Biocardia Inc. said the FDA has given its nod to start a phase III trial with CardiAMP, the firm's bone marrow-derived therapy for heart failure, but "we haven't made a decision as to whether or not we will begin the trial without having the full funding in place" to finish, said CEO Peter Altman, and the San Carlos, Calif.-based firm doesn't have enough for that now. Read More
After working quietly for five years on a drug delivery platform that could change the paradigm in treating attention deficit hyperactivity disorder (ADHD), Canadian specialty pharma Highland Therapeutics Inc. received significant validation of its efforts. Read More
Well, now it is official: The record number of 66 U.S. biotech initial public offerings (IPOs) that were completed in 2000 has been broken following the completion of another two IPOs last week. Read More
HONG KONG - A team of Japanese scientists has discovered a new single gene mutation that can cause infertility, which not only sheds new light on the causes of that condition, but could also lead to its early detection and treatment based on genetic diagnosis. Read More
Triphase Accelerator Corp., a tiny drug developer with big backing from a Celgene Corp. deal, is pushing to bring economic rationality to the long haul between investigational new drug application filings and phase II proof of concept. Read More
The Government Accountability Office (GAO) recommended that the Centers for Medicare & Medicaid Services (CMS) clarify its Medicare Part B payment policy for compounded drugs and align its payment practices with that policy. Read More
strong>Neothetics Inc. (formerly Lithera Inc.), of San Diego, set terms for its initial public offering. The company is seeking to raise $74.2 million, including overallotments, by offering 4.3 million shares priced in a range of $13 to $15. Read More
Aveo Oncology Inc., of Cambridge, Mass., signed a research and exclusive option agreement giving Ophthotech Corp., of New York, an exclusive license to investigate the potential of Aveo's small-molecule vascular endothelial growth factor tyrosine kinase inhibitor, tivozanib, outside Asia for the potential treatment of non-oncologic diseases of the eye. Read More
Actinium Pharmaceuticals Inc., of New York, reported interim data from the ongoing phase I/II trial of Actimab-A, its radiolabeled antibody, in older patients with newly diagnosed acute myeloid leukemia (AML), including median overall survival (OS) of the seven secondary AML patients (with prior myelodysplastic syndrome) of 9.1 months, compared to historical norms of typically two months to five months. Read More
Merck & Co. Inc., of Boston, said results from a phase II trial, dubbed C-Worthy, testing grazoprevir/elbasvir (MK-5172/MK-8742, the company's investigational NS3/4A protease inhibitor and NS5A inhibitor, respectively) with or without ribavirin (RBV) in treatment-naïve and previously treated (with peg-interferon/ribavirin) patients with chronic hepatitis C virus (HCV) genotype 1 (GT1) infection showed rates of sustained viral response 12 weeks after the completion of therapy (SVR12) greater than, or equal to 90 percent regardless of treatment duration or co-administration of RBV. Read More
GE Healthcare, of Chalfont St. Giles, UK, and Takeda Pharmaceutical Co., of Osaka, Japan, entered an alliance for research and development in the field of hepatic fibrosis, a key factor in the diagnosis and treatment of liver diseases. Read More
