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 […]
Drug-Device Combinations
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 […]
ViaCyte looks to cell replacement therapy to cure Type I diabetes
ViaCyte said today that it will begin clinical trials of its novel islet cell replacement therapy in development as a potential cure for Type I diabetes, after landing regulatory wins from the FDA and Health Canada. The company’s PEC-Direct candidate delivers stem cell-derived pancreatic progenitor cells in a device that is designed to enable direct […]
EuroPCR Roundup: Bioresorbable stents show promise, but metallic drug-eluting stents remain standard
Updated to include a statement from an Abbott spokesperson. Abbott‘s (NYSE:ABT) bioresorbable scaffold has been plagued with a myriad of troubling data, including a study that showed that the device is associated with an increase in thrombosis and target lesion failure. In April, Abbott restricted use of the Absorb devices to clinical registry studies. In response […]
Updated: Quvium’s cough monitor boosts compliance by involving caregivers
When Steven Schmidt worked at Vertex Pharmaceuticals (NSDQ:VRTX), Eric Olson – the man who led the development of the 1st drug to treat the underlying causes of cystic fibrosis – asked Schmidt to look into ways that families could become more engaged with managing a patient’s condition. Olson pointed towards a publication that showed that […]
BTG touts Ekos data from pulmonary embolism trial
BTG (LON:BTG) touted data today from the Optalyse PE trial showing that pulmonary embolism can be treated effectively with Ekos over a shorter period and with smaller doses of thrombolytic drugs compared to the current standard. The 101-patient trial randomized participants to receive therapeutic anticoagulation and Ekos acoustic pulse thrombolysis therapy at different doses for different lengths […]
BoneSupport launches trial of antibiotic-eluting bone graft
BoneSupport said today that the 1st patient has been enrolled in the pivotal investigational device exemption trial for its injectable antibiotic-eluting bone graft substitute. The company’s Fortify trial plans to evaluate Cerament G’s ability to improve the traditional management of patients with open factures of the tibial diaphysis. The trial is slated to enroll up […]