SAN DIEGO – Imbruvica (ibrutinib), the Bruton's tyrosine kinase (BTK) inhibitor that has racked up FDA approvals in B-cell cancers such as mantle cell lymphoma, chronic lymphocytic leukemia and Waldenström's macroglobulinemia has impressed in a non-oncology indication, chronic graft-vs.-host disease (cGVHD), with phase II data showing an overall response rate (ORR) of 67 percent. Read More
DUBLIN – Less than a week after Dendreon Corp. gained historic FDA approval, on April 29, 2010, for Provenge (sipuleucel-T) to treat prostate cancer, a group of scientists attached to Etablissement Français du Sang (EFS), the French blood transfusion service, and their collaborators published details of a cancer vaccine strategy based on a novel dendritic cell line derived from patients with a rare form of leukemia. Read More
CEO Jeff Jonas told BioWorld Today the regulatory path OK'd by the FDA for Sage Therapeutics Inc.'s postpartum depression (PPD) drug SAGE-547 hurries the potential availability in a severe unmet need by at least a year, and "shows the strength of the data package" brought to gatekeepers who said yes to a plan that the company had in mind all along. Read More
SAN DIEGO – With much of the focus at the Annual Meeting of the American Society of Hematology (ASH) on blood disorders, it can be easy to forget that a large ongoing need is for something that can substitute for blood for short periods of time. Read More
PERTH, Australia – Drug and device companies in Australia may soon be able to bring their products to market more quickly via a new priority review designation. Read More
Interquim S.A., an API manufacturer based in Barcelona, Spain, received an FDA warning letter citing the potential for cross-contamination due to inadequate cleaning procedures and equipment issues. During a May inspection, an FDA investigator discovered drug residue on cleaned equipment. Read More
Tetra Bio-Pharma Inc., of Ottawa, Ontario, said it is conducting a non-brokered private placement with Aphria Inc. of 5 million units at $0.20 each for aggregate gross proceeds of $1 million. Read More
Azurrx Biopharma Inc., of Brooklyn, N.Y., said it reached an agreement in principle with Transchem Inc. to license its transition state chemistry technology for MTAN (methylthioadenosine/S-adenosylhomocysteine nucleosidase) inhibition, which plays a key role in bacterial quorum sensing. Read More
Actinium Pharmaceuticals Inc., of New York, said an analysis of two trials with Actimab-A that enrolled 38 patients, 36 of whom were evaluable, validated its peripheral blast (PB) burden hypothesis, which suggests that patients below 200 blasts/µL have an increased response rate to Actimab-A while those above the threshold are unlikely to respond. Read More
Mast Therapeutics Inc., of San Diego, reported that the first patient has been enrolled in an investigator-sponsored phase II study of the company's lead product candidate, AIR001, for the treatment of heart failure with preserved ejection fraction (HFpEF). Read More
