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Evening Standard
a day ago
- Business
- Evening Standard
UK stock markets rise with trading steady while US tariffs ‘in limbo'
The biggest risers on the FTSE 100 were M&G, up 12.3p to 236.7p, GSK, up 51p to 1,507p, BT, up 5.5p to 179.45p, AstraZeneca, up 322p to 10,720p, and Unite Group, up 21.5p to 861p.
Daily Maverick
a day ago
- Health
- Daily Maverick
Understanding shingles: Risks, vaccination gaps, and the quest for better health solutions
The only shingles vaccine on the market in South Africa was discontinued in 2024. A newer and better vaccine is being used in some other countries, but has not yet been registered in South Africa, though it can be obtained by those with money who are willing to jump through some hoops. Shingles is a common and painful condition that mostly affects the elderly and people with weakened immune systems. It generally appears with a telltale red rash and cluster of red blisters on one side of the body, often in a band-like pattern. 'Shingles is pretty awful to get – it's extremely painful, and some people can get strokes, vision loss, deafness and other horrible manifestations as complications,' said infectious disease specialist, Professor Jeremy Nel. 'Shingles really is something to avoid, if at all possible.' One way to prevent the viral infection is to get vaccinated. But while two vaccines against shingles have been developed and broadly used in the developed world, neither is available in South Africa. Two vaccines Zostavax, from the pharmaceutical company MSD, was the first vaccine introduced to prevent shingles. It was approved for use in the US in 2006 and in South Africa in 2011. It is 51% effective against shingles in adults over 60. A more effective vaccine, Shingrix, which is more than 90% effective in preventing shingles, was introduced by GlaxoSmithKline (GSK) in the US in 2016. It is not yet authorised for use in South Africa, but GSK has submitted paperwork for approval with the South African Health Products Regulatory Authority (Sahpra), said company spokesperson Kamil Saytkulov. The superior protection offered by Shingrix compared with Zostavax quickly made it the dominant shingles vaccine on the market. As a result, MSD discontinued the production and marketing of Zostavax. MSD spokesperson Cheryl Reddy said Zostavax was discontinued globally in March 2024. Before then, the vaccine was sold in South Africa's private healthcare system for about R2,300, but it was never widely available in government clinics or hospitals. No registered and available vaccine Since Zostavax has been discontinued and Shingrix remains unregistered, the only way to access a vaccine against shingles in South Africa is by going through the onerous process of applying to Sahpra for a Section 21 authorisation – a legal mechanism that allows the importation of unregistered medicines when there is an unmet medical need. 'Access will only be available to those who are able to get Section 21 approval' and 'this is a costly and time-consuming process, requiring motivation by a doctor,' said Dr Leon Geffen, director of the Samson Institute for Ageing Research. The cost of the two-dose Shingrix vaccine imported through Section 21 authorisations is currently about R15,600, said Dr Albie de Frey, CEO of the Travel Doctor Corporate. People who seek Section 21 authorisation typically have to pay for this out of their own pockets. 'Shingrix is not covered [by Discovery Health] as it is unregistered in South Africa and is therefore considered to be a General Scheme Exclusion,' Dr Noluthando Nematswerani, chief clinical officer at Discovery Health, told Spotlight. The Department of Health did not respond to queries about whether Section 21 processes are being pursued for priority patients in the public sector or whether there has been any engagement with GSK on the price of this product. People who receive organ transplants, for example, should be prioritised to receive the shingles vaccine since the medications they are given to suppress their immune system puts them at high risk of developing shingles. Why is the price of Shingrix so high? Unlike South Africa, where companies must sell pharmaceutical products at a single, transparent price in the private sector, the US has no such requirement. Even so, the US Centers for Disease Control and Prevention (CDC) pays $250 (R4,600) for the two-dose Shingrix vaccine through CDC contracts. This is less than a third of the charge when Shingrix is imported to South Africa. Equity Pharmaceuticals, based in Centurion, Gauteng, is importing GSK's Shingrix for patients who receive Section 21 authorisations to use the unregistered vaccine. It is unclear what price Equity Pharmaceuticals is paying GSK for Shingrix to be imported under Section 21 approvals, or what its mark-up on the medicine is. Asked about the price of Shingrix in South Africa, Saytkulov told Spotlight: 'Equity Pharmaceuticals is not affiliated with GSK, nor is it a business partner or agent of GSK. Therefore we cannot provide any comments with regards to pricing of a non-licensed product, which has been authorised for importation through Section 21.' Equity Pharmaceuticals also said it was difficult to comment on the price. 