Hello, everyone, and how are you this morning? We are just fine, thank you, especially since we have made it to the middle of the week. This is always something of a milestone, in our view, given the hectic daily routine. To celebrate, yes, we are quaffing cups of stimulation and hope you will join us. Neurons need nurturing, too. Meanwhile, here are some tidbits. Have a lovely day and do drop us a line if you hear anything interesting …
The US Securities and Exchange Commission probe into Valeant Pharmaceuticals is focused on the relationship between the drug maker and Philidor Rx Services, the specialty pharmacy, but was sparked by Valeant’s own request that regulators investigate allegations made by a short seller that company accounting was fraudulent, Reuters reports. Valeant, meanwhile, called analysts to try to restore confidence in the company, The Wall Street Journal writes, and also challenged Hillary Clinton for her ads slamming its pricing practices.
The Canadian Medical Association is being accused of compromising the independence of its medical journal after firing its editor-in-chief and disbanding the editorial oversight committee, The Globe and Mail tells us. “It’s slightly Orwellian to remove the editor, disband the [oversight committee], which is charged with maintaining editorial independence, and then suggest you’re enhancing editorial independence,” one former committee member says.
Lawyers for patients who are suing Bayer and Johnson & Johnson over the safety of the Xarelto blood thinner say the drug makers misled editors at the New England Journal of Medicine, The New York Times says. They claim that a letter published in the journal about a review of trial data and written primarily by Duke University researchers omitted important lab data, but the companies were aware of the omission and remained silent.
AstraZeneca and Novo Nordisk are looking for a lift in coming weeks from a pair of closely watched trial results, according to Reuters. Novo hopes to demonstrate the cardiovascular benefits of its Victoza diabetes treatment, while AstraZeneca looks to prove that its Brilinta blood thinner can help stroke patients, not just those people with heart problems.
Gilead Sciences added a new product to its HIV franchise after the Food and Drug Administration approved Odefsey, a three-drug regimen taken as a single, once-daily tablet, PMLive writes.
The FDA’s Science Board met Tuesday, and Dr. Robert Califf, the newly confirmed commissioner, outlined plans to tackle pain management and opioid abuse, Regulatory Focus informs us.
The UK’s National Institute for Health and Care Excellence rejected Johnson & Johnson’s Imbruvica for patients with chronic lymphocytic leukemia over cost concerns, Pharma Times says.
An Indian health ministry committee recommended that licenses of at least 10 drug makers to make a generic version of a life-saving drug be suspended over quality concerns, The Economic Times reports.
Ipsen bought an oncology drug from Exelixis in a deal worth up to $855 million, plus potential royalties, according to Pharma Times.
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