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☆ J&J-spinoff Kenvue forecasts upbeat annual profit on strong self-care demand
▼ + stars: | 2023-07-20 | by ( ) www.reuters.com time to read: +2 min

Companies Kenvue Inc FollowNeutrogena Corporation FollowHaleon Plc Follow Show more companiesJuly 20 (Reuters) - Kenvue (KVUE.N), the former consumer health unit of Johnson & Johnson (JNJ.N), forecast full-year profit above Wall Street estimates on Thursday, betting on resilient demand for its skincare and self-care products such as Neutrogena and Tylenol. Kenvue, in its first results after being spun off from Johnson & Johnson in May, forecast full-year adjusted profit per share between $1.26 and $1.31. However, adjusted gross profit margin came in at 57.5%, compared to 59.3% a year earlier, dragged by a strong dollar and higher costs. Meanwhile, J&J raised its 2023 profit forecast on Thursday, banking on the strength in its medical devices business and demand for its cancer drugs such as Darzalex. Net sales rose 5.4% to $4.01 billion while adjusted profit per share came in at 32 cents.

Persons: Johnson, Haleon, J, Ananya Mariam Rajesh, Raghav, Devika Syamnath Organizations: Johnson, Wall, Thomson Locations: Bengaluru

☆ US FDA approves Sanofi-AstraZeneca's preventive RSV therapy for babies
▼ + stars: | 2023-07-17 | by ( ) www.reuters.com time to read: +2 min

July 17 (Reuters) - The U.S. Food and Drug Administration (FDA) said on Monday it had approved Sanofi (SASY.PA) and partner AstraZeneca's (AZN.L) antibody therapy to prevent respiratory syncytial virus (RSV) in infants and toddlers. The therapy, branded Beyfortus, was approved for preventing lower respiratory tract disease in infants born during or entering their first RSV season, and in children up to 24 months of age who remain vulnerable to severe RSV disease through their second such season. The companies plan to make Beyfortus available in the United States ahead of the upcoming RSV season, Sanofi said, adding that it plans to share more information about the therapy's price closer to the season. RSV is a leading cause of hospitalizations in infants and so far Swedish Orphan Biovitrum's (SOBIV.ST) treatment, Synagis, was the only approved preventive therapy in the United States for high-risk infants. The therapy comes with warnings and precautions about serious hypersensitivity reactions, and should be given with caution to infants and children with clinically significant bleeding disorders, the FDA said.

Persons: AstraZeneca's, Sanofi, Beyfortus, Bhanvi Satija, Shinjini Ganguli, Maju Samuel Organizations: U.S . Food, Drug Administration, Sanofi, American Academy of Pediatrics, FDA, Thomson Locations: U.S, United States, Bengaluru

July 14 (Reuters) - UnitedHealth Group's (UNH.N) quarterly profit beat Wall Street estimates on Friday as a smaller-than-expected jump in medical costs allayed fears that a resumption in long-delayed surgical procedures would hit profit growth, sending its shares up 5%. The beat from the industry bellwether lifted the shares of rivals Humana (HUM.N), Cigna (CI.N), CVS Health (CVS.N) and Elevance Health (ELV.N) between 2% and 5%. Chief financial officer John Rex said the company expects medical costs for the third quarter to be "a little bit lower" compared to the second quarter. UnitedHealth's profit of $6.14 per share for the second quarter beat analysts' expectations of $5.99, according to Refinitiv. Reporting by Bhanvi Satija and Raghav Mahobe in Bengaluru; Editing by Pooja DesaiOur Standards: The Thomson Reuters Trust Principles.

