Latest news with #FoodandDrugAdministration
Indian Express
3 hours ago
- Health
- Indian Express
US FDA approves HIV prevention drug: Why is this a breakthrough?
A twice-yearly injectable drug for the prevention of HIV infection has been approved by the United States' Food and Drug Administration. With better compliance expected — instead of daily pills on a shot every two months that people have to take at the moment — it is one of the most anticipated developments in the field of HIV prevention. The Lenacapavir injection — sold as Yeztugo by pharmaceutical giant Gilead — was approved based on the results of two Phase 3 trials that showed 99.9% of individuals remained HIV negative with the two shots taken annually. 'FDA approval … paves the way for WHO prequalification, which can accelerate national regulatory approvals … and procurement by donor agencies like the Global Fund… Lenacapavir's discreet, long-acting formulation may help overcome key barriers such as daily pill burden, frequent clinic visits and stigma associated with HIV prevention,' the World Health Organization (WHO) said. Lenacapavir is an anti-retroviral medication that can be used to treat as well as prevent HIV. As Sunlenca, it is used in combination with other antiretroviral drugs for the treatment of people who have been on pills for a very long time and are resistant to multiple drugs. As Yestugo, it is a pre-exposure prophylaxis (PrEP) to prevent the infection. The drug works by binding with the HIV capsid — a protein shell that protects the virus' genetic material. It then disrupts crucial steps needed for the virus to replicate and infect new cells. PrEP or pre-exposure prophylaxis is a drug or injectable meant to prevent HIV infection in people at a higher risk of contracting the disease. These medicines can reduce the risk of acquiring HIV infection through sexual activity by 99% and through injection drug use by 74%. At present, there are several types of PrEP available — pills such as Truvada or Descovy, Dapivirine vaginal ring and the injectable Cabotegravir that has to be taken every two months. It is important to be tested for HIV before taking PrEP. While these medicines are also used in the treatment of HIV, they are prescribed in combination with other antiretrovirals. Given alone to a patient with HIV, they might develop resistance to the drugs. PrEP is usually recommended for people living with an HIV positive partner, those who frequently change partners, those who have sex with people with unknown HIV status, those who work in the sex industry, and those who use injectable drugs. Medicines for post exposure prophylaxis are also available to be used as an emergency measure in cases such as inadvertent exposure in a hospital setting, after condom failure, or during sexual assault. While generic versions of the PrEP pills are approved in India — Cabotegravir injection is also available through a sub-licensing contract — they are not widely used. This is mainly owing to the cost of the medicines and the fact that they are not yet part of the country's national programme, which already provides life-long treatment to all who have been diagnosed with HIV. The new injectable will cost USD 28,218 annually, remaining out of reach for many. Even in the US, usage remains low. Only 36% of the 1.2 million people who would have benefited from the medicine were prescribed it. Anonna Dutt is a Principal Correspondent who writes primarily on health at the Indian Express. She reports on myriad topics ranging from the growing burden of non-communicable diseases such as diabetes and hypertension to the problems with pervasive infectious conditions. She reported on the government's management of the Covid-19 pandemic and closely followed the vaccination programme. Her stories have resulted in the city government investing in high-end tests for the poor and acknowledging errors in their official reports. Dutt also takes a keen interest in the country's space programme and has written on key missions like Chandrayaan 2 and 3, Aditya L1, and Gaganyaan. She was among the first batch of eleven media fellows with RBM Partnership to End Malaria. She was also selected to participate in the short-term programme on early childhood reporting at Columbia University's Dart Centre. Dutt has a Bachelor's Degree from the Symbiosis Institute of Media and Communication, Pune and a PG Diploma from the Asian College of Journalism, Chennai. She started her reporting career with the Hindustan Times. When not at work, she tries to appease the Duolingo owl with her French skills and sometimes takes to the dance floor. ... Read More
