Tekmira, developer of an RNAi treatment for Ebola, has come to terms with regulators on an access program for its in-development drug, allowing the company to provide doses to patients who have contracted the deadly virus.
The approvals, and the sales, just keep piling up for Eylea, the blockbuster that Bayer shares with developer Regeneron. Just weeks after getting an important nod in Europe, it has won approval in Japan, the world's third largest market, for use in myopic choroidal neovascularization.
The European Commission approved Merck Animal Health's poultry vaccine NOBILIS IB Primo QX to help protect chickens against viral infectious bronchitis.
Risk-sharing researcher Evotec wants what it's due, mounting a legal challenge to reclaim some outstanding royalties after a biotech buyout scandal left it high and dry.
Novo Nordisk is hustling to get work done so that it can resubmit its blockbuster hopeful Tresiba to the FDA next year with an eye on getting into the market by 2016, three years after the FDA squelched its plans with its initial denial. In the meantime, Novo is finding new ways to combo Tresiba up and sell it in Europe where it is approved.
President Obama is cracking down on so-called superbugs, those that cause deadly antibiotic-resistant infections, with an executive order that will establish a task force to combat the problem.
Health care venture capitalist, Lisa Suennen shared her take on what it would take to improve the situation. She recommends inexpensive new outpatient monitoring technologies, regulatory adjustments to encourage the system to play fair and more transparency in medical pricing, as well as patient education based of behavioral economics to help people take care of their own health.
"Mr. UDI" gave industry advice on complying with the complex unique device identification rules as medical device companies barrel toward the Sept. 24 deadline for adding identifiers to high-risk devices. Former FDA official Jay Crowley has acquired the nickname for his role in implementing and designing the UDI system. He is now a consultant for USDM Life Sciences.
The approval puts Gilead well on track to meet analyst expectations that Zydelig (idelalisib) will be hauling in $1.2 billion in annual sales by 2020, though there's little doubt Gilead will face pressure from European health agencies to keep a lid on the new drug's price.
Novo Nordisk picked up European approval for a combination of a long-acting insulin and its own Victoza, pioneering a once-a-day approach to Type 2 diabetes that could bring in blockbuster sales.