[1]courtey blu_pineappl13 flicker creative commons
Hello, everyone, and how are you this morning? We are just fine, thank you. Of course, another busy day is unfolding, and so we are coping by quaffing our mandatory cups of stimulation. As always, we invite you to join us. Remember, a prescription is not required. So why not fortify yourselves while you can? You can also enjoy a few items of interest we have assembled for you. Hope you conquer the world today and keep in touch…
Vertex Pharmaceuticals ceo Jeffrey Leiden told a chamber of commerce gathering that government efforts to rein in prescription drug prices could stymie the development of innovative medicines, The Boston Globe [2] tells us. “If you’re going to create very, very high-risk businesses — and these are the highest-risk businesses that I know — you have to create appropriate rewards for the companies” that make breakthroughs, he intoned.
Express Scripts, the largest pharmacy benefits manager in the U.S., says two costly new cholesterol treatments – the PCSK-9 inhibitors – will not be “budget busters” for its clients and that most prescriptions for the drugs have been rejected because patients did not meet required medical criteria, according to Reuters [3]. Why? A a lot of patients either fail to qualify or their physicians are not providing needed information.
A fight over how long to protect biologics from lower-cost imitators is now the leading obstacle to negotiations aimed at completing a 12-nation trade agreement spanning the Pacific, The Wall Street Journal [4] reports. U.S. negotiators are seeking an intellectual-property rule that would grant brand-name biologic drugs a period of exclusivity of up to 12 years, during which they are protected from generic imitations, but other countries are pushing for five years.
Sarepta Therapeutics released new data on its Duchenne muscular dystrophy drug the company believes make a strong case supporting U.S. approval early next year, Boston Business Journal [5] says. All the boys in a trial were still walking at an average age of about 12 1/2 - the average age at which patients typically are forced to start using wheelchairs. And the rate of decline in the distance they can walk in six minutes was less than if they were not treated.
As the FDA struggles to oversee increasing drug production in China, the agency has finally boosted the number of inspectors and conducted 120 inspections of drug facilities last year, Bloomberg News [6] informs us.
A U.K. pilot program to vaccinate children up to 11 in schools is on hold after AstraZeneca told the National Health Service that some batches of the nasal spray did not meet licensing specifications, The Guardian [7] writes.
Pfizer settled with environmental regulators by agreeing to pay $194 million in cleanup costs related to groundwater and soil contamination at a Bridgewater, N.J., Superfund site Courthouse New Service [8] reports.
Merck Serono is returning rights to a pair of drugs, including one for a rare generic disorder, to BioMarin for an upfront payment of $379 million and $206 million in additional milestones for both products, Pharma Times [9] says.
Bayer is restructuring operations and will create three divisions for pharmaceuticals, consumer health and crop science, according to PMLive [10].
Hundreds of hospitals are believed to have settled with the government as part of a nationwide investigation into the suspected overuse of implantable cardioverter defibrillators, or ICDs, Modern Healthcare [11] writes.