With its diabetes drug lixisenatide already undergoing regulatory review in Europe, Sanofi SA disclosed Monday, during the American Diabetes Association (ADA) meeting in Philadelphia, that it has now filed for regulatory approval in Japan.
LONDON – A first glimpse of the outer protein coat present on many bacteria, including some important pathogens, has revealed that it is a highly regular, tight-knit structure, which researchers have likened to medieval chain mail.
LONDON – ProFibrix BV has moved swiftly from Phase II development and treated the first patients in the Phase III trial of its hemostasis product FibroCaps, less than four months after meeting with the FDA to discuss how to proceed.
LONDON – Erytech Pharma is to lead a €21 million (US$26.2 million) project to develop enzyme therapies that attack cancers by depleting amino acids in the tumor environment that are essential for tumor growth, and will also discover biomarkers to identify patients who are likely to respond to those treatments.
In a deal that is an asset disposal in all but name, Basilea Pharmaceutica AG is banking £146 million up front (US$226.8 million) and could get between £30 million and £50 million more in regulatory milestones from a global agreement on its hand eczema drug Toctino (alitretinoin) with Stiefel, the dermatology subsidiary of London-based GlaxoSmithKline plc.
Genmab A/S is getting $2 million up front and could receive up to $173 million more in milestone payments on the strength of a deal with Novartis AG on its bispecific antibody technology, DuoBody.
LONDON – Acacia Pharma Ltd. reported positive results in a Phase II study of ADP421 in the prevention of postoperative nausea and vomiting (PONV) and is now progressing the compound to Phase III, as it mulls the commercialization strategy.
Genzyme Corp.'s once-daily oral multiple sclerosis drug Aubagio (teriflunomide) hit the two main clinical endpoints in a confirmatory pivotal Phase III trial: an annualized reduction in relapse rate and a reduction in the risk of sustained accumulation of disability.
CHICAGO – Roche AG subsidiary Genentech Inc. and partner ImmunoGen Inc. had what looks to be another winner at Sunday's plenary session of the American Society of Clinical Oncology (ASCO) annual meeting.
• BioAlliance Pharma SA, of Paris, said the FDA accepted for review its new drug application for Sitavig (acyclovir Lauriad) for recurrent orofacial herpes. The application was based on results from a Phase III study showing that a single application of the drug, marketed in Europe as Sitavir, significantly reduced the occurrence of vesicular lesions and crusts, their time to healing and the severity of symptoms.