Good Numbers For Alzheimer’s Drug Provoke Cautious Response

Stat: Eli Lilly Releases Detailed Results On Alzheimer’s Drug
Eli Lilly’s experimental Alzheimer’s medicine donanemab showed some of the best early results seen by pharmaceutical researchers in the field. What divides many researchers is whether that is a reason for excitement or not. (Herper and Feuerstein, 3/13)

Stat: A Deep Dive Into Eli Lilly’s Tantalizing Alzheimer’s Drug Data
Here is some analysis and perspective, not to mention a few burning questions, about the Phase 2 data Eli Lilly disclosed on its experimental Alzheimer’s therapy donanemab on Saturday. STAT earlier asked five independent scientists involved in Alzheimer’s research about the study; unsurprisingly, their opinions were quite mixed, with the data representing a Rorschah test for their views on Alzheimer’s drug development. The study was also published in the New England Journal of Medicine. (Feuerstein and Herper, 3/15)

In other pharmaceutical news —

Stat: Insulin Makers Win A Round In Minn. Lawsuit Accusing Them Of Racketeering
In a setback to efforts to control insulin prices, a U.S. court judge tossed key accusations made in a high-profile lawsuit filed by the Minnesota Attorney General accusing three drug makers of price gouging. The lawsuit, which was filed in 2018, alleged that Eli Lilly (LLY), Novo Nordisk (NVO), and Sanofi (SNY) fraudulently set artificially high wholesale prices, but then negotiated lower prices by paying rebates and discounts to pharmacy benefit managers. In turn, pharmacy benefit managers create lists of medicines that receive preferred insurance coverage known as formularies. But the negotiations are confidential. (Silverman, 3/15)

Stat: Solid Reports No Serious Toxicity With 'Safer' Duchenne Gene Therapy 
Solid Biosciences said Monday that it has restarted a clinical trial involving its experimental gene therapy for Duchenne muscular dystrophy without the serious safety issues that forced the study to shut down in 2019. The biotech also disclosed for the first time interim results from patients treated before the study was stopped, showing small improvements in muscle and lung function after one year of follow up. (Feuerstein, 3/15)

Stat: Rubius Drug Produces Anti-Tumor Responses — And More Questions
Two patients with cancer showed partial tumor shrinkage after infusions of a novel immune-boosting treatment derived from red blood cells, its maker Rubius Therapeutics said Monday. Rubius said the preliminary results of its early-stage clinical trial provided “clinical validation” of its treatment, called RTX-240. However, the company was unable to show data proving RTX-240 triggered the expected immune system attack against the patients’ tumors, leaving questions about its future unanswered. (Feuerstein, 3/15)

KHN: ‘Painless’ Glucose Monitors Pushed Despite Little Evidence They Help Most Diabetes Patients 
In the nation’s battle against the diabetes epidemic, the go-to weapon being aggressively promoted to patients is as small as a quarter and worn on the belly or arm. A continuous glucose monitor holds a tiny sensor that’s inserted just under the skin, alleviating the need for patients to prick their fingers every day to check blood sugar. The monitor tracks glucose levels all the time, sends readings to patients’ cellphone and doctor, and alerts patients when readings are headed too high or too low. (Galewitz, 3/16)

Also —

Stat: The Viability Of The U.S. Biosimilar Market Is Thrown Into Question Again
Despite periodic reports that biosimilars have finally arrived and will save the U.S. health care system billions of dollars, Peter Bach and Mark Trusheim remain unconvinced. So the high-profile skeptics have refreshed their controversial, two-year-old argument for overhauling the approach for making alternative versions of pricey biologic medicines available to the American public. (Silverman, 3/15)