Pharma News

Basel, 29 July 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA), under Priority Review, for faricimab for the treatment of neovascular or wet age-related macular degeneration (nAMD) and diabetic macular edema (DME). The FDA has also accepted the company’s submission for diabetic retinopathy.

SOUTH SAN FRANCISCO, Calif., July 28, 2021 (GLOBENEWSWIRE) Satsuma Pharmaceuticals, Inc a clinical-stage biopharmaceutical company developing STS101 (dihydroergotamine (DHE) nasal powder), a novel investigational therapeutic product candidate for the acute treatment of migraine announced randomization of the first subject in its SUMMIT Phase 3 efficacy trial of STS101 for the acute treatment of migraine.

A protein that helps regulate calcium signaling within heart cells could play a key role in preventing chronic heart failure, according to an international study led by University of Utah Health scientists. The researchers say disruption in the signaling pathway for this protein, VDAC2, causes severe impairment of heart cell contraction, making it harder for the heart to deliver blood to the body. The finding suggests that drugs and other therapeutic treatments targeting VDAC2 could eventually help alleviate heart failure.

New research conducted in monkeys reveals that T cells are not critical for the recovery of primates from acute COVID-19 infections. T cell depletion does not induce severe disease, and T cells do not account for the natural resistance of rhesus macaques to severe COVID-19. Furthermore, strongly T cell-depleted macaques still develop potent memory responses to a second infection. 

The research could help doctors optimise the choice, timing, dose and sequence of antibiotics used to treat common infections, helping to halt the growing threat of antibiotic resistance to modern medicine.

BDR Pharma gets license pact with the Defence Research and Development Organisation (DRDO) to manufacture, distribute, and market COVID-19 drug 2-Deoxy-D-Glucose (2-DG) in the country.

Last month, the Drugs Controller General of India (DCGI) had approved the oral medication for emergency usage as adjuvant therapy in mild to severe COVID-19 patients.

Saniona a clinical stage biopharmaceutical company focused on rare diseases announced that the U.S. Food and Drug Administration has granted orphan drug designation to Tesomet for the treatment of hypothalamic obesity. Tesomet is the first and only investigational treatment for HO to receive orphan drug designation. Saniona is preparing to initiate two Phase 2b studies of Tesomet in the second half of this year, one in HO and the other in Prader-Willi syndrome, for which Tesomet has already received orphan drug status.

Zydus Cadila has received tentative approval from the USFDA to market Ibrutinib Tablets, in the strengths of 140 mg, 280 mg, 420 mg and 560 mg. Ibrutinib belongs to a class of drugs known as kinase inhibitors and is used to treat certain cancers, such as mantle cell lymphoma or marginal zone lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma, and Waldenstrom's macroglobulinemia.

Sun Pharma and and Cassiopea SpA, a specialty pharmaceutical company developing and preparing to commercialize prescription drugs with novel mechanisms of action to address long-standing essential dermatological conditions today announced the signing of License and Supply Agreements for Winlevi (clascoterone cream 1%) in the United States and Canada. Winlevi  has been approved by the United States Food and Drug Administration FDA as a novel drug with a unique mechanism of action for the topical treatment of acne in patients 12 years and older.