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RESEARCH TRIANGLE PARK, N.C. – Asklepios BioPharmaceutical, Inc. (AskBio), a wholly owned and independently operated subsidiary of Bayer AG, announced that the U.S. Food & Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for LION-101 to proceed in a Phase 1/2 clinical study. LION-101 is a novel recombinant adeno-associated...
RESEARCH TRIANGLE PARK, N.C. — Asklepios BioPharmaceutical, Inc. (AskBio), a wholly owned and independently operated subsidiary of Bayer AG, announced today that the European Commission (EC) has granted orphan drug designation for AB-1003 (also known as LION-101)* for the treatment of limb-girdle muscular dystrophy (LGMD). AB-1003 is a novel investigational recombinant adeno-associated...
SAN DIEGO, Calif. — Aspen Neuroscience Inc. announced that the first patient has been dosed in the ASPIRO trial, a Phase 1/2a open label clinical trial to assess safety and tolerability of ANPD001, an autologous, dopaminergic neuron cell replacement therapy for participants with moderate to severe Parkinson’s disease (PD). Aspen Neuroscience...
Worcester, MA — Advanced Cell Technology, Inc. (OTC:ACTC.PK) and its collaborators at OHSU reported today the long-term safety and efficacy of human embryonic stem cell (hESC)-derived retinal pigment epithelium (RPE) produced under manufacturing conditions suitable for human clinical trials. Two important early potential hESC applications are the use of RPE...
WILMINGTON, Del. — AstraZeneca today announced the initiation of a Phase III trial to investigate the potential effect of triple-combination inhaled therapy BREZTRI AEROSPHERE® (budesonide/glycopyrronium/formoterol fumarate, or BGF) on severe cardiopulmonary outcomes, including death*, in people with chronic obstructive pulmonary disease (COPD) who also have elevated cardiopulmonary risk, irrespective of...
LYON, France and CAMBRIDGE, Mass. — Amolyt Pharma, a global, clinical-stage biopharmaceutical company specializing in developing therapeutic peptides for rare endocrine and related diseases, today announced it has entered into a definitive agreement for AstraZeneca to acquire Amolyt Pharma at a purchase price of $800 million upfront and a potential...
United Kingdom-based global pharmaceutical company AstraZeneca has integrated more than 10 molecular products worldwide in the rare diseases field and is promoting more than 20 clinical research programs, said an executive of the company.