Automated Insulin Delivery System Shows Promise In Clinical Trial

Stat: A Bionic Pancreas Aims To Take The Math Out Of Managing Type 1 Diabetes
New clinical trial results from an automated insulin delivery system from Beta Bionics suggest that computation can be reliably outsourced to a machine — potentially putting better blood glucose control in the hands of more patients. (Palmer, 9/28)

The Wall Street Journal: Bionic Pancreas Shown To Manage Blood-Sugar Levels For Type 1 Diabetics 
A wearable device that automatically regulates blood-sugar levels was found to help people with Type 1 diabetes better manage their condition, potentially expanding the field of treatments for the chronic disease. The iLet bionic pancreas made by Concord, Mass.-based Beta Bionics helped people with Type 1 diabetes reduce average blood-sugar levels more effectively than other treatment methods including similar devices, according to a study published Wednesday in the New England Journal of Medicine. (Mosbergen, 9/28)

On the cost of insulin and other drugs —

Roll Call: Lawmakers Eye Lame Duck For Unfinished Business On Insulin
A bipartisan Senate duo is still working to pass a bill to overhaul insulin prices, but the outlook is complicated by the messy drug pricing system, politics and a busy congressional calendar. (Clason, 9/28)

Stat: Medicare Lays Out The Bureaucracy It Will Need To Negotiate Drug Prices
New documents obtained by STAT outline how Medicare is planning to build out a sizable new bureaucratic infrastructure to handle its new power to negotiate drug prices and penalize drugmakers for price hikes. (Cohrs, 9/29)

In other pharmaceutical industry news —

Fox News: Melatonin Should Be Avoided In Children Unless Directed By A Health Care Professional, Says Sleep Academy
"While melatonin can be useful in treating certain sleep-wake disorders, like jet lag, there is much less evidence it can help healthy children or adults fall asleep faster," said Dr. M. Adeel Rishi, vice chair of the AASM Public Safety Committee and a pulmonology, sleep medicine and critical care specialist at Indiana University Health Physicians, in a press release. (Sudhakar, 9/28)

Bloomberg: Blood Clots Have Big Pharma Chasing $55 Billion Market
Blood clots are estimated to cause about 1 in 4 deaths worldwide, and the leading blood thinners prescribed to prevent them are among the most widely used medicines. Known under the brands Eliquis and Xarelto, the drugs are called Factor Xa inhibitors for the enzyme they block in the body’s natural clotting process. (Peebles, 9/28)

Reuters: Gilead Widens Battle Against Alleged Counterfeit HIV Drug Ring 
A federal judge in New York has frozen the assets of dozens of people and entities accused of operating a massive nationwide scheme to distribute counterfeit bottles of Gilead Sciences Inc HIV drugs, including two alleged "kingpins." Gilead, which has been pursuing alleged counterfeiters in a civil lawsuit since last year, said in a court filing unsealed on Wednesday it had uncovered an operation that was "staggering in scope," responsible for sales of hundreds of millions of dollars of counterfeit bottles of its top sellers Descovy, Genvoya and Biktarvy, and other medicines. (Pierson, 9/28)

Stat: Ebola Experimental Vaccine Trial May Begin Soon In Uganda
A clinical trial of one or perhaps two experimental vaccines designed to protect against the Ebola Sudan virus could soon begin in Uganda, as long as the country agrees to allow the research to take place, an official of the World Health Organization said Wednesday. (Branswell, 9/29)

Updates from the FDA —

Stat: FDA Says AI Tools To Warn Of Sepsis Should Be Regulated As Devices
The Food and Drug Administration on Tuesday published a list of artificial intelligence tools that should be regulated as medical devices, in some cases appearing to expand its oversight of previously unregulated software products. (Ross, 9/27)

Stat: FDA Official Acknowledges Agency's Slow Process For Health App Updates
The Food and Drug Administration’s approach to reviewing updates to software products is far slower than consumers have come to expect for apps, a top agency official acknowledged Tuesday. (Aguilar, 9/27)

Stat: New FDA Guidance On AI In Medicine Sparks Strong Reactions
New guidance from the Food and Drug Administration is triggering strong reaction from researchers and regulatory experts, who see it as an attempt to significantly expand the oversight of software tools used to guide clinical decisions. But they are sharply divided on whether that’s a much-needed change, or a dramatic overreach by regulators. (Ross, 9/28)