[1]mikequozl/flickrcreativecommons
Hello, everyone, and welcome back. It’s wonderful to see you again. After a brief hiatus, we are returning as part of Stat [2], which is devoted to health, medicine and life sciences, and will launch in a few short weeks. So think of this as Pharmalot XR, since we will re-emerge in stages and migrate to the new Stat site at that time. Meanwhile, please forgive any technical glitches that may arise as we grapple with the transitions. Now, though, the time has come to get cracking. So please join us we reach for that treasured cup of stimulation and dig in for a busy day. As always, we have assembled some tidbits to get you going. Hope you conquer the world and do stay in touch. Remember, we enjoy juicy tales and secret documents…
Democrats on the House oversight committee want a subpoena issued to Valeant Pharmaceuticals in order to obtain documents concerning large prices increases for two heart medications, according to this letter [3]. The drug maker had refused to submit documents sought by Rep. Elijah Cummings (D-Md.) and Sen. Bernie Sanders (I-Vt.), who want to know why there were 525% and 212% price increases on the two drugs the same day these were purchased. Their interest was prompted by our story [4] earlier this year. Meanwhile, Valeant ceo Mike Pearson issued a letter [5] to employees in response to concerns about its falling stock price, business strategy and the pricing controversy.
Hillary Clinton is proposing that brand-name drug makers should fund their generic rivals, Bloomberg News [6] tells us. Under the plan, the government would gather money from drug makers that fail to reach a minimum threshold on research spending. The resulting public fund would then provide grants to generics makers to make low-cost versions when none are available on the market. “A new idea to chew on,” Clinton wrote on Facebook in a question-and-answer session.
Hedge fund manager Kyle Bass was given a green light to try to profit from efforts to wipe out drug patents, a move that could fuel similar strategies by other deep-pocketed investment firms, Reuters [7] says. In a decision that comes as a blow to the pharmaceutical industry, a tribunal of the U.S. Patent and Trademark Office on Friday denied a request by Celgene to sanction Bass and his Coalition for Affordable Drugs by throwing out their challenges to its patents.
The FDA criticized a letter that was sent by several U.S. Senators who themselves chastised the agency for its policy allowing OxyContin prescriptions for youngsters, The Portland Press- Herald [8] writes. In their Sept. 9 letter, the senators lambasted the FDA for what they say are rules that would potentially increase the availability of opiates for children ages 11-16 who are prescribed the drugs to control pain. But an FDA spokesman says the new rule does not expand access to OxyContin, but sets prescribing standards.
A less-expensive version of the world’s top-selling insulin, Sanofi’s Lantus, could go on sale in the U.S. late next year after the drug makers settled a lawsuit over patents for Lantus SoloStar, its once-daily insulin in a pen-like injector, the Associated Press [9] says. The settlement allows Eli Lilly and Boehringer Ingelheim to sell their version of the Kwikpen device in the U.S. starting Dec. 15, 2016.
Bayer prevailed in a lawsuit filed by the U.S. Federal Trade Commission that accused the drugmaker of making unsubstantiated claims about a dietary supplement marketed to promote digestion, Reuters [10] reports. In an order made public on Friday, U.S. District Judge Jose Linares refused to hold Bayer in contempt for having allegedly violated a 2007 consent decree governing how it markets dietary supplements.
In a sign of how Medtronic is benefiting from moving its headquarters to Ireland from the U.S., the medical device maker is paying just $500 million in U.S. income tax on $9.8 billion of cash and investments that it has transferred to the U.S. from its overseas subsidiaries, according to The Wall Street Journal [11].
The first patient has been treated in Britain in a pioneering trial of a new treatment co-developed by Pfizer and derived from embryonic stem cells designed for patients with a condition that can cause blindness, Reuters [12] reports.
The FDA plans to increase fee rates for rare pediatric disease priority review vouchers for fiscal year 2016 by about $200,000, to $2,727,000, effective October 1 and it will remain in effect for the next year, Regulatory Focus [13] tells us.
The FDA named Michael Kopcha, who headed global R&D at Novartis Consumer Health, as permanent director of the Office of Pharmaceutical Quality, BioCentury [14]writes.
A UK supplier of metal catalysts to drug makers has been fined after a 2011 explosion at a facility left an employee with minor injuries, Outsourcing Pharma [15] informs us.
The FDA revoked an approval issued in March to Sun Pharma Advanced Research Company to launch a drug for seizures, citing manufacturing quality problems at its production site, according to Reuters [16].