Medical Ethicists Uneasy About Parkinson’s Experiment That Benefited Donor Who Gave $2M For Research

Stat: Ethics Questions Swirl Around Historic Parkinson's Experiment 
A secretive experiment revealed this week, in which neurosurgeons transplanted brain cells into a patient with Parkinson’s disease, made medical history. It was the first time such “reprogrammed” cells, produced from stem cells that had been created in the lab from the man’s own skin cells, had been used to try to treat the degenerative brain disease. But it was also a bioethics iceberg, with some issues in plain sight and many more lurking. (Begley, 5/14)

Stat: Some Cancer Patients See Remission With Allogene Off-The-Shelf CAR-T
Allogene on Wednesday released the first data on tumor responses to its off-the-shelf CAR-T cell therapy for an aggressive form of B-cell lymphoma, showing that at least some patients experienced complete remission. The new data are preliminary but important because they represent potential progress for the CAR-T field. If successful, the Allogene treatment, called ALLO-501, could be widely available and allow patients with advanced blood cancer to be treated on demand. Today’s bespoke CAR-Ts, by comparison, must be genetically engineered from each patient’s own cells. (Feuerstein, 5/13)

Stat: Roche's Checkpoint Inhibitor Delivers Mixed Results In Lung Cancer Study
Roche on Wednesday said a two-drug combination that includes a novel but still experimental checkpoint-blocking immunotherapy significantly delayed tumor progression in a mid-stage study of non-small cell lung cancer patients. Reaction to the results might be muted, however, because the new combination treatment — tiragolumab plus Tecentriq — only showed a meaningful benefit in a subset of lung cancer patients. That profile makes it unlikely to compete against Merck’s dominant Keytruda-chemotherapy combination. (Feuerstein, 5/13)

Stat: Amgen KRAS Blocker Shows Small Improvement In Colon Cancer Response
Amgen’s experimental KRAS-blocking drug is showing a modest improvement in response rates for patients with advanced colon cancer and other solid tumors, according to an update from an early-stage clinical trial released Wednesday evening. While moving in a positive direction, the new data on the Amgen drug called AMG 510 are unlikely to ease all the doubts that surfaced last year about whether it can be broadly effective against different types of solid tumors. (Adam Feuerstein, 5/13)

Stat: ‘Good’ Bacteria Could Help Fight A Common Vaginal Infection, New Data Show
Most companies in the microbiome space have focused on recurrent, deadly C. difficile bacterial infections. But microbes may also be able to help treat a common and pernicious condition called bacterial vaginosis, according to a new study. Women with the condition who inserted a powder made from a single type of bacteria, Lactobacillus crispatus, directly into their vaginas, saw their condition return about 30% of the time, down from the control group’s rate of 45%. That treatment, called Lactin-V, is the product of nearly two decades of work by California-based Osel, Inc. (Sheridan, 5/13)

Stat: CVS Long-Term Care Pharmacy Pays $15 Million For Opioid Violations 
Omnicare, which is the largest long-term care pharmacy in the U.S., agreed to pay a $15.3 million penalty for allegedly allowing opioids and other controlled substances to be dispensed without valid prescriptions. The CVS Health (CVS) unit failed to track limited stockpiles of the medicines that were stored in so-called emergency kits, which are supposed to be dispensed by long-term care facilities on an emergency basis, but only with valid prescriptions, according to the U.S. Drug Enforcement Administration. Omnicare also repeatedly failed to document and report emergency prescriptions. (Silverman, 5/13)