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The pan-European STOXX 600 index (.STOXX) dipped 0.2%, reversing gains of some 0.4%, to kick off the first day of the second half of the year on the back foot. The broader healthcare index (.SXDP) fell 2.0%, leading falls among sectors. The moves helped Italy's financials-heavy benchmark FTSE MIB (.FTMIB) climb 0.8%, a bright spot among other bourses in the region. The broader STOXX 600 had gained 8.7% in the first half of the year, largely due to strong gains early into 2023. "A muted atmosphere prevails across stock markets this afternoon," said Chris Beauchamp, chief market analyst at online trading platform IG.

Persons: Assicurazioni, Delfin, Italy's, Chris Beauchamp, Amruta Khandekar, Shreyashi Sanyal, Matteo Allievi, Nivedita Bhattacharjee, Janane Venkatraman, Conor Humphries Organizations: Miners, AstraZeneca, Generali, British, MIB, European Central Bank, Thomson Locations: China, Bengaluru, Gdansk

July 3 (Reuters) - AstraZeneca (AZN.L) said on Monday an experimental precision drug slowed progression of lung cancer in a late-stage trial, but the company's shares fell as much as 6% as analysts said the benefits may not be as pronounced as hoped. It declined to provide more trial details, saying they would be presented at an as yet undisclosed medical conference. At 0855 GMT, shares in AstraZeneca were down 5.8% at their lowest level in more than three months. Gilead (GILD.O) has pioneered the targeting of TROP2 with an ADC named Trodelvy, approved to treat certain types of breast and bladder cancer. AstraZeneca said that the datopotamab deruxtecan trial would continue as planned to assess the effect of the drug on overall survival of patients, another important efficacy criterion.

Persons: datopotamab, AstraZeneca, British drugmaker, Kelun, Maggie Fick, Ludwig Burger, Sinchita Mitra, Lucy Raitano, Krishna Chandra Eluri, Susan Fenton Organizations: AstraZeneca, Japan's, Merck & Co, Biotech of, Barclays, Thomson Locations: British, Biotech of China, London, Frankfurt, 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

GSK on Friday said the settlement reflected its desire to avoid distraction related to protracted litigation in this case. It did not admit any liability and said it would vigorously defend itself in any other Zantac cases. The trial was due to start on July 24, the first test of how Zantac cancer claims would fare before a jury. Lucy Coutts, investment director at wealth management firm JM Finn, which holds GSK shares, said the Goetz settlement could create a precedent to settle other cases. "It also removes the distraction of any protracted litigation as the company must focus on its future pipeline which is where value will be created for shareholders," she said.

Persons: drugmaker, James Goetz, Emily Field, Lucy Coutts, JM Finn, Goetz, Dado Ruvic, Boehringer Ingelheim, Zantac, Natalie Grover, Eva Mathews, Dhanya Ann Thoppil, Barbara Lewis Organizations: GSK, Barclays, GlaxoSmithKline, REUTERS, Pfizer, Sanofi, Companies, Bank of America, FDA, Thomson Locations: U.S, British, California, Delaware, London, Bengaluru

☆ GSK's RSV vaccine shows long-term efficacy in late-stage trial
▼ + stars: | 2023-06-21 | by ( ) www.reuters.com time to read: +1 min

June 21 (Reuters) - GSK (GSK.L) on Wednesday said its vaccine for the respiratory syncytial virus (RSV), which recently won EU approval, showed strong long-term protection in older adults in a late-stage trial. The British drugmaker said a 'Phase III' trial showed vaccine efficacy against RSV-lower respiratory tract disease and severe disease over two full RSV seasons, including in participants with underlying medical conditions. GSK's shot, called Arexvy is designed to protect people aged 60 and over from RSV, which typically causes cold-like symptoms, but is a leading cause of pneumonia in toddlers and the elderly. European regulators approved the shot earlier this month for the disease which causes thousands of hospitalisations and deaths annually. Reporting by Eva Mathews in Bengaluru; Editing by Janane VenkatramanOur Standards: The Thomson Reuters Trust Principles.

