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☆ Opioid overdose reversal drug likely safe for OTC use, says FDA
▼ + stars: | 2022-11-15 | by ( ) www.reuters.com time to read: +1 min

Nov 15 (Reuters) - Opioid overdose reversal drug naloxone may be safe and effective for over-the-counter use in some forms, the U.S. Food and Drug Administration (FDA) said on Tuesday, potentially paving the way for its use federally. The FDA would still require data on individual products from manufacturers for them to be available over the counter at a federal level. The drug regulator's preliminary assessment included up to 4 milligrams dose of naloxone nasal spray and up to 2 milligrams when given through an auto injector. The agency said the assessment does not cover higher dose naloxone products and those supplied in other forms for which more data was needed. More than 16,000 people have died from overdoses involving prescription opioids in 2020, according to government data.

☆ U.S. FDA panel votes against Veru's COVID-19 pill
▼ + stars: | 2022-11-09 | by ( ) www.reuters.com time to read: +2 min

The panel voted 8-5 against the oral drug sabizabulin's usage. The unfavorable vote decreases the chances of authorization for Veru, which is already lagging in the race to develop a COVID-19 treatment. If authorized, the pill would provide an additional treatment option as the disease moves from a pandemic to an endemic stage. While data has shown the drug can also produce antiviral and anti-inflammatory responses, the FDA staff reviewers have said its mechanism of action in COVID-19 was uncertain. The FDA is not obligated to follow the recommendations of the panel, but usually does.

☆ FDA staff flags uncertainties on Veru's COVID drug; EUA hopes lift shares
▼ + stars: | 2022-11-07 | by ( Bhanvi Satija | ) www.reuters.com time to read: +2 min

Nov 7 (Reuters) - Staff reviewers at the U.S. Food and Drug Administration on Monday identified several uncertainties around Veru Inc's (VERU.O) data for its experimental COVID-19 drug but did not raise any new concerns, sending its shares surging 52%. A panel of the health regulator's outside experts is scheduled to discuss authorization of the drug later this week, including whether additional data is required. Cantor Fitzgerald analyst Brandon Folkes said the FDA is "leading the advisory committee towards granting an EUA" provided Veru commits to an adequate post-EUA study. Veru has applied for an EUA for the drug, sabizabulin, as a treatment for hospitalized moderate-to-severe COVID-19 patients at high risk of developing an acute respiratory distress syndrome. If authorized, sabizabulin, which Veru was originally testing as a treatment for prostate cancer, would become its second drug on the market.

☆ FDA staff flags several uncertainties with Veru's COVID-19 drug
▼ + stars: | 2022-11-07 | by ( ) www.reuters.com time to read: +1 min

Nov 7 (Reuters) - U.S. Food and Drug Administration staff said on Monday Veru Inc's (VERU.O) experimental drug for COVID-19 met the main goal of reducing the death rate in a late-stage trial, but flagged a number of uncertainties with the data. Staff reviewers said the data did not help in clearly identifying a relevant patient population and remained unclear about the mortality rate in the placebo group. Veru has applied for emergency use authorization for its drug, sabizabulin, as a treatment for hospitalized moderate-to-severe COVID patients at high risk of developing an acute respiratory distress syndrome. A panel of FDA's outside experts is scheduled to discuss approval of the drug later this week. Reporting by Bhanvi Satija and Raghav Mahobe in Bengaluru; Editing by Shinjini GanguliOur Standards: The Thomson Reuters Trust Principles.

☆ Gilead, Kite in process of pausing Twitter advertising
▼ + stars: | 2022-11-07 | by ( ) www.reuters.com time to read: +1 min

Nov 7 (Reuters) - Gilead Sciences Inc (GILD.O) said on Monday the company and its unit Kite were in the "process of pausing advertising" on Twitter, after Elon Musk completed his takeover of the social media company. In a statement to Reuters, Gilead said it was monitoring its advertising spend and waiting to better understand how community standards and content moderation will be handled on Twitter now. Gilead joins a growing list of U.S. companies, including General Motors (GM.N) and General Mills (GIS.N), who have either paused or are in the process of re-evaluating advertising on the social media platform. Last week, the Wall Street Journal reported Oreo maker Mondelez International Inc (MDLZ.O) and U.S. drugmaker Pfizer Inc (PFE.N) had also temporarily halted advertising with Twitter. Reporting by Bhanvi Satija and Raghav Mahobe in Bengaluru; Editing by Krishna Chandra EluriOur Standards: The Thomson Reuters Trust Principles.

