Latest news with #USFoodandDrugAdministration
Indian Express
5 hours ago
- Health
- Indian Express
This word means: Ketamine
Billionaire Elon Musk engaged in extensive drug consumption as he became one of Donald Trump's closest advisers, taking ketamine so frequently it caused bladder problems and traveling with a daily supply of approximately 20 pills, according to a report by the New York Times. Musk had previously said that he was prescribed ketamine for depression, taking it about every two weeks. Ketamine is an anaesthetic that has been listed as a hallucinogen by the US Drug Enforcement Administration. It is referred to as a 'dissociative anaesthetic hallucinogen' because it creates a feeling of detachment from pain and the environment. In the US, ketamine was first used as an anaesthetic for animals in the 1960s. Around a decade later, the US Food and Drug Administration approved it for humans. The drug's use for treating depression and other mental illnesses is recent. Owing to its powerful effects, ketamine is consumed by those patients who haven't responded to traditional therapies. Ketamine is also used as a recreational drug, popularly known as K or Special K among clubgoers. Mental illness patients usually take ketamine through an IV, nasal spray or tablet once or twice a week for six to eight weeks (some might need it for longer). When it comes to recreational purposes, it is consumed by snorting a white crystalline powder. Ketamine can also be injected or smoked. In a recent report, The New York Times talked to 40 ketamine patients, many of whom said the drug was like a reset button for the brain. 'During treatment sessions, they experienced pleasant visualisations, sometimes accompanied by a sense of existing outside themselves and melding with the universe. Afterwards, their daily problems seemed less weighty,' according to the report. It also noted that ketamine garnered popularity as it affects brain receptors that traditional antidepressants do not target. 'The psychedelic-like trip, many believe, is integral to the drug's therapeutic effect,' the report said. If taken in high doses, the anaesthetic quality of ketamine becomes more pronounced. Some may find it difficult to move and may feel numb, and can experience more graphic hallucinations. 'This is sometimes called the 'k-hole' by users,' according to The Guardian. It's hard to say. Some doctors have emphasised that if taken only for medicinal purposes and in the right doses, ketamine is safe to consume and very effective in treating mental illnesses. However, many patients quoted in the NYT report said the drug can be addictive and, when taken chronically in high doses, can cause severe bladder damage. 'There are indications that abuse may also lead to cognitive impairment,' according to the report. Moreover, there has not been much research on prolonged ketamine treatment to determine if it's safe or not. There is also a lack of literature on addiction and abuse among medical users.
Business Standard
a day ago
- Business
- Business Standard
Alembic Pharma receives USFDA final approval for Bosutinib tablets
Alembic Pharmaceuticals has announced that it has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Bosutinib Tablets. Bosutinib tablets are indicated for the treatment of adult patients with chronic, accelerated, or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) who have shown resistance or intolerance to prior therapy. The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Bosulif Tablets, marketed by PF Prism C.V. (Pfizer). According to IQVIA, Bosutinib Tablets have an estimated market size of $ 291 million for the twelve months ending March 2025. Alembic has a cumulative total of 223 ANDA approvals (200 final approvals and 23 tentative approvals) from USFDA. Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world. Its research and manufacturing facilities are approved by regulatory authorities of many developed countries, including the USFDA. The companys consolidated net profit declined 12% to Rs 156.89 crore despite a 16.7% jump in net sales to Rs 1,769.64 crore in Q4 FY25 over Q4 FY24. The counter rose 0.97% to Rs 1,015.30 on the BSE.
