Shares of Arqule Inc. (NASDAQ:ARQL) hit a 52-week high Friday on news that the company's Bruton's tyrosine kinase (BTK) inhibitor, ARQ-531, achieved partial responses in four of six heavily pretreated people with relapsed/refractory (r/r) chronic lymphocytic leukemia (CLL) during an ongoing phase I trial. Read More
Kura Oncology Inc. CEO Troy Wilson told BioWorld that, based on powerful interim data with tipifarnib (often called "tipi" by researchers) in relapsed or refractory peripheral T-cell lymphoma (PTCL), to amend the ongoing phase II study – which has been rejiggered once already – into a registrational experiment is "a possibility. I think that would not be our preference, but you could do that." Read More
DUBLIN – Faron Pharmaceuticals Oy said it hopes to get its flagship program in acute respiratory distress syndrome (ARDS) back on track, following the Yoda pharmacokinetic/pharmacodynamic study of Traumakine (recombinant human interferon-beta 1a) in human volunteers, which demonstrated that concomitant administration of corticosteroids blocked the drug's action. Read More
AMSTERDAM – Sickle cell disease is "the most frequent red blood cell disorder worldwide," Jo Howard, of King's College London, told the audience at the 24th Congress of the European Hematology Association (EHA) on Friday. And with global migration patterns of the past decades, the disorder has gone from a tropical disease to global problem. Read More
AMSTERDAM – "We are seeing a rapid explosion of new agents in malignancies," Nathan Cherny told the audience at the 23rd Congress of the European Hematology Association (EHA). Read More
LONDON – The EMA is behind the curve in terms of its ability to qualify digital biomarkers of efficacy in clinical trials, but it is now looking to reshape internal expertise to fill the gap. Read More
BOGOTA, Colombia – A panel of experts is raising concerns about spotty access to biologics – and eventually biosimilars – across Latin America to treat multiple sclerosis (MS). Their concerns are linked to patient access, pricing, regulations and reporting, and also stem, in part, from the fragmented nature of the continent. Latin America has a population of 626 million scattered across 33 different markets with just as many regulatory structures. Read More
PARIS – The public-private university hospital consortium Dhune, from the Provence-Alpes-Côte d'Azur (PACA) region, reported the creation of a seed capital fund dedicated exclusively to life sciences, amounting to $112 million. "First [is] the [inaugural] specialized seed fund for a French region dedicated primarily to startups in the field of neurodegenerative disease, as well as health care," Olivier Blin, head of the clinical pharmacology and pharmacovigilance department at Marseille University Hospital, told BioWorld. Read More
The NIH also said it is considering an amendment of an existing license to Molecular Targeting Technologies Inc., of West Chester, Pa., for a radiotherapeutic agent for treatment of advanced, low- to medium-grade neuroendocrine tumors expressing receptors for somatostatin. Read More
Navidea Biopharmaceuticals Inc., of Dublin, Ohio, priced its previously announced underwritten public offering of 8 million shares of common stock at 75 cents per share. Read More
Eton Pharmaceuticals Inc., of Deer Park, Ill., will collaborate with Aucta Pharmaceuticals Inc., of Piscataway, N.J., to acquire U.S. marketing rights for ET-105, a patent-pending formulation of lamotrigine to be delivered to patients as an oral liquid. Read More
Researchers at Columbia University have discovered that Vibrio cholerae has co-opted CRISPR Cas9 systems into transposons for horizontal gene transfer, and that those transposons were capable of site-specific gene editing without the need for double-stranded DNA breaks. Read More
