FDA Said To Plan Expanding Clinical Trials Of Pig Organ Transplants
Reports say the Food and Drug Administration is planning to expand efforts to transplant pig organs into humans. A treatment from Celldex Therapeutics to tackle chronic hives, questions about fish oil medications said to tackle heart attacks, and other matters are also in the news.
The Wall Street Journal:
FDA Planning To Allow Clinical Trials Of Pig Organ Transplants
The Food and Drug Administration is devising plans to allow clinical trials testing the transplantation of pig organs into humans, a person familiar with the matter said. If the agency follows through, the trials could be a key step in an effort to ease the deadly shortage of human donor organs. (Marcus and Whyte, 6/30)
In other pharmaceutical news —
Stat:
A Celldex Treatment Induces Symptom Relief In Patients With Chronic Hives
An experimental drug from Celldex Therapeutics induced complete symptom relief in half of patients with chronic and severe hives — study results that are still preliminary but suggest a new way to tamp down immune reactions that can trigger the debilitating skin condition. The new data also validate Celldex’s strategic decision, taken two years ago, to pivot to treatments for autoimmune disease, following multiple setbacks with cancer therapies. (Feuerstein, 6/30)
Stat:
Analysis Of Amarin’s Vascepa Resurrects Big Questions On Effectiveness
A new analysis of Vascepa, a medicine derived from fish oil and used to prevent heart attacks in a select group of patients, raises big questions about the evidence that the medicine is effective. Several experts say the questions require a new clinical trial to be conducted, and some even say the Food and Drug Administration should reconsider the product’s approval. (Herper, 6/30)
In hospital industry news —
Stat:
Medicare Wants To Stop Publishing Some Hospital Safety Data
Medicare proposes to keep under wraps a composite score made of 10 metrics of patient safety and adverse events, including pressure ulcers, hip fractures, and sepsis after surgery. ...The agency — with the backing of hospitals — says the results would be skewed because the Covid-19 pandemic hit different parts of the country at different times, so hospitals’ performances will vary based on factors outside of their control. A spokesperson pointed out, too, that despite the proposed change, the agency is still collecting the data and monitoring hospital safety. (Bannow, 7/1)
Wyoming Public Radio:
Sublette County Receives Federal Dollars To Build Its First And Only Hospital
Sublette County received federal money to move forward with construction of a hospital later this summer. It is the last county in the state to not have a hospital. (Tan, 6/30)
