A new drug application (NDA) for Xaracoll, an implantable bupivacaine collagen matrix developed by Innocoll Holdings plc for postsurgical pain relief, must be filed as a drug/device combination product, the FDA said, dashing company hopes for an August 2017 approval. Read More
The biopharmaceutical industry won a nearly $80 billion vote of confidence in 2016 by way of 814 deals tracked by BioWorld, with most occurring in the months of January and December. Read More
A weight-losing outlier in the phase III trial's placebo group "should have been picked up earlier or should have been thrown out before we unblinded," Opko Health Inc.'s vice president, Steven Rubin, told BioWorld Today, and that anomaly, with potentially others, changed an otherwise-positive outcome with long-acting human growth hormone hGH-CTP in adults with growth hormone deficiency. Read More
HONG KONG – A neurotrophic brain protein has been shown to play an important role in how well cancer patients respond to chemotherapy, according to the findings of a new Chinese study reported Dec. 17, 2016, during the European Society for Medical Oncology (ESMO) Asia 2016 Congress in Singapore. Read More
Company managers, business executives and scientists expressed their views on a variety of topics throughout the year. Here we feature a selection of those that helped define the year that was. Read More
Helix Biopharma Corp., of Toronto, said it received private placement subscription agreements for units totaling aggregate proceeds of about C$1.82 million (US$1.4 million) and had closed on C$1.58 million. Terms called for the purchase of units at $1.20 each, with each unit consisting of one common share and one common share purchase warrant. Net proceeds are expected to be used for working capital and R&D activities. Read More
Lpath Inc., of Austin, Texas, said it completed its merger with medical device firm Apollo Endosurgery Inc., with Apollo emerging as the surviving business, and has a new ticker on Nasdaq under APEN. Read More
Prima Biomed Ltd., of Sydney, reported interim data for its TACTI-mel (Two ACTive Immunotherapeutics in melanoma) trial, with the database safety and monitoring board confirming that IMP321 is safe and well-tolerated at the first dose level when used in combination with a PD-1-blocking antibody, and dose-escalation can continue as planned. Read More
