Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating because the familiar routine of meetings, deadlines, and what-not has now returned. Our own to-do list, unfortunately, is punctured by the sound of drilling outside the Pharmalot campus, courtesy of our local water company. But we will persevere with help from a few cups of stimulation. Meanwhile, here are some tidbits. Hope your day goes well and keep in touch …
New global guidelines on treating heart failure endorse the use of Novartis’s Entresto, boosting the prospects for a drug that has struggled to gain traction since its launch last year, Reuters reports. US and European heart experts say that Entresto should replace two older types of drugs, which are known as ACE inhibitors and ARBs, in heart failure patients who have adequate blood pressure and can tolerate standard drugs.
The European Medicines Agency has lifted a warning on Pfizer’s Chantix smoking cessation drug, which is called Champix in Europe, after deciding that a clinical study found the pill does not appear to increase the risk of neuropsychiatric side effects, Reuters reports. The study, which is funded partly by Pfizer, was undertaken at the behest of the US Food and Drug Administration. The drug maker wants the FDA to remove similar warnings.
A new chewable, fruity ADHD medicine called Adzenys became available last week and is causing concern that the pill will accelerate the overmedication of children and lead to greater abuse, STAT says. The extended-release amphetamine, which was approved by the FDA in January for anyone 6 years old and up, comes in six dose strengths. “What’s next?” one psychiatrist laments. “Gummy bears?”
After years of increases in the number of prescriptions written for opioid painkillers, there was a 12 percent decline in the United States since 2012, the New York Times informs us. The drop suggests a notable change in prescribing habits following a steady stream of warnings about the highly addictive nature of the drugs and may reflect ongoing federal and state efforts to curb usage.
The FDA last month revoked four orphan drug designations for various drugs for treating hypertension in children, more than doubling the number of such revocations in the past 30 years, the FDA Law Blog says.
Sanofi shuffled its executive committee membership and responsibilities amid departures and an ongoing effort to jumpstart the drug maker.
Italian regulators say that pharmaceutical ingredients made by Krebs Biochemicals and Industries at a facility in India pose a “critical risk” to public health, according to InPharma Technologist.
Pfizer is battling the Services, Industrial, Professional and Technical Union in Ireland over plans to shift 1,000 employees from a defined pension plan, the Irish Examiner tells us.
The Delhi High Court has ordered Pfizer to withdraw its Medrol anti-inflammatory drug six months before the expiration date, the Press Trust of India writes.
AstraZeneca is cutting ties with nearly 1,600 contractual sales representatives, and some of its direct sales force could also be reduced as part of a sweeping reorganization under way, the News-Journal says.
Viamet Pharmaceuticals Holdings withdrew its plans for an initial public offering, according to a filing with the Securities and Exchange Commission.