In revisiting the safety and efficacy of a stable of broad-spectrum antibiotics that have been on the market for decades, the FDA is asking two advisory committees to look at the risk-benefit profile of fluoroquinolone drugs in treating non-life-threatening bacterial infections. Read More
Atreca Inc. played its hot cancer immunotherapy hand to amass an oversubscribed $56 million series A, enabling the company to exploit its Immune Repertoire Capture (IRC) technology in a ploy to advance therapies that optimize antitumor immune responses in concert with the use of checkpoint inhibitors and immune activators. Read More
LONDON – The first formal clinical trial of stem cell-based trachea transplants will open in 2016 following the UK Medicines and Healthcare product Agency's (MHRA) approval for the four-patient phase I study. Read More
MUNICH – As BIO-Europe drew to a close, the ongoing funding gap in Germany loomed large. Although European biotechnology looks set to have one of its best ever years for funding, Germany, as ever, is locked in a deep freeze, with little prospect of a thaw. Read More
The FDA has approved a biologic bone graft for use in the cervical spine. The i-Factor peptide-enhanced bone graft from Cerapedics Inc., of Westminster, Colo., a private orthobiologics company, got the nod as a drug-device combination product for use in anterior cervical discectomy and fusion (ACDF) procedures in patients with degenerative cervical disc disease. Read More
Mylan NV, of Hertfordshire, UK, agreed to sell the rights and assets of seven generic drugs to Alvogen Group Inc., of Pine Brook, N.J., to settle FTC charges that its proposed acquisition of Perrigo Co. plc, of Dublin, would be anticompetitive. Read More
Oncosec Medical Inc., of San Diego, said it entered agreements with institutional investors to purchase about $7.5 million of securities in a registered direct offering. Read More
Ironwood Pharmaceuticals Inc., of Cambridge, Mass., reported U.S. sales of constipation drug Linzess (linaclotide) totaling $117.5 million for the third quarter, a 47 percent increase compared to the same quarter in 2014. Sales were reported by partner Allergan plc, of Dublin. Read More
Genocea Biosciences Inc., of Cambridge, Mass., said findings from a pilot study involving a retrospective analysis of 10 checkpoint inhibitor (CPI)-treated patients' T-cell responses to 23 known tumor-associated antigens support the potential of ATLAS, the firm's rapid antigen identification screening system, to profile responses to immunotherapies for cancer. Read More
Biodel Inc., of Danbury, Conn., said it started a phase IIa trial (Study 3-157) to test BIOD-531-based regimens against a basal-bolus insulin regimen and in combination with a GLP-1 analogue. Read More
