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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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Kerala's decision to switch from an expensive branded medicine for children with spinal muscular atrophy (SMA) with a much cheaper Indian-made alternative has sparked a dispute over the drug’s safety, regulatory procedures and parents' right to know what treatment their children receive.
Health Minister K Muraleedharan has defended the switch to Natco Pharma's generic risdiplam, which is sold as Natsmart. However, some parents and opposition leaders have questioned why bottles supplied to children at the Sree Avittom Thirunal (SAT) Hospital in Thiruvananthapuram were labelled “Physician's Sample” and “For Clinical Trials Only”.
The controversy has since expanded beyond the medicine's price. It now concerns how the drug reached the hospital and what evidence backs its use in children already receiving treatment.
Also read: 1 In 5 US Lung Cancer Patients Never Smoked: Report Highlights Hidden Risk Factors
SMA is a rare inherited disorder that causes progressive muscle weakness and wasting because of the loss of motor neurons. It can affect movement, swallowing and breathing. Its treatment may need to continue over a long period.
The branded risdiplam, Evrysdi, is manufactured by Swiss pharmaceutical company Roche. Its reported market price is around ₹6.2 lakh per bottle. Natco's generic alternative, Natsmart, is listed at ₹15,900 per bottle. The Kerala government has negotiated even a lower procurement price.
The difference could substantially reduce public expenditure. The state has been providing risdiplam free to eligible children through its KARE programme. Reports indicate that around 109 children are receiving treatment under the scheme.
The generic switch was intended to make treatment more affordable.. Public health expert B Ekbal has backed the decision, arguing that lower-cost medicines can expand access without compromising quality.
The debate is not over whether generic medicines should be used. Opposition leaders, including former chief minister Pinarayi Vijayan, say their objections concern the handling of the medicine that were labelled for clinical trials and the transparency of its distribution.
The controversy surfaced after families received bottles bearing the clinical trial and physician sample labels. Parents questioned whether their children had been given medicine intended for testing and whether they had adequately informed before.
Former Kerala health minister and CPI(M) leader K K Shailaja raised concerns about quality and the need for transparency and evidence before changing treatment.
“Just because a new company offers a price reduction doesn’t mean we can purchase everything. Besides price reduction, quality is what matters most. Some companies might lower prices just to push unsold products or for other interests,” she said, according to The South First.
The government says the labels indicate that they belong to sample stock and do not mean that the children were enrolled in a clinical trial.
Dr R Shankar, who heads the technical committee that evaluated the medicine, said, “If the concern is over the label, there was ‘physician’s sample’ written on it. It means it is a tested molecule. The container contains the same medicine.”
Hospital authorities said the disputed bottles were taken back after parents raised concerns. The minister has maintained that this was done to address their apprehensions, not because the government had concluded that the medicine was unsafe.
Muraleedharan has said the switch was based on an expert committee's recommendations and that the drug had received regulatory approval.
On October 24, he said, “People had concerns, but the doctors have addressed them. The treating doctors themselves have cleared the doubts.” He also said he would provide further clarification in the state Assembly on October 26.
Also read: Keralam Senior Citizens Bill: What It Means For India’s Ageing Population
Amid the concerns, SMA patient Seba P A has defended Natsmart, saying she has taken Natco's generic risdiplam since April through a patient assistance programme. “Taking Natsmart produces the same effect as when I was taking Evrysdi,” she said. “I have felt no issues due to the change in brand.”
Seba also said bottles supplied to her free of cost carried the same physician sample and clinical trial labels. She argued that the labels were intended to prevent the free medicine from being resold.
Natsmart contains risdiplam, the same active pharmaceutical ingredient as Evrysdi. The Central Drugs Standard Control Organisation (CDSCO) has approved Natco's formulation for marketing in India.
They maintain that the generic medicine is suitable for patients and that the labels do not indicate an ongoing clinical trial involving the children.
However, questions have been raised about bioequivalence evidence, quality checks and the process followed before procurement. Bioequivalence studies are used to establish whether a generic formulation delivers an active ingredient into the bloodstream at a rate and to an extent comparable with the reference medicine.
The dispute therefore cannot be resolved by comparing prices or relying solely on individual patient experiences. Families need clear information about the product's approval, the evidence for its use in children, the significance of the labels and the safeguards in place to monitor adverse effects.
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A combination of two cancer drugs cut the risk of death by 58% in people who have advanced small cell lung cancer, an aggressive form of the disease, according to results from a Phase 3 clinical trial.
The combination pairs Imdelltra (tarlatamab), developed by Amgen, with Imfinzi (durvalumab), an immunotherapy made by AstraZeneca.
In the DeLLphi-305 trial, patients who received both drugs lived a median of 21.1 months, compared to 12.7 months among those who received Imfinzi alone.
The findings were presented at the European Society for Medical Oncology (ESMO) Congress in Madrid on October 24, 2026, and published in The New England Journal of Medicine.
Also read: 1 In 5 US Lung Cancer Patients Never Smoked: Report Highlights Hidden Risk Factors
The results indicated that using tarlatamab earlier in treatment could be beneficial. It is currently approved in the United States for adults with extensive-stage small cell lung cancer that has progressed during or after platinum-based chemotherapy.