Persons: John Rex, Stephens, Scott Fidel, UnitedHealth, Humana, Bhanvi Satija, Pooja Desai Organizations: Wall, Humana, CVS Health, Elevance, Health, Medicare, Thomson Locations: Bengaluru

☆ Pfizer makes equity investment in Caribou Biosciences
▼ + stars: | 2023-07-06 | by ( ) www.reuters.com time to read: +2 min

July 6 (Reuters) - Pfizer (PFE.N) has invested $25 million to buy a minority stake in Caribou Biosciences (CRBU.O), making it the latest small biotechnology firm to attract the pharmaceutical giant's interest. The news lifted shares of Caribou more than 61% in early trade. Pfizer purchased nearly 4.7 million Caribou shares at $5.33 per share, Caribou said on Thursday, representing a premium of about 30% over Caribou's previous close price. This represents 7.64% of outstanding shares in Caribou, according to Reuters' calculation based on Refinitiv IBES data. It also made a $25 million equity investment in Akero Therapeutics (AKRO.O) last year.

Persons: Caribou, NASH, Jennifer Doudna, Raghav Mahobe, Leroy Leo, Maju Samuel Organizations: Pfizer, Caribou Biosciences, Biohaven Pharmaceutical, Akero Therapeutics, Thomson Locations: Caribou, California, Bengaluru

☆ Nine new African countries to receive millions of malaria vaccines- GAVI
▼ + stars: | 2023-07-05 | by ( ) www.reuters.com time to read: +1 min

July 5 (Reuters) - Global vaccine alliance GAVI said on Wednesday 12 countries in Africa would receive 18 million doses of malaria vaccine over the next two years, expanding access to the shots to nine new countries in the region. Malaria remains one of the continent's deadliest diseases, killing nearly half a million children each year under the age of five. In 2021, Africa accounted for about 95% of global malaria cases and 96% of deaths, according to the World Health Organization (WHO). "At least 28 African countries have expressed interest in receiving the RTS,S (malaria) vaccine," WHO chief Tedros Adhanom Ghebreyesus said at a media briefing, adding that a second malaria vaccine was under review for pre-qualification and if successful, could provide additional supply in the short term. The first doses of the RTS,S vaccine are expected to reach the 12 African countries during the last quarter of 2023, allowing them to start rolling out by early next year.

Persons: GAVI, Tedros Adhanom Ghebreyesus, Raghav Mahobe, Shinjini Organizations: World Health Organization, WHO, GAVI, UNICEF, British, GSK, Democratic, Thomson Locations: Africa, Ghana, Kenya, Malawi, Benin, Burkina Faso, Burundi, Cameroon, Democratic Republic of the Congo, Liberia, Niger, Sierra Leone, Uganda, Bengaluru

☆ US FDA declines to approve Amneal's Parkinson's drug over safety concerns
▼ + stars: | 2023-07-03 | by ( ) www.reuters.com time to read: +2 min

July 3 (Reuters) - The U.S. Food and Drug Administration (FDA) has declined to approve Amneal Pharmaceuticals' (AMRX.N) drug designed to help control symptoms in Parkinson's disease patients for a longer duration, citing inadequate safety data. The complete response letter comes as a surprise, said Barclays analyst Balaji Prasad. The decision does not impact 2023 forecast as it did not include the revenue from the drug, the company said. Amneal has another Parkinson's drug, Rytary, on the market but has been struggling to gain a foothold in the treatment space. Only 4% of patients use the drug since its approval in 2015, as per company estimates.

Persons: Balaji Prasad, Amneal, Raghav Mahobe, Khushi, Sriparna Roy, Pooja Desai, Shweta Agarwal, Sriraj Organizations: U.S . Food, Drug Administration, Amneal Pharmaceuticals, FDA, Barclays, Thomson Locations: U.S, Bengaluru

☆ BioXcel cites issues at Alzheimer's drug trial site, shares plunge
▼ + stars: | 2023-06-29 | by ( Khushi Mandowara | ) www.reuters.com time to read: +2 min

June 29 (Reuters) - BioXcel Therapeutics (BTAI.O) flagged issues related to the recording of safety data at one of the sites for late-stage trial of its Alzheimer's drug, sending its shares plunging more than 67% in premarket trading on Thursday. The drug, named BXCL501, was being studied to treat patients with agitation related to Alzheimer's disease. The issue highlighted by the company overshadowed results of the drug's trial, which was also reported on Thursday. BioXcel said it plans to submit an application to expand the use of the drug in the second half of this year. The drug is already approved by the FDA for treating agitation associated with schizophrenia or bipolar I or II disorder in adults.

