Good morning, everyone, and welcome to another working week. The weekend respite went by quickly, did it not? Well, that happens. And so, we are now immersed in yet another round of deadlines, meetings, and the like. No doubt, you can relate. So please join us as we reach for another cup of stimulation and get busy. Here are some items of interest to help you along. Hope your day is productive …
GlaxoSmithKline (GSK) is betting that it can revamp the decades-old approach for combating HIV with a two-drug regimen, the Wall Street Journal reports. The company hopes to combine its dolutegravir, one of a class of HIV drugs known as integrase inhibitors that rapidly reduce the level of virus in the blood, with one other medicine. Glaxo CEO Andrew Witty says this could be a “game changer” because fewer drugs can mean fewer side effects.
Hoping to defuse anger over EpiPen pricing, Mylan plans to sell a so-called authorized generic version of the auto-injector at a list price of $300 per two-pack — roughly half the cost of the brand-name version, STAT writes. The generic is expected to become available in several weeks. Mylan CEO Heather Bresch called the move “an extraordinary commercial response” to patient anger and frustration over the rising cost of the EpiPen.
The US Food and Drug Administration issued emergency authorization for a Zika diagnostics test from Roche (RHHBY), skirting normal approval channels, Reuters says. The test can be used to screen patients exhibiting Zika symptoms that meet CDC criteria, including fever, rash, joint pain, and red eyes. Through last week, the US reported 2,517 Zika cases, 29 of which were likely acquired in Florida locally through mosquito bites and the rest brought by travelers.
Moderna (MRNA) Therapeutics, which has stockpiled more than $1 billion to develop a new type of medicine, is more than halfway toward raising another $600 million, The Boston Globe tells us. Launched by Flagship Ventures, the company has attracted widespread interest by pioneering a technology called messenger RNA that can carry protein replacement drugs inside cell membranes, where they can help fight cancers and other genetic disorders.
Frontida BioPharma received a warning letter from the FDA concerning quality issues at two plants in Illinois and Pennsylvania that were recently purchased from Sun Pharma.