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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

☆ Advil maker Haleon misses revenue estimates as North America demand drags
▼ + stars: | 2023-11-02 | by ( ) www.reuters.com time to read: +2 min

REUTERS/Brendan McDermid/File Photo Acquire Licensing RightsCompanies Haleon Plc FollowGSK plc FollowNov 2 (Reuters) - Haleon (HLN.L) missed market estimates for third-quarter revenue on Thursday, as the world's largest consumer healthcare firm grappled with weak demand for its painkillers, digestive health and vitamin supplements in North America. For the three months ended Sept. 30, Haleon reported a 5% organic increase in revenue to 2.79 billion pounds ($3.40 billion), but it came slightly below analysts' expectations of 2.83 billion pounds, according to a company-compiled consensus. The company said overall volumes for the quarter declined by 1.6%, while North America revenues fell 7.5% on a reported basis. Haleon, which was carved out of British drugmaker GSK (GSK.L) last year, has been raising prices to offset high costs. ($1 = 0.8215 pounds)Reporting by Eva Mathews in Bengaluru; Editing by Rashmi Aich and Gerry DoyleOur Standards: The Thomson Reuters Trust Principles.

Persons: Brendan McDermid, Haleon, Eva Mathews, Rashmi Aich, Gerry Doyle Organizations: New York Stock Exchange, REUTERS, GSK, Consumer, Thomson Locations: New York City, U.S, North America, British, Bengaluru

☆ GSK raises annual forecasts powered by strong Arexvy launch
▼ + stars: | 2023-11-01 | by ( ) www.reuters.com time to read: +2 min

Analysts expect the British drugmaker's RSV vaccine Arexvy to power future growth, amid worries about the strength of its pipeline of drugs in development and costly U.S. litigation over discontinued heartburn drug Zantac. Arexvy, launched in the United States recently, is expected to garner full-year sales of between 900 million pounds to 1 billion pounds ($1.22 billion), GSK said. For the third quarter, the shot recorded sales of 709 million pounds, trouncing analysts' expectations of 358 million pounds, according to a company-compiled consensus. Meanwhile, sales are seen to rise by 12% to 13% in 2023 compared with earlier expectations of 8% to 10%. For the reported quarter, sales of Shingrix, the company's top-selling drug to treat shingles, generated 825 million pounds, below market estimates of 868 million pounds.

Persons: Dado Ruvic, Eva Mathews, Subhranshu Sahu, Tomasz Janowski Organizations: GSK, GlaxoSmithKline, REUTERS, Thomson Locations: United States, Bengaluru

A nurse fills a syringe with malaria vaccine before administering it to an infant at the Lumumba Sub-County hospital in Kisumu, Kenya, July 1, 2022. REUTERS/Baz Ratner/File photo Acquire Licensing RightsGENEVA, Oct 2 (Reuters) - The World Health Organization (WHO) recommended on Monday the use of a second malaria vaccine to curb the life-threatening disease spread to humans by some mosquitoes. recommended the broad use of the world's first malaria vaccine called RTS,S," WHO chief Tedros Adhanom Ghebreyesus told a briefing in Geneva. "Today, it gives me great pleasure to announce that WHO is recommending a second vaccine called R21/Matrix-M to prevent malaria in children at risk of the disease." "GSK has always recognised the need for a second malaria vaccine, but it is increasingly evident that RTS,S, the first ever malaria vaccine and the first ever vaccine against a human parasite, set a strong benchmark," GSK said in a statement.

Persons: Baz Ratner, Tedros Adhanom Ghebreyesus, Tedros, Poonawalla, Takeda, Hanna Nohynek, Gabrielle Tétrault, Farber, Leroy Leo, Gareth Jones, Mark Potter Organizations: Lumumba, REUTERS, Rights, World Health Organization, WHO, Britain's University of Oxford, UNICEF, Serum Institute of India, Reuters, GSK plc, United Nations, GSK, Takeda Pharmaceuticals, Thomson Locations: Kisumu, Kenya, Geneva, Ghana, Malawi, Bengaluru

☆ US CDC panel weighs use of Pfizer's maternal RSV vaccine to protect infants
▼ + stars: | 2023-09-22 | by ( ) www.reuters.com time to read: +2 min

[1/3] A child suffering from an RSV infection at the pediatric intensive care unit at the Asklepios Clinic in Sankt Augustin, Germany, December, 6, 2022. RSV is a common respiratory virus that usually causes mild, cold-like symptoms but can also lead to serious illness and hospitalization. It is typically a seasonal illness, starting in the autumn and peaking in the winter in most of the U.S., according to the CDC. An estimated 58,000 to 80,000 children below the age of five years are hospitalized every year due to RSV infection in the U.S., according to government data. However, the agency said the difference did not appear to be statistically significant, thus might have been due to chance.