The trial examined its application as a maintenance treatment after patients had completed initial chemotherapy and immunotherapy without their cancer progressing.
“For a disease where durable survival has remained extremely difficult to achieve, the magnitude and consistency of benefit in DeLLphi-305 are striking,” said Jacob Sands, an associate chief of the Lowe Center for Thoracic Oncology at Dana-Farber Cancer Institute and an investigator in the trial.
The Phase 3 trial included 563 patients with extensive-stage small cell lung cancer whose disease had not progressed after initial treatment with Imfinzi, platinum-based chemotherapy and etoposide. The main findings were:
- 58% lower risk of death: The combination reduced the risk of death compared to Imfinzi alone.
- 21.1 months median overall survival: This compared to 12.7 months in the Imfinzi-only group.
- Nearly 80% alive at one year: About 79% of patients receiving the combination were alive after 12 months, compared to 53% of those receiving Imfinzi alone.
- 66% lower risk of progression or death: Median progression-free survival was 7.4 months with the combination, versus 1.9 months with Imfinzi alone.
These results indicate that the combination improved both overall survival and the time patients lived without their cancer progressing.
Also read: 'I Never Recovered From That Crash': US Physicist Recalls Her Years-Long Battle With Long COVID
Imdelltra, also known as tarlatamab, is a bispecific antibody that brings immune system T cells into contact with cancer cells, helping the immune system recognise and attack them.
Imfinzi, or durvalumab, blocks the PD-L1 protein, which some cancer cells misuse to evade immune attack.
The two drugs therefore target different aspects of the immune response. Researchers hope that combining them will improve the body's ability to control the cancer.
Jay Bradner, Amgen's executive vice-president of research and development, said, “These results represent an unprecedented advance for patients with extensive-stage small cell lung cancer, demonstrating a magnitude of survival benefit rarely seen in this aggressive disease.”
Side effects related to grade 3 or higher treatment occurred in 20.9% of the patients who received the combination, compared to 10.8% of those receiving Imfinzi alone.
Cytokine release syndrome, an inflammatory reaction caused by immune system activation, occurred in 49.6% of patients who received Imdelltra. Most cases were mild or moderate, and one was classified as severe. No deaths were reported.
The findings provide evidence that adding tarlatamab to maintenance immunotherapy can extend survival in extensive-stage small cell lung cancer. The researchers also reported benefits among patients with brain or liver metastases.
Despite promising findings, researchers say that the trial focused on a particular cancer type and treatment. Regulatory authorities will need to examine the evidence adopting this combination for earlier stage of treatment.
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The legalisation of recreational marijuana in the United States may have led to increase in hospitalisations for multiple cardiovascular hospitalisations, including heart attacks, heart failure and abnormal heart rhythms, according to a new study published in BMJ Open.
Researchers studied more than 50 million hospital records from 2012 to 2018 and compared cardiovascular hospitalisation patterns in the western United States, where recreational cannabis sales began earlier, with trends in other regions.
They found that hospital admissions for three cardiovascular conditions increased faster in the West after legalisation, sparking questions about the health consequences of legalising recreational marijuana.
The study, titled Cannabis legalisation and cardiovascular hospitalisations in the United States: nationwide difference-in-differences analysis, 2012–2018, was led by Samuel D. Slavin and colleagues.
It analysed records of hospitalisations for acute heart failure, heart attacks, atrial fibrillation, ischaemic stroke, venous thromboembolism and ventricular tachycardia.
The analysis found that, for each additional year of recreational cannabis sales in the western region, hospitalisation rates rose faster than in other regions for these three heart conditions:
Atrial fibrillation is an abnormal heart rhythm that can increase the risk of stroke. Heart failure occurs when the heart cannot pump blood effectively to meet the body's needs, while a heart attack occurs when blood flow to the heart is blocked.
Hospitalisation rates for the other conditions also increased, but the differences were not as significant. The researchers say that their study addresses a gap in existing research.
“While several studies have examined the association of recreational cannabis legalisation on psychiatric conditions, substance use, emergency visits, and traffic accidents, ours is the first study to examine the association with cardiovascular hospitalisations,” they wrote.
Cannabis contains compounds that can affect the cardiovascular system. Tetrahydrocannabinol (THC), its main psychoactive component, can increase heart rate and affect blood pressure.
Researchers have also examined links between cannabis use, blood vessel function and blood clot formation. However, cardiovascular effects may vary depending on the product, frequency of use and method of consumption.
The study suggests that legalisation may have wider health implications because it can change the availability and use of cannabis products across a population. However, the researchers did not directly state that cannabis use caused the hospitalisations observed.
The findings show an association between legalisation and changing hospitalisation trends, not cause and effect proof.
The analysis compared regional hospitalisation patterns rather than tracking individual cannabis users. Researchers could not distinguish between different methods of cannabis consumption, examine trends separately for each state or fully account for changes in illegal cannabis use.
The authors said, “While an observational study cannot prove causality, our findings point to potential adverse effects of recreation legalisation on population health.”
They added, “Globally, our findings support a cautious approach to legalisation laws accompanied by data collection on [cardiovascular] outcomes.”
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