Press Releases

AstraZeneca has completed the studies that support the first regulatory filings for the transition of Breztri/Trixeo Aerosphere (budesonide/glycopyrronium/formoterol fumarate or BGF) to an innovative, next-generation propellant with 99.9% lower Global Warming Potential than propellants used in currently available inhaled medicines.1 Breztri is a triple-combination therapy for chronic obstructive pulmonary disease (COPD) and will be the first medicine in AstraZeneca’s portfolio

Results from an interim analysis of the dose-optimization part of the ongoing IDeate-Lung01 phase 2 trial showed ifinatamab deruxtecan (I-DXd) continues to demonstrate promising objective response rates in patients with pretreated extensive-stage small cell lung cancer (ES-SCLC). These data were featured today as part of a press conference and will be presented during an oral presentation (OA04.03) on Sunday at the 2024 World Conference on Lung Cancer (#WCLC24) hosted by the International Ass

Sun Pharma and Israel-based Moebius Medical Limited announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation (FTD) to MM-II (Large Liposomes of DPPC and DMPC) for the treatment of osteoarthritis knee pain. Planning for confirmatory Phase 3 clinical trials for MM-II is underway.   The FDA's Fast Track program is designed to facilitate the development and expedite the review of therapies intended to treat serious conditions and addres

Eli Lilly and Company today announced positive topline results from the QWINT-1 and QWINT-3 phase 3 clinical trials evaluating once weekly insulin efsitora alfa (efsitora) in adults with type 2 diabetes using basal insulin for the first time (insulin naïve) and in those who have switched from daily basal insulin injections, respectively. In these long-term treat-to-target trials, efsitora showed non-inferior A1C reduction compared to the most frequently used daily basal insulins glo

Vetter, a leading global Contract Development and Manufacturing Organization (CDMO), has successfully completed the first 100 clinical batches of liquid and lyophilized vials at its dedicated site in Rankweil, Austria. Vetter Development Services Austria supports the manufacturing and quality control of medicinal products for clinical trials and displays an impressive development pace following its inception in 2021. “Since opening our state-of-the-art clinical production site

Moderna, Inc. today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has authorized its updated COVID-19 vaccine targeting the JN.1 variant of SARS-CoV-2. Following the MHRA decision, doses will be available for eligible groups as part of the NHS autumn vaccination program, which is prioritized for use in people at greatest risk of serious illness from COVID-19. For the first time in the UK, the updated vaccine, Spikevax® JN.1, will al

Merck, known as MSD outside of the United States and Canada, and EyeBio, a wholly-owned subsidiary of Merck & Co., Inc., Rahway, N.J., USA, today announced the initiation of the Phase 2b/3 BRUNELLO trial evaluating Restoret™ (MK-3000, formerly EYE103) for the treatment of diabetic macular edema (DME). MK-3000 is an investigational, potentially first-in-class tetravalent, tri-specific antibody that acts as an agonist of the Wingless-related integration site (Wnt) signaling

Crucial Data Solutions, a leading provider of data collection and trial management software to advance clinical research, has announced the launch of TrialKit AI, the latest innovation in its end-to-end eClinical platform, TrialKit. This advanced AI-driven reporting and analytics module is designed to transform the way clinical trial data are leveraged, enabling researchers to gain deeper insights at a faster pace, accelerate decision-making, and reduce operational costs. With Trial

The U.S. Food and Drug Administration (FDA) has granted  an emergency use authorization (EUA) for an updated version of Novavax’s COVID-19 vaccine that more closely targets currently circulating variants to provide better protection against severe COVID-19 outcomes, including hospitalization and death. The updated vaccine is authorized for use in individuals 12 years of age and older. It includes a monovalent (single) component that corresponds to the JN.1 strain of the SARS-CoV-2

Azurity Pharmaceuticals, a pharmaceutical company focused on developing innovative dose forms and formulations of products to serve the needs of overlooked patients, announced today that the U.S. Food and Drug Administration (FDA) has approved Nymalize® (nimodipine) oral solution in a 30 mg/5 mL prefilled ENFit® syringe. "Patients are our priority, and our purpose is to bring them new formulations and delivery systems that help them benefit from established medicines,&q