Regenerative medicine company ViaCyte said today that the first patients have been implanted in a trial of its islet cell replacement therapy, PEC-Direct. San Diego-based ViaCyte is developing the cell therapy as a functional cure for patients with Type I diabetes who are at risk of suffering acute life-threatening complications. The company’s open-label clinical trial […]
Drug-Device Combinations
Innoviva proposes $175m private placement
Innoviva (NSDQ:INVA) said today that it plans to offer $175 million in a private placement to certain qualified institutional buyers. The Brisbane, Calif.-based company said it expects to give initial buyers a 30-day option to buy up to an additional $17.5 million in notes. The terms of the convertible senior notes, which are due 2025, are […]
Mallinckrodt enrolls first infant in registry for inhaled nitric oxide gas
Mallinckrodt Pharmaceuticals (NYSE:MNK) said today that it included the first patient in its Phase IV registry evaluating the use of inhaled Inomax nitric oxide gas for premature neonates compared to term and near-term newborns. Inomax, which has FDA approval, is designed to boost oxygenation and lessen the need for extracorporeal membrane oxygenation in term and near-term […]
Milestone Scientific wants to bring subcutaneous injections into the 21st century
As a dentist, Mark Hochman gave countless injections to his patients and watched as many of them would cringe from pain. Frustrated with a technology that he said hasn’t improved in decades, he decided to take a different approach to the common method of drug delivery. “A team of us got together to evaluate whether […]
Express Scripts covers Mylan’s EpiPen on 2018 formulary, excluding rivals
Express Scripts (NSDQ:ESRX) said yesterday that it would include Mylan‘s (NSDQ:MYL) EpiPen emergency allergy device on its 2018 formulary, favoring the drugmaker’s product over auto-injectors from competitors like Impax Laboratories (NSDQ:IPXL) and Kaleo. The largest pharmacy benefit manager in the U.S. has practiced excluding certain medicines from its list of covered drugs since 2014, pointing towards […]
AcelRx’s pain relief drug-device combo succeeds in late-stage trial
AcelRx Pharmaceuticals (NSDQ:ACRX) touted device functionality outcomes today from the Phase III trial of its Zalviso drug-device combination product. Zalviso is designed to deliver a sublingual formulation of an opioid, sufentanil, to adult patients with moderate-to-severe pain in a hospital setting using a hand-held, pre-programmed system. The device allows patients to self-administer sufentanil as often as […]
Anika names medtech veteran as new president | Personnel Moves – July 31, 2017
Anika Therapeutics (NSDQ:ANIK) last week named medtech veteran Joseph Darling as president, taking over the role from CEO Charles Sherwood. The chief exec plans to stay in the corner office as he transitions the role of president to Darling. Previously, Darling worked as an executive in privately-held orthopedic companies. He has also held senior level executive […]
FDA grants priority review to Indivior’s monthly buprenorphine depot
Indivior (LON:INDV) said today that the FDA accepted the new drug application for its once-monthly injectable buprenorphine depot as a treatment for adults with opioid use disorder. The regulatory agency also granted priority review designation to the company’s NDA. Indivior’s application was supported by data from a pivotal Phase III trial, which evaluated the safety and efficacy […]
NantCell takes on troubled CytRx chemotherapeutic
NantCell, one of controversial biotech entrepreneur Patrick Soon-Shiong’s many businesses, said last week that it inked a deal to acquire CytRx‘s (NSDQ:CYTR) aldoxorubicin cancer drug. The compound has faced several obstacles in clinical trials, including when it missed the primary endpoint of a late-stage clinical trial, failing to help patients with second-line soft tissue sarcoma […]
Titan Pharmaceuticals lands $10m debt facility
Titan Pharmaceuticals (NSDQ:TTNP) said last week that it inked a $10 million venture loan and security deal with Horizon Technology Finance Corp. The first $7 million tranche was triggered after the groups inked a deal, Titan reported, and a second option of $3 million is available to the California-based company until March 31, 2018, contingent upon […]