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The US Food and Drug Administration has approved TNKase or Tenecteplase, which is a thrombolytic or clot-dissolving agent, for the treatment of acute ischemic stroke in adults.
Ischemic strokes happen when a blood clot blocks a blood vessel in your brain. It can cause permanent brain damage and death. If enough brain cells die, you can also lose the abilities or body functions those cells control. They are also the most common types of stroke, with 80% of all strokes being ischemic strokes.
It is delivered as a single five-second intravenous bolus, which is faster than the standard of care Activase or alteplase, which is administered as an intravenous bolus followed by a 60-minute infusion. The manufacturer of TNKase, Genetech said a new 25-mg vial configuration will also be available in the coming months.
The approval came at the backdrop of a study that compared TNKase to Activase in patients with acute ischemic stroke. These patients also presented with a disabling neurological deficit. Results show that TNKase was comparable to Activase in terms of efficacy and safety.
In the United States it self, it affects more than 795,000 people each year and is the leading cause of long-term disability. It is also the fifth leading cause of death. Since brain damage can happen if this progresses rapidly, one needs an immediate, fast-acting medical care.
TNKase thus provide a faster and simpler administration which can be critical for anyone. The chief medical officer and head of global product development at Genetech, Levi Garraway, MD., PhD., said, "Today's approval is a significant step forward and underscores our commitment to advancing stroke treatment options for patients."
Some of the most common symptoms include weakness or paralysis on one side of your face and body. You may also feel trouble speaking or have loss of speech, also known as aphasia. You may faced slurred or garbled speaking, also known as dysarthria. Other symptoms include loss of muscle control on one side of your face, or sudden worsening or loss of your senses, including vision, hearing, smell, taste, and touch.
While these are symptoms one has who is prone to this condition. However, often, many may confuse it with other illnesses. It is best to keep an eye out for warning signs. These could be looking out for yourself or your loved one. Note if there is a sudden loss of balance. Look out for sudden vision loss or changes in one or both eyes. Look for a droop on one or both sides of your face, especially when you smile. Raise both arms and see if one arm sags or drops in a way it usually does not. Note for your speech. Are you as fluent? Are you have trouble speaking? If you see any of such signs, start tracking it and talk to your healthcare provider.
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The White House has announced that US President Donald Trump is in “excellent health”. But doctors flag missing medical details.
Trump, 79, underwent an annual medical examination at the Walter Reed National Military Medical Center on May 26. Shortly after the test that lasted three hours, he shared that “everything checked out perfectly.”
Dr. Sean Barbabella, physician to the president, in a memorandum released late last week, said that “President Trump is demonstrating strong cardiac, pulmonary, neurological, and overall physical function.” He added that Trump is “fully fit to carry out all duties of the Commander-in-Chief and Head of State.”
However, doctors stated that the test results authorized by the President for public release contain notable gaps.
According to experts, the physical examination lacks detailed results from tests used to assess cardiovascular health.
Barbabella’s description of Trump’s cardiac health cites results from a coronary CT angiography, an echocardiogram, and an artificial-intelligence-enhanced electrocardiogram analysis.
Jonathan Reiner, Professor of Medicine and Surgery, Interventional Cardiologist, in a post on social media platform X, questioned the need for another coronary artery CT on Trump, as he was last scanned in October.
"We don’t typically scan patients 6 months later unless we are concerned about a finding on the initial scan. What prompted the repeat CT?" he said.
Further, to fully assess the president’s cardiac health, other doctors said they would want to see a calcium score, a description of any plaque in the arteries, and a CAD-RADS score to assess narrowing in the arteries, The Wall Street Journal reported.
“If I were creating a report to send to another physician, I would have mentioned a little bit more about the carotid ultrasound,” William Shutze, a Texas vascular surgeon, was quoted as saying. “What amount of plaque there is going to be—because almost all of us are going to have some buildup there.”
Also Read: President Donald Trump Remains In Excellent Health, Says White House
Further, Trump’s cholesterol numbers and medication regimen also attracted attention from physicians who reviewed the memorandum.
According to the report, his HDL (good cholesterol) level was 70 mg/dL, while his LDL (bad cholesterol) level was 53 mg/dL.
The report said Trump takes rosuvastatin and ezetimibe for cholesterol management.
“He’s got like the best cholesterol numbers you’ll see,” said Daniel Torrent, adding that it is unusual for medication alone to achieve such favorable values. “We don’t usually manage people to the point where they’re that good.”
“That report is almost too good to be true for somebody of his age,” Shutze said. “This seems to be a filtered narrative.”
Notably, neurological condition of Trump, the oldest elected as President of America, has remained a subject of serious discussion, with many doctors pointing out that he's suffering from dementia. But the test results revealed him to be in “normal mental status".
Cognitive function, assessed using the Montreal Cognitive Assessment (MoCA), was also within normal limits, with a score of 30 out of 30.
"Why was the president again given a MOCA dementia screening test? He’s had 3 in the recent past," Reiner asked, while also questioning Trump's "more frequent than the traditional yearly exam?"
Also read: ‘Sea Or See?’ Donald Trump's Remark Sparks Fresh Cognitive Health Speculation
“President Trump has publicly released more detailed information about his health than any other president in history—showing he is in excellent health,” White House communications director Steven Cheung said in a written statement.
He criticized outside physicians for speculating about a report for a patient not under their care, the WSJ said.
The White House added that “the absence of discussion regarding a specific medication, dosage, or historical medical condition should not be interpreted as a lack of monitoring or treatment”.
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Ebola has affected more than 1,100 people in the Democratic Republic of Congo and Uganda, according to the African Union's health agency.
