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 […]
Drug-Device Combinations
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 […]
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 […]
Tandem shares slide after Q2 sales miss
Shares in Tandem Diabetes Care (NSDQ:TNDM) fell yesterday after the medical device maker missed sales expectations but beat EPS estimates on Wall Street with its second quarter results. The San Diego, Calif.-based company posted a loss of -$21.8 million, or -44¢ per share, on sales of $21.3 million for the 3 months ended June 30, for bottom-line […]
West misses on sales, beats EPS in Q2
Shares in West Pharmaceutical (NYSE:WST) fell today after the manufacturer missed sales estimates on Wall Street with its second quarter results. The Exton, Penn.-based company posted profits of $38.8 million, or 51¢ per share, on sales of $397.6 million for the 3 months ended June 30, for bottom-line loss of -13% on sales growth of 2.5% compared […]
United Therapeutics logs Q2 beat
Shares in United Therapeutics (NSDQ:UTHR) fell today even though the biotech beat expectations on Wall Street with its second quarter results. The company recorded a net loss for the quarter and revealed that it has set aside $210 million for a possible settlement with the Dept. of Justice, according to United’s quarterly regulatory filing. Get the full story […]
FDA grants priority review to Kaleo’s auto-injector for infants, kids
Kaleo said today that the FDA granted priority review to a supplemental new drug application for Kaleo’s Auvi-Q 0.1 milligram epinephrine auto-injector. The privately-held pharmaceutical company touted this version of its device as the first specifically designed for the treatment of life-threatening allergic reactions in infants and small kids. The 0.1 mg auto-injector sports a shorter […]
Anika tops EPS estimate by 32 cents in Q2
Shares in Anika Therapeutics (NSDQ:ANIK) rose today after the orthopedics medicine company topped expectations on Wall Street with its second quarter results. The Bedford, Mass.-based company posted profits of $11.4 million, or 78¢ per share, on sales of $33.5 million for the 3 months ended June 30, for bottom-line growth of 32% on sales growth of 26% […]