ello, everyone, and welcome to the middle of the week. Yet another steamy day is on the way, and we are trying to stay cool with cups of iced stimulation. We hope you are doing the same. We should note that we will be taking an extended break starting later today and will return next week. So we hope you survive the next few days. Meanwhile, here are some tidbits. Hope all goes well …
A new type of injectable cholesterol drug may save the health system from paying for heart attacks and strokes, but the high list price would still mean an increase total health care spending by 4 percent, according to a study in the Journal of the American Medical Association. In order to be cost-effective, the PCSK9 inhibitors should cost just over $4,500 per year. The roughly $14,000 list price, however, does not include manufacturer rebates. The companies selling these drugs disputed the findings.
The Alli weight-loss pill has been supported by problematic clinical studies that “systematically understated” its potential harms, according to STAT, citing a study in PLOS Medicine. The study compared published journal articles with data summaries submitted to European regulators and found the publications disclosed just 14 percent to 33 percent of adverse events compared with the data summaries.
ViiV Healthcare started Phase 3 trials of a two-drug regimen for HIV that might simplify treatment for patients who receive therapy for the first time, PMLive tells us.
Drug makers that change hard gelatin capsule suppliers do not need to seek approval beforehand under a policy introduced by the Food and Drug Administration, InPharma Technologist says.
Zhejiang Medicine, which makes antibiotics sold in the US, hid quality testing results that may have indicated the products were contaminated, according to a warning letter issued by the FDA.
Carl Icahn bought 3.4 million shares in Allergan valued at $785.7 million, Reuters reports. Icahn began acquiring shares in the drug maker last spring after its $160 billion buyout deal with Pfizer fell through.
A new study falls far short of showing that mothers taking acetaminophen during pregnancy increases their child’s risk of behavioral problems, writes STAT.
Roche signed a licensing deal worth up to $270 million with Eleven Biotherapeutics to develop a monoclonal antibody for ocular conditions such as diabetic macular edema, PharmaTimes reports.
An issue at a GlaxoSmithKline ingredients plant will limit supplies of the Avycaz antibiotic sold by Allergen for the next six months, according to InPharma Technologist.