Industry News

Moderna, Inc a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it has submitted a request for emergency use authorization (EUA) for its COVID-19 vaccine (mRNA-1273) in children 6 months to under 2 years and 2 years to under 6 years of age to the U.S. Food and Drug Administration and that similar requests are underway with international regulatory authorities. The requests are based on a 25 μg two-dose primary series of mRNA-1273.

Gesynta Pharma AB announces that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to the company's drug candidate GS-248 for the treatment of systemic sclerosis. GS-248 is currently being evaluated in a Phase II clinical trial as a treatment for Raynaud’s phenomenon secondary to systemic sclerosis.

Pfizer Inc and BioNTech SE submitted an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of a 10-µg booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age (also referred to as children ages 5 through <12).

Zydus Lifesciences announced the publication of two manuscripts detailing the DREAM-ND and DREAM-D Phase 3 study results of Desidustat, a novel HIF-PH inhibitor in the prestigious American Journal of Nephrology.

ERYTECH Pharma a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, today announced the sale of its U.S. manufacturing facility to Catalent, a leading contract development and manufacturing organization (CDMO) in advanced therapies.

WHO made a strong recommendation for nirmatrelvir and ritonavir, sold under the name Paxlovid, for mild and moderate COVID-19 patients at highest risk of hospital admission, calling it the best therapeutic choice for high-risk patients to date. However, availability, lack of price transparency in bilateral deals made by the producer, and the need for prompt and accurate testing before administering it, are turning this life-saving medicine into a major challenge for low- and middle-income countries.

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

Alembic Pharmaceuticals Limited announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Ivabradine Tablets, 5 mg and 7.5 mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Corlanor Tablets, 5 mg and 7.5 mg, of Amgen Inc. (Amgen).

Regulatory submission for the treatment of anaemia of chronic kidney disease based on the ASCEND phase III clinical trial programme, consisting of five trials that all met their primary efficacy and safety endpoints in non-dialysis and dialysis patients.

US FDA regulatory submission acceptance is the third major regulatory milestone for daprodustat following the European Medicines Agency (EMA) regulatory submission acceptance and approval of Duvroq in Japan