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Top of the morning to you. Another busy day is unfolding here on the Pharmalot campus, where the shortest person has left for the local schoolhouse and the official mascots are romping through the mounds of leaves dotting the grounds. As for us, we are as busy as ever, brewing still more cups of stimulation. As always, here are some tidbits. We would like to note, though, that we will be taking a long weekend starting tomorrow, so we hope those of you on this side of the pond have a lovely break yourselves. Have a successful day, meanwhile, and see you soon …

CVS Health decided that Amgen’s Repatha will be the only PCSK9 inhibitor, a new injectable cholesterol drug, on the formulary of covered medicines maintained by its Caremark pharmacy benefits manager. The move is a blow to Sanofi and Regeneron Pharmaceuticals, which sell the rival Praluent treatment. The $14,000-plus price tags for the medicines have been an issue. Recently, Express Scripts, the biggest PBM, received discounts to cover both drugs.

The Food and Drug Administration is holding a widely anticipated advisory panel meeting today to review a drug for combating Duchenne muscular dystrophy. But whether the panel will recommend agency approval is unclear after FDA medical staff last week released briefing documents raising serious doubts about efficacy, not just safety. You can read the documents and catch the webcast by going to this link.


Would drug makers and insurers work together over the cost of medicines? The trade groups for both industries have new leaders and STAT tells us they recently met for breakfast at a French bistro in Washington, D.C., in what could turn out to be “a tentative step toward an alliance.” Drug makers regularly blame insurers for shifting higher premium costs to consumers, while insurers berate drug companies for inflating prices beyond consumer means.

Can Zafgen recover from a patient death in a clinical trial? Xconomy explores the sad and possibly educational tale of what happened when a 23-year-old patient suffered a pulmonary embolism while taking its lead drug for a rare genetic condition called Prader-Willi syndrome. The company botched communications, though, and the episode is weighing on its future.


The Medicines Patent Pool signed its first license for a hepatitis C drug with Bristol-Myers Squibb, which means it can make daclatasvir, without paying royalties, in 112 low- and middle-income countries, IP Watch reports. The organization, which is backed by the United Nations, distributes licenses to generic drug makers to copy the treatment.

Bill Ackman’s Pershing Square Capital Management increased its stake in Valeant Pharmaceuticals to 9.9 percent from 5.7 percent, making it the second largest shareholder in the drug maker, The New York Times says.

The FDA approved Bristol-Myers Squibb’s Opdivo to treat advanced renal cell carcinoma, a type of kidney cancer, Reuters says. The drug is already approved to treat advanced melanoma and a common form of lung cancer.

The European Commission approved Entresto, a new Novartis drug for treating adult patients with symptomatic chronic heart failure, Reuters tells us.

Drug makers that sell opioid painkillers say a lawsuit filed by the city of Chicago is impossible to decide without determining whether the pills are safe and effective, which should be decided by the FDA, Forbes writes.

The European Commission approved Genvoya, a Gilead Science once-daily, single-tablet regimen for treating HIV, according to Pharma Times.