BioCorRx (OTC:BICX) said today that the FDA has granted the anti-addiction developer a pre-investigational new drug meeting, scheduled for Sept. 19. The Anaheim, Calif.-based company said it is slated to review the development and marketing plan for BICX101, an injectable, sustained-release formulation of naltrexone as a therapy for opioid addiction and alcohol use disorders. At […]
Drug-Device Combinations
Medtronic launches study of In.Pact Admiral drug-coated balloon in end-stage renal disease
Medtronic (NYSE:MDT) said today that the 1st patient was enrolled in a study of its In.Pact Admiral drug-coated balloon in patients with end-stage renal disease. The FDA approved the investigational device exemption study to evaluate the device as a treatment for failing arteriovenous fistulas in end-stage renal disease patients. “We are delighted to enroll and treat […]
ATS Roundup: Emulate models viral infection in “asthma-on-a-chip”
Emulate‘s small airway-lung chip could help researchers study viral-induced exacerbations of asthma, according to data presented this week at the American Thoracic Society’s annual meeting. The studies were conducted as part of the company’s partnership with (NYSE:MRK). The collaborative project was designed to enable development of new anti-inflammatory treatments for patients with asthma, according to Emulate. […]
Valeritas touts cost savings, real-world outcomes with V-Go insulin pump
In a retrospective analysis of 86 diabetic patients who switched from multiple daily insulin injections to the V-Go insulin pump, Valeritas (NSDQ:VLRX) reported this week that use of its device led to a 44% reduction in total daily insulin dose per patient. A drastic cut to a patient’s daily insulin dose and improvement to their blood sugar levels […]
Novartis’ Ultibro Breezhaler tops inhaled corticosteroid for COPD in head-to-head study
Novartis (NYSE:NVS) said today that a new analysis of its head-to-head Flame trial showed that inhaled corticosteroids may not be necessary in some chronic obstructive pulmonary disease patients with high blood eosiophil counts. The data demonstrated that the company’s Ultibro Breezhaler provided better or similar benefits compared to Seretide, an inhaled corticosteroid, in COPD patients […]
Cerus lowers Intercept sales guidance after Fresenius Kabi supply snafu
Cerus (NSDQ:CERS) said today that it expects a U.S. supply shortage of Fresenius Kabi’s (NYSE:FMS) platelet additive solution will impact blood centers that use PAS to produce Intercept platelets. The pending shortage is due to “an unanticipated delay” in FDA approval of a plastic component used to manufacture the PAS container. The original component was discontinued […]
Proteus, Otsuka take another run at FDA approval for Abilify-smart pill combo
Otsuka Pharmaceutical (TYO:4578) and Proteus Digital Health said today that the FDA accepted its resubmitted new drug application for their “smart pill”. The drug-device product combines Abilify and a Proteus ingestible sensor in a single tablet. The FDA is slated to make a decision on the NDA resubmission in the 4th quarter this year. After the […]
Symic Bio raises $30m for peripheral vein graft failure therapy
Symic Bio said yesterday that it raised $30 million in a Series B financing round, led by existing investors and HEDA Ventures. Funds from the round are slated to support the company’s clinical programs, including a drug designed to prevent peripheral vein graft failure, SB-030, and a therapy for pain management of osteoarthritis of the knee, […]
Intersect ENT updates on Sinuva steroid-releasing sinus implant
Intersect ENT (NSDQ:XENT) said today that the FDA is slated to make a decision on its new drug application for the Sinuva steroid-releasing sinus implant by January 7, 2018. The Sinuva implant, which was previously called the Resolve implant, is placed during an in-office doctors appointment and is designed to be a treatment option for […]
Triple-combo inhaler for COPD wins recommendation for approval in EU
Chiesi Group said today that the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended that the EMA approve its extra-fine triple combination inhaler for the treatment of chronic obstructive pulmonary disease. The Trimbow device combines an inhaled corticosteroid, a long-acting beta2-agonist and a long-acting muscarinic antagonist. The healthcare group said it is […]