Persons: Vimal Mehta, Robyn Karnauskas, BioXcel, Khushi Mandowara, Krishna Chandra Eluri Organizations: BioXcel Therapeutics, U.S . Food, Drug Administration, Truist Securities, Thomson Locations: Bengaluru

☆ US FDA declines to approve Regeneron's higher-dose Eylea, shares tumble
▼ + stars: | 2023-06-27 | by ( ) www.reuters.com time to read: +2 min

The Food and Drug Administration cited an ongoing review of inspection findings at a third-party filler of the higher dose for the decision. Eylea, which recorded $9.65 billion in global sales last year, has been hit since Roche's (ROG.S) rival treatment Vabysmo was approved last year for wet AMD. Two late-stage trials had shown Eylea was as effective as the lower dose version when given at 8 milligrams at longer intervals without any additional safety issues. The two trials included treatment of patients with wet AMD and diabetic macular edema (DME). An estimated 1.1 million people in the U.S. have wet AMD, while 1.2 million are estimated to have DME, according to Regeneron.

Persons: Vabysmo, Regeneron, Eylea, Raghav Mahobe, Krishna Chandra Eluri, Maju Samuel, Sriraj Organizations: Regeneron Pharmaceuticals, Drug Administration, FDA, AMD, biosimilars, Thomson Locations: U.S, Bengaluru

☆ Moderna seeks US FDA authorization for updated COVID vaccine
▼ + stars: | 2023-06-22 | by ( ) www.reuters.com time to read: +1 min

June 22 (Reuters) - Moderna (MRNA.O) said on Thursday it has completed a submission to the U.S. Food and Drug Administration seeking authorization for its updated COVID-19 vaccine to target the XBB.1.5 subvariant. The submission from the company follows the FDA's advice last week to manufacturers that are updating their COVID-19 vaccines to develop monovalent shots to target XBB.1.5. Moderna said preliminary clinical data demonstrated a robust immune response by its XBB.1.5 monovalent vaccine against XBB descendent lineage viruses. Pending authorization, the updated shot would be available in time for the fall vaccination, Moderna said. Other COVID vaccine makers Pfizer (PFE.N)/BioNTech (22UAy.DE) and Novavax (NVAX.O) are already developing versions of their respective vaccines targeting XBB.1.5 and other currently circulating subvariants.

Persons: Moderna, Raghav Mahobe, Krishna Chandra Eluri Organizations: U.S . Food, Drug Administration, Pfizer, Thomson Locations: U.S, Bengaluru

☆ Oracle beats quarterly revenue estimates on cloud services demand
▼ + stars: | 2023-06-12 | by ( ) www.reuters.com time to read: +1 min

June 12 (Reuters) - Oracle (ORCL.N) topped fourth-quarter revenue estimates on Monday, boosted by growing demand for its cloud offerings from companies deploying AI. Revenue for the quarter stood at $13.84 billion, compared with analysts' estimates of $13.74 billion, according to Refinitiv. The cloud and software company has also boosted its AI cloud offerings, including its partnership with Nvidia (NVDA.O) to make the chip company's AI software and chips available to Oracle customers via its cloud services. Revenue at Oracle's cloud services and license support unit, its largest, rose to $9.37 billion in the quarter from $7.61 billion a year earlier. Reporting by Samrhitha Arunasalam and Raghav Mahobe in Bengaluru; Editing by Maju SamuelOur Standards: The Thomson Reuters Trust Principles.

Persons: Cerner, Samrhitha Arunasalam, Maju Samuel Organizations: Oracle, Revenue, Microsoft, Nvidia, Thomson Locations: Austin , Texas, Bengaluru

☆ General Electric to sell over $2 bln stake in GE HealthCare
▼ + stars: | 2023-06-05 | by ( ) www.reuters.com time to read: 1 min

June 5 (Reuters) - General Electric Co (GE.N) is offering 25 million of common stock, or over a $2 billion stake, in GE HealthCare Technologies Inc (GEHC.O), according to a regulatory filing on Monday. Reporting by Raghav Mahobe in Bengaluru; Editing by Maju SamuelOur Standards: The Thomson Reuters Trust Principles.

