Amphivena Therapeutics Inc., of San Francisco, said the FDA accepted its IND for AMV564, its T-cell redirecting bispecific CD33/CD3 antibody. The company plans to initiate a phase I dose-escalation and expansion trial of AMV564 in acute myeloid leukemia patients this year. The trial will evaluate safety, pharmacokinetics and pharmacodynamics of escalating AMV564 doses and will be followed by a preliminary evaluation of the antitumor activity. It also will allow for the identification of the maximum tolerated dose as well as the recommended dose for phase II studies. Read More
For the third time in two years, Prima Biomed Ltd., of Sydney, (NASDAQ:PBMD) received notification from Nasdaq's listing qualifications department indicating that the closing bid price of the company's American depositary shares had not been sufficiently maintained at the minimum required closing bid price of at least $1 per share. Read More
Acadia Pharmaceuticals Inc., of San Diego, said it priced an underwritten public offering of 6 million shares of its common stock at $33 per share with the gross proceeds expected to be approximately $200 million. Read More
HONG KONG – In the wake of a couple of incidents that have highlighted holes in China's drug traceability and distribution systems, the country's drug regulation has put forward a series of regulatory revisions. Read More
Versartis Inc. lassoed its first commercial partner, Teijin Pharma Ltd., to develop and market its long-acting recombinant human growth hormone (rhGH) candidate, somavaratan (VRS-317), in Japan. Read More
Medivation Inc.'s second-quarter revenue miss is unlikely to dampen big pharma's interest in the firm as a takeout target, in the view of most analysts, though company management steered clear of any M&A talk during its earnings call, focusing instead on the commercial growth of Xtandi (enzalutamide) in prostate cancer and touting its late-stage PARP inhibitor, talazoparib. Read More
LONDON – Pharming Group NV has seized on Valeant Pharmaceuticals Inc.'s need to "stabilize" its organization and streamline the portfolio, taking back all U.S. rights to Ruconest (recombinant human C1 esterase inhibitor) in the treatment of acute hereditary angioedema (HAE). Read More
Adelene Perkins, CEO of Infinity Pharmaceuticals Inc., told BioWorld Today that her firm's "going-in assumption is that we will be successful" in selling rights to PI3K inhibitor duvelisib despite Abbvie Inc.'s pullout from their partnership, which followed Gilead Sciences Inc.'s trial-death woes related to Zydelig in the same class and put the jitters into investors even as they hold out hope from the promising approach. Read More