'The price of a Section 21 product depends on a number of fair considerations, including the forex rate, the quantity, transportation requirements, and the country of importation. Once the price and lead time are defined for an order, the information is shared with the healthcare provider to discuss with their patient and the medical aid,' the company's spokesperson, Carel Bouwer, said. Nematswerani pointed out that 'Section 21 pricing is not regulated' and that the price can change due to many factors including supplier costs, product availability and inflation. What causes shingles? Shingles is caused by the same highly infectious virus that causes chickenpox. Most people are infected with the varicella-zoster virus (VZV) during childhood. Chickenpox occurs when a person is first infected by VZV. When a person recovers from chickenpox, the VZV virus remains dormant in their body but can reactivate later in life as the immune system weakens. This secondary infection that occurs, typically in old age when the dormant virus reactivates, is called shingles. People who were naturally infected with chickenpox, as well as those vaccinated against chickenpox with a vaccine containing a weakened form of the VZV virus, can get shingles later in life. But, people who were vaccinated against chickenpox have a significantly lower risk of developing shingles later in life compared with those who naturally contracted chickenpox, according to the World Health Organization (WHO). The chickenpox vaccine is available in South Africa's private sector but is not provided in the public sector as part of the government's expanded programme on immunisation. Chickenpox is usually mild in most children, but those with weakened immune systems at risk of severe or complicated chickenpox should be vaccinated against it, said Professor James Nuttall, a paediatric infectious diseases sub-specialist at the Red Cross War Memorial Children's Hospital and the University of Cape Town. Who should be vaccinated against shingles? South Africa does not have guidelines for who should receive the shingles vaccine and when. The US CDC recommends that all adults older than 50 receive the two-dose Shingrix vaccine. It also recommends that people whose immune systems can't defend their body as effectively as they should, like those living with HIV, should get the vaccine starting from age 19. While Shingrix works better than Zostavax at preventing shingles, it has other advantages that make it a safer and better option for people with weak immune systems. The Zostavax vaccine contains a weakened live form of the VZV virus and thus poses a risk of complications in people with severely weakened immune systems. 'In the profoundly immunosuppressed, the immune system might not control the replication of this weakened virus,' explained Nel. The Shingrix vaccine does not contain any live virus and therefore does not present this risk. In March 2025, the WHO recommended that countries where shingles is an important public health problem consider the two-dose shingles vaccine for older adults and people with chronic conditions. '[T]he vaccine is highly effective and licensed for adults aged 50 and older, even if they've had shingles before,' according to the WHO. It advised countries to weigh up how much the vaccine costs with the benefits before deciding to use it. The cost of not vaccinating against shingles The cost of not vaccinating against shingles is high for people who develop the condition, as well as the health system. '[T]he risk of getting shingles in your lifetime is about 20 to 30%… by the age of 80 years, the prevalence is almost 50%,' said Geffen. 'Shingles is often a painful, debilitating condition, with significant morbidity. It can result in chronic debilitating pain which affects sleep, mood and overall function,' he added. Beyond preventing shingles and its complications, new evidence suggests that getting the vaccine may also reduce the risk of developing dementia and heart disease. In April, a large Welsh study published in Nature reported that people who received the Zostavax vaccine against shingles were 20% less likely to develop dementia seven years after receiving it compared with those who were not vaccinated. In May, a South Korean study published in the European Heart Journal reported that people vaccinated against shingles had a 23% lower risk of cardiovascular events, such as stroke or heart disease, for up to eight years after vaccination. DM
Reuters
a day ago
- Business
- Reuters
Regeneron shares slide on mixed trial data on smoker's lung drug