Persons: Raghav, Maju Samuel Organizations: General Electric Co, GE HealthCare Technologies Inc, Thomson Locations: Bengaluru

[1/3] A vial labelled "CureVac COVID-19 Vaccine" is seen in this illustration taken January 16, 2022. REUTERS/Dado Ruvic/IllustrationMay 19 (Reuters) - CureVac NV said on Friday it had filed an expanded patent infringement claim against Pfizer Inc (PFE.N) and BioNTech over the use of mRNA technology and that a U.S. court had granted its request to transfer the trial. In July 2022, CureVac had filed a patent lawsuit against BioNTech over the use of mRNA technology in the companies' COVID-19 vaccine. Pfizer and BioNTech in response had filed a complaint with the U.S. District Court in Massachusetts, seeking a judgment that they did not infringe U.S. patents held by CureVac. The companies have previously told the court that their COVID vaccine Comirnaty does not work in the same way as CureVac's patented technology.

Novavax, whose COVID vaccine is its lone marketed product after 35 years in business, is relying on launching an updated COVID shot this fall to match circulating strains and cost cuts to improve its prospects. Novavax said $800 million of that was from "locked-in" overseas purchase contracts for the COVID shot that it has committed to ship this year. Novavax is working to produce an update version of its protein-based vaccine in time for the fall COVID-19 booster season. Novavax expects the cost cuts to reduce its annual research and commercial expenses by 20% to 25% from last year. Data from a mid-stage trial in adults aged 50 to 80 years showed that the combination shot produced an immune response comparable to its protein-based COVID vaccine and already approved influenza shots, Novavax said.

☆ Novavax shares surge on COVID/flu shot data, job cuts
▼ + stars: | 2023-05-09 | by ( ) www.reuters.com time to read: +2 min

May 9 (Reuters) - Novavax (NVAX.O) on Tuesday announced plans to cut a fourth of its workforce and unveiled promising data for its COVID-flu combination vaccine, spurring hopes of a recovery for the cash-strapped biotech and sending its shares more than 50% higher. Novavax, whose coronavirus vaccine is its lone marketed product after 35 years in business, is now banking on its cost-control measures and a successful trial for its COVID/flu combination vaccine candidate to help it stay afloat. Data from a mid-stage trial in adults aged 50 to 80 years showed that the combination shot produced an immune response comparable to its protein-based COVID vaccine and already approved influenza shots. The new data comes at a time when global regulators expect COVID vaccination campaigns to be conducted annually like flu inoculations. The biotech expects the cost cuts to reduce its annual research and commercial expenses by 20% to 25% from last year.

☆ Novavax lays off 25% of workforce, releases 2023 outlook
▼ + stars: | 2023-05-09 | by ( ) www.reuters.com time to read: +1 min

May 9 (Reuters) - Novavax (NVAX.O) said on Tuesday it will reduce its global workforce by 25% as the cash-strapped biotech pushes forward with its plans to slash expenses and navigate tepid demand for its COVID-19 vaccines. Separately, Novavax said its COVID/flu combination shot was safe and well-tolerated in a mid-stage study, sending shares of the company up 9% before the bell. For the first quarter, it reported a net loss of $293.9 million, compared with a year-ago profit of $203.4 million. The biotech expects the cost-cut plans to help reduce its annual research and commercial expenses by 20% to 25% from last year. The company had $637 million in cash and equivalents at the end of the quarter, compared with $1.3 billion as of Dec. 31.