Time of India
12 hours ago
- Health
- Time of India
FDA Pune steps up food inspections along wari route
1 2 3 Pune: On the cusp of the annual palkhi procession's journey, the Food and Drug Administration (FDA) in Pune has stepped up vigilance at temporary food stalls along the route and at designated halts. FDA will be checking hygiene practices, food quality, and oil and water used in edible preparations. During the monsoon in particular, lack of hygiene maintenance at eateries can lead to rapid spread of diarrhoea, indigestion, typhoid, and other waterborne diseases, said FDA officials. Since there are two starting points of the wari, FDA has formed two teams, each consisting of six or seven food safety officers, who will conduct the inspections en route and one day prior to the halts. "Temporary food stalls will be inspected by our officers in advance to prevent large-scale outbreaks. The teams will take samples and send them to our labs for testing as required," Suresh Annapure, joint commissioner (food) for FDA Pune region, told TOI. Food safety officers will also inspect the quality of prasad handed out during the journey. "We will conduct daily tests. We also have a TPC (Total Polar Compounds) meter to check the number of times oil has been reused for cooking. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Investire è più facile che mai BG SAXO Scopri di più Undo We will continue our inspections until the processions reach Indapur and Nira. Further inspections will be taken up by other region officers," said a nodal food safety officer, who will be on the ground for inspections. Meanwhile, as the monsoon progresses, FDA officials will also begin routine food safety checks at roadside eateries and stalls. They will be looking out for sub-standard food, hygiene practices, and if food safety norms are being adequately followed. "Pune Municipal Corporation (PMC) has also asked citizens to boil water before use. It is becoming risky to eat out during the monsoon. If there are regular inspections, the chances of availability of sub-standard food will reduce substantially. Even hygiene of raw materials used by vendors should be inspected," said Abhishek Sharma, a resident of Pashan. During summer, FDA collected and inspected 50 samples from ice cream, mango, juice, and ice gola vendors in the city. Punitive action was taken for adulteration. Pune: On the cusp of the annual palkhi procession's journey, the Food and Drug Administration (FDA) in Pune has stepped up vigilance at temporary food stalls along the route and at designated halts. FDA will be checking hygiene practices, food quality, and oil and water used in edible preparations. During the monsoon in particular, lack of hygiene maintenance at eateries can lead to rapid spread of diarrhoea, indigestion, typhoid, and other waterborne diseases, said FDA officials. Since there are two starting points of the wari, FDA has formed two teams, each consisting of six or seven food safety officers, who will conduct the inspections en route and one day prior to the halts. "Temporary food stalls will be inspected by our officers in advance to prevent large-scale outbreaks. The teams will take samples and send them to our labs for testing as required," Suresh Annapure, joint commissioner (food) for FDA Pune region, told TOI. Food safety officers will also inspect the quality of prasad handed out during the journey. "We will conduct daily tests. We also have a TPC (Total Polar Compounds) meter to check the number of times oil has been reused for cooking. We will continue our inspections until the processions reach Indapur and Nira. Further inspections will be taken up by other region officers," said a nodal food safety officer, who will be on the ground for inspections. Meanwhile, as the monsoon progresses, FDA officials will also begin routine food safety checks at roadside eateries and stalls. They will be looking out for sub-standard food, hygiene practices, and if food safety norms are being adequately followed. "Pune Municipal Corporation (PMC) has also asked citizens to boil water before use. It is becoming risky to eat out during the monsoon. If there are regular inspections, the chances of availability of sub-standard food will reduce substantially. Even hygiene of raw materials used by vendors should be inspected," said Abhishek Sharma, a resident of Pashan. During summer, FDA collected and inspected 50 samples from ice cream, mango, juice, and ice gola vendors in the city. Punitive action was taken for adulteration.
