logo
FDA approves twice-a-year shot to prevent HIV

FDA approves twice-a-year shot to prevent HIV

CNN13 hours ago

FDA approves twice-a-year shot to prevent HIV
A drug already used to treat HIV has now been given FDA approval to prevent new infections, and the drugmaker says it is remarkably effective.
01:20 - Source: CNN
Vertical Top News 14 videos
FDA approves twice-a-year shot to prevent HIV
A drug already used to treat HIV has now been given FDA approval to prevent new infections, and the drugmaker says it is remarkably effective.
01:20 - Source: CNN
Iranian missile strikes major Israeli medical center
CNN's International Diplomatic Editor, Nic Robertson, reports from Beer Sheva, Israel, where a hospital was struck during an Iranian attack. Iran said it was targeting an Israeli intelligence and command center 'near a hospital.' There have been no reported deaths from the strike.
01:04 - Source: CNN
Israel's defense minister: Khamenei cannot 'continue to exist'
Israel's Defense Minister Israel Katz said Iran's Supreme Leader Ayatollah Ali Khamenei cannot be allowed to 'continue to exist,' after an Israeli hospital was struck by an Iranian missile on Thursday.
00:13 - Source: CNN
SpaceX Starship rocket explodes
An explosion occurred late Wednesday night at SpaceX's Starbase facility in South Texas. A Starship rocket preparing for its tenth flight test experienced a 'major anomaly,' SpaceX says. There were no injuries and all employees are accounted for, according to SpaceX. The cause of the explosion and the extent of any damage are unclear. CNN has reached out to local police and fire departments for more information.
00:35 - Source: CNN
Sole survivor of Air India crash mourns brother
Vishwash Kumar Ramesh is the only survivor among 242 on board an Air India flight that crashed in Ahmedabad on June 12. On Wednesday Ramesh attended the funeral for his brother, who died in the tragedy.
00:30 - Source: CNN
Hear former President Obama's warning about direction of the US
Former President Barack Obama warned that the United States is 'dangerously close' to becoming 'consistent with autocracies' during a civic group event in Connecticut.
00:56 - Source: CNN
Anne Burrell dead at 55
Anne Burrell, a chef and television personality whose joyful demeanor made her a beloved fixture on the Food Network, has died, according to the network. She was 55.
00:38 - Source: CNN
NYC mayoral candidate arrested at immigration court
New York City Comptroller and mayoral candidate Brad Lander was released from federal custody Tuesday afternoon, hours after he was arrested by officers at an immigration court in Manhattan when he tried to escort a migrant whom officers were attempting to arrest.
01:48 - Source: CNN
Trump's new phone looks a lot like one from China
The Trump Organization says its upcoming T1 smartphone will be 'proudly designed and built in the United States.' But experts tell CNN they're skeptical that goal can be achieved-- and say the T1's specifications are strikingly similar to a Chinese-made phone already on the market.
01:07 - Source: CNN
This is how the US could get involved in the Israel-Iran conflict
CNN's Nick Paton Walsh reports on how the US could get involved in the conflict between Israel and Iran while the countries continue trading strikes for a sixth day, with civilians in flashpoint areas facing waves of attacks.
02:14 - Source: CNN
Trump's sons announce mobile phone company
Trump Mobile, a wireless service created by the Trump Organization, aims to rival US carrier companies like AT&T, Verizon and T-Mobile. The Trump Organization, run by President Donald Trump's eldest sons Eric and Donald Jr., announced the business and launched a new gold smartphone for pre-order.
01:09 - Source: CNN
What Iranian residents are texting to CNN as strikes hit
As Israeli strikes zeroed in on Iran's capital city of Tehran, CNN's Clarissa Ward reports from Tel Aviv some of the messages she's received from residents in Iran offering a glimpse into the daily anxieties of living in a country faced with an ever-escalating conflict in the sky.
01:33 - Source: CNN
Minnesota suspect went to 4 state lawmaker homes night of shootings
The suspect in the killing of a Minnesota lawmaker and her husband in addition to the shooting of another lawmaker and his wife also visited two more politicians' homes, according to authorities.
02:08 - Source: CNN
Trump slams G7 for kicking out Russia
President Donald Trump kicked off his visit to the G7 summit in Canada by criticizing nations for kicking out Russia eleven years ago.
00:36 - Source: CNN

Orange background

Try Our AI Features

Explore what Daily8 AI can do for you:

Comments

No comments yet...

Related Articles

BMJ Investigation Increases Concerns About Ticagrelor Trials
BMJ Investigation Increases Concerns About Ticagrelor Trials

Medscape

time2 hours ago

  • 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.

Ukrainian girl, 7, with rare cancer who flew to Israel for a cure is killed by Iranian strike
Ukrainian girl, 7, with rare cancer who flew to Israel for a cure is killed by Iranian strike

Yahoo

time3 hours ago

  • Yahoo

Ukrainian girl, 7, with rare cancer who flew to Israel for a cure is killed by Iranian strike

A seven-year-old Ukrainian girl who was diagnosed with a rare cancer and moved to Israel in hope of a cure has been killed by an Iranian air strike. Nastya Buryk died alongside members with her family in Bat Yam last week when a missile fired by the Islamic regime struck their apartment block. Nastya, her mother, grandmother and two brothers, were all killed in the blast on June 13, the first night of Iran's barrage, it was reported by Israeli news outlet Ynet. Her father, Artem, who is fighting against Russian invaders in Kyiv, remains alive. She had been undergoing treatment for lymphoblastic leukaemia, a rare cancer that attacks blood and bone marrow. Nastya, from Odesa, was first diagnosed in 2022 and underwent chemotherapy in Ukraine. Her condition improved but she later relapsed. 'On August 29, 2022, we heard the terrible news: 'Your daughter has cancer,'' her mother Maria Peshkureva wrote on social media. 'Since that day, I have been living in a parallel reality, where the main thing is to save. To breathe. To not give up.' As her health worsened, her family searched for more specialist treatment and, thanks to charitable donations, they sought medical care in Israel, where Nastya had a bone marrow transplant. The procedure was unsuccessful and her leukaemia returned. Earlier this year, her family turned to a new treatment in Israel, while her grandmother, Olena, 60, and two brothers, Konstantin and Ilya, nine and 13, flew from Ukraine to be with her. Both of the boys attended a local school. Nastya's father, who joined Ukraine's 95th Airborne Assault Brigade in 2022, recorded videos from the front line to appeal for donations as the cost of his daughter's care escalated. Her family believed they would be safer in Israel than Odesa, which has suffered deadly shelling from Russian forces. Ukraine's embassy in Israel said: 'On June 14, five Ukrainian citizens, including three minors, were killed in a massive Iranian missile attack on Israel, with a missile hitting a residential building in the city of Bat Yam. 'Ukrainian diplomats and consuls are in close contact with the police and other services to identify and organise the process of returning the bodies of the dead.' The attack on Bat Yam also killed four other people and injured more than 100. Since June 13, Iran has fired missiles at Israel every day in response to Israel's 'pre-emptive strike' on the regime's nuclear facilities on June 12.

DOWNLOAD THE APP

Get Started Now: Download the App

Ready to dive into a world of global content with local flavor? Download Daily8 app today from your preferred app store and start exploring.
app-storeplay-store