☆ Regeneron's Eylea drug misses sales estimates as competition heats up
▼ + stars: | 2023-05-04 | by ( ) www.reuters.com time to read: +1 min

The drug recorded sales of $2.28 billion in the quarter, missing expectations of $2.43 billion, according to an average of six analysts' estimates polled by Refinitiv. The company has also been leaning on its anti-inflammatory drug Dupixent - a treatment currently approved for five indications including asthma and atopic dermatitis, or eczema. Quarterly sales of Dupixent, recorded by Regeneron's partner Sanofi (SASY.PA), rose about 37% to $2.49 billion, above expectations of $2.38 billion. Regeneron's total revenue of $3.16 billion beat estimates of $3 billion. Excluding items, the company reported a profit of $10.09 per share, above estimates of $9.56.

☆ US FDA approves first RSV vaccine from GSK
▼ + stars: | 2023-05-03 | by ( ) www.reuters.com time to read: +1 min

May 3 (Reuters) - The U.S. Food and Drug Administration has approved GSK Plc's (GSK.L) respiratory syncytial virus (RSV) vaccine, the British drugmaker said on Wednesday, making it the first shot to be cleared for protection against a common respiratory disease that can be fatal for older people. The vaccine was approved for people aged 60 and older, the company said. The approval makes GSK, which has been neck-and-neck with Pfizer (PFE.N) in RSV vaccine development, the first company to tap into a multi-billion-dollar market and puts it ahead of rivals such as Moderna Inc (MRNA.O) and Bavarian Nordic (BAVA.CO). Analysts have estimated the market for RSV vaccines to cross $10 billion by 2030. GSK expects the vaccine to be available before the next RSV season in the United States, Chief Commercial Officer Luke Miels told Reuters on Wednesday before the approval.

May 3 (Reuters) - CVS Health Corp (CVS.N) said on Wednesday it would pause its recent acquisition spree as it focuses on integrating purchases of healthcare service provider Signify Health and primary care provider Oak Street Health. CEO Karen Lynch said CVS will focus on integrating Signify and Oak Street with its other businesses in the near term. CVS cut its full-year profit forecast on Wednesday to account for transaction and integration costs related to the two deals, and its shares fell 3%. The earlier-than-expected closing of the Oak Street deal on Tuesday is likely to result in increased interest costs for the year, analysts said. Morningstar analyst Julie Utterback said investors might be disappointed that the company pushed down its profit forecast after completing the Oak Street acquisition this week.

☆ Pfizer beats profit estimates on demand for new drugs, COVID products
▼ + stars: | 2023-05-02 | by ( ) www.reuters.com time to read: +1 min

Companies Pfizer Inc FollowMay 2 (Reuters) - Pfizer Inc (PFE.N) on Tuesday beat analysts' estimates for first-quarter profit on strong demand for its newly acquired drugs and steady demand for its COVID products, sending its shares up nearly 3% before the bell. The company has said it expects 2023 to be a "transition year" for its COVID products, before potential returning to growth in 2024. The company said it expects significantly lower sales contributions from COVID products in the second quarter from the first quarter. Excluding COVID products, Pfizer said first-quarter revenue was mostly driven by recently acquired products, including migraine drug Nurtec ODT and sickle cell disease treatment Oxbryta. Pfizer also maintained its annual COVID products revenue forecast of about $21.5 billion from both the vaccine and the pill.

☆ Sarepta drops as report says FDA almost rejected under-review gene therapy
▼ + stars: | 2023-04-13 | by ( ) www.reuters.com time to read: +1 min

April 13 (Reuters) - Sarepta Therapeutics Inc's shares (SRPT.O) fell more than 6% on Thursday as Stat News reported that the U.S. health regulator's staff were inclined to reject the company's gene therapy which is currently under review. Some staff at the U.S. Food and Drug Administration (FDA) had reached a "non-binding conclusion" that Sarepta's gene therapy should not be given approval, prompting FDA official Peter Marks to intervene and instead schedule an advisory meeting on May 12, Stat News reported, citing sources. The company is seeking approval for its gene therapy for treating a rare muscle-wasting disorder called Duchenne muscular dystrophy under the FDA's accelerated pathway. Brokerage William Blair said it still sees a "likely" approval for the therapy. Shares of Catalent Inc (CTLT.N), which holds the contract manufacturing rights for the therapy, fell as much as 5.5% in early trade.

