Bacteria-Tainted Eye Drops Linked To 4 Deaths

USA Today: Recalled Eye Drops Linked To Bacteria Tied To Four Deaths, CDC Says
Four people have now died in a multistate outbreak of a drug-resistant bacteria strain tied to recalled eye drops, according to the Centers for Disease Control and Prevention. The CDC and the Food and Drug Administration in February warned patients and clinicians to stop using EzriCare or Delsam Pharma’s Artificial Tears products after one death from an infection and reactions in dozens of patients, some who experienced permanent eye loss. (Snider, 5/20)

In other pharmaceutical industry news —

CIDRAP: Tuberculosis Drug Shows Protective Effect Against Leprosy
The results of a randomized controlled trial in China suggest that an antibiotic used for tuberculosis treatment can protect household contacts from leprosy, researchers reported yesterday in the New England Journal of Medicine. (Dall, 5/19)

Stat: FDA Approves First Therapy For Devastating Skin Condition
The Food and Drug Administration on Friday approved the first treatment for a devastating condition that causes the skin to be so fragile that even a touch can cause it to splinter, bringing another gene therapy onto the market. The therapy, known as Vyjuvek and made by Krystal Biotech, will soon be available for patients with dystrophic epidermolysis bullosa, a genetic disease that causes painful blisters and persistent wounds. (Joseph, 5/19)

Stat: Drug In Early Trial Appears To Reduce Harmful Protein Buildup In Heart
An early-stage drug for a heart disease called ATTR-CM showed potential to reverse disease progression, opening up a new way of attacking the condition as existing drugs have been designed to only slow or stall the disease. In a small Phase 1 trial, the drug, a monoclonal antibody named NI006, appeared to reduce harmful protein buildup in the heart based on imaging, according to the study, published Saturday in the New England Journal of Medicine. (Chen, 5/20)

Stat: CRISPR Epigenome Editing Cuts Cholesterol In Monkeys 
A defanged form of CRISPR, which doesn’t slice or nick DNA, but rather alters the epigenome — the layers of chemical coding that sit on top of DNA and control the activity of genes — has aced its first substantive test. When researchers used CRISPR “epigenome editing” to dial down a cholesterol-associated gene in monkeys, the animals’ blood levels of heart-disease-causing LDL, or “bad” cholesterol, plummeted by more than 50%, Jennifer Kwon, senior scientist at Tune Therapeutics, announced on Friday at the American Society of Gene and Cell Therapy meeting in Los Angeles. (Molteni, 5/19)

Reuters: Thermo Fisher's Test To Detect Pregnancy-Related Complication Gets FDA Nod 
The U.S. Food and Drug Administration (FDA) has cleared Thermo Fisher Scientific Inc's test, the first of its kind in the country, to detect women with risk of severe preeclampsia, the company said on Friday. Preeclampsia is a leading cause of mortality in pregnant women globally, where they could experience high blood pressure after 20 weeks of pregnancy and during the postpartum period. (5/19)

Stat: FDA Advisers Vote Against Approving Intercept’s NASH Drug
A panel of expert advisers to the Food and Drug Administration voted Friday against approving Intercept Pharmaceuticals’ investigational treatment for NASH, a prevalent liver disease with no available medicines. (Garde, 5/19)

Also —

KFF Health News: A More Aggressive FTC Is Starting To Target Drug Mergers And Industry Middlemen
Under the leadership of an aggressive opponent of anti-competitive business practices, the Federal Trade Commission is moving against drug companies and industry middlemen as part of the Biden administration’s push for lower drug prices at the pharmacy counter. On May 16, the FTC sued to block the merger of drugmakers Amgen and Horizon Therapeutics, saying the tangled web of drug industry deal-making would enable Amgen to leverage the monopoly power of two top Horizon drugs that have no rivals. (Allen, 5/22)

Stat: New Study Highlights Transparency Concerns Over Clinical Trials
Amid increased concerns over a lack of transparency in clinical trials, a new study found that one in five primary endpoints were changed after a late-stage study had begun, and 70% of the trials examined did not include information about primary endpoint changes in articles published in medical journals. (Silverman, 5/19)