Top of the morning to you. A warm and shiny sun is enveloping the chilly Pharmalot campus, where the short person is sleeping in and the official mascots are happily snoozing themselves. As for us, we are as busy as ever, attempting to tackle the ever-growing to-do list. To cope, we are relying on some cups of stimulation and invite you to join us. Remember, no prescription is required. So time to get cracking. Here is the usual list of interesting items. Hope your day goes well and do keep in touch …
A largely federally funded trial of older men who received testosterone replacement found that raising their levels to those of younger men improved sexual function but had a minimal effect on energy levels and walking ability, The Wall Street Journal reports. The $50 million effort is designed to answer questions about whether testosterone can alleviate age-related concerns. Testosterone replacement had been widely promoted, but more recently sales have waned amid safety concerns as regulators required warnings about cardiovascular risks to be placed on labeling.
But there are caveats. Full results must still be reported to properly gauge any side effects. More than half of the participants were obese and losing weight can boost testosterone levels. And as STAT notes, the tests used to gauge sexual function may give pause. “The results show that testosterone therapy did yield certain benefits, but at this point their clinical importance is uncertain,” Dr. Eric Orwoll, an endocrinologist at the Oregon Health & Sciences University, wrote in an editorial in the New England Journal of Medicine, where the latest study also appeared.
An Alexion Pharmaceuticals treatment for a rare disease may be useful in treating babies with a rare disorder, but the UK’s National Institute for Health and Care Excellence does not believe its $700,000-per-year cost represents good value, Pharma Times writes. Kanuma is designed for treating lysosomal acid lipase (LAL) deficiency, a rare inherited genetic disease in which fats build up in cells.
The head of the US-India Business Council says that the US pharmaceutical industry wants India to issue a written declaration that compulsory licenses will not be issued for generic drug manufacturing, even though verbal assurances have been given, The Hindu Business Line reports. “Verbal assurance could be easily undermined if personnel or government officials change swiftly,” says Mukesh Aghi.
Athersys stock jumped significantly Thursday morning after results from a mid-stage study showed patients who suffered ischemic stroke displayed improvement following treatment with its intravenous stem cell treatment compared with those on placebo within 36 hours.
Ennaid Therapeutics says it is developing therapeutic cures for combating the Zika virus, and these may be available in less than four years, InPharma Technologist says.
Zafgen’s diet drug beloranib reduced body weight in diabetics between 12.7 and 13.5 percent, depending on the dosage, Reuters reports.
Regulus Therapeutics says that combining its experimental, injectable hepatitis C medicine with currently approved oral drugs reduced the level of the virus to undetectable levels in 97 percent of patients, TheStreet tells us.
Dr. Reddy’s Laboratories is waiting for a response from the Food and Drug Administration about the fate of three plants for which the agency had issued a warning letter, The Economic Times writes.