☆ Cutera fires CEO, stock tumbles and large investor speaks out
▼ + stars: | 2023-04-12 | by ( Svea Herbst-Bayliss | ) www.reuters.com time to read: +2 min

CEO David Mowry and activist investor J. Daniel Plants, who has served on the board for eight years, were terminated for alleged violations of their employment contracts, Cutera said. RTW Investments, Cutera's second biggest investor with a 9.3% stake, called on the company to reinstate Mowry and to hold a special meeting. Market reaction to Mowry's removal "demonstrates the need for the Special Meeting and the lack of confidence in the board," RTW said in a statement. Top Cutera executives, including the chief financial officer, on Tuesday supported Mowry and Plants, arguing the men work well together and had earned their trust. The California-based company, which sells devices including laser treatments for tattoo removal and acne, appointed independent board member Sheila Hopkins as interim CEO.

☆ McDonald's cuts pay packages for some employees - WSJ
▼ + stars: | 2023-04-07 | by ( ) www.reuters.com time to read: +1 min

April 7 (Reuters) - McDonald's Corp (MCD.N) is cutting pay packages for some employees as part of a restructuring that includes layoffs and the shutting down of some offices, the Wall Street Journal reported on Friday, citing people familiar with the matter. Reuters on Monday reported that the number of corporate employees the company was planning to lay off this week will tally in the "hundreds." The fast-food chain has offered some employees a chance to remain at the company with reductions in their compensation packages, including changes to titles and benefits such as bonuses and equity grants, the WSJ report said. Job cuts and changes at McDonald's are affecting employees in the United States and abroad, at the company's Chicago headquarters and in its field offices, and across departments including marketing and operations, the report added. Reporting by Raghav Mahobe in Bengaluru; Editing by Mark Porter and Chizu NomiyamaOur Standards: The Thomson Reuters Trust Principles.

☆ China holds the key to understanding COVID-19 origins: WHO chief
▼ + stars: | 2023-04-06 | by ( ) www.reuters.com time to read: +3 min

"Without full access to the information that China has, you cannot say this or that," said Director-General Tedros Adhanom Ghebreyesus in response to a question about the origin of the virus. That's WHO's position and that's why we have been asking China to be cooperative on this." Data from the early days of the COVID pandemic was briefly uploaded by Chinese scientists to an international database last month. The WHO's Maria Van Kerkhove, technical lead for COVID-19, said the latest Chinese information offered some "clues" on origins but no answers. She added WHO still did not know whether some of the research required had been undertaken in China.

☆ Pinterest to reduce office spaces as part of restructuring
▼ + stars: | 2023-03-27 | by ( ) www.reuters.com time to read: 1 min

March 27 (Reuters) - Pinterest Inc (PINS.N) will end leases of certain office spaces as part of a restructuring plan, the image-sharing platform said on Monday, in addition to about 4% workforce reduction it started last month. U.S. companies from technology to finance have stepped up cost cuts as they brace for a potential recession. Pinterest said it expected to incur between $100 million and $125 million in charges related to the restructuring plan. The office space reductions are expected to be completed in 2023. Reporting by Raghav Mahobe in Bengaluru; Editing by Shilpi MajumdarOur Standards: The Thomson Reuters Trust Principles.

March 24 (Reuters) - The U.S. Food and Drug Administration (FDA) on Friday approved Pharming Group's drug to treat a rare genetic disorder that leads to a weakened immune system, the Dutch company said. APDS causes a lack of functioning immune cells, B cells and T cells, which makes it difficult for people with this disorder to fight off bacterial and viral infections. At least two analysts expected the drug to be priced at as much as $400,000. Oppenheimer analyst Hartaj Singh expected Joenja to be priced between $250,000 and $400,000, and forecast peak sales of $200 million to $300 million, ahead of the approval. Joenja is an oral drug that targets and blocks a form of the protein called phosphoinositide 3-kinase delta (P13K).

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