Shares in Novartis (NYSE:NVS) rose today after the pharmaceutical company met expectations on Wall Street with its second quarter results. The company posted profits of $1.98 billion, or 84¢ per share, on sales of $12.24 billion for the 3 months ended June 30, for bottom-line growth of 9% on sales loss of -2% compared with the […]
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Provention Bio evaluates vaccine to prevent onset of T1D
Provention Bio said today that it licensed an enterovirus vaccine platform that it plans to evaluate as a way to prevent the onset of Type I diabetes by vaccinating against infection by a coxsackievirus B pathogen. Previous work has shown that CVB infection could be responsible for 50% of Type I diabetes cases worldwide, according […]
Corium touts clinical data for transdermal delivery of Alzheimer’s drug
Corium (NSDQ:CORI) touted data today from a pilot bioequivalence study, comparing its Corplex Donepezil transdermal patch to oral Aricept as delivery method for the most commonly prescribed treatment for Alzheimer’s disease. Data from the pilot study demonstrated that Corium’s transdermal patch met the criteria for bioequivalence to oral Aricept, as measured by primary pharmacokinetic endpoints […]
Voluntis wins regulatory nod to integrate Toujeo insulin with Insulia mobile app
Voluntis said today its digital management system for people with Type II diabetes, Insulia, won FDA clearance and CE Mark approval to integrate Sanofi‘s (NYSE:SNY) Toujeo insulin glargine. The company’s software already works with Lantus and Levemir. The Insulia digital companion is composed of a patient mobile app and healthcare worker web portal. The app […]
FDA grants regenerative medicine advanced therapy status to Mallinckrodt’s StrataGraft
Mallinckrodt Pharmaceuticals (NYSE:MNK) said today that its StrataGraft regenerative skin tissue won regenerative medicine advanced therapy status from the FDA. The tissue-based therapy is among the first products to be granted the designation. The 21st Century Cures Act, which was passed in 2016, enabled the FDA to give accelerated review approval to products that meet RMAT criteria. […]
Anika inks $350k settlement with former CMO Mascioli, hits $5m milestone
Anika Therapeutics (NSDQ:ANIK) said last week that it agreed to pay former chief medical officer Dr. Stephen Mascioli $350,000 “for all alleged damages and attorneys’ fees.” In return, Mascioli agreed not to pursue legal action against the Bedford, Mass.-based company. Mascioli departed from Anika in January this year, after spending less than a year there. According […]
OpGen prices $10m public offering
OpGen (NSDQ:OPGN) said earlier this month that it priced a $10 million public offering of 25 million units of common stock and warrants at 40¢ apiece. The molecular diagnostics company said each common warrant has an exercise price of 43¢ per share and expires five years after issuance. The offering is slated to close tomorrow. […]
Mobile diagnostic device detects tumor cells in blood
Researchers from the Rovira i Virgili University have developed and patented a mobile diagnostic device that can detect tumor cells in blood, according to a study published in Scientific Reports. The team reported that the device can quantify tumor cells in a blood sample in real-time, positioning it as a tool to boost the diagnosis and […]
Whitehouse Labs expands drug delivery device testing capabilities
Whitehouse Laboratories, a division of Albany Molecular Research, said today that it has expanded its drug delivery device testing capabilities to include services for ISO 80369 standards. The 8 standards described in ISO 80369 were designed to prevent connector errors in medical device and drug delivery systems. Whitehouse Labs said that the group’s latest expansion […]
Titan Pharmaceuticals partners for long-acting antimalarial implant
Titan Pharmaceuticals (NSDQ:TTNP) this month revealed a collaboration with the Walter Reed Army Institute of Research to evaluate the use of its ProNeura drug-delivery technology for the long-term prevention of malaria. The company is already working to develop its implant for an array of applications. Titan president & CEO Sunil Bhonsle told Drug Delivery Business News that this […]