[1]thx to andrew watson on flickr creative commons
And so, another working week will soon draw to a close. You knew this would happen, yes? As you know, this is our treasured signal to daydream about weekend plans. Candidly, we have a rather modest agenda. We hope to catch up on paperwork and reading, indulge the shortest of our short people and take a nap or three. And what about you? This is a fine time of year to enjoy the great outdoors, unless a hurricane is stopping by. In that event, you could tidy up around the castle, reach out to someone special or simply plan the rest of your life. Well, whatever you do, have a grand time. But be safe. See you soon…
Hillary Clinton wants stricter federal regulation of prescription painkillers, calling them a primary contributor to the nation’s opioid addiction crisis, The Boston Globe [2] reports. “We have got to take another look at the ease with which the opioids are being prescribed,” Clinton told a crowed in Boston yesterday, where she vowed to make the FDA review the way the drugs are prescribed.
Harvard Medical School is re-evaluating conflict-of-interest rules amid complaints by some professors the restrictions slow the process of turning discoveries into research tools and treatments, Stat [3] reports. The review will examine the research support rule, which bars faculty who own equity in a company from receiving grants or contributions from that company. Also being examined is the clinical research rule, which prohibits faculty from conducting clinical trials on a company’s products if they have equity in or earn at least $10,000 in income from that company.
The FDA approved the first therapy combining two cutting-edge cancer agents – Bristol-Myers Squibb’s Opdivo and Yervoy – to treat certain patients with advanced skin cancer, The Wall Street Journal [4] tells us. The combination, which harnesses the body’s own immune system to combat tumors – will cost more than $250,000 per patient for the first full year. One doc says it will be difficult to assess whether the cost of the combination is justifiable because the magnitude of the treatment’s benefit on patient survival is not yet known.
The US Federal Trade Commission argued in a court filing [5] yesterday that drug makers that make minor tweaks to their medicines in order to blunt competition from cheaper generics may be violating antitrust laws. At issue is a practice known as product hopping, which received considerable attention this past year when Allergan tried to substitute a pricier and slightly modified version of an Alzheimer’s pill and prematurely halt sales of its older drug before its patent expired. The FTC argues this type of switching thwarts generics, which hurts consumers.
Italy’s Guido Rasi will resume leadership [6] of the European Medicines Agency, one year after he was forced to step down amid a mess over the way he was originally appointed. Last November, a European tribunal annulled his 2011 appointment, following an appeal by Emil Histrov, a former head of the Bulgarian drug agency, who complained [7] at not being short-listed for the job.
Two pharmaceutical-grade drugs are being marketed as brain-boosting botanical supplements, MedPage Today [8] reports, citing research in Drug Testing and Analysis [9] that analyzed brands sold at GNC and the Vitamin Shoppe.
The FDA has accepted a regulatory submission from Sandoz, the generic unit of Novartis, for approval of a biosimilar copy of Amgen’s blockbuster Enbrel drug, Reuters [10] says.
Teva Pharmaceuticals agreed to pay $2.3 billion to buy Representaciones e Investigaciones Médicas, a manufacturer and wholesaler in Mexico, The Philadelphia Business Journal [11] writes.
Novartis has licensed a potential first-in-class immuno-oncology program from XOMA in a deal potentially worth more than $500 million, Pharma Times [12] notes.
Xenoport will stop developing on its own a drug that showed high rates of side effects in a study and instead focus on its treatment for restless leg syndrome, Reuters [13] informs us, adding that its ceo stepped down, too.