Good morning, everyone, and welcome to another working week. We hope the weekend respite was exhilarating and restorative, because the crushing routine of meetings, deadlines, and whatnot has now officially returned. You knew this would happen, though, yes? So to cope, as always, we are reaching for cups of stimulation and invite you to join us. Meanwhile, here is a bunch of tidbits. Have a smashing day and do stay in touch …
“Valeant (Pharmaceuticals) was a sewer, and those who created it deserved the opprobrium they got,” Charlie Munger, Warren Buffett’s right-hand man, told the Berkshire Hathaway annual meeting over the weekend, Reuters writes. And Buffett suggested Valeant was similar to “chain letter” companies designed to fool investors. The stock is down 87 percent from its 2015 high. Valeant has until May 16 to submit its first-quarter financial results or it may breach agreements with bondholders who own $19.5 billion of its debt, Bloomberg News tells us.
A federal judge reopened Merck’s patent case against Gilead Sciences over a hepatitis C drug amid claims a former Merck scientist lied to a jury that awarded the company $200 million in damages, Bloomberg News reports. US District Judge Beth Labson Freeman was “outraged” about an allegation the now-retired scientist misled jurors with testimony that he was responsible for early breakthroughs on compounds that led to a cure for the liver disease.
Reckitt Benckiser was fined $1.3 million by an Australian court for misleading consumers, according to the BBC. The drug maker advertised that its Nurofen specific pain products were distinctly formulated to treat back pain, period pain, migraine pain, and tension headaches, when they all had the same active ingredient.
The European Medicines Agency is reviewing all drugs that relied on studies conducted by Semler Research, a contract research organization, after recent inspections uncovered data integrity violations at its Bangalore, India, facility. Last week, the US Food and Drug Administration alerted drug makers that applications containing trial data prepared by Semler would not be accepted. The World Health Organization also issued a notice of concern.
Vertex Pharmaceuticals cut the pay of chief executive Jeff Leiden by 23 percent last year in response to an overhaul of compensation policies, the Boston Business Journal writes.
Cempra filed a new drug application with the FDA for its solithromycin antibiotic for which it has a contract with the US Biomedical Advanced Research and Development Authority to develop the treatment for pediatric use.
An European Medicines Agency committee endorsed a GlaxoSmithKline antiseptic gel for preventing umbilical cord infections in newborn babies, which was developed from a mouthwash, the Philadelphia Business Journal says.
Bristol-Myers Squibb plans to boost spending for an ongoing ad campaign to promote its Opdivo cancer treatment, according to Medical Marketing & Media.
Eagle Pharmaceuticals sued the FDA for refusing to grant its new Bendeka cancer drug seven years of marketing exclusivity as an orphan drug for rare diseases, Bloomberg News says.
EMD Serono, the US arm of Germany’s Merck KGaA, plans to spend $12 million to expand an R&D facility in Billerica, Mass., and add 150 jobs, including 100 scientists, the Boston Globe writes.
The Indian government may ask the Supreme Court to curb all cases related to its ban on 344 fixed dose combination drugs pending in various courts, the Economic Times tells us.
Regeneron Pharmaceuticals says an experimental drug to treat moderate-to-severe osteoarthritis pain was successful in a late-stage study, according to Reuters.
Acadia Pharmaceuticals won US regulatory approval for Nuplazid, which is the first drug the FDA has approved to treat psychosis associated with Parkinson’s disease, the Wall Street Journal reports.