Hello, everyone, and how are you today? A gorgeous, shiny sun and delicious breeze are enveloping the unusually quiet Pharmalot campus this morning, because the short people appear to be sleeping in and the official mascots are doing the same. As for us, we are wide awake, thanks to a series of phone calls and cups of stimulation. After all, there is much to do. No doubt, you relate. So here are some tidbits to help you along. Have a great day …
The New England Journal of Medicine published four articles offering some degree of support for data sharing, but two noteworthy articles do not, CardioBrief informs us. Those two articles were written by some of the most prominent clinical trial researchers in the United States and Canada, and they express grave concerns about data sharing, while proposing limitations and safeguards that could significantly restrict its impact.
If Biogen is acquired — the biotech was reportedly approached by Merck and Allergan — it would likely mean the loss of local control for the largest remaining biotech in Massachusetts and the state’s most valuable public company, the Boston Globe laments. “It would be the end of an era,” Leora Schiff, a principal at Altius Strategy Consulting, tells the paper. “Biogen is the last of the industry’s early trailblazers.”
Using data collected from insurance claims, Aetna is contacting doctors whose prescribing habits are far outside the norm, the Washington Post tells us. The health insurer last week wrote 931 doctors and noted that if those physicians aligned their refill rates with the national average for all physicians who prescribe opioids, 1.4 million fewer pills would be dispensed annually.
Novo Nordisk’s Victoza diabetes drug failed to reduce deaths or re-hospitalizations in a study of patients with advanced heart failure, the Philadelphia Inquirer reports.
The National Institutes of Health has permanently halted clinical trial drug production at a site where manufacturing violations were identified last year, according to this letter. Operations were suspended in June.
Roche has ended its collaboration with Inovio after stepping away from the development of yet another drug, a hepatitis B vaccine, PharmaTimes writes.
Merck’s PD-1 inhibitor Keytruda added a new indication in Europe, getting a green light for use in non-small cell lung cancer, PMLive tells us.
Adaptimmune suffered a setback after the US Food and Drug Administration asked for a hold on a planned pivotal trial in a rare connective tissue cancer, PharmaPhorum reports.
A new draft guidance on procedures for the institutional review boards overseeing human research has been released by the FDA and HHS Office for Human Research Protections, Regulatory Focus says.
The UK’s National Institute for Health and Care Excellence is recommending Celgene’s Otezla for treating plaque psoriasis for England’s National Health Service, after all, PharmaTimes says.