Good morning, everyone, and welcome to another working week. We hope the weekend respite was refreshing and invigorating, because that relentless routine of meetings, deadlines, and whatnot has returned. And it has brought a spot of rain along with it. Nonetheless, we are pushing ahead with our usual reliance on cups of stimulation and, as always, we invite you to join us. Meanwhile, here are some tidbits. Have a smashing day and do stay in touch …
The US pharmaceutical industry trade group plans to send scientists, researchers, and patients to meet with congressional lawmakers in a bid to fend off criticism over drug prices, The Hill reports. The plan represents a big shift from what Steve Ubl, who heads the Pharmaceutical Researchers and Manufacturers of America, acknowledges has been a strategy “focused on defense.”
The Scottish government is being questioned about withholding details of a $30 million fund for treating patients with rare diseases, and it turns out much of it was spent on just one drug, according to The Scotland Herald. Nearly 86 percent of its budget was spent on the Kalydeco cystic fibrosis drug sold by Vertex Pharmaceuticals. The treatment, also known as Ivacaftor, costs about $255,000 per patient.
The Valeant Pharmaceuticals board deserves additional scrutiny, according to The Deal. “While blame for this failure should fall upon management, culpability has to extend to the audit committee,” Charles “Chuck” W. Mulford, the founding director of Georgia Tech’s Financial Reporting and Analysis Lab, tells the website. Meanwhile, Valeant chief executive Michael Pearson was subpoenaed to testify at a Senate Aging Committee hearing next month.
India’s Central Drugs Standard Control Organization will soon start conducting surprise inspections at manufacturing sites, The Economic Times reports. The move comes amid ongoing concern over quality control issues at Indian drug makers, which has led the US Food and Drug Administration to increase its own oversight of Indian manufacturing plants.
Sanofi has gone to court to challenge an Indian government decision banning the manufacture and sale of its fixed dose combination diabetes drug, Amaryl MP, InPharma Technologist tells us.
FDA staffers questioned whether an Acadia Pharmaceuticals drug to treat psychosis associated with Parkinson’s disease showed a clinically meaningful benefit, BioCentury says.
Celltrion is close to striking deals with different companies in Europe to market two new biosimilars that are expected to win approval later this year, The Korea Herald writes.
Ireland will factor significantly into testing plans that Regeneron Pharmaceuticals has for a new drug for a skin condition, The Irish Times says.