Persons: British drugmaker, Eva Mathews, Janane Organizations: GSK, Thomson Locations: British, 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

June 7 (Reuters) - European regulators have approved the region's first vaccine for respiratory syncytial virus (RSV), which causes thousands of hospitalisations and deaths annually. The shot, called Arexvy, is made by British drugmaker GSK (GSK.L) and is designed to protect people aged 60 and over. The complex molecular structure of the virus and safety concerns with previous vaccine attempts had stymied efforts to successfully develop a shot since the virus was first discovered in 1956. Given the different definitions of the trial endpoints across the GSK and Pfizer trials, a direct comparison of efficacy is difficult. In Europe, RSV leads to over 270,000 hospitalisations and about 20,000 in-hospital deaths in adults over 60 each year.

Persons: Luke Miels, Peter Welford, TD Cowen, Steve Scala, Natalie Grover, Eva Mathews, Maggie Fick, Savio D'Souza, Mark Potter Organizations: GSK, European Commission, European Medicines Agency, Reuters, U.S . Food, Drug Administration, Pfizer, Jefferies, Thomson Locations: British, Europe, U.S, London, Bengaluru

☆ AstraZeneca to leave leading U.S. drug lobby group
▼ + stars: | 2023-05-16 | by ( Maggie Fick | ) www.reuters.com time to read: +1 min

LONDON, May 16 (Reuters) - AstraZeneca (AZN.L) has decided to leave the main U.S. drug lobby group, the Pharmaceutical Research and Manufacturers of America (PhRMA), and pursue other ways of engaging in advocacy at the state and federal level, the company said. AstraZeneca decided not to continue its membership after a recent assessment of whether it was "the most productive and effective use of (company) resources", a spokesperson for the British drugmaker said in an emailed statement. PhRMA said in a separate emailed statement that AstraZeneca had decided not to renew its membership for the second half of 2023. AstraZeneca's exit follows those of AbbVie, maker of blockbuster arthritis drug Humira, and Teva, a leading manufacturer of generic drugs. AstraZeneca will redirect the funds previously used on its PhRMA membership to continue U.S. advocacy efforts with state and federal policymakers, its statement read.

☆ 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.

☆ Sales, spins and splits — what are the differences and why do they matter for investors like us?
▼ + stars: | 2023-04-30 | by ( Kevin Stankiewicz | ) www.cnbc.com time to read: +20 min

Investors may get one share in the spun-out entity for every share of the parent company they owned. What's left of J & J will be focused on pharmaceuticals and medical technologies, which were responsible for over 84% of the company's total 2022 revenue of $94.94 billion. It underscores that once free of the parent company tethers a divested company can chart its own destiny. Those priorities may not have necessarily been wrong when considering J & J as the overall enterprise. We believe J & J and Danaher are poised to deliver two more examples.

☆ 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.

LONDON, April 26 (Reuters) - GSK (GSK.L) began 2023 with a quarterly performance that beat analyst expectations and extended a series of positive results following strong sales of its roster of vaccines as well as HIV and respiratory medicines. Investors are also concerned about the company's long-term prospects, given the pending loss of patent protection of one of GSK's HIV compounds and setbacks in its marketed oncology portfolio. GSK is also relying in part on its potential blockbuster vaccine for RSV, which leads to thousands of hospitalisations and deaths each year. It anticipates launching the vaccine later this year in the U.S. and Europe, pending regulatory approval, as does rival Pfizer (PFE.N). ($1 = 0.8039 pounds)Reporting by Maggie Fick and Natalie Grover in London, Editing by Louise HeavensOur Standards: The Thomson Reuters Trust Principles.

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.

