(Reuters) – The European Medicines Agency (EMA), eager to accelerate access to promising new drugs, may be getting too cozy with the pharmaceutical companies it regulates. That is the concern of the watchdog charged with overseeing administrative irregularities in the European Union, which is launching a strategic inquiry to see if early-stage interactions with firms […]
Drugmakers talk competition & innovation with FDA leaders
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 […]
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 […]
Inovio looks to raise $75m in public offering
Inovio Pharmaceuticals (NSDQ:INO) said yesterday that it is launching an underwritten public offering to sell $75 million shares of common stock. The Plymouth Meeting, Penn.-based company said it plans to grant underwriters an option to buy up to $11.3 million additional shares of common stock. Inovio is slated to use its newly-acquired funds to support general […]
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 […]
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. […]