Drugmakers, payers and patient advocates convened at the FDA’s White Oak campus yesterday to present before a panel of regulatory leaders about competition and innovation in the pharmaceutical industry. The meeting, which was titled “Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access,” opened with FDA commish Scott Gottlieb, who announced that the […]
Pharmaceuticals
Employee alleges Teva hid antitrust, bribery probes
Teva Pharmaceuticals (NYSE:TEVA) employee Robert Huellemeier launched a proposed class action suit against the generic drugmaker this week, alleging that the company hid that it was under investigation for price fixing and bribery. Huellemeier, who bought TEVA shares through a company program, accused the company of leaving out any mention of multiple investigations in regulatory notes […]
CDC gives $12m to states to fight opioid epidemic
The Centers for Disease Control and Prevention said today that it plans to award more than $12 million this week to 23 states and the District of Columbia to support their efforts in tackling the opioid overdose epidemic. The funding comes from the fiscal year 2017 omnibus appropriations bill that became law in May. States […]
Novartis sales down -2% but ahead of estimates in Q2
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 […]
Gerresheimer launches new syringe safety solutions
Gerresheimer announced that it has acquired an exclusive license from West Pharmaceutical Services to complete its prefillable syringes portfolio with passive syringe safety solutions. “As a result of our long-standing partnership with the leading manufacturer of packaging components and delivery devices for parenteral drugs, we are pleased to have acquired the rights to market this […]
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 […]