Enforcement Report - Week of July 5, 2023
Enforcement Report - Week of February 22, 2023
Eugia's Generic Amphotericin B Receives Approval in the U.S.
SASKATOON, SK / ACCESSWIRE / April 8, 2022 / To some, particularly in Canada and the United States, investing in research to find a scalable way to treat leishmaniasis in the tropics might seem like an odd investment of research dollars.
Sun Pharmaceutical Industries Limited announced that one of its wholly-owned subsidiaries has received final approval from US FDA for its Abbreviated New Drug Application (ANDA) for generic amphotericin B liposome for injection, 50 mg/vial single-dose vial.
BEDMINSTER, N.J., Dec. 16, 2021 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company focused on improving the intracellular delivery of critical therapeutics through its paradigm-changing lipid nanocrystal (LNC) platform delivery technology, today announced that the independent Data and Safety Monitoring Board (DSMB) of the EnACT trial (Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial) has completed a prespecified review of the third cohort and unanimously recommended progression to the fourth and final cohort of patients. Enrollment in the next randomized EnACT cohort, with 40 active-treatment patients, is expected to begin early first quarter 2022.
The Pharmaceuticals Export Promotion Council of India (Pharmexcil) has urged the Union ministry of commerce and industry to lift restriction on export of remdesivir and amphotericin-B injections considering current circumstances of reduction in local caseload of Covid-19 and associated mucormycosis cases.
BEDMINSTER, N.J., Sept. 13, 2021 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company focused on improving the intracellular delivery of critical therapeutics through its paradigm-changing lipid nanocrystal (LNC) platform delivery technology, today announced positive efficacy and safety data from the first two cohorts of patients in the ongoing Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial (EnACT) of MAT2203 (oral amphotericin B) for the treatment of cryptococcal meningitis, which is being sponsored by the National Institute of Allergy and Infectious Diseases (NIAID).
The Federation of Pharmaceutical Merchant Exporters and Allied Products (FPME) has urged the Directorate General of Foreign Trade (DGFT) to permit exports of amphotericin B by merchant exporters with prior permission, and treat them at par with manufacturer exporters.
The Federation of Pharmaceutical Merchant Exporters and Allied Products (FPME) has urged the Directorate General of Foreign Trade (DGFT) to permit exports of amphotericin B by merchant exporters with prior permission, and treat them at par with manufacturer exporters.