ello, everyone, and how are you today? This may be the middle of the week for many people, but on this side of the pond, the pace is slowing down — somewhat — as a holiday nears. A Wild Turkey moment, as some say. As for us, we will be taking a long weekend ourselves. On that note, we hope that those of you who are doing the same have a wonderful time and for everyone else, well, you will survive. Meanwhile, here are some tidbits. See you soon …
Eli Lilly reported that a hotly anticipated clinical trial of a drug to treat Alzheimer’s patients with a mild form of the disease failed, STAT reports. The drug, called solanezumab, did not meet the primary endpoint of a Phase 3 study that measured cognitive decline compared with patients given a placebo. The failure may continue to raise questions about a theory that sweeping away beta-amyloid plaques, which build up in the brains of patients with Alzheimer’s, is key to success.
A handful of doctors, many with close ties to Insys Therapeutics executive chairman John Kapoor, are responsible for outsize levels of prescriptions for Subsys, a form of the opioid fentanyl, the Wall Street Journal reports. He personally traveled to Mobile, Ala., to attend a business dinner with the doctors, who were also paid as frequent speakers and consultants for the drug maker. Prosecutors allege many of the payments were actually bribes.
Meanwhile, the proportion of older Americans living with dementia fell between 2000 and 2012, according to a study in in JAMA Internal Medicine, although researchers say the reasons for the drop are not clear. They analyzed data from a US survey of people 65 years and older, including 10,546 people in 2000 and 10,511 in 2012. The decline occurred despite a rise in heart health risk factors like high blood pressure and obesity, Reuters notes.
Will the US Food and Drug Administration be dismantled? STAT notes that, as a Trump administration nears, public health advocates are bracing for a seismic shift: a surrender of agency rules for off-label promotion of drugs; the importation of more drugs from other countries; and fewer requirements for clinical trials — long the gold standard for determining whether medicines are safe and effective.
Allergan agreed to pay $125 million plus milestone payments for Chase Pharmaceuticals, which is developing a compound to treat Alzheimer’s symptoms.
The Indian government says that an effort to fix prices for more than 800 medicines deemed as essential helped consumers save money, according to the Economic Times.
QuintilesIMS formed a collaboration with Bristol-Myers Squibb, Eli Lilly, Merck KGaA, and Pfizer to determine how cancer treatments are used by patient types, in which sequences and combinations, and indications.
The UK’s National Institute for Health and Care Excellence draft guidelines recommend “routine” use of Celgene’s Imnovid to treat some patients with multiple myeloma, PharmaTimes writes.
Shire will lease the Genzyme Center building in Cambridge’s Kendall Square and create a “rare disease innovation hub” that also will serve as a base for its US operations, the Boston Globe reports.
European regulators expanded use of Bristol-Myers Squibb’s Opdivo immunotherapy to treat certain patients with Classical Hodgkin lymphoma, PharmaTimes tells us.
Johnson & Johnson wants to move the growing litigation over its Invokana diabetes drug from state to federal court, the Legal Intelligencer reports. More than 100 lawsuits claim the drug causes kidney failure and a condition called diabetic ketoacidosis.