Top of the morning. And a fine one, it is. Clear skies and a shiny sun are greeting us today as we brace ourselves for the mid-week crush. As usual, the to-do list remains quite long at this time of the week. We trust you can relate. So please join us for the mandatory cup of stimulation, which we hope has some beneficial effects, despite yet another questionable bit of evidence. We can dream, after all. Meanwhile, here are some tidbits to help you along. Have a smashing day and do keep us in mind when you hear something intriguing …
The UK’s cost-effectiveness watchdog rejected Repatha, the new cholesterol fighter from Amgen, because there are no studies to gauge a direct effect on cardiovascular events, according to Pharma Times. The National Institute for Health and Care Excellence also noted it remains an open question whether the drug, which is a PCSK9 inhibitor and reduced LDL cholesterol, can lower rates of heart attacks and strokes.
A new deadline of Dec. 24 was set for the FDA and Pacira Pharmaceuticals to try to resolve a closely watched legal battle over off-label marketing and free speech, according to a court document. Pacira recently filed a lawsuit accusing the agency of overstepping its authority to thwart inappropriate marketing. The drug maker argues that the FDA has retroactively attempted to narrow the approved product labeling for a painkiller.
A World Health Organization survey found that 25 percent of people believe it is OK to use antibiotics that were given to a friend or family member if it was used to treat the same illness. And 43 percent believe it is OK to buy the same antibiotics used during a previous sickness. These practices lead to improper use of the medicines and, ultimately, antibiotic resistance, according to the WHO, which surveyed more than 9,700 people in 12 countries.
For all the political talk about controlling prescription drug prices, none of the rhetoric suggests anything discussed so far would make a difference, Beltway watchers tell STAT. “None of the proposals on the table move the needle that much,” said Caroline Pearson, senior vice president at Avalere Health. “I’ve yet to see anything that you wave the magic wand and it solves the problem in a major way.”
The Indian government hopes to meet with device makers and the health ministry, among others, on Nov. 23 to develop a model for capping prices, The Times of India writes.
The FDA accepted an application from Sandoz, the Novartis unit, for a biosimilar version of Amgen’s Neulasta drug, marking its third biosimilar filing in the US, Reuters tells us.
Novartis has taken “remedial action” at its two plants run by its Sandoz generic unit in India that received a warning letter from the FDA and expects regular operations to resume shortly, according to NDTV.
Some big investors are bailing on Valeant Pharmaceuticals, while others are picking up shares in hopes the beleaguered drug maker will soon rebound, USA Today reports.
Clovis Oncology stock sank after the FDA requested more data on its leading drug candidate, which will likely delay approval, Forbes writes.
India’s health ministry plans to redo its guidelines for approving biosimilars so they more closely match guidelines found in other countries, The Economic Times says.