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☆ WHO says it still does not have full access to Ethiopia's Tigray
▼ + stars: | 2022-12-02 | by ( Bhanvi Satija | ) www.reuters.com time to read: +2 min

REUTERS/Tiksa NegeriBENGALARU, Dec 2 (Reuters) - The World Health Organization said on Friday it still does not have the unfettered access to Ethiopia's northern Tigray region stipulated in a truce signed a month ago. Troops from Eritrea, to the north, and forces from the neighbouring Ethiopian region of Amhara, to the south, fought alongside Ethiopia's military in Tigray but were not party to the ceasefire. "That peace process has not yet resulted in the kinds of full access, unfettered access and in the massive scale of medical and health assistance that the people of Tigray need," WHO's emergencies director Mike Ryan said. Ethiopia's Minister of Health Lia Tadesse, State Minister Redwan Hussien, and government spokesperson Legesse Tulu did not respond to requests for comment. WHO chief Tedros Adhanom Ghebreyesus in October accused Ethiopia's government of using the denial of food and healthcare as weapons of war in Tigray.

Dec 1 (Reuters) - Biotech firm Roivant Sciences (ROIV.O) on Thursday launched a company with Pfizer Inc (PFE.N) focused on an experimental bowel disease treatment, as the drugmakers seek to tap into a multibillion dollar market. The drug, RVT-3101, was originally developed by Pfizer, which will hold a 25% stake in the new business, with Roivant holding the majority interest. SVB Securities analyst David Risinger says the deal shows how Pfizer is prioritizing research spending for its oral ulcerative colitis drug, etrasimod, which holds a near-term blockbuster opportunity. RVT-3101 could represent a nearly $15 billion commercial opportunity in the United States for Roivant as a treatment for both ulcerative colitis and Crohn’s disease, said Risinger. Pfizer has also licensed its inflammatory autoimmune disease drug brepocitinib to Roivant in exchange for a 25% stake in another jointly held company called Priovant.

Nov 24 (Reuters) - Manulife Financial Corp (MFC.TO) will outsource its property operations in Canada to focus on its entrepreneurial investment management unit, Canada's biggest life insurer said Thursday. The change to a new structure will result in Manulife Investment Management, which overseas the real estate portfolio, shedding 50 jobs, two sources familiar with the matter told Reuters on Thursday. Among other financial services companies, Canada's biggest lender, Royal Bank of Canada (RY.TO) and Bank of Montreal (BMO.TO) have recently cut jobs in the United States. Manulife Investment Management's real estate arm uses a pool of capital to invest in real estate in 29 cities across the United States, Asia and Canada. According to its annual report, the insurer had about C$13.2 billion ($9.90 billion) worth of real estate investments in 2021.

Nov 22 (Reuters) - Medtronic Plc (MDT.N) on Tuesday lowered its full-year outlook for profit and revenue growth, blaming a stronger dollar and a slower-than-anticipated recovery in supply chain disruptions, sending the medical device maker's shares down nearly 6%. Medtronic cut its revenue growth expectations for fiscal 2023 to 3.5% to 4%, from 4% to 5%. The company said cost-cutting measures will likely offset lower revenue and inflationary pressures in the second half of the year. A slower-than-anticipated recovery in supply chain disruptions impacted Medtronic's medical surgical business the most, with the unit's revenue falling 10% to $2.07 billion. Reporting by Khushi Mandowara and Bhanvi Satija in Bengaluru; Editing by Maju SamuelOur Standards: The Thomson Reuters Trust Principles.

☆ Pfizer/BioNTech's updated COVID shot shows strong response against BQ.1.1
▼ + stars: | 2022-11-18 | by ( ) www.reuters.com time to read: +2 min

Nov 18 (Reuters) - Pfizer Inc (PFE.N) and its German partner BioNTech SE said on Friday their Omicron-tailored shot produced higher virus-neutralizing antibodies in older adults against the emerging subvariant BQ.1.1 than its original vaccine. Antibody levels against the variant rose nearly nine-fold in older adults, aged 55 and above, who received the Omicron shot compared to a roughly 2-fold increase in participants with the original shot, according to data posted on online archive bioRxiv. The variant and related BQ.1 are gaining ground in the United States, and are expected to cause a rise in cases in the winter in Europe. The companies had recently released data that showed their Omicron-tailored shot produced a strong antibody response in older adults than the original shot after one month against the BA.4/5 subvariants. Pfizer and BioNTech said the bivalent shot also produced an immune response against newer Omicron subvariants including BA.4.6, BA.2.75.2 and XBB.1.

