Insys Therapeutics Inc., of Phoenix, said its collaboration with the Center for Medicinal Cannabis Research at the University of California San Diego School of Medicine has added a third study, aimed at evaluating pharmacological effects of cannabidiol oral solution on anxiety associated with anorexia nervosa in adults. The IND is on track for filing in the fourth quarter. Read More
Verastem Inc., of Boston, priced an offering of 5 percent convertible senior notes due 2048 through a registered direct offering. The aggregate principal amount is $150 million. Net proceeds will total about $145.4 million and will be used for continued development of recently approved Copiktra (duvelisib) and other candidates, with the balance to fund working capital, capital expenditures and other general corporate purposes. Lazard Frères & Co. LLC acted as placement agent. (See BioWorld, Sept. 26, 2018.) Read More
Shares of Immune Design Corp. hit an all-time low Friday after the company scrapped phase III testing for one of its two lead candidates, the prime-boost cancer vaccine CMB-305 in synovial sarcoma. Signs that combining it with Tecentriq (atezolizumab, Roche Holding AG) in a phase II trial is unlikely to offer a survival benefit for relapsed synovial sarcoma patients also shaped the decision. All efforts at the West Coast company will now shift to its second lead cancer vaccine, the intratumoral TLR4 agonist G-100. Read More
"What we've all been waiting for" is how H.C. Wainwright analyst Joseph Pantginis characterized details about the successful end-of-phase-II meeting with the FDA disclosed by Iovance Biotherapeutics Inc., news that helped the San Carlos, Calif.-based company raise $219.3 million through a stock sale. Read More
Members of the FDA's Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) on Friday seemed to have more questions about Dsuvia for Acelrx Pharmaceuticals Inc. than did FDA reviewers, who followed up their mostly positive briefing document by observing the company had submitted "the kinds of information" needed to resolve last year's complete response letter (CRL) for the opioid analgesic. Read More
In June 2015, when officials of Matinas Biopharma Holdings Inc. saw the results of the 42-patient trial testing its omega-3 fatty acid-based MAT-9001 for high triglycerides against the approved Vascepa (icosapent ethyl) from Dublin-based Amarin Corp. plc, they knew they had something. But, at the time, "there was not a lot of wind in the sails" of cardiovascular (CV) research, Matinas CEO Jerome Jabbour told BioWorld. "Everyone knew it would be another three years before Amarin was ready to talk about its outcomes study." Read More
Scientists have succeeded in growing human brain organoids in vivo in adult mice brains, opening up a new avenue for studying neurodevelopmental disorders and making it possible to model patient-specific cortical development. Read More
A team from the Mount Sinai School of Medicine and Columbia University Medical Center has shown aberrant splicing was a widespread feature in Alzheimer's disease (AD), and that alternatively spliced variants were present in several AD risk genes. Read More