May 30 (Reuters) - Regeneron (REGN.O), opens new tab shares fell nearly 13% before the bell on Friday after its experimental drug for patients with a type of lung condition commonly called "smoker's lung" failed a late-stage trial, although it succeeded in another. Regeneron and partner Sanofi ( opens new tab were studying the potential blockbuster drug, itepekimab, as a treatment for chronic obstructive pulmonary disease (COPD) in adult former smokers. The condition has limited treatment options and the drug was expected to target a broader patient population compared to Regeneron and Sanofi's blockbuster Dupixent, which is also approved for the condition. But after Friday's data, Barclays analyst Emily Field said Dupixent is likely to remain the first choice for doctors. GSK's (GSK.L), opens new tab Nucala, approved recently for COPD, is also a blockbuster drug. Nearly 16 million U.S. adults suffer from COPD, according to government data. Regeneron's shares, which have already fallen 15% this year, were trading at $530 in premarket trading. The company has a market capitalization of $65.36 billion. The company's itepekimab showed a significant reduction in exacerbations or flare-ups in the condition by 27% compared to placebo at 52 weeks in a 1,127-patient study. But the second study - which had enrolled fewer former smokers compared to the first - did not meet its goal although a benefit was seen earlier in the trial. The experimental drug, which is being jointly developed by Regeneron and Sanofi, binds to and inhibits interleukin-33, a type of protein that causes inflammation in COPD. COPD is a common lung disease causing restricted airflow and breathing problems. It typically affects smokers, but can also be caused by pollutants. Sanofi and Regeneron are assessing the data and will discuss with regulatory authorities to evaluate their next steps, the companies said. Regeneron's price to earnings ratio, a common benchmark for valuing stocks, was 16.15, compared with 13.62 for Gilead (GILD.O), opens new tab and 7.29 for Bristol Myers Squibb (BMY.N), opens new tab.
Yahoo
2 days ago
- Business
- Yahoo
SPRO Stock Soars 245% on GSK-Partnered UTI Drug Meeting Study Goal
Shares of Spero Therapeutics SPRO more than tripled in market value yesterday after a phase III study evaluating its investigational oral antibiotic for complicated urinary tract infections (cUTIs) was stopped early due to efficacy. The drug, called tebipenem HBr, is being developed in partnership with GSK plc GSK. This late-stage study, called PIVOT-PO, enrolled hospitalized adult patients with cUTIs, including pyelonephritis (a type of kidney infection). The decision to stop the study early was made following a recommendation from an independent committee, which found that the study met its primary endpoint of non-inferiority. In other words, treatment with tebipenem was as effective as intravenously (IV) administered antibiotic imipenem-cilastatin, a commonly prescribed treatment for cUTIs. These findings are based on an interim analysis of data from 1,690 patients enrolled in the study. Based on the positive results, Spero's partner, GSK, plans to submit a regulatory filing seeking approval for the drug with the FDA later this year. Full data from the PIVOT-PO study will be presented at a future medical meeting. Per Spero, around 2.9 million cases of cUTIs are treated annually in the United States alone. The current standard of care for cUTIs typically involves IV antibiotics, which require hospital administration. If approved, tebipenem HBr will be the first oral carbapenem antibiotic for cUTIs. An effective oral alternative would represent a major shift in the treatment paradigm, potentially reducing hospital stays, lowering costs and improving patient convenience. Year to date, shares of Spero have skyrocketed 128% against the industry's 5% decline. Image Source: Zacks Investment Research Tebipenem is being developed as part of a licensing agreement between Spero Therapeutics and GSK, signed in 2022. Per the terms, Spero is responsible for certain development work, including the PIVOT-PO study, while GSK holds exclusive rights to market the drug globally, except in certain Asian territories. The drug has also been granted Qualified Infectious Disease Product (QIDP) and Fast Track designations from the FDA, which are intended to expedite development and review. QIDP status provides priority review and five additional years of market exclusivity upon approval, whereas Fast Track allows for more frequent FDA interaction and rolling submissions. Notably, this is the second anti-infective program stopped early by GSK due to efficacy. Like tebipenem, GSK had also stopped the late-stage EAGLE 2 and 3 studies, which evaluated Blujepa (gepotidacin), an oral antibiotic for treating uncomplicated urinary tract infections (uUTIs). This drug was recently approved by the FDA for uUTIs. Spero currently carries a Zacks Rank #4 (Sell). Spero Therapeutics, Inc. price | Spero Therapeutics, Inc. Quote A couple of better-ranked stocks from the industry