Hello, everyone, and nice to see you again. We hope the extra-long weekend respite was relaxing and invigorating, because the familiar routine of meetings, deadlines, and whatnot has returned. This is, of course, a short week on this side of the pond, but nonetheless, there is work to be done. So grab a cup of stimulation and get ready to dig in. As usual, here are some tidbits to get you started. Good luck and keep in touch …
US Food and Drug Administration Commissioner Dr. Robert Califf appeared in a federal database of payments made last year by drug makers to physicians that was updated last week, Regulatory Focus reports. The database says he received received five payments from GlaxoSmithKline for travel, lodging, and food, and more than $5,000 in consulting fees from AstraZeneca. The FDA is looking to see whether these were reported erroneously. In 2014, when he was not working for the FDA, Califf received almost $32,000 from companies.
Teva Pharmaceuticals, one of the largest purveyors of copycat drugs, recently bid to join the US trade group for brand-name drug makers, underscoring how the lines between the two camps are increasingly blurring, the New York Times writes. But some brand-name drug makers say that conflicts with generics — notably, over patents — should disqualify Teva for membership.
AstraZeneca and Genzyme were cited for breaching voluntary industry codes in the UK, Pharma Times notes. AstraZeneca provided misleading instructions to doctors for a system that records and shares information, which could have led to inappropriate treatment with its Forxiga diabetes drug. Genzyme was chastised for making a presentation to an expert advisory group about Shire’s Fabrazyme rare disease drug that was “misleading.”
Almost 1 in 5 active pharmaceutical ingredient facilities inspected by the European Directorate for Quality of Medicines and Healthcare last year failed to meet quality standards, InPharma Technologist reports, citing the agency’s annual report. Eighteen percent of 38 facilities failed inspections, while 12 percent of 34 facilities failed the previous year.
Roche plans to cut about 350 information technology jobs by the end of 2017, a spokesman tells Reuters, confirming a report by the Basler Zeitung newspaper. About 100 positions will be eliminated in Switzerland and another 100 from the US. Meanwhile, Roche plans to add around 300 positions at shared services locations, which include Madrid and Kuala Lumpur. Meanwhile, Roche is phasing out production at a plant in Ireland, the Clare Herald says.
The cost of Mylan’s EpiPen injector has increased by approximately $170 and now totals $550 for a single order, a rise attributed to a lack of competition, according to Pharmaceutical Processing. From January through June, the drug maker raised the price by 15 percent, according to Wells Fargo analyst David Maris.
A California state ballot initiative designed to lower prescription drug prices is generating concerns from some patient advocacy groups, the New York Times writes.
Pfizer expects to submit plans to expand a plant in West Dublin and may add several hundred jobs, according to the Irish Times.
Biocad plans to fight a sales ban on two biosimilar versions of Roche cancer drugs — trastuzumab and bevacizumab — in a Sri Lanka court, Rapsi reports. Roche claims manufacturing processes were violated.
Johnson & Johnson has announced a launch schedule for its One Touch Via insulin patch, four years after it was first approved in the US, InPharma Technologist tells us.
The UK’s National Institute for Health and Care Excellence refused to recommend Bristol-Myers Squibb’s Opdivo for treating kidney cancer for people whose diseased progressed after receiving previous treatment, PM Live says.
Merck plans to acquire a controlling interest in Vallee, a producer of animal-health products in Brazil, for $400 million, the Wall Street Journal reports.
Almirall, which is building up its business in skin treatments, may be interested in acquiring dermatology products from Valeant Pharmaceuticals, according to Reuters.
A federal appeals court revived a lawsuit filed by Bristol-Myers Squibb accusing Mylan Laboratories of breaching an agreement to distribute a generic version of an AIDS drug in developing countries, Reuters writes.
Aurobindo Pharma is among the companies considering a bid for Teva Pharmaceuticals’ portfolio of drugs in the UK, Ireland, and Iceland, Bloomberg News tells us.