Hello, everyone, and how are you today? We are just fine, thank you, despite the gray skies and chilly temperatures greeting us this morning. As usual, we are keeping warm with some cups of stimulation — our flavor today is French Vanilla — and invite you to join us. Remember that a prescription is not required. And now, it is time to get cracking. The to-do list is beckoning. So here are some tidbits. Have a grand day and hope you conquer the world …
A Sanofi vaccine to combat dengue was approved by Mexican regulators, marking the first immunization program against the virus, but there are still questions about pricing, The Wall Street Journal writes. Dengvaxia is highly effective, but pricing will determine the extent to which governments across Latin America and Asia, where the disease is most widespread, will be embraced in large-scale vaccination campaigns.
A Senate Special Committee on Aging hearing on rising prescription drug costs condemned Valeant Pharmaceuticals and Turing Pharmaceuticals for buying medicines and then quickly jacking up prices, Reuters reports. But calls for increased use of lower-priced compounding medicines prompted one advocacy group, The Pew Charitable Trusts, to urge the committee leaders to resist the allure of products that are not approved by the FDA.
Sprout Pharmaceuticals chief executive Cindy Whitehead, who oversaw the launch of the Addyi pill for female sexual dysfunction, is stepping down just a few weeks after the company was bought by Valeant Pharmaceuticals, BizWomen reports. Whitehead also helped spur a pressure campaign accusing the Food and Drug Administration of gender bias, which the agency denied before approving the pill last summer.
As Rick Pazdur, who heads the Office of Hematology and Oncology Products in the FDA Center for Drug Evaluation and Research, watched his 63-year-old wife, Mary, ultimately lose her battle with ovarian cancer, the experience transformed him into something of a patient advocate, The Cancer Letter writes.
In 2017, Alnylam Pharmaceuticals plans to start final clinical trials for a drug to treat a deadly blood disease known as PNH, a market now served by just one drug that costs $440,000 a year, writes Bloomberg News. That drug, called Soliris, is sold by Alexion Pharmaceuticals and is the most expensive therapy in the world.
There are additional safety concerns about the new Entresto heart failure drug from Novartis from researchers who suggest it may cause complications for the central nervous system and the eye, MedPage Today reports.
Gavi, the global vaccine alliance funded, in part, by the Bill and Melinda Gates Foundation, agreed to provide $500 million over the next five years India to support an immunization program, The Economic Times says.
The FDA issued a draft document outlining best practices for communicating with the agency during drug development, according to InPharma Technologist.
An Indian business group claims that international criticism for pharmaceutical manufacturing plants can be traced to a “severe shortage” of inspectors, InPharma Technologist reports.