Roche Alzheimer’s Drug Fails Long-Running Trial

USA Today: Closely Watched Alzheimer’s Study Fails To Prevent Advance Of Disease
The Alzheimer's drug crenezumab did not slow or prevent cognitive decline in a long-running study of Colombian families who carried a genetic mutation that put them at near certain risk to develop the mind-robbing disease. The study of 252 people tested whether the pharmaceutical giant Roche's antibody crenezumab could slow or halt the disease if participants took the medication before memory or thinking problems surfaced. The drug did not demonstrate a significant benefit in tests measuring cognitive abilities or memory function among study participants, Roche said Thursday in a news release. (Alltucker, 5/16)

The New York Times: Trial Of New Alzheimer’s Drug Reports Disappointing Results 
In the trial, 169 people with the mutation received either a placebo or the drug, crenezumab, produced by Genentech, part of the Roche Group. Another 83 people without the mutation received the placebo as a way to protect the identities of people likely to develop the disease, which is highly stigmatized in their communities. The trial investigators had hoped that intervening with a drug years before memory and thinking problems were expected to emerge might hold the disease at bay and provide important insights for addressing the more common type of Alzheimer’s that is not driven by a single genetic mutation. (Belluck, 6/16)

Stat: A Roche Alzheimer's Treatment Fails To Slow Cognitive Decline In Patients
The study was noteworthy because it enrolled people from an extended family in Colombia diagnosed with autosomal dominant Alzheimer’s disease caused by a mutation in a gene called presenilin 1 E280A. The study participants began the study before they showed any signs of disease, with the hope that regular infusions of crenezumab would slow or prevent the onset of cognitive decline and memory loss. This inherited form of early onset Alzheimer’s is relatively rare, but the failure of crenezumab is another setback for the scientific argument that removing toxic protein plaques called beta amyloid from the brain can slow or prevent Alzheimer’s disease. (Feuerstein, 6/16)

In other pharmaceutical industry news —

Stat: FTC Warns Drugmakers And PBMs On Illegal Rebate Schemes
In a notable move, the Federal Trade Commission put drugmakers and pharmacy benefit managers on notice that the agency will “ramp up enforcement” of any “illegal bribes and rebate schemes” that make it harder for patients to access lower-cost medicines. The new policy statement noted the FTC plans to scrutinize rebates and assorted fees for signs that these payments are violating antitrust and consumer protection laws. As part of that effort, the agency expects to monitor lawsuits and file its own legal briefs in cases where it can provide assistance in analyzing illegal practices that may raise prescription drug prices. (Silverman, 6/16)

Bloomberg: Walgreens Aims To Add Diversity To Drug Trials Through Stores
Walgreens Boots Alliance Inc. is moving into a new dimension of health care with a business designed to help improve diversity in drug trials by making them more accessible to patients. Typically conducted in hospitals, doctors’ offices, universities and research clinics, human trials of experimental drugs and devices have often failed to reach a wide variety of ages, races and ethnicities. Walgreens will start offering its retail locations, which number more than 9,000, and connections to patients to help fix the long-standing problem. (Rutherford, 6/16)

Bloomberg: Bausch Health Suspends Plan For IPO Of Skin-Care Unit
Bausch Health Cos. has suspended plans for an initial public offering of its Solta Medical skin-care business, a month and half after the spinoff of another unit fell short of its fundraising goals. With its own stock battered this year amid volatility and inflation fears, Bausch Health said in a statement Thursday that it decided to suspend its Solta plans “in light of challenging market conditions and other factors.” The company said the interests of its stakeholders are best served in the near-term by focusing on driving Solta’s revenue, profits and cash flow. (Hytha, 6/16)

KHN: A Proposal To Import Drugs From Other Countries Creates An Unusual Alliance In The Senate 
Harmony is not often found between two of the most boisterous senators on Capitol Hill, Bernie Sanders (I-Vt.) and Rand Paul (R-Ky.). But it was there at Tuesday’s Senate Health, Education, Labor and Pensions Committee markup of legislation to reauthorize the Food and Drug Administration’s user fee program, which is set to expire Sept. 30. (Knight, 6/17)

Also —

The Hill: More Than 400,000 Bottles Of Over-The-Counter Medication Recalled Due To Issues With Child-Proofing 
The Consumer Product Safety Commission on Thursday announced the recall of over 400,000 bottles of over-the-counter medicine due to issues with the child-resistant packaging, which did not meet the requirements in the Poison Prevention Packaging Act. Aurohealth recalled about 137,300 units of Walgreens brand acetaminophen, as well as approximately 25,660 units of Kroger brand arthritis pain acetaminophen. (Scully, 6/16)