Smiths Medical allegedly conspired with United Therapeutics to stifle a generic version of pulmonary arterial hypertension drug Remodulin, according to a lawsuit filed this week by Novartis (NYSE:NVS) unit Sandoz. The Smiths Group (LON:SMIN) subsidiary, which is slated for a spinout as a separately traded company next year, makes the infusion pumps and single-use cartridges for the PAH drug treprostinil, sold […]
Cook Medical said today that it is releasing de-identified patient-level data from a clinical trial of its Zilver PTX peripheral paclitaxel-eluting stent. The move comes only a month after the FDA said that its preliminary review of long-term follow-up data found a “potentially concerning signal” of increased long-term mortality in people with peripheral artery disease […]
Surmodics (NSDQ:SRDX) shares have ticked up today after the company updated on the TRANSCEND clinical trial of its SurVeil drug-coated balloon, saying that it has resumed patient enrollment in the trial. Last month, the Eden Prairie, Minn.-based company paused enrollment after the FDA wrote a letter to doctors detailing a trend of heightened mortality in people with […]
Pulmatrix (NSDQ:PULM) said yesterday that it inked a deal with Cipla to co-develop and commercialize an inhaled iSperse formulation of the anti-fungal drug itraconazole, intended for treating allergic bronchopulmonary aspergillosis in asthma patients. Lexington, Mass.-based Pulmatrix said that it in the deal, Cipla’s Cipla Tech subsidiary will make an upfront payment of $22 million to Pulmatrix […]
The FDA has rejected Evoke Pharma’s (NSDQ:EVOK) application for a metoclopramide nasal spray for diabetic women with gastroparesis. The Solana Beach, Calif. company’s stock price tumbled 40% on the news yesterday that the agency had found dosing inconsistencies in the pivotal pharmacokinetic study for the spray, Gimoti. In an earlier multi-disciplinary letter to the company, […]
Ocular Therapeutix (NSDQ:OCUL) said today that the FDA has accepted a new supplemental New Drug Application for its Dextenza, an ocular insert designed to release dexamethasone to relieve pain following ophthalmic surgery. The Bedford, Mass.-based company’s device is designed to deliver drugs for up to 30 days following treatment in a physician’s office. Ocular Therapeutix is […]
Valeritas (NSDQ:VLRX) said today that it inked an exclusive distribution deal with Tritech Biomed to commercialize its V-Go wearable insulin delivery device designed for patients with Type 2 diabetes in Israel. Through the deal, the Bridgewater, N.J.-based company said that Tritech Biomed will have rights to promote, market and sell the V-Go system to diabetes clinics […]
Privately-held Breath Therapeutics said today that it kicked off a Phase III clinical program for its liposomal formulation of cyclosporine A for the treatment of bronchiolitis obliterans syndrome. The company’s primary drug candidate, L-CsA-i, is an inhaled therapy delivered via Pari Pharma‘s investigational eFlow nebulizer. Get the full story at our sister site, Drug Delivery Business News.
Medtronic (NYSE:MDT) responded to a study presented this week which highlighted usability concerns with its MiniMed 670G automated insulin pump, writing that the company had “made many enhancements to the system since the study was done which would likely mitigate many of the issues experienced.” Earlier this week, physicians from Boston Children’s Hospital reported that nearly one-fifth of participants […]
Data from an 83-person study of Medtronic‘s (NYSE:MDT) MiniMed 670G hybrid closed-loop insulin pump showed that nearly one-fifth of participants stopped using the device after struggling with the technical demands of the system, researchers reported. Medtronic’s MiniMed 670G device is designed to automatically track and adjust a patient’s blood sugar levels by measuring blood glucose every […]
Novartis (NYSE:NVS) has launched its Ultibro Breezhaler and Seebri Breezhaler in China for the treatment of chronic obstructive pulmonary disease. The Ultibro Breezhaler system is a once-daily fixed-dose combination of indacaterol and glycopyrronium bromide. Seebri Breezhaler is a fixed-dose formulation of glycopyrronium bromide. Get the full story at our sister site, Drug Delivery Business News.