Latest news with #AstraZeneca
Medscape
14 minutes ago
- Health
- Medscape
BMJ Investigation Increases Concerns About Ticagrelor Trials
An investigation by The BMJ is raising fresh concerns about the clinical studies that supported the approval of the antiplatelet drug ticagrelor (Brilinta, AstraZeneca), almost 15 years after the medication was first approved and as generic versions are set to hit the market. Peter Doshi, PhD, a senior editor at The BMJ , previously reported inconsistencies and omissions in data reporting from the 2009 PLATO study, published in The New England Journal of Medicine , which showed ticagrelor was superior to clopidogrel in treating acute coronary syndrome. Now a follow-up investigation of two supporting studies published in Circulation , ONSET/OFFSET and RESPOND, has revealed primary endpoints were reported inaccurately, data were missing from the submission to the US Food and Drug Administration (FDA), and study centers may not have received adequate training. Doshi said the results of his investigations call into question the drug's approval and suggested that it should be revisited. 'The FDA's approval in 2011 went against the evidence according to its reviewers, and now, my investigations into PLATO, ONSET/OFFSET, and RESPOND, suggest that even the data presented to the FDA and reported in The New England Journal of Medicine and Circulation , is not trustworthy,' he told Medscape Medical News. The investigation identified several problems with data integrity in the two trials. The original primary endpoint results for RESPOND, which aimed to test whether ticagrelor could convert nonresponders to clopidogrel into responders, were statistically nonsignificant ( P = .157) but were subsequently reported in Circulation as significant ( P = .005) because of an undeclared change in its primary endpoint definition. For ONSET/OFFSET, which reported ticagrelor provided faster and greater inhibition of platelets than clopidogrel, the investigators now claim several patients were excluded from the analysis. However, those who remained were identified as the 'intention-to-treat' population, implying all patients were included. Implausible data points were also included in the analysis of the primary endpoint but were first transformed through an unpublished data analysis, Doshi claimed. Doshi also gained access to readouts from some of the platelet function test machines used in the trial. He found more than 60 of 282 readings were not present in the datasets submitted to the FDA, and the levels of platelet activity in those readings were significantly higher than those reported in Circulation . Victor Serebruany, MD, from Johns Hopkins University in Baltimore, and one of the more high-profile critics of ticagrelor, told The BMJ the missing readings show 'there are episodes of skyrocketing rebound and profound platelet inhibition after ticagrelor, making patients prone to thrombosis or bleeding. If doctors had known what happened in these trials, they would never have started using ticagrelor.' The investigation also revealed oddities around the authorship of the publications. One active trial investigator was never identified as a study author, while one author told The BMJ he was not involved in the trial. The BMJ states that AstraZeneca, the journal Circulation , and many of the original investigators either declined to comment on the new claims or were unreachable. Ticagrelor has been under fire since the beginning. The drug failed in its first bid for FDA approval and was the subject of an investigation by the US Department of Justice in 2013 at the urging of Serebruany. That investigation was closed in 2014 with no further action. A review of several major trials of ticagrelor by Eric Bates, MD, professor of internal medicine at the University of Michigan in Ann Arbor, Michigan, and a co-author of the US guidelines that recommend ticagrelor, concluded 'the clinical conventional wisdom and clinical trial guideline support for…ticagrelor compared with clopidogrel may be overemphasized.' Bates is now calling for a review of ticagrelor's recommendation in guidelines, according to the earlier The BMJ report.
