With its lead cancer drug unpartnered and a new CEO yet to be chosen, Synta Pharmaceuticals Corp. is advancing the phase II/III AML LI-1 trial to test the chemosensitizing mettle of the heat-shock protein 90 inhibitor ganetespib when paired with low-dose cytarabine (Ara-C) in acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome patients who are not eligible for intensive chemotherapy. Read More
SHANGHAI – Cellular Biomedicine Group Inc. (CBMG) of Shanghai, has had a busy month, successfully listing on Nasdaq as the first "pureplay" biotech company from China and closing a $10 million stock transaction. Read More
Synlogic Inc. tucked a $29.4 million series A into its belt as it aims at the nexus of synthetic biology and the microbiome with the development of therapeutic microbes. Atlas Venture and New Enterprise Associates led the round, which will enable Cambridge, Mass.-based Synlogic to build out its microbial engineering platform and advance its preclinical pipeline through clinical proof of concept in several applications. Read More
Policy changes expanding access to patient health data and better fostering collaboration through transparency will be crucial to expediting patient access to new therapies, witnesses told members of the House Subcommittee on Health Tuesday, where lawmakers and experts alike testified to their frustrations over the yawning gap between the power data-sharing has enabled in the private sector and the barriers created by regulation and interoperability issues in American health care. Read More
LONDON – Biosceptre Ltd. announced positive results from a U.S. phase I study of its lead antibody, BIL-010t, providing proof of concept for what the company said is a highly specific target found in at least 20 different cancers, and paving the way for a £20 million (US$34.2 million) funding round to take two products through to phase IIb development. Read More
HONG KONG – Sinopharm Group, one of the largest biotech companies in China, is likely to undergo major structural reforms as the government kicks off a series of reforms on its state-owned enterprises (SOEs). Read More
One of the worries about biosimilar drug development is that the regulatory pathway will be just an onerous as it is for novel drugs, preventing any significant price reductions in biosimilar products. Read More
Citing "the proliferation of increasingly creative private agreements designed to silence or otherwise limit employees' rights to act as SEC whistleblowers," a coalition of more than 250 organizations asked the commission to strengthen its whistleblower program. Read More
Genentech Inc., of South San Francisco, a member of the Roche Group, said the FDA accepted its supplemental biologics license application (sBLA) and granted priority review for Avastin (bevacizumab) plus chemotherapy for the treatment of women with recurrent platinum-resistant ovarian cancer. Read More
Nymox Pharmaceutical Corp., of Hasbrouck Heights, N.J., disclosed positive efficacy data for U.S. Study NX02-0022, the company's phase III repeat injection study of NX-1207 for benign prostatic hyperplasia (BPH). Read More
Antares Pharma Inc., of Ewing, N.J., said the first patient was dosed in a double-blind, multiple-dose, phase III study to evaluate the efficacy and safety of Quickshot Testosterone administered subcutaneously once each week to testosterone-deficient adult males. Read More
