Rise and shine. Another busy day is on the way. But this is to be expected, yes? No matter. Keeping busy is a good thing and we are helped along by another cup of stimulation that is brewing in our trusty coffee kettle. Feel free to indulge, as well. After all, no prescription is required. Meanwhile, here are some items of interest to keep you moving in the right direction. Hope you have a smashing day and do stay in touch …
Janet Woodcock, who heads the Food and Drug Administration drug-review division, is “very comfortable” with her controversial decision to approve the Sarepta Therapeutics medicine for Duchenne muscular dystrophy, the Boston Globe says. But she also criticized Sarepta because its clinical work “left so many questions” and added that Sarepta executives “had a much overblown idea of the pharmacodynamic effect” of their drug.
Roche agreed to cut the price of its Perjeta breast cancer treatment in the UK after the National Institute for Health and Care Excellence refused to endorse the drug for England’s National Health Service. An estimated 1,380 women a year will benefit from the drug, which is given to patients with the HER2-positive form of breast cancer once they are diagnosed. The discount means the drug is a “cost effective use of NHS money,” says NICE official Carole Longson.
Regeneron Pharmaceuticals and Sanofi say their Odyssey Outcomes trial evaluating the effect of Praluent will continue following a second interim analysis. The trial for the cholesterol-lowering drug is examining the extent to which cardiovascular events occur in patients with prior acute coronary syndrome. Some investors hoped the trial would end early.
A Japanese health ministry council approved a 50 percent cut in the price of the Opdivo cancer drug made by Bristol-Myers Squibb and marketed in the country by Ono Pharmaceutical, Reuters writes. The current annual list price is $321,787, compared with an average list price of $13,100 per month, or $157,200 per year in the US. The US list price was raised 15 percent earlier this year.
Commercial problems, not technical hurdles, undermined an effort by Novo Nordisk to make an oral form of insulin, Reuters says. “The problem is that in the reimbursement market we are now facing it is unlikely that such a tablet could be made available at a price that would be acceptable to the payers,” Novo chief executive Lars Rebien Sorensen told investors earlier this week.
An experimental therapy being developed by Amgen and Novartis to prevent chronic migraine has hit its primary targets in a late-stage trial, according to Reuters. The companies are racing rivals including Eli Lilly, Alder Biopharmaceuticals, Allergan, and Teva Pharmaceuticals to have a new, more effective migraine treatment approved by US and European regulators.
Taro Pharmaceuticals USA, which is owned by Sun Pharma, is recalling 17,100 Kamedis Bio-Herbal dandruff care kits in the US due to a sub-potent drug, the Economic Times tells us.