☆ U.S. FDA greenlights Provention Bio's diabetes drug
▼ + stars: | 2022-11-17 | by ( Bhanvi Satija | ) www.reuters.com time to read: +2 min

Nov 17 (Reuters) - Provention Bio (PRVB.O) said on Thursday the U.S. Food and Drug Administration had approved the use of its drug teplizumab in those aged eight years and older, the first treatment aimed at delaying the onset of insulin-dependent type 1 diabetes. In October, Provention signed a co-promotion deal for the drug with Sanofi (SASY.PA), offering the French drugmaker first negotiation for exclusive global rights to commercialize the drug in exchange for an upfront payment of $20 million. As per the deal, the approval will also allow Sanofi to purchase up to $35 million of Provention's common stock. Current standard of care for type 1 diabetes requires patients to monitor and manage symptoms such as low or high blood sugar levels through regular insulin intake. Type 1 diabetes, previously known as juvenile diabetes, is a disease in which the immune system attacks and destroys the insulin-producing beta cells in the pancreas, leaving sufferers reliant on regular insulin injections.

☆ Fake account shows 'challenges' with Twitter - Lilly CEO
▼ + stars: | 2022-11-16 | by ( ) www.reuters.com time to read: +1 min

[1/3] FILE PHOTO: Twitter app logo is seen in this illustration taken, August 22, 2022. REUTERS/Dado Ruvic/Illustration/File Photo/File PhotoNov 16 (Reuters) - Eli Lilly & Co (LLY.N) Chief Executive Officer Dave Ricks said on Wednesday that the recent imposter Twitter account incident "demonstrates some of the challenges" on the social media platform. Speaking at the STAT Summit 2022, Ricks described the incident as "disappointing" and said that the apology which followed from Lilly did not "happen quickly enough". The drugmaker had issued an apology from its official Twitter account, @LillyPad, after an imposter Twitter account with the handle @EliLillyandCo tweeted that insulin would be free, amid political backlash and scrutiny into high medicine costs. Reporting by Bhanvi Satija in Bengaluru; Editing by Maju SamuelOur Standards: The Thomson Reuters Trust Principles.

☆ Novartis weighs sale of ophthalmology, respiratory units - Bloomberg
▼ + stars: | 2022-11-16 | by ( Hadeel Al Sayegh | ) www.reuters.com time to read: 1 min

Nov 16 (Reuters) - Swiss drugmaker Novartis AG (NOVN.S) is considering to sell its ophthalmology and respiratory units, a Bloomberg report said on Wednesday citing people familiar with the matter. Reporting by Bhanvi Satija in Bengaluru; Editing by Vinay DwivediOur Standards: The Thomson Reuters Trust Principles.

☆ Immunogen's $6,220 ovarian cancer drug to be shipped within days
▼ + stars: | 2022-11-15 | by ( ) www.reuters.com time to read: +1 min

Nov 15 (Reuters) - Drugmaker Immunogen (IMGN.O) said on Tuesday it will sell its newly approved ovarian cancer drug at a list price of $6,220 per vial and start shipping it "in a matter of days". Most patients will receive three to four vials per treatment cycle, putting the cost at about $18,500 to $25,000 a cycle, said Immunogen Chief Executive Mark Enyedy on a conference call. Late on Monday, Immunogen said the U.S. Food and Drug Administration had approved its drug, mirvetuximab soravtansine, for treatment of platinum-resistant ovarian cancer in adults. Shares of the Massachusetts-based company rose nearly 8% to $6.20 before the bell. Reporting by Bhanvi Satija in Bengaluru; Editing by Shinjini GanguliOur Standards: The Thomson Reuters Trust Principles.

☆ Moderna's Omicron shots shows better immune response than original COVID vaccine
▼ + stars: | 2022-11-14 | by ( ) www.reuters.com time to read: +1 min

Nov 14 (Reuters) - Moderna Inc (MRNA.O) said on Monday its Omicron-tailored vaccines produced a better immune response against the BA.4/5 subvariants in a mid-to-late stage study, when given as a booster dose, compared with its original shot. Data shows that both of Moderna's Omicron-tailored shots, mRNA-1273.214 and mRNA-1273.222, produced a higher antibody response against BA.4/5 subvariants than its original shot in vaccinated and boosted adults, the company said. Moderna, however, said levels of neutralizing antibody response dropped nearly 5-fold against the emerging subvariant BQ.1.1 when compared with BA.4/5, in an analysis of about 40 participants, although the virus neutralizing activity still remained "robust". Rival Pfizer Inc (PFE.N) and its German partner, BioNTech SE , said earlier this month their Omicron-tailored shot targeting the BA.4/5 subvariants produced a strong antibody response in older adults than the original shot after one month. Reporting by Bhanvi Satija in Bengaluru; Editing by Vinay DwivediOur Standards: The Thomson Reuters Trust Principles.