Africa Centers for Disease Control and Prevention (CDC) Director General Jean Kaseya said there were 263 confirmed cases in both countries as of Saturday, with 43 confirmed deaths, The Financial Times reported.
On Thursday, the Africa CDC said there had been 246 suspected deaths from the virus.
Meanwhile, Brazil reported two suspected Ebola cases involving people who had travelled from affected countries.
On May 31, local health authorities reported that a man from the Democratic Republic of the Congo with suspected Ebola infection in Brazil's São Paulo state tested positive for meningitis, Reuters reported. He had previously presented with a fever after a recent visit to an African country.
The second case emerged in Rio de Janeiro state after a recent travel to Uganda, but the patient tested positive for malaria. In neither case does the diagnosis of other diseases rule out the possibility of Ebola, authorities said, adding that both cases remain under investigation.
In a separate statement, Brazil's Health Ministry said the man in São Paulo has been intubated, and his condition is serious, Reuters reported.
The latest outbreak of Ebola has been caused by the rare Bundibugyo virus, which has no approved treatment or vaccine. It is also known to kill about a third of those infected.
Offering a much-needed sign of hope, the World Health Organization (WHO) has reported five Ebola recoveries.
Five patients have recovered from a rare type of Ebola, said WHO Director-General Tedros Adhanom Ghebreyesus during the opening of a new Ebola treatment centre in Bunia, the provincial capital of Ituri.
“Four people will be discharged today, and there was one who was discharged the day before yesterday,” he said, adding that work is ongoing on “vaccines and treatments, but that doesn’t mean that people cannot recover from Ebola”.
Also read: Ebola: Inside India’s RT-PCR Tests For The Bundibugyo Strain| Explained
The WHO has also identified experimental treatments and vaccine candidates for the Bundibugyo strain.
The global health agency convened several expert and advisory groups and recommended prioritizing treatment of Bundibugyo cases with:
For post-exposure prophylaxis among contacts of confirmed and probable cases, the oral antiviral obeldesivir was identified as a priority candidate.
The expert groups also identified the single-dose rVSV Bundibugyo vaccine, being developed by the International AIDS Vaccine Initiative (IAVI), as the most promising vaccine candidate.
Another vaccine candidate, ChAdOx1 Bundibugyo — being developed by Oxford University and the Serum Institute of India — could potentially become available within 2–3 months for efficacy assessment through a clinical trial. However, additional animal data are still required to support and confirm further prioritization.
The experts also reviewed the potential role of Merck's Ervebo, the only licensed Ebola vaccine currently available.
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Developed by the US-based late-stage clinical oncology company Revolution Medicines, daxaronrasib has shown promise in improving survival rates among patients with metastatic pancreatic ductal adenocarcinoma (PDAC).
In a clinical trial, daxaronrasib demonstrated a median overall survival of 13.2 months, compared with 6.7 months for standard chemotherapy.
Experts believe the drug may also prove effective against other cancers, including cancerous tumors in lung and ovaries.
The drug works by targeting mutations in the KRAS gene, which are found across multiple cancer types, including lung, colorectal, ovarian, endometrial and a type of bile duct cancer known as cholangiocarcinoma.
“Daxaronrasib provides a clear and highly meaningful step forward for patients with pancreatic cancer who have experienced progression on prior treatment, typically chemotherapy,” said Brian M. Wolpin, professor of medicine at Harvard Medical School and principal investigator of the trial.
“Pancreas cancer may be the first for this drug, but there will be others,” he added, noting that “Now the floodgates open.”
Also read: Former US Senator Ben Sasse Opens Up About Battle With Terminal Stage 4 Pancreatic Cancer
Daxaronrasib is a daily oral pill that has demonstrated statistically significant and clinically meaningful improvements in progression-free survival (PFS) and overall survival (OS) compared with standard intravenous chemotherapy.
Described as a multi-selective inhibitor of RAS(ON) proteins, it is the first investigational drug in a new class of RAS inhibitors designed to target a broad spectrum of cancer-causing RAS mutations.
The drug works by blocking KRAS signalling proteins that drive tumor growth.
“It’s been incredibly hard to drug that mutation,” Wolpin said, NBC News reported. “That mutated protein is like a round ball, and you just can’t get the drug to stick to it, to block the effect.” It’s only “through some really amazing chemistry work,” he said, that scientists have been able to develop a drug to work on the mutation.
Daraxonrasib is that first drug. It works by pairing up with a protein called cyclophilin A inside cells, acting like a “molecular glue,” Wolpin said, glomming onto the mutated protein.
Pancreatic cancer is considered one of the most RAS-dependent cancers, with more than 90 per cent of patients carrying tumours driven by RAS protein mutations. Similar RAS-targeting drugs are also being developed for pancreatic, lung and colon cancers.
“It’s the beginning, not the end,” said Elizabeth Jaffee in comments to The New York Times.
The findings was presented at a plenary session of the American Society of Clinical Oncology’s meeting in Chicago on May 31, and simultaneously published in the New England Journal of Medicine.
Read More: Ozempic-Style Drugs May Slowdown Cancer, Study Finds
According to the company, “Daxaronrasib was generally well tolerated, with a manageable safety profile and with no new safety signals.”
Previous studies have shown that rash is the most common side effect. Other frequently reported adverse effects include:
Based on the first interim analysis, all progression-free survival and overall survival results are now considered final.
Revolution Medicines said it plans to submit the data to global regulators, including the U.S. Food and Drug Administration (FDA), as part of a future New Drug Application under a Commissioner’s National Priority Voucher.
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