/PRNewswire/ Therapeutic Solutions International, Inc., (OTC Markets: TSOI), announced today receipt of a written communication from the Food and Drug.
Protalix BioTherapeutics and Chiesi Global Rare Diseases Receive Complete Response Letter for Pegunigalsidase Alfa from FDA
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CARMIEL, Israel and BOSTON, April 28, 2021 /PRNewswire/ Protalix BioTherapeutics, Inc. (NYSE American:PLX) (TASE:PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx
® plant cell-based protein expression system, and Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., an international research-focused healthcare Group (Chiesi Group), today announced that they received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) seeking accelerated approval of pegunigalsidase alfa (PRX‑102) for the proposed treatment of adult patients with Fabry disease.
Amgen Provides Updated Information On LUMAKRAS™ (Sotorasib)¹ Dose Comparison Study
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THOUSAND OAKS, Calif., April 28, 2021 /PRNewswire/ Amgen (NASDAQ:AMGN) today announced that it agreed last night with the FDA s proposed post-marketing requirement to conduct, as part of the ongoing development program, a multi-center randomized clinical trial to compare the safety and efficacy of LUMAKRAS™ at 960 mg once daily versus a lower daily dose of the drug. Based on the preclinical, pharmacokinetic, and clinical data, Amgen intends to proceed with the previously disclosed study comparing 960 mg once daily to a 240 mg once daily dose.
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DUBLIN, April 27, 2021 /PRNewswire/ Alkermes plc (Nasdaq: ALKS) today announced the initiation of ARTISTRY-6, a global phase 2 trial evaluating the anti-tumor activity, safety and tolerability of nemvaleukin alfa (nemvaleukin) monotherapy in patients with melanoma who have been previously treated with anti-PD-(L)1 therapy. The study will evaluate intravenously administered (IV) nemvaleukin in patients with mucosal melanoma and subcutaneously administered (SC) nemvaleukin in patients with advanced cutaneous melanoma. Nemvaleukin, Alkermes lead immuno-oncology candidate, is a novel, investigational engineered interleukin-2 (IL-2) variant immunotherapy. Nemvaleukin was granted orphan drug designation for the treatment of mucosal melanoma by the U.S. Food and Drug Administration (FDA) in March 2021.
Bugworks secures funding from US Government s Defense Threat Reduction Agency (DTRA) to validate its clinical asset against the toughest bacterial biothreats
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BANGALORE, India, April 26, 2021 /PRNewswire/ Bugworks Research, Inc ( Bugworks ), secures funding from the Defense Threat Reduction Agency (DTRA) to support development of its novel broad-spectrum antibiotic BWC0977, against the most critical bacterial biothreats.
DTRA will provide funding, through its Bacterial Rapid Acquisition Platform program, to support the nonclinical biodefense aspects of the development of BWC0977, including execution of in vivo efficacy studies to test BWC0977 against biothreat bacterial pathogens, beginning with