Alimera Sciences (NSDQ:ALIM) and Knight Therapeutics (TSE:GUD) said today that Health Canada accepted the companies’ New Drug Application for its intravitreal implant, Iluvien. The FDA approved Atlanta-based Alimera’s sustained release intravitreal implant in 2014 to treat diabetic macular edema in patients who have been previously treated with corticosteroids and did not have a clinically significant rise in […]
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FDA accepts Ocular’s NDA resubmission for Dextenza
Ocular Therapeutix (NSDQ:OCUL) said today that the FDA accepted the company’s resubmitted New Drug Application for its post-surgical ocular pain reliever, Dextenza. The hydrogel plug, inserted into a patient’s tear duct, is designed to deliver a sustained dose of dexamethasone over 4 weeks following opthalmic surgery. The Bedford, Mass.-based company has had trouble gaining regulatory approval […]
Researchers develop smart drugs using ‘DNA computers’ for controlled delivery
Researchers from the Eindhoven University of Technology have developed the 1st “DNA computer” that can detect several antibodies in the blood and perform calculations based on what it detects. The team published their work in Nature Communications and said that it’s an important step towards developing smart drugs that allow for more targeted and controlled medication delivery. […]
Common Sensing, Welkin Health collaborate on digital diabetes management system
Common Sensing and Welkin Health said last month that the companies are partnering to develop a digital diabetes management program designed to improve insulin adherence. The companies plan to craft a program that combines insulin dosing data collected from Common Sensing’s Gocap smart insulin pen with Welkin Health’s digital coaches to support patients with diabetes. […]
Adapt Pharma seeks regulatory nod for naloxone nasal spray in Europe
Adapt Pharma said today that it filed a European Marketing Application for its naloxone hydrochloride nasal spray for the treatment of opioid overdose. The Dublin-based company’s product is a ready-to-use, needle-free device that delivers a single dose of naloxone in an 0.1 mL nasal spray and does not require assembly prior to use, according to […]
CareFusion expands Alaris warning
The U.K.’s Medicines & Healthcare Products Regulatory Agency issued an 2nd warning for CareFusion‘s Alaris drug pump after the company discovered that the Alaris pumps with broken springs in the plunger assembly could accidentally release a single dose of medication. The UK watchdog 1st warned customers in December last year that the pump could release a dose […]
Fresenius Kabi launches Dilaudid injection in Simplist prefilled syringes
Fresenius (NYSE:FMS) business group Fresenius Kabi said today that its Dilaudid hydromorphone HCl injection is available in 4 different presentations of the Simplest prefilled syringes. The Lake Zurich-Ill. company’s Simplist syringes have a 2-year shelf life and do not require any assembly or point-of care preparation. The prefilled syringes sport different colors associated with different dose […]
TiGenix, Takeda highlight data for cell therapy in patients with Chron’s disease
Takeda (TYO:4502) and TiGenix (EBR:TIG) today touted long-term data from its phase III Admire-CD trial evaluating its suspension of allogenic expanded adipose-derived stem cells, Cx601, in patients with Chron’s disease. The study showed that Cx601 maintained long-term remission of treatment refractory complex perianal fistulas over 52 weeks. The randomized, phase III trial compared Cx601 to […]
CMS nominee Verma: Mylan’s EpiPen case ‘disturbing’
Seema Verma, the nominee to head the Centers for Medicare & Medicaid, said at her confirmation hearing that she would like to review the way pharmaceutical companies classify products as generic or branded, citing the case of Mylan‘s (NSDQ:MYL) EpiPen emergency allergy device. Mylan faced criticism this year for classifying EpiPen as a generic and paying smaller rebates to Medicaid […]
QuiO adds MedCrypt data security to Smartinjector pen
MedCrypt and QuiO said earlier this month that the companies are partnering to integrate MedCrypt’s data security software into QuiO’s Smartinjector devices. According to the agreement, MedCrypt will provide software security for QuiO’s Si One pen for specialty drugs and the Si Pen for diabetes patients. The companies plan to integrate the devices with software […]