are Adaptive Biotechnologies ADPT and Agenus AGEN, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. In the past 60 days, estimates for Adaptive Biotechnologies' 2025 loss per share have improved from 92 to 87 cents. During the same timeframe, estimates for 2026 loss per share have narrowed from 69 to 65 cents. Adaptive Biotechnologies' earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 21.38%. Shares of ADPT have surged 53% year to date. Agenus' loss per share estimate for 2025 has narrowed from $6.43 to $2.78 over the past 60 days, and the same for 2026 has improved from $6.57 to $5.26 during the same period. Agenus' earnings beat estimates in two of the trailing four quarters and missed the mark on the other two occasions, delivering an average negative surprise of 22.71%. Year to date, its shares have gained 10%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report GSK PLC Sponsored ADR (GSK) : Free Stock Analysis Report Agenus Inc. (AGEN) : Free Stock Analysis Report Adaptive Biotechnologies Corporation (ADPT) : Free Stock Analysis Report Spero Therapeutics, Inc. (SPRO) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Error while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
Yahoo
3 days ago
- Business
- Yahoo
Scynexis resumes dosing in Phase III MARIO study after lengthy delay
Scynexis has resumed dosing of its vaginal yeast infection drug Brexafemme (ibrexafungerp) in a Phase III trial after a 19-month clinical hold by the US Food and Drug Administration (FDA). The resumption of dosing in the MARIO study (NCT05178862) comes after the FDA lifted the clinical hold last month, originally in place due to concerns about cross-contamination. Scynexis said the investigational sites were reactivated a few days ago, as per a 28 May press release. The issue was highlighted after a review from GSK, which signed a licensing deal for the drug with Scynexis in 2023. The British big pharma noted that the manufacturing site for Brexafemme also produced a non-antibiotic beta-lactam substance. This drug, which can cause allergic reactions in some patients, has been the subject of an FDA draft guidance that details the separation of manufacturing processes for these compounds. In September 2023, Scynexis issued a voluntary recall of Brexafemme, an FDA-approved treatment for vulvovaginal candidiasis (VVC), due to the potential for cross-contamination. Scynexis said the study has resumed following the manufacture of new clinical supplies at another site. The Phase III MARIO study is investigating oral Brexafemme as a potential step-down antifungal therapy following intravenous (IV) echinocandin for invasive candidiasis, a potentially life-threatening infection. The trial has enrolled around 25% of its 220-patient target. 'We are pleased to announce the dosing of the first new patient in the Phase III MARIO study following the lifting of the clinical hold by the FDA in April,' said Scynexis CEO David Angulo. 'The rapid resumption of patient enrolment, just a few days after the investigational sites were reactivated in the study, reflects the eagerness of the scientific community to have new treatment options for this life-threatening infection.' MARIO being back on track comes amid a saga between Scynexis and GSK, with the companies pointing fingers at each other with regard to trial duties. During its Q1 earnings report, Scynexis said that GSK had tried to terminate the study, with Angulo affirming plans to move forward with Brexafemme in this new indication. There used to be substantial cash on the line. The partnership in 2023 included not just a $90m upfront payment, but up to $503m in milestone payments. However, after the commercial delays, millstone payments were cut in a revised deal in December 2023. Approval-based milestones were slashed from $70m to $49m, whilst commercial counterparts were halved from $115m to a potential $57.5m. Milestone payments based on sales were also downwardly revised. By dosing the first new patient, Scynexis believes it has now triggered a $10m payment, with another $20m to arrive by the six-month anniversary of dosing. 'As previously disclosed, there is a disagreement between Scynexis and GSK regarding the resumption of the MARIO Study and GSK's responsibility for paying these milestones. Scynexis is working to resolve the disagreement,' Scynexis said in a statement. GSK did not immediately respond to Clinical Trials Arena's request for comment. Scynexis reported $3.7m in revenue for 2024, which primarily consisted of the licence agreement with GSK. Brexafemme generated sales of $5m in 2022 before the recall. GlobalData's Pharma Intelligence Center forecasts global sales of $139m by 2031, a valuation that hinges on the outcome of the MARIO study and a subsequent label expansion. GlobalData is the parent company of Clinical Trials Arena. "Scynexis resumes dosing in Phase III MARIO study after lengthy delay" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