☆ COVID variants BQ.1/BQ.1.1 make up 35% of U.S. cases
▼ + stars: | 2022-11-04 | by ( ) www.reuters.com time to read: +2 min

The subvariants made up nearly 9% of total cases in the week of Oct. 15 and their proportion has been rising steadily among circulating cases since then. New variants are monitored closely by regulators and vaccine manufacturers in case they start to evade protection offered by current shots. BQ.1.1 made up nearly 19% of circulating variants and BQ.1 was estimated to make up 16.5% of circulating cases in the week of Nov. 5, the U.S. CDC said on Friday. The BA.5 subvariant, which drove up cases earlier this year, is estimated to make up about 39% of cases, compared with nearly 51% in the week ended Oct. 29. Coronavirus cases saw a small uptick for the week ended Nov. 2, data from CDC showed.

☆ Humana profit beats on slow elective-care rebound
▼ + stars: | 2022-11-02 | by ( ) www.reuters.com time to read: +2 min

Nov 2 (Reuters) - Humana Inc (HUM.N) beat third-quarter profit estimates on Wednesday, as a sluggish recovery in elective procedures helped the health insurer keep medical costs in check. Humana's guidance to enroll 325,000 to 400,000 Medicare Advantage members next year marks a return to industry rate, one year ahead of schedule, Stephens analyst Scott Fidel said in a note. In September, Humana raised it forecast, citing no COVID-19 "headwind materializing" and lower-than-expected medical cost trends in the company's Medicare Advantage and Medicaid businesses. A lower ratio is better for a health insurer as it indicates a tight rein on costs. Humana said its adjusted profit for the third quarter was $6.88 per share, above estimates of $6.28, according to Refinitiv data.

[1/2] The company logo for Johnson & Johnson is displayed to celebrate the 75th anniversary of the company's listing at the New York Stock Exchange (NYSE) in New York, U.S., September 17, 2019. J&J is focused on its pharmaceuticals and medical devices operations with the consumer health spinoff expected by November 2023. Chief Executive Joaquin Duato has said he will look to build up the medical devices unit through acquisition. Abiomed will operate as a standalone business within the healthcare conglomerate's medical technology division. J&J's medical technology business includes surgical, orthopedic and various other devices.

☆ J&J to buy heart pump maker Abiomed in $16.6 bln deal
▼ + stars: | 2022-11-01 | by ( ) www.reuters.com time to read: +1 min

[1/2] The company logo for Johnson & Johnson is displayed to celebrate the 75th anniversary of the company's listing at the New York Stock Exchange (NYSE) in New York, U.S., September 17, 2019. REUTERS/Brendan McDermidNov 1 (Reuters) - Johnson & Johnson (JNJ.N) said on Tuesday it will buy heart pump maker Abiomed Inc (ABMD.O) in a deal valued at $16.6 billion to boost its cardiovascular devices business. The deal comes at a time when J&J is spinning off its consumer health business to focus on its pharmaceuticals and medical devices operations. Abiomed shareholders will also get rights to receive up to $35 per share in cash if certain commercial and clinical milestones are achieved. Reporting by Raghav Mahobe and Leroy Leo in Bengaluru; Editing by Shounak DasguptaOur Standards: The Thomson Reuters Trust Principles.

☆ Johnson & Johnson's blood cancer therapy gets U.S. FDA approval
▼ + stars: | 2022-10-25 | by ( Khushi Mandowara | ) www.reuters.com time to read: +2 min

Oct 25 (Reuters) - The U.S. Food and Drug Administration (FDA) has approved Johnson & Johnson's (JNJ.N) therapy for treating a type of multiple myeloma, the company said on Tuesday, giving another treatment option to patients with the incurable blood cancer. Tecvayli is a bispecific antibody, which is engineered to redirect body's immune system to recognize and kill cancer cells. It is the first drug of its class to be approved for multiple myeloma. Though multiple myeloma is rare compared to breast or prostate cancer, it is a common type of blood cancer, which develops in the bone marrow and can spread throughout the body. According to the American Cancer Society's estimates, close to 35,000 new cases of multiple myeloma are likely to be diagnosed in the United States this year.

