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 […]
Wall Street Beat
Align Technology shares dip despite Q2 beat
Shares in Align Technology (NSDQ:ALGN) fell today despite the orthodontic device maker beating expectations on Wall Street with its 2nd quarter earnings results. The San Jose, Calif.-based company posted profits of $69.2 million, or 85¢ per share, on sales of $356.5 million for the 3 months ended June 30, for bottom-line growth of 37.9% while sales […]
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 of […]
Injectable, extended-release bipolar drug wins FDA nod
Otsuka Pharmaceutical (TYO:4578) and Lundbeck said last week that its extended-release injectable aripiprazole suspension, Abilify Maintena, won FDA approval as a maintenance monotherapy for adults with bipolar I disorder. The once-monthly intramuscular formulation was created by Otsuka and co-developed and commercialized with Lundbeck, the companies reported. Get the full story at our sister site, Drug Delivery Business News.
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 in […]
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 […]
QT Vascular launches pivotal trial for drug-coated peripheral balloon
QT Vascular said today that it launched the U.S. pivotal trial for its Chocolate Touch drug-coated peripheral balloon in the hopes of winning FDA approval. The device won CE Mark clearance in September 2015. The trial is slated to compare the safety and effectiveness of the Chocolate Touch balloon with Bard‘s(NYSE:BCR) Lutonix drug-coated balloon catheter. The company […]
Aerie inks deal for implantable drug-delivery system
Aerie Pharmaceuticals (NSDQ:AERI) said today that it inked a collaborative R&D and licensing agreement with DSM to develop an implantable drug-delivery system for patients with glaucoma and other retinal diseases. DSM has reportedly developed an injectable drug-delivery fiber using polyesteramide polymers that has proven successful in preclinical work with Aerie’s compounds. Get the full story at our sister […]
C.R. Bard faces DoJ FCA probe, posts Q2 earnings
C.R. Bard (NYSE:BCR) said today that the US Department of Justice is investigating possible False Claims Act violations related to the sales and marketing of its FloChec and QuantaFlow devices, alongside releasing Q2 earnings which topped expectations on The Street. The Murray Hill, N.J.-based company said this month it was served with a “civil investigative demand” […]
Omnicell shares surge after Q2 beat
Shares in Omnicell (NSDQ:OMCL) soared today after the company beat expectations on Wall Street with its second quarter results. The Mountain View, Calif.-based company posted profits of $837,000, or 2¢ per share, on sales of $180.9 million for the 3 months ended June 30, for sales growth of 4.6% compared with the same period last year. Get […]