☆ AstraZeneca confident new COVID antibody protects against known variants
▼ + stars: | 2023-04-18 | by ( Maggie Fick | ) www.reuters.com time to read: +2 min

REUTERS/ Albert GeaCompanies AstraZeneca PLC FollowBARCELONA, April 18 (Reuters) - AstraZeneca is confident that its new version of COVID-19 antibody treatment could protect immunocompromised patients against all known virus variants, its vaccines head said. AstraZeneca plans, pending more positive data and regulatory approval, to make the antibody available by the end of 2023. In January, the U.S. health regulator withdrew its emergency use authorization for AstraZeneca's original COVID-19 antibody cocktail Evusheld, as new dominant variants made it obsolete. AstraZeneca's AZD3152, it new COVID-19 antibody, was acquired through a $157 million deal last year with British biotech start-up RQ Bio. However, demand for COVID-19 vaccines have dramatically declined with competition from mRNA vaccines and given many countries already have an oversupply of COVID-19 shots.

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.

☆ GSK licenses companies to make cheap copies of HIV prevention drug
▼ + stars: | 2023-03-30 | by ( Maggie Fick | ) www.reuters.com time to read: +2 min

LONDON, March 30 (Reuters) - British drugmaker GSK (GSK.L) has signed deals with three companies allowing them to make inexpensive generic versions of its long-acting HIV preventive medicine for use in lower-income countries, where the majority of new HIV cases occur. The injected drug cabotegravir was approved by regulators in the United States in late 2021. Last July, GSK announced a program with the United Nations-backed healthcare organisation, the Medicines Patent Pool, aiming to get poor countries access to new HIV therapies far earlier than they did for previous HIV medicines. GSK said last year the new program could result in the generic form of its injection being available in lower-income countries beginning in 2026. The generic copies will be supplied in 90 countries, subject to regulatory approvals there, the statement said.

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.

☆ With positive combo meningococcal vaccine data, GSK eyes US approval
▼ + stars: | 2023-03-14 | by ( ) www.reuters.com time to read: +3 min

If approved, the combo vaccine could simplify the immunisation schedule in the United States and likely expand GSK's already dominant market share there for vaccines used to prevent illnesses caused by meningococcal bacteria. These responses were compared to participants who received GSK's approved vaccines, Bexsero and Menveo. In the United States, a four-shot regimen of Bexsero and Menveo is needed to protect against the five most common strains of meningococcal bacteria. There is no combination vaccine on the market - a gap GSK intends to fill with the new combination. GSK has the world's largest vaccine R&D department and has a broad portfolio of shots, including its blockbuster shingles vaccine Shingrix.

☆ Pfizer ready to launch RSV vaccines for older adults, pregnant women in US, Europe
▼ + stars: | 2023-03-09 | by ( Maggie Fick | ) www.reuters.com time to read: +2 min

PUURS, Belgium March 9 (Reuters) - U.S. drugmaker Pfizer (PFE.N) is ready to launch its respiratory syncytial virus (RSV) vaccine for both older adults and pregnant women in the U.S. and Europe later this year, executives said on Thursday. Both Pfizer and British drugmaker GSK (GSK.L) have RSV vaccines they hope to launch in the U.S. and Europe this year, pending regulators’ approval. “We are anticipating approval in both the U.S. and Europe in time for rollout in the fall,” Kena Swanson, Pfizer's head of viral vaccines research & development, told a media briefing at the company's biggest manufacturing and packaging site globally. GSK told Reuters on Wednesday that it is also ready to launch its RSV vaccine for older adults in the U.S. this year without supply constraints. GSK last year voluntarily stopped its clinical trial of its own RSV vaccine on pregnant women and is currently only pursuing the use of its vaccine on older adults, a company spokesperson told Reuters on Thursday.

☆ U.S. FDA panel to review expanded use of Merck-AstraZeneca's cancer drug
▼ + stars: | 2023-03-02 | by ( ) www.reuters.com time to read: +2 min

The U.S. Food and Drug Administration's (FDA) committee is scheduled to meet on April 28. The companies' are seeking approval of the drug Lynparza in combination with other medications – abiraterone and prednisone or prednisolone – for the treatment of a type of treatment-resistant prostate cancer in adult patients. Lynparza was approved in March last year by the FDA as a treatment for patients with early-stage breast cancer with certain mutations. The drug is also approved in the United States as a standalone treatment for another 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 of prostate cancer in 2023, according to the American Cancer Society’s estimates.

