Good morning, everyone, and how are you today? A shiny sun is enveloping the Pharmalot campus, where our short person has long since left for the local schoolhouse and the official mascots are romping around the grounds. As for us, we are as busy as ever tackling our ever-growing to-do list. We trust you can relate. So time to get cracking. Here are some tidbits to help you along. Hope you have a wonderful day …
The US Food and Drug Administration approved a Roche drug called Tecentriq for treating advanced bladder cancer, the Wall Street Journal notes. The drug, a PD-L1 inhibitor that will cost about $12,500 per patient a month, is the first product in its class to get FDA regulatory approval to treat advanced cases of a common type of bladder cancer called urothelial carcinoma. And the agency is not requiring doctors to administer a PD-L1 diagnostic first.
An estimated 40 percent of 655 people who took Merck’s Keytruda drug in a clinical trial to treat advanced melanoma were still alive three years after starting treatment, the Wall Street Journal reports. The study reinforces the potential for new immune-boosting drugs to prolong the lives of people with the deadly form of skin cancer. The median overall survival among patients in the study was about two years.
A federal court allowed a 20-year-old college student to resume participation in a clinical trial the FDA had approved but recently halted, GoLocalProv reports. The agency stopped the trial after finding problems with the S.R. Burzynski Manufacturing Facility, which is testing a treatment for a rare pediatric cancer. Stanislaw Burzynski, a Houston doctor, has tussled with authorities for years over claims he discovered natural substances that can fight certain cancers.
A trial showed that Pfizer’s Ibrance, when used with another drug, thwarted advanced breast cancer significantly longer than the standard treatment alone, Reuters tells us. Meanwhile, Novartis halted a late-stage trial of a breast cancer medication after it met the study objectives, and regulatory approval would make the treatment the first direct competitor to Pfizer’s Ibrance, which generated $429 million in first-quarter sales this year, PMLive points out.
Researchers at DeCode Genetics, which is an Amgen unit, say they have identified a new genetic variant that reduces the risk of heart disease and stroke by 34 percent, Forbes says. The people with the variant had substantially lower levels of harmful cholesterol, which the researchers believe accounted for a portion of the lower heart risk. The variant was found in one of about 120 people in the study and was associated with an additional year of life.
The FDA says that patients in a clinical trial studying canagliflozin, which is contained in two Janssen Pharmaceuticals diabetes drugs, including Invokana, were twice as likely to undergo amputations as patients taking a placebo, MedPage Today says.
Dr. Reddy’s Laboratories is recalling over 50,000 bottles of Ondansetron tablets made at its Bachupally plant in India due to failed impurities and degradation, according to the Economic Times.
Suir Pharma is set to close or be sold with the loss of 130 jobs less than a year after it was acquired by Saneca Pharmaceuticals, an ingredients manufacturer, Outsourcing Pharma reports.