[1]thoseguys119 on flickr creative commons
Hello, everyone, and how are you today? A bright, shiny sun is enveloping the Pharmalot campus, where the shortest of short people has left for the local schoolhouse, the official mascots are lolling about and we are, as usual, quaffing cups of stimulation. Thankfully, a prescription is not required. Perhaps you can relate. Meanwhile, here are some items of interest to keep things moving along. Have a smashing day and keep us in mind for fascinating tidbits…
Prices have been rising for priority review vouchers, which FDA awards developers of drugs for rare pediatric conditions or tropical diseases, The Wall Street Journal [4] notes. Vouchers are supposed to encourage research into underfunded diseases, and drug makers receive them after FDA approval of drug. But they can redeem them to speed FDA consideration of a subsequent drug for any disease or sell them, creating a lucrative secondary market.
Can the access to medicines campaign score another victory? The heated battle between patient advocates and the pharmaceutical industry over AIDS medicines in South Africa may have ended more than a decade ago. But Foreign Affairs [5] writes how the struggle over patient access and patent rights is now shifting to other life-saving treatments, notably for cancer (subscription may be required for this one).
An investigational Pfizer drug was given breakthrough status by the FDA for treating acute lymphoblastic leukemia, according to Pharma Times [6].
Johnson & Johnson’s immune disorder drug Stelara significantly reduced symptoms of the inflammatory bowel condition Crohn’s disease with just one infusion in about half the patients tested, the Associated Press [7] says.
New medical research guidance in India call for deferring testing in children until adult testing has demonstrated efficacy and safety, Regulatory Focus [8] says.
Eli Lilly launched a consumer ad campaign for its Trulicity injectable diabetes drug as it seeks to fend off four other drugs in the competitive GLP-1 receptor agonist class in the US, Medical Marketing & Media [9] writes.
AstraZeneca opened a new $224 million drug manufacturing and packaging factory in Russia, and would produce about 40 million packs and 850 million tablets of some 30 medicines every year, according to Reuters [10].
Bluebird Bio stock hit its lowest price this year after the company said a patient treated with a first-generation version of its gene therapy suffered a relapse seven years later, TheStreet [11]tells us.