Yahoo
2 days ago
- Business
- Yahoo
Helix releases pharmacogenomics tests for use in neurology and oncology
US-based genomics company Helix has released a new suite of pharmacogenomics (PGx) tests, widening its portfolio to offer personalised patient care in neurology and oncology. The suite includes a PGx Fluoropyrimidines DPYD test to detect individuals with dihydropyrimidine dehydrogenase (DPYD) gene variants at risk for side effects from certain chemotherapies, aligning with the recent guidelines from the National Comprehensive Cancer Network. The DPYD test provides insights into a patient's metabolism of cancer treatments. It targets therapies used in treating breast, pancreatic, head and neck, colorectal, and oesophageal cancers. Additionally, the suite includes the PGx APOE test to evaluate the status of apolipoprotein E (APOE) relevant to Alzheimer's drugs. It assesses the risk of serious adverse effects such as amyloid-related imaging abnormalities (ARIA) for individuals treated with Leqembi or Kisunla. These drugs have US Food and Drug Administration (FDA) boxed warnings for individuals with two copies of the APOE ε4 allele. With these tests, Helix now covers all neurology and oncology-associated PGx haplotypes cited in the agency's warnings. The company noted that its PGx tests offer accuracy across varied populations, utilising its Exome+ assay and comprehensive star allele caller. Its Sequence Once, Query Often model allows for exomes to be sequenced just once, with subsequent genetic tests not requiring additional samples. This facilitates rapid results, enabling genetic insights at the point of care. Helix's latest PGx tests encompass medications for cancer, cardiovascular diseases, pain management, gastrointestinal conditions, and anaesthesia guidance. These tests add to the company's existing PGx offerings for blood clotting, mental health, and immune suppression treatments. In addition, Helix has also developed the Helix Research Network in collaboration with its partners. This precision clinical research network comprises health systems focused on integrating genomics into routine care and advancing human health through genomics research. It also creates real-world evidence to support a wide range of initiatives, including studies showing the genomics' clinical use. Helix chief science officer Will Lee said: 'By focusing on patients with neurodegenerative conditions and cancer, and actively identifying those at higher risk for adverse outcomes, we can help providers treat vulnerable patients more precisely and effectively.' "Helix releases pharmacogenomics tests for use in neurology and oncology" was originally created and published by Medical Device Network, 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
Yahoo
2 days ago
- Business
- Yahoo
UW Health aids FDA approval of Alzheimer's blood test
MADISON, Wis. (WFRV) – Officials with the US Food and Drug Administration say they have cleared the first-ever blood test that will help in diagnosing cases of Alzheimer's disease. Those at UW Health state that this could not have happened without their help, as the work being done at the UW schools of Medicine and Public Health in Madison has been at the forefront of biomarker research. Brown County courts request aid to address felony case backlog This kind of research allows those already with cognitive impairment to get a blood test as a way to test for Alzheimer's instead of needing a PET scan of the brain or a spinal tap. We have been at the forefront of biosomething research, those are tasks looking at the protein of Alzheimer's disease, and we've been doing this for years. And that's because our research participants have been willing to do lumbar punctures for the past two decades. And we've had the technology to really look for these proteins Nate Chin, UW Health Alzheimer's Disease Research Center Medical Director Chin adds that UW Health is looking to make these blood tests available for cognitively healthy people as well, before eventually pairing it with future preventive Alzheimer's treatments. No other information is available at this time. Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
Yahoo
2 days ago
- Business
- Yahoo
FDA clears Distalmotion's robotic system for cholecystectomy procedures
The US Food and Drug Administration (FDA) has granted 510(k) clearance for Distalmotion's DEXTER robotic surgery system to be used in adult cholecystectomy (gallbladder removal) procedures, marking its second approved indication in the country. The clearance follows a previous de novo clearance for inguinal hernia repair in Q4 2024. Distalmotion CEO Greg Roche said: 'With indications for inguinal hernia repair and now cholecystectomy, we're meaningfully building the reach of DEXTER in the US so that more surgical teams and patients will benefit from robotic surgery.' According to the company, cholecystectomy is one of the most common general surgeries in the US, typically performed in outpatient departments and ambulatory surgery centres (ASCs). With a shift towards outpatient settings for soft tissue procedures, there is a high demand for robotic systems that provide precision. Specifically intended for outpatient settings, DEXTER meets this demand, offering a small, mobile footprint that allows it to fit into an operating room (OR). The system integrates into existing workflows to facilitate high-volume procedures, and its suite of fully wristed single-use robotic instruments is designed to improve precision in surgical procedures. DEXTER's sterile console enables surgeons to remain close to the patient, facilitating quick access to the bedside and transitions between laparoscopic and robotic methods. The system features an open architecture that is compatible with current and future OR technologies, supporting cost-effective supply chain operations. In Europe, it is indicated for use in various laparoscopic surgical procedures, including urologic, general, and gynaecologic surgeries. It is also indicated for laparoscopic inguinal hernia repair and cholecystectomy in adults aged 22 and above in the US. Distalmotion noted that DEXTER has been leveraged in 2,000 procedures across more than 30 types of surgical procedures, expanding its presence in the US and Europe. The company is further extending its reach in the US market with the completion of its pivotal HYPER trial for benign hysterectomy and ongoing subject enrolment in its sacrocolpopexy trial. "FDA clears Distalmotion's robotic system for cholecystectomy procedures" was originally created and published by Medical Device Network, 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