☆ U.S. teen tobacco use down to 3 mln in 2022, 'more work to be done,' health officials say
▼ + stars: | 2022-11-10 | by ( Bhanvi Satija | ) www.reuters.com time to read: +2 min

The data found that one-in-nine U.S. teenagers were currently using a tobacco product. E-cigarettes were the most commonly used tobacco product among teens for the ninth consecutive year, according to the study published in the U.S. Centers for Disease Control and Prevention (CDC) Morbidity and Mortality Weekly Report. Use of combustible tobacco products was highest among Black students at 5.7%. More than 3% of Black students reported smoking cigars, while 2.3% reported using a hookah. “With an ever-changing tobacco product landscape, there’s still more work to be done,” U.S. Food and Drug Administration's director of tobacco products Brian King said about reducing adolescent usage of nicotine products.

☆ European regulator recommends Pfizer's Omicron booster for children
▼ + stars: | 2022-11-10 | by ( ) www.reuters.com time to read: 1 min

Nov 10 (Reuters) - Pfizer Inc (PFE.N) and its partner BioNTech said on Thursday the EU health regulator has recommended authorising the use of their bivalent COVID-19 shot as a booster in children aged 5 through 11. The Omicron-tailored vaccine is already authorised by the European Commission for individuals aged 12 years and above. The updated bivalent booster shot targets the original coronavirus strain as well as the BA.4 and BA.5 sub-variants of Omicron. In October, European Medical Agency backed authorization of Moderna Inc's (MRNA.O) COVID-19 tailored booster shots for 12 and above to further vaccination campaigns in the region. Reporting by Bhanvi Satija and Khushi Mandowara in Bengaluru; Editing by Shounak Dasgupta amd Shinjini GanguliOur Standards: The Thomson Reuters Trust Principles.

☆ 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.

☆ Novavax says Omicron shot shows strong immune response as second booster
▼ + stars: | 2022-11-08 | by ( ) www.reuters.com time to read: +2 min

Nov 8 (Reuters) - Vaccine maker Novavax Inc (NVAX.O) said on Tuesday its COVID-19 shot retooled against the Omicron BA.1 variant showed a strong immune response as the fourth dose and met the main goal of strain change in a late-stage study. Data showed the shot, NVX-CoV2515, produced 1.6 times the amount of neutralizing antibodies in people who had previously not been exposed to COVID-19 compared to Novavax's original coronavirus vaccine. The trial included Novavax's so-called bivalent vaccine, the BA.1-tailored shot and its prototype vaccine. Novavax says the results from the study showed its Omicron-tailored shot can be changed to target a new variant vaccine if necessary. Novavax's COVID shot has not yet received approval in the United States as a second booster dose.

☆ 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.

☆ Pfizer, BioNTech start COVID-flu combination vaccine study
▼ + stars: | 2022-11-03 | by ( ) www.reuters.com time to read: +1 min

Nov 3 (Reuters) - U.S. drugmaker Pfizer Inc (PFE.N) and its German partner BioNTech SE have started an early-stage study to evaluate a combination vaccine targeting COVID-19 and influenza, the companies said on Thursday. The single-dose vaccine candidate is a combination of Pfizer's mRNA-based flu shot and the companies' Omicron-tailored COVID-19 booster shot. The early-stage study, which is being sponsored by BioNTech, aims to evaluate the combination shot's safety, tolerability and immunogenicity, or the ability to generate immune response. Rivals Moderna Inc (MRNA.O) and Novavax Inc (NVAX.O) are also developing combination vaccines targeting both COVID-19 and influenza. read moreReporting by Bhanvi Satija in Bengaluru; Editing by Savio D'Souza and Vinay DwivediOur Standards: The Thomson Reuters Trust Principles.

☆ 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.

☆ Eli Lilly's bleak annual forecast overshadows quarterly beat
▼ + stars: | 2022-11-01 | by ( ) www.reuters.com time to read: +2 min

The company's shares fell nearly 4% in premarket trading as a forecast cut for the third time this year overshadowed strong performance by its newly approved diabetes drug. The drugmaker also trimmed its full-year revenue forecast, citing a $300 million hit to its revenue from the strong dollar. Lilly now sees revenue in the range of $28.5 billion to $29 billion, below analysts' estimates of $28.76 billion at mid-point. Lilly flagged a total impact of about $1 billion from the strong dollar for the full year. The company posted better-than-expected results for the third quarter, as demand for its recently approved diabetes drug, Mounjaro, helped counter declining sales of its diabetes and cancer treatments.

