Good morning, everyone, and welcome to another working week. We hope the weekend respite was refreshing and invigorating, because that relentless routine of meetings, deadlines, and whatnot has returned. You knew this would happen, yes? As always, we are coping by downing a few cups of needed stimulation and invite you to join us. Remember, no prescription is required. And of course, here are some tidbits, too. Have a great day and do keep in touch …
European regulators announced their new PRIME initiative, which is meant to mimic the FDA’s breakthrough designation and speed approval of innovative drugs. The European Medicines Agency expects to receive about 100 applications a year through PRIME, which the agency hopes will improve planning for drug development and help companies generate data needed for faster approvals.
Johnson & Johnson was accused by Maryland Attorney General Brian Frosh of conspiring with retailers to set a higher minimum price for contact lenses. Customers are paying 35 percent more for a monthly supply of Acuvue lenses based on a pricing strategy imposed on club membership discount stores, according to a lawsuit the AG filed late last week.
Royalty Pharma paid $1.14 billion to the University of California, Los Angeles, for royalty rights to the Xtandi prostate cancer drug, The Los Angeles Times writes. UCLA patented the key chemical compound and, in 2005, licensed it to Medivation, which received regulatory approval to market Xtandi in 2012 and reported $1.9 billion in worldwide sales of the drug last year.
About 15 companies are working to develop Zika vaccines, mostly in the early stages, The Wall Street Journal tells us, citing data from the World Health Organization. But at the same time, the paper writes that researchers are also debating whether the drugs and vaccines being should be offered to pregnant women, because these would have to go through extra — and potentially lengthy — regulatory hurdles to evaluate the potential risk to the unborn baby.
Venezuela has settled debts with at least three global drug makers — Novartis, Sanofi, and Bayer — by giving them bonds that trade at a heavy discount, Reuters reports. The companies acquired dollar-denominated bonds from the state-owned oil company, PDVSA, and resold the bonds for as little as a third of the face value, which contributed to about $500 million in foreign-exchange losses the drug makers experienced in Venezuela in 2015.
The Food and Drug Administration approved CSL Behring’s Idelvion, which becomes the only factor IX therapy offering up to 14-day dosing to protect against or reduce bleeds in hemophilia B patients, Pharma Times says.
GlaxoSmithKline says its Nucala asthma drug, which is already approved in the US and Europe, showed a similar safety profile in a long-term study compared with previous studies, Reuters says.
Novartis says its Cosentyx psoriasis treatment controlled skin plaques longer than a rival therapy in a clinical trial of about 670 people, Bloomberg News writes.
The Indian government plans to amend rules so that a principal investigator can undertake more than three clinical trials at a time, according to PharmaBiz.
Officials from two Nepalese drug makers were released from jail over the weekend after their warehouses were raided over charges of selling medicines at prices higher than allowed by the government, The Katmandu Post reports.