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Isolagen announced that preliminary results from its Phase III clinical trial, which consisted of two simultaneous dermal studies, met three of the four primary end points and achieved statistical significance when the results of the two studies were combined.
Takeda Pharmaceutical announced that one of its U.S. affiliates, Takeda Global Research and Development Center of Illinois, has received fast-track designation by the FDA for TAK-242, its investigational compound designed for the treatment of severe sepsis.
Par Pharmaceutical announced that the U.S. District Court for the District of New Jersey has issued a summary judgment ruling that GlaxoSmithKline's U.S. Patent Nos. 5,578,628 and 4,753,789 for Zofran ODT (ondansetron HCl) Orally Disintegrating Tablets are valid, enforceable and infringed by Par's wholly-owned subsidiary, Kali Laboratories.
Morria Biopharmaceuticals has announced that its leading inhaled drug candidate, MRX3, markedly ameliorated asthma symptoms and reduced the levels of several key inflammatory mediators in preclinical trials in animals.
Transition Therapeutics announced that patient enrollment has commenced for a Phase I/II clinical trial of its Interferon Enhancing Therapy, HCV-I.E.T. in hepatitis C patients.
Allon Therapeutics announced it will begin Phase I human clinical trials next month evaluating its second drug product AL-208 intended as a treatment for mild cognitive impairment associated with cardiac artery bypass graft surgery.
AVANT Immunotherapeutics has announced positive preliminary results from a Phase II clinical trial of CholeraGarde, its cholera treatment, in infants and children.
Renovis has announced that following consultations with regulators and the SAINT II trial Steering Committee its exclusive licensee for Cerovive, AstraZeneca, has increased the planned enrollment of the Phase III SAINT II trial to 3,200 patients from the originally planned 1,700 patients.