☆ Eli Lilly cuts annual profit forecast on stronger dollar
▼ + stars: | 2022-11-01 | by ( ) www.reuters.com time to read: +1 min

Nov 1 (Reuters) - Eli Lilly and Co (LLY.N) on Tuesday cut its annual profit forecast for the third time, as a stronger dollar piled more pressure on the drugmaker struggling with lower insulin prices and generic competition for its cancer drug. The company's shares fell nearly 4% in premarket trading as the forecast cut overshadowed strong performance by its newly approved diabetes drug. Eli Lilly now expects adjusted full-year earnings of $7.70 to $7.85 per share, compared to its prior forecast of $7.90 to $8.05. Multinational companies such as Abbott Laboratories and Johnson & Johnson (JNJ.N) have been hit by the dollar's strength against a basket of currencies. Lilly flagged a total impact of about $1 billion from the strong dollar for the full year.

☆ U.S. CDC director experiences COVID rebound after taking Pfizer's Paxlovid
▼ + stars: | 2022-10-31 | by ( ) www.reuters.com time to read: +1 min

Oct 31 (Reuters) - The director of the U.S. Centers for Disease Control and Prevention (CDC), Rochelle Walensky, experienced a COVID-19 rebound after completing a course of Pfizer Inc's (PFE.N) COVID-19 pill, the agency said on Monday. Walensky had experienced mild COVID-19 symptoms less than ten days ago. After completing a course of Pfizer's Paxlovid, and a period of isolation, she had tested negative for the virus, but on Sunday, she tested positive again, CDC added. Some people who took the antiviral drug have suffered from a relapse or a rebound that occurred days after the five-day treatment course had ended, studies have shown. Last month, the U.S. Food and Drug Administration asked Pfizer to test the effects of an additional course of its antiviral Paxlovid among people who had experienced a rebound in COVID-19 after treatment.

☆ EU regulator recommends adding heavy periods to side effects of mRNA COVID shots
▼ + stars: | 2022-10-28 | by ( Natalie Grover | ) www.reuters.com time to read: +2 min

[1/2] A medical worker holds a vial of the "Comirnaty" Pfizer-BioNTech COVID-19 vaccine at a coronavirus disease (COVID-19) vaccination center in Nice, France, December 1, 2021. REUTERS/Eric Gaillard/File PhotoOct 28 (Reuters) - A European Medicines Agency (EMA) committee on Friday recommended adding heavy menstrual bleeding to the list of side effect of mRNA COVID-19 vaccines made by Moderna (MRNA.O), as well as Pfizer (PFE.N) and its partner BioNTech (22UAy.DE). The regulator has now concluded that there is at least a "reasonable possibility" that heavy menstrual bleeding is causally associated with these vaccines. Menstrual disorders can occur due to a range of reasons, including underlying medical conditions as well as stress and tiredness. Health authorities have highlighted that cases have also been reported following COVID-19 infection.

☆ Tuberculosis deaths rose during pandemic, reversing years of decline, WHO says
▼ + stars: | 2022-10-27 | by ( Bhanvi Satija | ) www.reuters.com time to read: +2 min

Oct 27 (Reuters) - Global deaths from tuberculosis are estimated to have increased between 2019 and 2021, reversing years of decline as the COVID-19 pandemic severely derailed efforts to tackle the disease, the World Health Organization said on Thursday. Global efforts to tackle deadly diseases such as AIDS, tuberculosis and malaria have suffered during the COVID-19 pandemic. WHO urged the world to apply lessons learnt from the pandemic to tuberculosis, which severely affects countries such as India, Indonesia, the Philippines and Pakistan. WHO’s annual TB report estimates that tuberculosis killed 1.6 million people in 2021, above the estimated 1.5 million deaths in 2020, and 1.4 million deaths in 2019. Under its "End TB Strategy", the WHO set a target of reducing TB deaths by 35% from 2015 to 2020, but the net reduction was 5.9% between 2015 and 2021.

Oct 25 (Reuters) - Biogen Inc (BIIB.O) on Tuesday said the Alzheimer's disease drug it is developing with Japan's Eisai Co Ltd (4523.T) would be used by doctors in a competitive market as investors wait for data from rival therapies made by Eli Lilly and Co (LLY.N) and Roche (ROG.S). The drug, lecanemab was shown to slow the progress of the disease by 27% in a trial last month, and additional data is expected next month. "The data needs to be seen from the other anti-amyloid therapies before we decide what is going to be meaningful," said Biogen interim research chief Priya Singhal. Its costs were about halved as the company significantly cut back on commercial infrastructure around the launch of Aduhelm, its previous Alzheimer's drug that has sputtered amid controversy over efficacy and lack of coverage by health insurers. read moreInvestors have been pinning hopes on the Alzheimer's drug as cheaper generics of Biogen's multiple sclerosis treatment Tecfidera have entered the market, hurting sales.

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