LONDON, March 2 (Reuters) - Haleon (HLN.L), the world's biggest standalone consumer health business with brands such as Sensodyne toothpaste and Advil painkillers, reported its first full-year results on Thursday which analysts said were in line with expectations. Analysts said on Thursday that Haleon has had a strong start to 2023, and its full-year revenue growth forecast of 4% to 6% was in line or just ahead of consensus estimates. Rivals with consumer health operations, such as Bayer (BAYGn.DE) and Reckitt (RKT.L), have charged higher prices to partly offset broader falls in sales volumes. "Our organic (full-year) revenue growth ... was well balanced between volume and price, with two thirds of the business gaining or holding share," McNamara said. Haleon, which is made up of assets previously owned by GSK and Pfizer (PFE.N) reported organic revenue growth of 9% last year, just ahead of the 8-8.5% increase it predicted for 2022.

REUTERS/Brendan McDermid/IllustrationFeb 16 (Reuters) - GSK Plc (GSK.L) is expected to urge a California judge on Thursday to limit what expert testimony jurors can hear in the first trial over claims that the company's heartburn drug Zantac caused cancer. The trial, scheduled to begin Feb. 27 before Alameda County Superior Court Judge Evelio Grillo, will offer the first test of how Zantac cancer claims may fare in state courts. The plaintiff in the upcoming trial, James Goetz, says he developed bladder cancer from taking Zantac sold by British drugmaker GSK. Lawsuits began piling up soon after the recalls began from people who said they developed cancer after taking Zantac. Cases have been filed linking Zantac to at least 10 types of cancer.

The company also predicted a return to growth in China, one of its key markets, after reporting a second consecutive quarter of growth even as prices remain under pressure. Sales of its best-selling cancer drugs — Tagrisso, Imfinzi and Lynparza — came in just below estimates from Cowen analysts. Sales started to pick up in the second half of 2022 and in the fourth quarter grew by 3% at constant currency rates. Of key interest to investors is the experimental cancer drug, datopotamab deruxtecan, being evaluated in a keenly anticipated late-stage trial involving lung cancer patients. Partner Daiichi Sankyo (4568.T) this month said results of that study have been delayed to the second quarter from the first quarter of 2023.

[1/2] The logo for AstraZeneca is seen outside its North America headquarters in Wilmington, Delaware, U.S., March 22, 2021. REUTERS/Rachel Wisniewski/Companies AstraZeneca PLC FollowLONDON, Feb 9 (Reuters) - Britain's business climate is deterring biopharma companies from investing in the country, AstraZeneca (AZN.L) chief Pascal Soriot said on Thursday, highlighting his company's decision to shift plans for a new manufacturing plant to Ireland. He highlighted AstraZeneca's recent decision to build a manufacturing facility in Ireland instead of the UK as evidence of Britain becoming less attractive for drugmakers. The decision, made in 2021, was also linked to the UK government's Voluntary Scheme for Branded Medicines Pricing and Access (VPAS), a company spokesperson added. Reporting by Natalie Grover and Maggie Fick Editing by Tomasz Janowski, Barbara Lewis and Susan FentonOur Standards: The Thomson Reuters Trust Principles.

☆ European shares hit fresh nine-month high on earnings boost
▼ + stars: | 2023-02-09 | by ( Ankika Biswas | ) www.reuters.com time to read: +3 min

The pan-European STOXX 600 (.STOXX) was up 0.8% at 0920 GMT, extending gains for a third straight session. Shares of Sweco AB (SWECb.ST), a Swedish construction and engineering company, jumped 11% to top the STOXX 600 following its upbeat fourth-quarter earnings. An over 5% gain in AstraZeneca (AZN.L) on 2023 earnings and revenue growth forecast boosted the healthcare sub-index (.SXDP). Of the 93 STOXX 600 companies that have reported earnings so far, more than half have beaten market expectations, Refinitiv data showed on Tuesday. Signs of economic resilience and better-than-feared corporate earnings have helped European stocks outperform their U.S. counterparts so far this year.

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