New York Post
16 hours ago
- Health
- New York Post
Children's cough syrup recalled due to possibly deadly food poisoning risk: ‘Stop using it immediately'
Parents: You might want to check your medicine cabinet. A New York-based pharmaceutical company is voluntarily recalling several batches of a popular children's cough syrup over fears they may be contaminated with harmful bacteria. The Food and Drug Administration is urging consumers to 'stop using it immediately' if they have any of the affected lots of Little Remedies® Honey Cough Syrup, according to an alert issued by the agency on Wednesday. Advertisement 3 The recalled product may contain Bacillus cereus Little Remedies The affected bottles were sold both in stores and online between Dec. 14, 2022, and June 4, 2025. The syrup comes in a 4-fluid-ounce amber bottle, packaged in an outer carton. Lot codes, which identify the recalled products, can be found on the bottle label and the bottom of the box. Advertisement The following five batches are affected: 3 FDA No other Little Remedies products are part of the recall. Syrup affected by the recall may be tainted with Bacillus cereus, a bacteria that can lead to two types of food-borne illnesses, according to the FDA. Advertisement One causes nausea, vomiting, and stomach cramps within six hours of exposure. The other triggers diarrhea and cramping, typically 8 to 16 hours after use. 3 The product is intended for children ages 1 year and older. redpepper82 – 'While healthy individuals may suffer only short-term illness, exposure to high levels of B. cereus can be fatal,' the agency said in an alert. So far, no illnesses have been reported. The FDA recommends that anyone experiencing symptoms seek medical attention and report any adverse reactions through their website. Advertisement Manufacturer, Medtech, is offering full refunds for the recalled products. Customers can contact the company directly by email at medicalaffairs@ through its website or by phone at (800) 754-8853 from 8:30 a.m. – 5:30 p.m. Monday through Friday.
The Hill
19 hours ago
- Health
- The Hill
Children's cough syrup recalled over bacteria concerns
(WKBN) – The presence of a bacterium that can cause two types of foodborne illnesses has prompted the recall of multiple lots of a children's cough syrup, a notice posted to the Food and Drug Administration's website announced this week. Medtech Products Inc. is recalling five lots of Little Remedies Honey Cough Syrup due to the presence of Bacillus cereus, as well as the 'loss of shelf-stability,' the company explained. The recalled products were distributed nationwide. They were sold 4-ounce bottles, both in stores and online, between Dec. 14, 2022, and June 4, 2025. Identifying information, including the UPC and lot numbers, as well as the expiration dates, can be found below: No other Little Remedies products were included in the recall. While no serious adverse events have been reported in connection to the cough syrup, the FDA warns that Bacillus cereus can cause short-term illness and, in some cases, lead to death. Bacillus cereus, or B. cereus, is a spore-forming bacterium that commonly exists in our environment, the Cleveland Clinic explains. Exposure to the toxin it creates can result in one of two types of illness — one described as a diarrheal syndrome and another as a vomiting syndrome. The first is characterized by cramps and watery diarrhea, while the second more commonly causes nausea and vomiting. In severe cases, Bacillus cereus infection can lead to death. Those who believe they may be suffering from an illness caused by Bacillus cereus are urged to contact a healthcare provider. Customers who purchased the recalled Little Remedies cough syrup are being told to discard the product. Those with questions or refund requests can reach Medtech at 1-800-754-8853, by email at medicalaffairs@ or through the company's website.
Malaysian Reserve
20 hours ago
- Business
- Malaysian Reserve
Pharmaceutical Membrane Filters Market Size to Surpass USD 20.05 Billion by 2031, at 13.1% CAGR: The Insight Partners
NEW YORK, June 19, 2025 /PRNewswire/ — According to a new, comprehensive report from The Insight Partners, the pharmaceutical membrane filters market is growing significantly owing to increasing demand for biopharmaceuticals. The report runs an in-depth analysis of market trends, key players, and future opportunities. The pharmaceutical membrane filters market is analyzed based on technology, design, material, and end user. The report from The Insight Partners provides several stakeholders—including manufacturers and end users—with valuable insights to successfully navigate this evolving market landscape and unlock new opportunities. To explore the valuable insights in the Pharmaceutical Membrane Filters Market report, you can easily download a sample PDF of the report – Overview of Report Findings Market Growth: The global pharmaceutical membrane filter market is expected to reach US$ 20.05 billion by 2031 from US$ 8.47 billion in 2024; it is estimated to register a CAGR of 13.1% during the forecast period. The increasing demand for high-purity products