Industry News

Alembic Pharmaceuticals Limited announced that its joint venture Aleor Dermaceuticals Limited (Aleor) has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Nystatin and Triamcinolone Acetonide Ointment USP, 100,000 units/gram. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Nystatin and Triamcinolone Acetonide Ointment USP, 100,000 U/g/0.1%, of Taro Pharmaceuticals U.S.A. Inc. Nystatin and Triamcinolone

Biotechnology company Zymergen is pleased to announce early results from its work on infectious disease, discovering hundreds of potential novel hits against malaria, tuberculosis, and COVID-19 targets. Hits for PfAPP, a critical target in the treatment of malaria, are now being advanced for validation, with hits for an emerging COVID-19 target, PLpro, expected to follow.

Zydus Lifesciences Ltd a discovery-driven, global lifesciences company announced that it has received approval for its New Drug Application (NDA) from the Drug Controller General of India for OxemiaTM (Desidustat), a first-of-its-kind oral treatment in India for anemia associated with Chronic Kidney Disease (CKD).

AstraZeneca’s Rare Disease group, has closed an exclusive global collaboration and licence agreement with Neurimmune AG for NI006, an investigational human monoclonal antibody currently in Phase Ib development for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM), an underdiagnosed, systemic condition that leads to progressive heart failure and high rate of fatality within four years from diagnosis.1,2

Alexion has been granted an exclusive worldwide licence to develop, manufacture and commercialise NI006.

Lupin Limited announced the launch of Sevelamer Hydrochloride Tablets, 800 mg, having received an approval from the United States Food and Drug Administration (FDA). The product will be manufactured at Lupin's facility in Nagpur, India.

Sevelamer Hydrochloride Tablets, 800 mg is a generic equivalent of Renagel® Tablets, 800 mg of Genzyme Corporation.

Medicago, a biopharmaceutical company headquartered in Quebec City, and GlaxoSmithKline announced that Health Canada has granted approval for COVIFENZ, COVID-19 vaccine, (plant-based virus-like particles [VLP], recombinant, adjuvanted). This vaccine is indicated for active immunization to prevent coronavirus disease 2019 (COVID‑19) caused by severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2) in individuals 18 to 64 years of age.

Merck, a leading science and technology company, today announced in a European worksharing procedure (WSP) an extension to the label for metformin products in the EU - Glucophage (metformin hydrochloride [HCL] immediate release), Glucophage XR (metformin HCL extended release) and Stagid® (metformin embonate immediate release) - for use throughout pregnancy.

CTI BioPharma Corp announced the U.S. Food and Drug Administration (FDA) has approved VONJO (pacritinib) for the treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with a platelet count below 50 × 10⁹/L. VONJO is a novel oral kinase inhibitor with specificity for JAK2 and IRAK1, without inhibiting JAK. The recommended dosage of VONJO is 200 mg orally twice daily.

The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration (FDA) has approved CARVYKTI™ (ciltacabtagene autoleucel; cilta-cel) for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.