Industry News

Myovant Sciences and Pfizer Inc announced that the U.S. Food and Drug Administration (FDA) accepted for review a supplemental New Drug Application (sNDA) for MYFEMBREE® (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) for the management of moderate to severe pain associated with endometriosis. The FDA set a target action date of May 6, 2022 for this sNDA under the Prescription Drug User Fee Act (PDUFA).

Novartis today announced an update on the Phase III BELINDA study investigating Kymriah (tisagenlecleucel) in aggressive B-cell non-Hodgkin lymphoma (NHL) after relapse or lack of response to first-line treatment. The BELINDA study did not meet its primary endpoint of event-free survival compared to treatment with the standard-of-care (SOC). SOC was salvage chemotherapy followed in responding patients by high-dose chemotherapy and stem cell transplant. The safety profile was consistent with the established safety profile of Kymriah.

SAN FRANCISCO, Aug. 19, 2021 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based immunotherapies, today announced that it has entered into a third clinical trial collaboration and supply agreement with Merck (known as “MSD” outside the United States and Canada).

Merck known as MSD outside the United States and Canada announced that the U.S. Food and Drug Administration (FDA) has approved WELIREG, an oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for the treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery.

Germanys specialty glass company SCHOTT AG has a new partner: Serum Institute of India, the world's largest vaccine producer and manufacturer of highly-effective biologies, has bought the 50% stake in the Indian joint venture SCHOTT Kaisha from former co-owners Kairus Dadachanji and Shapoor Mistry. The joint venture is the leading Indian manufacturer of pharma packaging products such as vials, syringes, ampoules and cartridges used to package life-saving medications.

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.

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.