Good morning, everyone, and how are you today? We are just fine, thank you, despite another steamy day unfolding here on the Pharmalot campus, where the short people and the official mascots are all sleeping in. As for us, we are quaffing cups of stimulation, since the neurons can use a little help. Feel free to join us. And of course, here are some tidbits to enjoy, as well. Have a lovely day and do keep in touch …
The Irish Pharmaceutical Healthcare Association acknowledged it would have been better if more Irish doctors consented to being named as the recipients of payments from drug makers, the Irish Medical Times writes. The value of payments to health care providers and organizations was made public for the first time in June as part of a voluntary Europe-wide initiative, but only 55 percent of Irish doctors consented to being named.
Vertex Pharmaceuticals is ending a late-stage study testing a two-drug combination treatment on a small group of cystic fibrosis patients after an independent board concluded the therapy did not provide any benefit, the Boston Globe reports. The company had warned the trial might not prove effective. However, one Wall Street analyst noted this subgroup of patients is the primary untapped opportunity in cystic fibrosis that remains for Vertex.
At the end of June, drug and device makers had donated $594,000 to Hillary Clinton, compared with about $1 million to President Obama in 2012, STAT writes. However, this does not include personal donations from industry executives to the super PACs that can collect unlimited amounts of money. If you count those contributions, Clinton has raised more industry money than Obama had by mid-2012, even though she has bashed drug makers.
A chance collaboration between an immunologist helping his stepmother fight cancer and the oncologist who treated her led to a discovery that could help more patients benefit from a transformative therapy, the Wall Street Journal writes. The researchers, from the University of California, San Francisco, say they identified a unique type of immune-system cell that predicts whether patients will respond to a checkpoint inhibitor.
The US Food and Drug Administration has carryover balances of unspent user fees that total nearly $300 million. User fees, you may recall, are paid by drug makers to the agency for product reviews, among other things. But given concerns about drug prices, Avalere Health’s Jay Jackson suggests the agency should use the unspent fees to accelerate approvals — especially for medicines that would pose new competition to existing treatments.
German regulators want statin ingredients made by Artemis Biotech to be banned after finding various manufacturing violations at a facility in Hyderabad, India, according to this report. The regulators, who found five major deficiencies, raised questions about quality management systems, documentation of repackaging, and labeling pharmaceutical ingredients, among other things.
Drug makers in China will have to report to the country’s FDA any changes in approved manufacturing processes and to conduct studies demonstrating new processes do not affect drug quality, BioCentury says.