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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 Clesrovimab to Protect Infants from RSV Infection
19 Dec 2024 19:11 GMT
… and efficacy of clesrovimab versus palivizumab (Synagis; Swedish Orphan Biovitrum … phase 2b/2 trial demonstrated that clesrovimab reduced RSV … authors noted that the trial met both the secondary … points.3
The FDA set a prescription drug user fee act …
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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 …
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FDA Accepts BLA for Merck’s Monoclonal Antibody for Infant Protection Against RSV
17 Dec 2024 16:50 GMT
… SMART trial evaluating the safety and efficacy of clesrovimab versus palivizumab in … and efficacy endpoints, including reducing medically attended lower respiratory infections (MALRI … been accepted.
The FDA's Prescription Drug User Fee Act (PDUFA …
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Merck application for RSV treatment Clesrovimab for infants accepted by USFDA
19 Dec 2024 07:49 GMT
… U.S. Food and Drug Administration (FDA) has accepted the … a randomized placebo-controlled trial evaluating a single dose … efficacy of clesrovimab versus palivizumab in infants and children … disease. Data from these trials were presented during IDWeek …