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Infectious Disease Treatments on FDA’s Watchlist for Q2 2025
01 Apr 2025 17:58 GMT
… 2025, the FDA is reviewing treatments in infectious disease … RSV). The treatment reduced RSV-associated medically attended lower … Phase 3 trial comparing Clesrovimab with Palivizumab in high- … trials, Innoviva Specialty Therapeutics plans to submit a New Drug …
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Intas Pharmaceutical Gets CDSCO Panel Nod to study Vedolizumab Powder for Concentrate for Solution for Infusion
09 Feb 2025 21:59 GMT
… Drug Standard Control Organization (CDSCO) to conduct the Phase I clinical trial … clinical trial titled “A randomized, double-blind, three-treatment, balanced … 53) of Intas Pharmaceuticals Limited, India with Entyvio … to study Palivizumab solution for injection
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Shionogi’s RSV antiviral reduces viral load in Phase II human challenge trial
30 Jan 2025 18:57 GMT
… the US Food and Drug Administration (FDA) in October 2024. … 47;AbbVie‘s Synagis (palivizumab), a mAb only used … Trials Arena.
Elsewhere in the RSV space, US company Blue Lake Biotechnology … I/IIa trial. Meanwhile, Enanta Pharmaceuticals has reported positive …
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AstraZeneca gets CDSCO Panel nod to study Palivizumab solution
for injection
27 Jan 2025 22:17 GMT
… the drug major AstraZeneca to conduct the study of Palivizumab solution … to a group of medicines known as immunizing agents. … the condition that clinical trial sites should be geographically … sites.
Also Read: Exemed Pharmaceutical Gets CDSCO Panel Nod To …
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RSV Vaccines and Treatments Face Global Access Hurdles
07 Jan 2025 10:28 GMT
… the US Food and Drug Administration (FDA) in July 2023. … However, Midulla said that pharmaceutical companies are pushing to … to healthcare and supportive treatments, such as supplemental oxygen … well as the MEDLEY trial of palivizumab. All funding for these …
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Govt funding expands pharmac medicine access
01 Jan 2025 18:09 GMT
… four years to enhance medicine availability.
“Pharmac operates … in negotiating deals with pharmaceutical companies, ensuring the … who have previously undergone treatment.
HER2-positive metastatic … children, the funding of Palivizumab (Synagis) offers relief …
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New Year, New Medicines
31 Dec 2024 20:13 GMT
… people who have received other treatments previously.
“Patients with HER2-positive … trastuzumab deruxtecan (branded as Enhertu).
“Palivizumab (branded as Synagis) will also … entity responsible for deciding which medicines and medical devices are funded in …
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FDA Accepts Biologics License Application for Infant RSV Antibody
17 Dec 2024 23:25 GMT
The FDA has accepted a biologics … release. The FDA has also set a Prescription Drug User Fee Act … trial evaluating the effectiveness of clesrovimab compared to Merck’s competition, palivizumab … Abrysvo was approved by the FDA to prevent lower respiratory tract …
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FDA Accepts Merck’s BLA for Clesrovimab
17 Dec 2024 22:49 GMT
… season. The FDA has set a Prescription Drug User Fee … efficacy of clesrovimab versus palivizumab in infants and children … disease. Data from these trials were presented during IDWeek … get special offers
from American Pharmaceutical Review – all delivered right …
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FDA Accepts Merck's BLA for Clesrovimab, an Investigational mAb Against RSV in Infants
17 Dec 2024 17:05 GMT
… to Merck. In clinical trials clesrovimab is being studied … a randomized placebo-controlled trial evaluating a single … incidence of RSV-associated medically attended lower respiratory infections … for clesrovimab and palivizumab and no drug-related serious AEs …