FDA Approves First Pill-Based Fecal Transplant Treatment
The treatment from Seres Therapeutics is said to provide a simpler version of stool-based transplant procedures that some specialists have been performing. Meanwhile, a penicillin G benzathine shortage is hitting the U.S. as syphilis and strep cases rise — it joins other drugs in short supply.
AP:
First Pill For Fecal Transplants Wins FDA Approval
U.S. health officials on Wednesday approved the first pill made from healthy bacteria found in human waste to fight dangerous gut infections — an easier way of performing so-called fecal transplants. The new treatment from Seres Therapeutics provides a simpler, rigorously tested version of stool-based procedures that some medical specialists have used for more than a decade to help patients. The Food and Drug Administration cleared the capsules for adults 18 and older who face risks from repeat infections with Clostridium difficile, a bacteria that can cause severe nausea, cramping and diarrhea. (Perrone, 4/27)
In updates on drug shortages —
Bloomberg:
Penicillin Shortage In US As Syphilis, Strep Cases Rise
A common type of penicillin used to treat syphilis is in short supply in the US as cases of the sexually transmitted disease continue to rise. Penicillin G benzathine, an antibiotic sold in the US by Pfizer Inc., was added to the Food and Drug Administration’s shortage list on Wednesday. Pfizer has limited supply of the drug because of increased demand, according to the agency, and the situation may persist into September. (Swetlitz, 4/26)
CIDRAP:
Some Critical Drugs Have Been In Shortage For More Than 8 Years
At least 20 critical drugs have been intermittently in shortage since 2015, according to the American Society of Health-System Pharmacists (ASHP) database. All but three of these drugs are also on the Resilient Drug Supply Project's (RDSP's) Critical Acute and COVID-19 Drug List. The US Food and Drug Administration's (FDA's) drug shortage database includes some, but not all, of the drugs as being in shortage. (Van Beusekom, 4/26)
In other pharmaceutical news —
Stat:
Alnylam’s ‘Upstream’ Alzheimer’s Treatment Shows Early Promise
An early-stage Alzheimer’s disease treatment from Alnylam Pharmaceuticals showed promising signs of benefit in a small clinical trial, the company said Wednesday, suggesting the medicine might be able to prevent the toxic brain plaques thought to drive the disease. (Garde, 4/26)
Stat:
Early Look At Gene Therapy Death Suggests CRISPR Wasn't Cause
In February, four months after the first patient in the trial of a designer CRISPR therapy suddenly died, around 100 researchers gathered in a Tucson, Ariz., conference hall to hear investigators in the study walk through the results of an autopsy. (Mast, 4/26)
NBC News:
Ritalin, Amphetamines Often Prescribed With Antidepressants, Research Finds
A large number of U.S. adults are being prescribed drugs like amphetamines, which have a risk for misuse, along with medications for depression and anxiety, a new study has found. The practice, the authors say, could lead to higher rates of misuse and addiction and cause unknown side effects. (Lovelace Jr., 4/26)
The Atlantic:
Weight-Loss Surgery Still Beats Ozempic
The Ozempic craze shows no signs of slowing. Demand for the drug, popularly used for weight loss, is so monumental that it is already changing the diet industry and spurring a “marketing bonanza” among the dozens of telehealth start-ups that now prescribe it. A highly public ad campaign from one start-up, Ro, banks on the drug’s simple premise: “A weekly shot to lose weight.” (Tayag, 4/25)
Also —
CNBC:
No Prison Yet For Elizabeth Holmes Following Last-Ditch Appeal
Disgraced Theranos founder Elizabeth Holmes will not go to prison this week, despite a judge’s order that she begin serving her 11-year sentence on Thursday. Late Tuesday, Holmes’ attorneys appealed that ruling to the U.S. 9th Circuit Court of Appeals in San Francisco. Under the court’s rules, that means Holmes will remain free on bail for now. (Cohn, 4/26)
