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Pharma Tech

AstraZeneca | November 13, 2020

Months after drugmakers launched an unprecedented COVID-19 research effort, some existing medicines have turned in promising results—but more of them have failed against the virus. And AstraZeneca’s blood cancer med Calquence just became one of them, falling short in two tests in hospitalized patients. AstraZeneca said Thursday that the medicine—already approved in mantle cell lymphoma—didn't help patients survive the virus and reduce respiratory failure any better th...

Business Insights

Hikma Pharmaceuticals PLC | September 21, 2021

Hikma Pharmaceuticals PLC (Hikma), the multinational generic pharmaceutical company, announces the signing of an exclusive US license agreement with FAES Farma S.A. to commercialise Bilastine tablets, a non-sedating second generation antihistamine molecule for the treatment of allergic rhinitis and urticaria. Under the terms of the agreement, Hikma will be responsible for obtaining regulatory approval of Bilastine by the US Food and Drug Administration (FDA) and for the commercial...

Pharmacy Market

Ascentage Pharma | January 05, 2021

Ascentage Pharma (6855.HK), an internationally engaged, clinical-stage biotechnology organization occupied with creating novel treatments for malignancies, persistent hepatitis B (CHB), and age-related sicknesses, today reported that the US Food and Drug Administration (FDA) has allowed an Orphan Drug Designation (ODD) to the organization's novel Bcl-2 inhibitor, APG-2575, for the therapy of patients with intense myeloid leukemia (AML). This is the fourth ODD allowed to APG-2575 by the US FD...

Business Insights, PHARMA TECH

businesswire | April 19, 2023

Simulations Plus, Inc. a leading provider of modeling and simulation software and services for pharmaceutical safety and efficacy, announced that the U.S. FDA has renewed its licenses to the DILIsym® software platform, the flagship quantitative systems toxicology (QST) software for predicting and investigating drug-induced liver injury (DILI). The one-year renewal provides continued access to DILIsym software for authorized FDA employees across all FDA divisions. Dr. Paul B....