Industry News

Zydus Lifesciences Ltd has received final approval from the USFDA to market Colestipol Hydrochloride Tablets in the strength of 1mg (US RLD: Colestid). Colestipol hydrochloride tablets are indicated as adjunctive therapy to diet for the reduction of elevated serum total and LDL-C in patients with primary hypercholesterolemia (elevated LDL-C) who do not respond adequately to diet.

Colestipol Hydrochloride is a highly complex macro molecule drug substance with little or no systemic absorption.

The SMILE-100 System is a breast thermography device that helps healthcare personnel to review, measure and analyse thermally significant indications in the breast region

Sentynl Therapeutics, Inc. (Sentynl), a U.S. based biopharmaceutical company and a wholly owned subsidiary of Zydus Lifesciences Ltd. (formerly known as Cadila Healthcare Ltd.), focused on bringing innovative therapies to patients living with rare diseases and BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio), a commercial-stage biopharmaceutical company that focuses on genetic diseases and cancers, today announced the execution of an asset purchase agreement (the Agreement) for the sale of BridgeBio’s NULIBRY (Fosdenopterin) for Injection.

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.