should be stopped. The company gained access to magrolimab with its $4.9 billion buyout of Forty Seven Inc in March 2020. Magrolimab is also in development for other types of cancer such as acute myeloid leukemia and solid tumours. Reporting by Sriparna Roy in Bengaluru Editing by Vinay DwivediOur Standards: The Thomson Reuters Trust Principles.

Persons: Gilead, Robert W, Baird, Brian Skorney, Magrolimab, Sriparna Roy, Vinay Dwivedi Organizations: Gilead Sciences, Gilead Sciences Inc, Seven Inc, Thomson Locations: Bengaluru

July 14 (Reuters) - Eli Lilly and Co (LLY.N) said on Friday it will buy privately held Versanis for potentially up to $1.93 billion to strengthen its position in the fast-growing market for weight-loss treatments. Shares of Eli Lilly rose 3% after the deal that gives it access to an experimental obesity drug being tested along with rival Novo Nordisk's (NOVOb.CO) weight-loss treatment in a mid-stage study. Analysts expect the market for weight-loss drugs to reach up to $100 billion within a decade, with early movers such as Eli Lilly and Novo Nordisk grabbing a large chunk of the market. "One of the key concerns with weight loss medications is the loss of lean mass. The goal is to lose more fat vs. muscle, but with any weight loss program calorie restriction could impact both," said BMO Capital Markets analyst Evan Seigerman.

Persons: Eli Lilly, Novo, Evan Seigerman, Lilly, Sriparna Roy, Arun Koyyur Organizations: Novo Nordisk's, Novo Nordisk, Capital, Novartis, Thomson Locations: Swiss, Bengaluru

July 13 (Reuters) - The U.S. Food and Drug Administration on Thursday approved the first over-the-counter contraceptive pill, paving the way for millions of women in the country to purchase birth control without prescription. Perrigo will next week share its pricing plan for the pill, which will be available in stores and online in the first quarter of next year. Women should take a progestin-only pill within the same three hours every day to avoid pregnancy. The National Catholic Bioethics Center and other groups have opposed making Opill available without prescription, saying physicians should be involved in health decisions, especially for teenagers, along with parental supervision, to avoid harm. Perrigo gained the daily-use pill first through its $2.13 billion acquisition of Paris-based HRA Pharma in 2021.

Persons: Roe, Wade, Xavier Becerra, Opill, Jeffrey Singer, Perrigo, Manas Mishra, Sriparna Roy, Arun Koyyur Organizations: U.S . Food, Drug Administration, Perrigo, Human Services, Cato Institute, FDA, Catholic Bioethics Center, HRA Pharma, Thomson Locations: U.S, Paris, Bengaluru

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