And so, another working week will soon draw to a close. And not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda includes indulging the shortest of short people at a sugary destination, catching up on our naps, and possibly visiting the Pharmalot ancestors. And what about you? It’s never too late to enjoy the great outdoors. You could catch up on reading or putter around your castle. Or debate politics, an interesting pastime this year. Well, whatever you do, have a grand time, but be safe. See you soon …
In a setback for Bristol-Myers Squibb, the drug maker says top-line study results show its non-small cell lung cancer drug, Opdivo, did not meet its primary endpoint in a Phase 3 clinical trial. Opdivo is already approved to treat some types of cancer and was being investigated for previously untreated advanced non-small cell lung cancer. The disclosure sent Bristol-Myers stock plummeting in pre-market trading.
As part of its plan to counter anger over high drug prices, the pharmaceutical industry trade group is adding new members, whose fees will help build a war chest, Politico reports. The extra dues, which are based on company sales, will help fund a new ad campaign. Among those who may join are Genentech and Gilead Sciences. Meanwhile, the trade group is holding meetings with not just politicians, but also industry insiders who will shape policy on prices.
The US Chamber of Commerce and a Texas business group filed this lawsuit against the federal government, alleging the Treasury Department’s rules limiting tax inversions violate the law. Last April, the government issued new regulations that prompted Pfizer and Allergan to scrap a merger that would have located headquarters in Ireland, where corporate tax rates are lower.
The number of biotech financing rounds in the US continued its upward creep in June, as did the aggregate value of those rounds, according to a Venture Valuation report. There were 14 rounds in June worth $421 million, a 14 percent increase, but this was lower than the previous 12-month average of $580 million. Phase 3 financing jumped in this year’s second quarter to 26 percent, compared with 6 percent in the first quarter and 10 percent a year ago.
A US Food and Drug Administration advisory panel recommended approval of a long-acting opioid painkiller from Egalet called Arymo ER, Reuters reports. The panel noted, however, that the drug may deter abuse, but does not eliminate the risk of abuse if addicts try to snort, chew, or inject it. The tablets are designed to be extremely hard, making them more difficult to break down to extract the active ingredient.
Danish regulators say that several children have been hospitalized by a vitamin D supplement made by Inno Pharma, according to InPharma Technologist.
Companies making biologics and biosimilars are split between those who do and do not want the FDA to include a statement on interchangeability status on each new product label, Regulatory Focus says.
The European Union approved a plan for Sanofi to exchange its animal-health unit for most of Boehringer Ingelheim’s consumer health-care business if they divest several businesses, the Wall Street Journal reports.
Bayer and AbbVie are focusing on endometriosis, a women’s disease that is hard to diagnose and harder to cure, Bloomberg News tells us.
Sandoz, the Novartis generics unit, is launching a long-acting buprenophine patch in the UK following victory in a patent battle with Napp Pharmaceuticals, PharmaTimes writes.