☆ Elevance raises annual profit forecast after quarterly beat
▼ + stars: | 2022-10-19 | by ( ) www.reuters.com time to read: +1 min

Oct 19 (Reuters) - Health insurer Elevance Health Inc (ELV.N) on Wednesday raised its annual profit forecast after beating estimates for quarterly earnings on lower-than-expected medical costs and strong performance of its Medicaid business. Last week, larger rival UnitedHealth Group Inc (UNH.N) raised its annual profit forecast for the third straight quarter and said the direct impact of COVID-19 was expected to ease next year. The lower the ratio, the better it is for a health insurer as it indicates a tight rein on costs. Elevance, which was previously known as Anthem, now expects annual adjusted earnings to be higher than $28.95 per share, compared with its prior forecast of more than $28.70 per share. Excluding items, the company reported earnings of $7.53 per share, above analysts' estimates of $7.15, according to IBES estimates from Refinitiv.

People are seen shopping in a Walgreens, owned by the Walgreens Boots Alliance, Inc., in Manhattan, New York City, U.S., November 26, 2021. REUTERS/Andrew Kelly/File PhotoOct 13 (Reuters) - Walgreens Boots Alliance Inc (WBA.O) reported a better-than-expected quarterly profit on Thursday, as higher UK retail sales helped more than offset waning COVID vaccination demand. Shares of Walgreens, one of the largest U.S. pharmacies, rose nearly 3% amid bigger market weakness after the company also forecast a "better-than-feared" full-year profit. Register now for FREE unlimited access to Reuters.com RegisterDespite inflationary challenges, Walgreens saw an uptick in retail sales, helped by higher demand for health and wellness as well as beauty products. The company also benefited from its Walgreens Health segment, which was launched last year as part of Walgreens' efforts to diversify its business.

☆ Europe likely entering another COVID wave, says WHO and ECDC
▼ + stars: | 2022-10-12 | by ( ) www.reuters.com time to read: +1 min

Oct 12 (Reuters) - Another wave of COVID-19 infections may have begun in Europe as cases begin to tick up across the region, the World Health Organization and European Centre for Disease Prevention and Control (ECDC) said on Wednesday. "We are unfortunately seeing indicators rising again in Europe, suggesting that another wave of infections has begun." Public health experts have warned that vaccine fatigue and confusion over available vaccines will likely limit booster uptake in the region. read moreMillions of people across Europe remain unvaccinated against COVID-19, the WHO and ECDC noted. They urged European countries to administer both flu and COVID-19 vaccines ahead of an expected surge in cases of seasonal influenza.

☆ U.S. FDA proposes new rules for packaged foods to qualify as 'healthy'
▼ + stars: | 2022-09-28 | by ( ) www.reuters.com time to read: +1 min

Sept 28 (Reuters) - The U.S. Food and Drug Administration (FDA) on Wednesday proposed new rules for labeling packaged foods as "healthy", as it seeks to help people make informed nutritional choices which can help lower the risk of chronic diseases. The proposed changes to food labeling come on the day of the first White House summit on hunger, nutrition and health in more than 50 years. "Too many people may not know what constitutes healthy food. FDA's move will help educate more Americans," U.S. HHS Secretary Xavier Becerra said in a statement. Register now for FREE unlimited access to Reuters.com RegisterReporting by Raghav Mahobe; Editing by Vinay DwivediOur Standards: The Thomson Reuters Trust Principles.

☆ U.S. FDA approves Fennec's hearing loss therapy
▼ + stars: | 2022-09-21 | by ( ) www.reuters.com time to read: +1 min

Register now for FREE unlimited access to Reuters.com RegisterSignage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File PhotoSept 21 (Reuters) - The U.S. Food and Drug Administration has approved Fennec Pharmaceuticals Inc's (FENC.O) intravenous therapy to prevent chemotherapy-induced hearing loss in children, according to the health regulator's website. Cisplatin is used in treating a range of cancers in children such as liver, bone and brain cancer, but can cause permanent hearing loss. Register now for FREE unlimited access to Reuters.com RegisterPedmark is now the only approved therapy to prevent cisplatin-induced hearing loss in the United States, with most patients opting for either cochlear implants or hearing aids. Register now for FREE unlimited access to Reuters.com RegisterReporting by Raghav Mahobe and Mrinalika Roy in Bengaluru; Editing by Dhanya Ann ThoppilOur Standards: The Thomson Reuters Trust Principles.

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