Persons: Benjamin Westhoff, Sriparna Roy, Bill Berkrot Organizations: Asklepios, REUTERS, Pfizer, GSK, U.S . Centers for Disease Control, Prevention, U.S . Food, Drug Administration, CDC, FDA, Thomson Locations: Sankt Augustin, Germany, U.S, Bengaluru

☆ Vir Biotech slumps to over 3-year low as flu prevention therapy fails trial
▼ + stars: | 2023-07-20 | by ( ) www.reuters.com time to read: +1 min

July 20 (Reuters) - Vir Biotechnology's (VIR.O) shares plunged 45% to a more than three-year low on Thursday after the company's experimental antibody therapy to prevent a type of flu failed to meet its goals in a mid-stage trial. The biotechnology firm, which came into prominence through its COVID-19 antibody therapy sotrovimab developed in partnership with GSK plc (GSK.L), lost over $1 billion in market capitalization in early trade hit by the therapy's failure. The company said it will conduct further analyses on the trial data to "better understand these outcomes", but TD Cowen analyst Phil Nadeau does not expect the therapy to undergo further development. The company is developing antibody therapies against hepatitis B and D, for which data is expected later this year, and also has development programs for COVID-19, HIV and influenza. Reporting by Leroy Leo in Bengaluru; Editing by Shailesh KuberOur Standards: The Thomson Reuters Trust Principles.

Persons: Vir Biotechnology's, sotrovimab, Cowen, Phil Nadeau, Nadeau, Leroy Leo, Shailesh Organizations: GSK plc, COVID, Alnylam Pharmaceuticals, Vertex Pharmaceuticals, Thomson Locations: Bengaluru

The STOXX 600 (.STOXX) index closed 0.3% lower after data showed euro zone business growth stalled this month as the downturn in manufacturing deepened. "A hike was fully expected, but the magnitude of the rise surprised most," said RBC Brewin Dolphin’s head of asset allocation, Paul Danis. Germany's DAX index (.GDAXI) shed 1.0%, leading losses among regional peers as shares of Siemens Energy (ENR1n.DE) sank 37.3%. DATA DIGESTWhile euro zone business growth stalled in June, a separate reading showed German business activity slowed notably this month. French business activity contracted this month for the first time in five months, data showed.

Persons: Germany's DAX, Paul Danis, DAX, Clemente De Lucia, Shreyashi Sanyal, Bansari, Eileen Soreng, Jonathan Oatis Organizations: Siemens Energy, GSK, Bank of England, Norges Bank, Swiss National Bank, Investors, RBC, Bank, Siemens, Deutsche Bank Research, Thomson Locations: U.S, Stockholm, Helsinki, Bengaluru

CompaniesCompanies Law Firms Pfizer Inc FollowSanofi SA FollowJune 23 (Reuters) - GSK (GSK.L) reached a settlement with a U.S. citizen who alleged its discontinued heartburn drug Zantac caused cancer, the British pharmaceutical giant said on Friday, preventing the first such lawsuit from going to trial. The case, brought by California resident James Goetz in Alameda County Superior Court, was to go to trial on July 24 and would have been the first test of how Zantac cancer claims fared before a jury. The parties reached a confidential settlement and the trial will be dismissed, GSK said. Originally marketed by a forerunner of GSK Plc, Zantac was later sold successively to Pfizer (PFE.N), Boehringer Ingelheim and finally Sanofi (SASY.PA). Last month, a Canadian court dismissed a proposed class action against Zantac over increased cancer risk.