in the pharmaceutical industry and stringent regulatory guidelines for drug safety and efficacy drive market growth. The rising demand for biologics, such as monoclonal antibodies and vaccines, necessitates advanced filtration technologies to ensure product purity. Soaring Demand for Biopharmaceuticals: The surging demand for biopharmaceuticals is a major driver for the pharmaceutical membrane filters market. Biopharmaceuticals—such as monoclonal antibodies, vaccines, and recombinant proteins—are sensitive, high-molecular-weight compounds that require precise and contamination-free processing. The expanding pipeline of biologic drugs necessitates the establishment of manufacturing, propelling the adoption of advanced membrane filtration solutions to ensure safety, efficacy, and regulatory compliance. Stringent Regulatory Requirements and Quality Assurance: Stringent regulatory requirements and quality assurance standards ensure high sterility, purity, and consistency levels in drug manufacturing processes. The Food and Drug Administration (FDA), European Medicines Agency (EMA), and World Health Organization (WHO) enforce strict guidelines to prevent contamination and ensure patient safety, especially for sterile injectable drugs and biologics. Membrane filters are essential in meeting these requirements, as they effectively remove microorganisms and particulates. As regulations become rigorous, pharmaceutical companies invest in advanced filtration technologies to maintain compliance and ensure product integrity, thereby boosting demand for membrane filters. Geographic Insights: In 2022, North America led the market with a substantial revenue share, followed by Europe and Asia Pacific. Further, Asia Pacific is expected to register the highest CAGR during the forecast period. Market Segmentation Based on the technology, the pharmaceutical membrane filter market is segmented into microfiltration, ultrafiltration, reverse osmosis, and nanofiltration. The microfiltration segment held the largest share of the market in 2022. In terms of design, the pharmaceutical membrane filter market is segmented into spiral wounds, tubular systems, hollow fiber, plates & frames. The hollow fiber system segment led the market in 2022. By material, the pharmaceutical membrane filters market is segmented into polyethersulfone (PES), polysulfone (PS), cellulose-based, polytetrafluoroethylene (PTFE), polyvinyl chloride (PVC), polyacrylonitrile (PAN), and others. The polyethersulfone system segment led the market in 2022. Per end user, the pharmaceutical membrane filter market is segmented into pharmaceutical and biotech industries, CROs, and CDMOs. The pharmaceutical and biotech industries segment held the largest share of the market in 2022. The pharmaceutical membrane filters market is segmented into five major regions: North America, Europe, Asia Pacific, the Middle East & Africa, and South & Central America. Stay Updated on The Latest Pharmaceutical Membrane Filters Market Trends: Competitive Strategy and Development Key Players: Major companies operating in the pharmaceutical membrane filters market are Sartorius AG, Parker Hannifin Corporation, Repligen Corporation, Asahi Kasei Corporation, GEA Group, Alfa Laval, TAMI Industries, Membrane Solutions, Koch Industries, W L Gore and Associates Inc. Trending Topics: Single-use Filtration Systems, Nanofiltration and Ultrafiltration Technologies, etc. Global Headlines on Pharmaceutical Membrane Filters Market Asahi Kasei Launches Membrane System to Produce Water for Injection DuPont to Acquire Ultrafiltration Membrane Business from BASF Purchase Premium Copy of Global Pharmaceutical Membrane Filters Market Size and Growth Report (2021-2031) at: Conclusion The pharmaceutical membrane filter market is expanding, driven by the growing adoption of single-use technologies, integration of IoT and automation for process optimization, and an increasing focus on sustainability. As the industry shifts toward biologics and personalized medicine, membrane filtration is critical in ensuring product purity and process efficiency. North America continues to lead the market due to strong regulatory frameworks and R&D infrastructure, while Asia-Pacific is witnessing increased pharmaceutical manufacturing and investment. The market is poised for sustained growth as companies prioritize scalable, efficient, and environmentally conscious filtration solutions. Trending Related Reports: About Us: The Insight Partners is a one stop industry research provider of actionable intelligence. We help our clients in getting solutions to their research requirements through our syndicated and consulting research services. We specialize in industries such as Semiconductor and Electronics, Aerospace and Defense, Automotive and Transportation, Biotechnology, Healthcare IT, Manufacturing and Construction, Medical Device, Technology, Media and Telecommunications, Chemicals and Materials. Contact Us: If you have any queries about this report or if you would like further information, please contact us: Contact Person: Ankit MathurE-mail: +1-646-491-9876Press Release – Logo: View original content:
