Latest news with #Augmentin
Time of India
2 days ago
- Time of India
Fake drugs with face value of 17L seized
Ahmedabad: The state Food and Drug Control Administration (FDCA) raided multiple locations and seized spurious allopathic medicines worth Rs 17 lakh. Twenty samples have been sent for lab tests. Tired of too many ads? go ad free now FDCA commissioner H G Koshia said, "We caught duplicate medicines with names of Torrent Pharma's leading product Chymoral Forte, Glaxo's Augmentin, Ipca Company's Zerodol SP, Bioswift's Swifcef, and others on the packages. Primary assessment shows that these were made by using chalk powder and bought from other states in cash at half price without bills." He added, "Our team got information about this racket and raided houses and businesses in Vatva, Amraiwadi and Bapunagar. Our teams also caught stock of duplicate medicines. Our teams also raided shops in Vadodara, Surat's Katargam area, and Rajkot and seized duplicate medicines."
Business Wire
14-07-2025
- Business
- Business Wire
Kaizen Biosciences Announces Multiple Abstract Acceptances and Presents Pediatric Antibiotic PK Data to ISOM; Targets FDA's New CNPV Pathway Ahead of September NDA Filing
PHILADELPHIA--(BUSINESS WIRE)-- Kaizen Biosciences, Co., a biopharmaceutical company, today announced the acceptance of its abstract for presentation at IDWeek 2025, which serves as a premier forum for infectious disease (ID) professionals to knowledge-sharing around improving patient care and overall public health. The acceptance of our work at major clinical meetings, along with our anticipated engagement with the FDA's new CNPV program, underscores the significance and urgency of our approach In addition, the company recently presented new pharmacokinetic data at the International Society of Pharmacometrics (ISoP/ISOM) a biennially meeting, spotlighting a novel amoxicillin-reduced clavulanate formulation for use in children aged 3-24 months. The data, presented by Dr. Carl Peck, former Director of the FDA Center for Drug Evaluation and Research (CDER), compared the pharmacokinetics of Augmentin ES-600 with the amoxicillin-reduced clavulanate formulation. The study revealed that Augmentin ES-600 delivered elevated clavulanic acid exposures—exceeding the amount found in adult approved Augmentin formulations, suggesting a need to revisit clavulanate dosing found in the current pediatric approved oral suspension formulations. Dr. Peck further highlighted that the proposed formulation, while containing less clavulanate, still provided the AUC/MIC required for bacterial killing or net bacterial stasis when tested against 5 different H. influenzae strains. Kaizen Biosciences is preparing to submit a New Drug Application (NDA) in September 2025 for its novel amoxicillin-reduced clavulanate formulation. The company is also actively pursuing the FDA's recently announced Commissioner's National Priority Voucher (CNPV) Program, which is designed to accelerate review periods. Kaizen intends to formally request consideration under this pathway, highlighting the public health need for an optimized antibiotic and beta-lactamase inhibitor for children aged 3–24 months, while also supporting increased domestic drug manufacturing—a hallmark of national security. 'We're excited to share this important data with the medical and regulatory communities and we remain committed to pursuing our company philosophy of 'Change, For the Better,'' said Keith-Harrison Dewedoff, Co-Founder & Executive Chair. 'The acceptance of our work at major clinical meetings, along with our anticipated engagement with the FDA's new CNPV program, underscores the significance and urgency of our approach.' About Kaizen Biosciences Kaizen Biosciences is a clinical-stage biotechnology company focused on serving patients in a variety of therapeutic areas where big, traditional pharmaceutical companies often overlook. The company's lead program is an improved amoxicillin-clavulanate formulation which reduced the unnecessary quantities of clavulanic acid in children aged 3–24 months while remaining efficacious against S. pneumoniae, H. influenzae, or M. catarrhalis pathogens.
Yahoo
06-06-2025
- Health
- Yahoo
11 ICE Officers Are Stuck In A Shipping Container In Djibouti
A group of 11 Immigration and Customs Enforcement officers and eight migrant detainees are stuck in a shipping container in Djibouti after a federal judge blocked the Trump administration from deporting immigrants to third-party countries without due process. The group's plight was described in a filing in U.S. District Court on Thursday, where Melissa Harper, a senior ICE official overseeing deportations, said they're currently being housed in a converted shipping container on the U.S. Naval base in Camp Lemonnier, Djibouti. 'This has been identified as the only viable place to house the aliens,' said Harper. According to Harper, the daily temperature outside exceeds 100 degrees Fahrenheit. At night, Djibouti ignites burn pits near the base to dispose of trash and human waste, creating a lingering smog cloud. Upon their arrival, defense officials also warned the group 'of imminent danger of rocket attacks' from terrorist groups in nearby Yemen. Harper said members of the group have fallen ill and complained about a lack of medical equipment, including testing for what agents described as upper respiratory infections, all developed within 72 hours of landing. (The U.S. Department of Defense, which operates the base, might contest that description, having reportedly supplied the agents with Augmentin (an antibiotic), Azithromycin (another antibiotic), Doxycycline (a third antibiotic), Prednisone (steroid), inhalers, Zyrtec (treats allergies), Tylenol (pain and fever reliever), Motrin (pain reliever), Benadryl, Mucinex, Sudafed, nasal spray, and eye drops.) While showers are available to both the ICE agents and the migrants, Harper complained they're only available every other day. The three ICE officers originally assigned to the deportation flight were replaced on May 27 with an expanded team of 11 officers and two medical support staffers, who Harper said will also soon be swapped out for a fresh team. Which means the only members of the group consistently being subjected to the inhospitable conditions of Djibouti are the migrants. Trina Realmuto, an attorney for the deportees, told the Washington Post they're increasingly concerned about the conditions they're being held in, especially if they're being shackled. The detainees, who hail from Cuba, Laos, Mexico, Myanmar and Vietnam, were quietly flown out of the country more than two weeks ago, violating the orders of a federal judge barring the government from deporting people to a third-party country — a nation other than the U.S. or their nation of origin — without first giving them a meaningful chance to contest it. Lawyers for the migrants said in court documents that they were given just hours before they were deported, instead of 15 days as directed by the judge. As a result, the flight, originally bound for South Sudan, instead got stuck in Djibouti. It's unclear if DHS attempted to deport the migrants to their countries of origin before settling on South Sudan. Federal law prohibits deporting migrants to countries that are unsafe or where they could be persecuted. It's also unclear why ICE would continue to subject the group to inhospitable conditions when they could simply return to the United States for the requisite hearings. The Department of Homeland Security didn't respond to a question to that effect. Instead, DHS spokesperson Tricia McLaughin lambasted the U.S. District Judge Brian E. Murphy on social media, accusing Murphy of 'putting the lives of our ICE law enforcement in danger by stranding them in Djibouti without proper resources, lack of medical care, and terrorists who hate Americans running rampant. 'Our @ICEgov officers were only supposed to transport for removal 8 *convicted criminals* with *final deportation orders* who were so monstrous and barbaric that no other country would take them. This is reprehensible and, quite frankly, pathological.' Read Harper's sworn declaration, below: Judge: U.S. Officials Must Keep Control Of Migrants Sent To South Sudan Trump Administration 'Unquestionably' Violated Deportation Order, Judge Says White House Confirms Trump Is Exploring Ways To 'Deport' U.S. Citizens People Are 'Disappearing' Since Trump Took Office. Here's What That Means.
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Business Standard
06-06-2025
- Business
- Business Standard
Indian pharma market grows 7.2% in May led by chronic therapies
Indian pharma market grew 7.2% in May with strong performance in chronic therapies such as cardiac and anti-infectives, along with gains from price hikes and new launches Sanket Koul New Delhi The Indian Pharma Market (IPM) grew 7.2 per cent in May this year with almost all major therapies showing positive growth, according to market research firm Pharmarack. Data suggest that big chronic therapies such as cardiac and anti-infectives, which account for nearly 25 per cent of the overall domestic market, recorded value growth of 11.7 per cent and 7.6 per cent, respectively. On the other hand, several smaller supergroups such as urology and antineoplastics, which made up 2 per cent each of the IPM's sales value for the month, also recorded double-digit growth in May at 12.3 per cent and 11.7 per cent, said Sheetal Sapale, vice-president, commercial, Pharmarack. Data suggest that the overall value growth for the IPM in May was driven by price growth and new introductions. The IPM also reported a minuscule 0.4 per cent unit growth during the month, with the chronic segments such as antidiabetics (6.1 per cent) and cardiac (4.8 per cent) performing better than the overall market figure. Experts believe that the antidiabetic segment saw a 6.1 per cent rise in volume in May due to a key drug, empagliflozin, going off-patent, as companies launched several plain and combination medications in the segment. Growth in the moving annual turnover (MAT) for the IPM between June 2024 and May 2025 stood at 8.1 per cent, leading to a total turnover of over Rs 2.29 trillion, while volumes in the domestic market grew by 1.1 per cent. The MAT of leading therapy areas such as cardiac, gastrointestinal and anti-infectives, which constitute around 38 per cent of the pharmaceutical market, showed robust volume growth at 10.4 per cent, 9.5 per cent and 6.5 per cent, respectively. While the top 20 brands in the IPM registered modest monthly value growth in the domestic market during the month, Sun Pharma and Dr Reddy's posted significant monthly value growth at 11.2 per cent each. They were followed by Torrent Pharma and Ipca Laboratories at 10.8 per cent, and Alkem Laboratories at 10.3 per cent monthly value growth. According to Pharmarack data, GlaxoSmithKline's (GSK) antibiotic medication Augmentin and USV's anti-diabetic drug Glycomet GP continued to be the top-selling medicine brands at the MAT level, with sales worth Rs 819 crore and Rs 810 crore, respectively.
Business Standard
14-05-2025
- Business
- Business Standard
GSK Pharma gains as Q4 PAT rises 35% YoY to Rs 260 cr; declares dividend of Rs 42/share
Glaxosmithkline Pharmaceutical advanced 3.21% to Rs 2,879.70 after the company's standalone net profit jumped 34.73% to Rs 260.14 crore on a 6.06% increase in revenue from operations to Rs 966.08 crore in Q4 FY25 over Q4 FY24. Profit before tax stood at Rs 354.90 crore, up 32.08% from Rs 268.71 crore in the same period last year. Total expenses declined 3.53% YoY to Rs 650.64 crore. Notably, the cost of materials consumed dropped 43.65% YoY to Rs 108.35 crore, while employee benefits expense fell 11.49% to Rs 152.97 crore. On a full-year basis, the company's net profit jumped 57.19% to Rs 919.06 crore on a 9.28% rise in revenue to Rs 3,723.49 crore in FY25 over FY24. Bhushan Akshikar, managing director of GlaxoSmithKline Pharmaceuticals, said, Our diversified portfolio of general medicines, specialty, and vaccines has shown improved growth due to sustained innovation, enhanced healthcare professional (HCP) engagement, and rapid digital acceleration. This has enhanced reach, expanded coverage, and provided a seamless omnichannel experience for our customers. Our key brands, including Augmentin, Calpol, Ceftum, T-Bact, and Trelegy, have played a significant role in driving growth throughout the year. Shingrix is experiencing increased adoption, driven by heightened awareness and our efforts to develop the adult vaccination ecosystem in the country. The company said it is on track to launch Zejula (Niraparib), a PARP inhibitor for ovarian cancer, and Jemperli (Dostarlimab), an immunotherapy for second-line treatment of endometrial cancer. Meanwhile, the board recommended a final dividend of Rs 42 per equity share for FY25, subject to shareholder approval at the companys 100th Annual General Meeting. GlaxoSmithKline Pharmaceuticals is a subsidiary of GlaxoSmithKline plc, one of the world's leading research-based pharmaceutical and healthcare companies.