Persons: James Goetz, Zantac, Boehringer Ingelheim, GSK's, Eva Mathews, Dhanya Ann Thoppil, Barbara Lewis Organizations: Law, Pfizer, Sanofi, GSK, Alameda County Superior Court, GSK Plc, U.S . Food, Drug Administration, Thomson Locations: California, Alameda County, U.S, Zantac, Bengaluru

☆ GSK says FDA extends review period for experimental drug momelotinib
▼ + stars: | 2023-06-16 | by ( ) www.reuters.com time to read: 1 min

June 16 (Reuters) - British drugmaker GSK Plc (GSK.L) on Friday said the U.S. Food and Drug Administration has extended the review period for its experimental drug momelotinib, which is designed to treat anaemic patients with a type of bone marrow cancer called myelofibrosis. Momelotinib is not currently approved in any market. Reporting by Eva Mathews in Bengaluru; Editing by Dhanya Ann ThoppilOur Standards: The Thomson Reuters Trust Principles.

Persons: Momelotinib, Eva Mathews, Dhanya Ann Thoppil Organizations: drugmaker GSK, U.S . Food, Drug Administration, Thomson Locations: U.S, Bengaluru

☆ GSK's cancer drug Jemperli gets file acceptance from US FDA
▼ + stars: | 2023-06-06 | by ( ) www.reuters.com time to read: 1 min

[1/2] GSK (GlaxoSmithKline) logo is seen in this illustration, August 10, 2022. REUTERS/Dado Ruvic/IllustrationCompanies GSK plc FollowJune 6 (Reuters) - GSK (GSK.L) said on Tuesday that the U.S. Food and Drug Administration had granted file acceptance for its cancer drug, Jemperli, when combined with chemotherapy to treat adult patients with certain types of endometrial cancer. (The story has been refiled to change the image)Reporting by Radhika Anilkumar in Bengaluru; Editing by Savio D'SouzaOur Standards: The Thomson Reuters Trust Principles.

Persons: Dado Ruvic, Radhika Anilkumar, Savio D'Souza Organizations: GSK, GlaxoSmithKline, REUTERS, U.S . Food, Drug Administration, Thomson Locations: U.S, Bengaluru

Neuralink's valuation jump in secondary trades is in sharp contrast to other startups. About 85% of pre-IPO companies are currently valued in secondary trades at an average discount of 47% to their last funding round, according to data provider Caplight. The maximum amount sought for the Neuralink shares marketed for sale at a $7 billion valuation was just $500,000, according to the email seen by Reuters. Sim Desai, chief executive of Hiive, an online platform where the shares are traded, said demand for Neuralink stock has been "tremendous." Neuralink stock that some of the employees hold has jumped around 150% in value in just two years, based on the secondary trades.

Persons: Elon, Kip Ludwig, Musk, Neuralink, Sim Desai, Arun Sridhar, Sridhar, Galvani, Rachael Levy, Marissa Taylor, Krystal Hu, Greg Roumeliotis, David Gregorio Our Organizations: U.S . National Institutes of Health, Reuters, U.S . Food, GSK Plc, Sciences, FDA, U.S . Department of Agriculture, Department of Transportation, Thomson Locations: Neuralink's, U.S, Washington ,, New York

☆ Musk's Neuralink valued at about $5 billion despite long road to market: Reuters
▼ + stars: | 2023-06-05 | by ( ) www.cnbc.com time to read: +4 min

Such so-called secondary trades are an imperfect gauge of a company's value; their volume is thin and they lack the wider market consensus of a fundraising round or initial public offering (IPO). About 85% of pre-IPO companies are currently valued in secondary trades at an average discount of 47% to their last funding round, according to data provider Caplight. In Neuralink's last known fundraising in 2021, it raised $205 million at an approximately $2 billion valuation, according to data provider Pitchbook. The maximum amount sought for the Neuralink shares marketed for sale at a $7 billion valuation was just $500,000, according to the email seen by Reuters. Sim Desai, chief executive of Hiive, an online platform where the shares are traded, said demand for Neuralink stock has been "tremendous."

Persons: Elon, Kip Ludwig, Musk, Neuralink, Sim Desai, Arun Sridhar, Sridhar, Galvani Organizations: U.S . National Institutes of Health, Reuters, U.S . Food, GSK Plc, Sciences Locations: Neuralink's, U.S

☆ Cramer's Lightning Round: I am not a believer in Coinbase
▼ + stars: | 2023-05-15 | by ( Julie Coleman | ) www.cnbc.com time to read: +2 min

Stock Chart Icon Stock chart icon Chewy's year-to-date stock performance. Stock Chart Icon Stock chart icon Enterprise Products Partners year-to-date stock performance. Stock Chart Icon Stock chart icon Coinbase Global's year-to-date stock performance. Stock Chart Icon Stock chart icon Amgen's year-to-date stock performance. Stock Chart Icon Stock chart icon Snowflake's year-to-date stock performance.

☆ 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.

☆ US FDA panel backs restricted use of AstraZeneca's prostrate cancer drug
▼ + stars: | 2023-04-28 | by ( ) www.reuters.com time to read: +2 min

April 28 (Reuters) - A panel of U.S. Food and Drug Administration advisers on Friday voted for the restricted use of British drugmaker AztraZeneca Plc's (AZN.L) experimental treatment, jointly developed with Merck & Co (MRK.N), for a type of prostate cancer. The FDA panel voted 11-1 with one abstention, in favor of Lynparza, in combination with other medications – abiraterone and prednisone or prednisolone – as a first-line treatment for a type of treatment-resistant prostate cancer in adult patients. They were withdrawn last year as second line of treatment for ovarian cancer patients after the FDA limited the use of PARP inhibitors and requested companies to pull the drug. Lynparza is already approved by the FDA to treat a type of breast cancer, ovarian cancer, as well as a different form of prostate cancer. Prostate cancer is the most common form of cancer among men in the United States with about 288,300 new cases in 2023, according to the American Cancer Society's estimates.

Companies GSK plc FollowLONDON, April 26 (Reuters) - British drugmaker GSK on Wednesday warned that the overhaul of laws governing the EU's pharmaceuticals industry risks forcing companies to invest and innovate elsewhere, which would hurt EU efforts to improve access to medicines. The European Commission will publish its long-awaited draft on Wednesday, detailing the biggest overhaul of medical laws in 20 years. The Commission has said the reforms aim to tackle unequal access to medicines across Europe while retaining the region's competitiveness for pharma companies developing and bringing new treatments to market. However, pressure to weaken market exclusivity protections could discourage companies from researching and launching treatments in Europe, she added. Reporting by Maggie Fick and Natalie Grover Editing by David GoodmanOur Standards: The Thomson Reuters Trust Principles.

LONDON, April 21 (Reuters) - African countries are lining up to approve a new vaccine for malaria, with 20 million doses available for them to buy this year, the shot’s manufacturer told Reuters. African countries that do not have extensive resources for drug regulation have previously relied on the U.N. agency to initially review new medicines. "We expect many more countries to come through," Mary Hamel, the WHO's malaria vaccine implementation head, told the expert meeting on Tuesday. “We are committed to making the R21 vaccine available to people who need it most,” Poonawalla said. FUNDING DOUBTSThe moves are a further sign that African countries want to exert their own pharmaceutical oversight after COVID-19 exposed inequity in vaccine supply.

Oxford scientist Adrian Hill said Ghana's drug regulator has approved the vaccine domestically for the age group at highest risk of death from malaria - children aged 5 months to 36 months. Oxford has a deal with Serum Institute of India to produce up to 200 million doses of the vaccine - known as R21 - annually. "This shows how close the world is to having a second approved vaccine to fight malaria," he said. MEETING THE NEEDThe first malaria vaccine, Mosquirix from British drugmaker GSK (GSK.L), was endorsed by the WHO last year after decades of work. Since it began in 2019, 1.2 million children across the three countries have received at least one dose of the Mosquirix vaccine.

☆ RSV cases in US show signs of return to pre-pandemic seasonality - CDC
▼ + stars: | 2023-04-06 | by ( ) www.reuters.com time to read: +2 min

April 6 (Reuters) - Respiratory syncytial virus (RSV) circulation is showing signs of return to pre-pandemic seasonality in the U.S. after two years of irregular onsets and peaks, the Centers for Disease Control and Prevention (CDC) said on Thursday. Typically, cases of RSV virus that can cause severe illness or death in the very young and old rose in October before waning in April. The varying timing could be challenging for drugmakers racing to get their RSV vaccines to the market. In both pre-pandemic and pandemic periods, RSV cases began to surge earlier in Florida and the Southeast and later in regions further north and west, the researchers said. "Policy makers should consider RSV seasonality when making recommendations about the timing of studies and administration of new immunization and other RSV prevention products," the report said.

March 30 (Reuters) - A federal judge in Texas on Thursday blocked Obamacare's mandate that health insurance plans cover pre-exposure prophylaxis against HIV (PrEP) and other preventive care including cancer and diabetes screenings. U.S. District Judge Reed O'Connor in Fort Worth, Texas, said the PrEP mandate violated a federal religious freedom law and that the other preventive care mandates were based on recommendations by an illegally appointed task force. The ruling was a victory for conservative businesses and individuals that sued to challenge the mandates in 2020. The U.S. Department of Health and Human Services, which oversees Obamacare, did not immediately respond to a request for comment. Reporting By Brendan Pierson in New York; Editing by Mark PorterOur Standards: The Thomson Reuters Trust Principles.

☆ Companies Urged to Take Stock of Their Impact on Nature and Related Risks
▼ + stars: | 2023-03-28 | by ( Joshua Kirby | ) www.wsj.com time to read: +5 min

“We used to think of nature as an endless supplier of resources into our business practices,” he said. “We’re trying to shift the conversation around the nature of the relationship between nature and business.”The final framework should give priority to the end result in natural areas, said Kat Bruce, founder and director of environmental-DNA startup NatureMetrics. Some $44 trillion of global economic value is moderately or highly dependent on nature, according to the World Economic Forum. Companies and shareholders should pay more attention to the material risk of natural degradation, Mr. Goldner said. The draft framework includes sector-specific guidance for areas including agriculture, mining, energy and financial services.

The trial will be the first test of how Zantac cancer claims will fare before a jury. GSK said in a statement it disagreed with the ruling and would defend the case at trial. Originally marketed by a forerunner of GSK, it was later sold successively to Pfizer (PFE.N), Boehringer Ingelheim and finally Sanofi (SASY.PA). While NDMA is found in low levels in food and water, it is known to cause cancer in larger amounts. Analysts said it was not surprising that Grillo ruled differently from the federal court because California's courts are known to be friendlier to plaintiffs.

☆ Vaccine makers prep bird flu shot for humans 'just in case'; rich nations lock in supplies
▼ + stars: | 2023-03-20 | by ( Jennifer Rigby | Thomson Reuters | Jen Reports On Health Issues Affecting People Around The World | ) www.reuters.com time to read: +5 min

There has also been a push among companies to develop a bird flu vaccine for poultry, a market potentially far larger than that for humans. Many countries' pandemic plans say flu shots should go first to the most vulnerable while supply is limited. The agreements include six of the largest seasonal flu manufacturers, such as GSK, Sanofi and CSL Seqirus, the WHO said. NEW APPROACHESIn a pandemic, vaccine manufacturers would shift production of seasonal flu vaccines and instead make shots tailored to the new outbreak when needed. The results will be closely watched, as the data on Moderna’s seasonal flu candidate was mixed.

The panelists seemed significantly more confident about the demographic profile used during the GSK study in comparison to Pfizer's (PFE.N) RSV vaccine, which was recommended by the FDA panel on Tuesday. Pfizer and GSK are running a tight race to tap into the RSV vaccine market, which is estimated to be over $5 billion and could exceed $10 billion by 2030, according to analysts. There is currently no approved vaccine to prevent lower respiratory tract disease caused by RSV in older adults, which causes death of 14,000 adults aged 65 and older annually in the United States. In October, late-stage data of GSK's RSV vaccine showed it to be 82.6% effective in preventing lower respiratory tract disease in people aged 60 and over, while Pfizer's vaccine was 66.7% effective. If approved, we estimate peak sales for GSK vaccine to be about $2.8 billion globally, said Evan Wang, Guggenheim Securities analyst, ahead of the panel vote.

☆ FDA advisory panel votes in favor of adult RSV vaccine from GSK PLC
▼ + stars: | 2023-03-01 | by ( ) www.cnbc.com time to read: 1 min

Share Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailFDA advisory panel votes in favor of adult RSV vaccine from GSK PLCCNBC's Meg Tirrell joins 'Power Lunch' to discuss GSK PLC's RSV vaccine receiving FDA support, ongoing questions around the drug's approval and the timeline for the drug to be available for children.

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