Top of the morning to you. Another deliciously shiny day is unfolding over the Pharmalot campus, where the skies are blue and a cool breeze is circulating. Although there is much work to be done, please join us as we pause ever so briefly to relish the moment with a tasty cup of stimulation — our choice today is peppermint mocha. After all, life is short, so why not stop to appreciate, yes? Once you’ve finished, you can dig in to the menu of interesting items below. And of course, have a wonderful day. …
Drugmakers are trying to blunt Medicare’s newfound power to negotiate medicine prices while coping with internal industry disputes and ebbing influence in Washington, D.C., The Wall Street Journal reports. Yet the lobbying comes without some key lawmakers in the industry’s corner, and at a moment when one of its biggest trade groups, the Biotechnology Innovation Organization, must find a new leader after its chief executive clashed with board members and resigned. BIO and the Pharmaceutical Research and Manufacturers of America, the other major trade group, said the law threatened investment in drug development while not doing enough to lower patient drug costs.
After a three-day hearing, an expert panel of advisers to the U.S. Food and Drug Administration voted to uphold an effort by the regulator to withdraw a controversial drug for preventing premature births, STAT reports. The 14-to-1 vote came after the agency and Covis Pharma, the manufacturer of the drug, offered highly contrasting views of reams of clinical evidence — which they parsed in excruciating detail — in order to settle the fate of the treatment, known as Makena. The FDA successfully persuaded the panel that the medication should be withdrawn because the results of a clinical trial, which was required when the agency approved Makena in 2011, failed to show the expected benefit.
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