Daily Mail
9 hours ago
- Health
- Daily Mail
Top medics issue urgent warning over heart drug taken by millions - as makers AstraZeneca are accused of 'misreporting' safety data
Millions of patients at high risk of a fatal heart attack could be taking a drug that may not even be effective, top doctors have warned. Anti-clotting pill ticagrelor was approved for use on the NHS in 2011 after trials claimed it could prevent one in five deaths after a heart attack. The twice-daily pill, sold as Brilinta, is given to people with acute coronary syndrome —a sudden reduction of blood to the heart—reducing the risk of deadly clots and strokes. Since then, studies have questioned if the AstraZeneca drug is as good as its rivals, such as clopidogrel, with some even suggesting it may even increase the risk of bleeding. Now, experts have discovered 'evidence of serious misreporting' in two clinical trials, pivotal to getting the drug approved in the UK and US, 'raising doubts over its approval'. The BMJ investigation claimed the 'primary endpoint' results—the key measure to determine whether a treatment is effective—for both trials were inaccurately reported in leading cardiology journal Circulation. It also said around a quarter of the readings from machines used in the trials were not included in the data sets, the US medicine's regulator, the Food and Drug Administration (FDA) used to approve the drug. Dr Victor Serebruany, an expert in cardiovascular pharmacology at Johns Hopkins University in Maryland, who has been critical of the drug for over a decade said: 'It's been obvious for years that there is something wrong with the data. Since then, studies have questioned if the AstraZeneca drug is as good as its rivals, such as clopidogrel, with some even suggesting it may even increase the risk of bleeding 'That the FDA 's leadership could look past all these problems—on top of the many problems their own reviewers identified and are now being discovered by The BMJ—is unconscionable. 'We all need to know how and why that happened. 'If doctors had known what happened in these trials, they would never have started using ticagrelor.' In order for ticagrelor to get approved, clinical trials had to prove that it was a better drug than competitors in a phase 3 trial. After phase 3 and drug approval, the FDA and MHRA in the UK, continues monitoring it in phase 4 trials, to see if there are any additional problems with the drug. But the BMJ analysis of two phase 2 trial results found there were instances of patients who's blood 'platelet aggregation dramatically increased'. This is where platelets—a type of blood cell—stick together to form clumps which can lead to blood clots, exactly what the drug aims to prevent. It 'suggests incorrect laboratory readings', the BMJ said. Assessing the readings from platelet machines used at the two trial sites, led by cardiologist Dr Paul Gurbel, they also found more than 60 of the 282 readings were not included in the datasets submitted to the FDA. 'The platelet activity levels not entered were significantly higher than those used in the Circulation papers and FDA datasets,' they claimed. 'It is unclear whose blood was sampled, and why those measurements did not contribute to data in either trial.' A spokesperson for the Sinai Center for Thrombosis Research and Drug Development, which Dr Gurbel leads, said: 'Any allegations of any research misconduct in the two studies are baseless and erroneous.' In the UK, the drug is prescribed around 45,000 times per month on the NHS. According to medicines watchdog the National Institute for Health and Care Excellence (NICE), patients are advised to take the drug twice a day at 90mg for around a year after a heart attack. A lower dose of 60mg, may then be prescribed by doctors for up to a further three years. It may also be taken by those who have suffered a minor stroke or a transient ischaemic attack at 90mg alongside aspirin. The body naturally forms blood clots in order to patch wounds and stop bleeding. But over time, things like age, smoking and excessive weight gain can make blood clots more common. These kinds of clots also become more common after someone has a heart attack or blood vessel disorder, coronary artery disease. When someone overproduces these clots they can clog blood vessels, interrupting blood flow or weakening the walls of blood vessels, causing aneurysms and heart attacks. Circulation and AstraZeneca did not respond to a request for comment from the BMJ. MailOnline has also approached AstraZeneca for comment.
Yahoo
12 hours ago
- Business
- Yahoo
IonQ (NYSE:IONQ) Announces Quantum Breakthrough in Protein Folding and Computation
IonQ recently announced a significant achievement with Kipu Quantum, solving the most complex protein folding problem on a quantum computer. This breakthrough likely contributed to the company's impressive 87% share price gain last quarter. The successful partnership with AstraZeneca and others to accelerate drug development, and collaborations with Toyota Tsusho and KISTI, bolster its global presence. Additionally, positive earnings projections and leadership changes further supported market confidence. While the broader market saw a modest yearly gain, IonQ's advancements in quantum computing positioned it to significantly outperform industry trends during the quarter. We've identified 5 warning signs for IonQ (1 is significant) that you should be aware of. AI is about to change healthcare. These 22 stocks are working on everything from early diagnostics to drug discovery. The best part - they are all under $10b in market cap - there's still time to get in early. Looking at the broader picture, investors in IonQ have seen extraordinary returns over a three-year period, with the company's total shareholder returns climbing by over 694%. This performance towers above the US Tech industry's past year return of -9% and the general US market, which returned 9.9% over the same period. Such a return underscores the market's current enthusiasm for IonQ's innovative breakthroughs in quantum computing, particularly its solutions like the recent protein folding achievements which hold great promise for drug discovery applications. The company's recent advancements and strategic partnerships suggest strong potential for future revenue growth, projected at 41% per year. However, IonQ remains unprofitable, with its Q1 earnings reflecting a net loss of US$32.25 million, and forecasts indicating ongoing losses in the upcoming years. Analyst consensus places a fair value target at US$43, slightly above the current share price, indicating a restrained outlook relative to recent market exuberance. Nevertheless, IonQ maintains a strong trajectory in revenue growth, supported by their global expansion and successful collaborations with industry giants like AstraZeneca, which could bolster its future market position. Upon reviewing our latest valuation report, IonQ's share price might be too optimistic. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include NYSE:IONQ. This article was originally published by Simply Wall St. Have feedback on this article? Concerned about the content? with us directly. Alternatively, email editorial-team@
Yahoo
15 hours ago
- Business
- Yahoo
IonQ (NYSE:IONQ) Announces Quantum Breakthrough in Protein Folding and Computation
IonQ recently announced a significant achievement with Kipu Quantum, solving the most complex protein folding problem on a quantum computer. This breakthrough likely contributed to the company's impressive 87% share price gain last quarter. The successful partnership with AstraZeneca and others to accelerate drug development, and collaborations with Toyota Tsusho and KISTI, bolster its global presence. Additionally, positive earnings projections and leadership changes further supported market confidence. While the broader market saw a modest yearly gain, IonQ's advancements in quantum computing positioned it to significantly outperform industry trends during the quarter. We've identified 5 warning signs for IonQ (1 is significant) that you should be aware of. AI is about to change healthcare. These 22 stocks are working on everything from early diagnostics to drug discovery. The best part - they are all under $10b in market cap - there's still time to get in early. Looking at the broader picture, investors in IonQ have seen extraordinary returns over a three-year period, with the company's total shareholder returns climbing by over 694%. This performance towers above the US Tech industry's past year return of -9% and the general US market, which returned 9.9% over the same period. Such a return underscores the market's current enthusiasm for IonQ's innovative breakthroughs in quantum computing, particularly its solutions like the recent protein folding achievements which hold great promise for drug discovery applications. The company's recent advancements and strategic partnerships suggest strong potential for future revenue growth, projected at 41% per year. However, IonQ remains unprofitable, with its Q1 earnings reflecting a net loss of US$32.25 million, and forecasts indicating ongoing losses in the upcoming years. Analyst consensus places a fair value target at US$43, slightly above the current share price, indicating a restrained outlook relative to recent market exuberance. Nevertheless, IonQ maintains a strong trajectory in revenue growth, supported by their global expansion and successful collaborations with industry giants like AstraZeneca, which could bolster its future market position. Upon reviewing our latest valuation report, IonQ's share price might be too optimistic. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include NYSE:IONQ. This article was originally published by Simply Wall St. Have feedback on this article? Concerned about the content? with us directly. Alternatively, email editorial-team@ Sign in to access your portfolio
Zawya
2 days ago
- Business
- Zawya
FTSE 100 rises after positive inflation data; focus on Fed, BoE meetings
Britain's FTSE 100 rose on Wednesday as investors weighed positive inflation data ahead of key central bank meetings in the U.S. and the UK, though Middle East tensions tempered market optimism. The blue-chip FTSE 100 index, with its exposure to oil stocks, rose 0.2% by 0930 GMT. The domestically focussed mid-cap index was unchanged. British inflation slowed in May, with services price inflation - a crucial metric for the Bank of England - cooling to 4.7% from 5.4% in April, matching the top bank's forecast for May. The central bank is slated to meet on Thursday and is widely expected to hold base rate. However, the inflation data has given it room to make further cuts. "Investors and homeowners will be looking hard at today's figures, trying to gauge whether what feels like a stabilising inflationary environment will give the Monetary Policy Committee room to make a further cut to interest rates," said Nick Saunders, CEO of investment platform Webull. "It feels too early, but the tranquil waters give hope for optimism. Certainly, the voting split will be scrutinised hard." The conflict between Iran and Israel entered its sixth day, with increasing concerns over direct U.S. military involvement after U.S. President Donald Trump called for Iran's "unconditional surrender." Pharmaceutical and biotechnology stocks were under pressure, with GSK and AstraZeneca both down more than 1%, after Trump said pharma tariffs were coming soon. The Personal Goods Price Index also faced selling pressures. Burberry, Dr. Martens and Moonpig Group were among top decliners on the mid-cap. In individual stocks, electronics retailer AO World slipped 3.2% despite reporting a 27% rise in annual profit. Across the Atlantic, the Federal Reserve's policy decision later in the day will be under scrutiny as investors try to gauge expectations for upcoming rate cuts. Other economic data showed that UK house price growth halved in April.
