FDA Officials Find Worrying Hygiene At Eye Drop Factory In India
Kilitch Healthcare India manufactures eye drops that were being sold in the U.S. until a recent recall. Inspectors visiting the plant found cracked floors, barefoot workers, and altered records. Separately, the FDA cited Dr. Reddy’s Laboratories, another India-based drugmaker, for quality-control issues.
AP:
Barefoot Workers And Cracked Floors Were Found At A Factory That Made Recalled Eyedrops, FDA Says
An Indian company that recently recalled eyedrops sold in the U.S. had a host of sanitation and manufacturing problems, including barefoot workers, cracked floors and altered records, U.S. health inspectors found. Food and Drug Administration officials uncovered more than a dozen problems at the Mumbai plant operated by Kilitch Healthcare India, according to a preliminary inspection report posted by the agency. The factory produced more than two dozen varieties of eyedrops that were subject to an FDA safety warning last month. (Perrone, 11/16)
Stat:
FDA Cites Dr. Reddy's For Quality Control Issues At A Biologics Plant
Dr. Reddy’s Laboratories, one of the world’s largest generic drugmakers, was cited by the U.S. Food and Drug Administration for a host of manufacturing violations at one of its plants in India, the latest instance in which the company was tagged by the regulator for quality-control problems. (Silverman, 11/16)
In other pharmaceutical news —
Reuters:
Walgreens To Close Nearly All Pharmacies On Thanksgiving For First Time
Walgreens Boots Alliance will close nearly all of its stores and pharmacies on Thanksgiving Day for the first time in the chain's history, amid pushback from pharmacists and technicians over poor work conditions and under-staffing. Peer CVS Health (CVS.N) also said it plans to shut all of its non-24-hour pharmacy locations early next Thursday, while Rite Aid said its pharmacies will be closed but retail stores will remain open. (11/16)
Stat:
Even As Wegovy Rides High, Interest Surges In Weight Loss Drugs That Preserve Muscle
Have you ever seen a mouse with a set of muscles more appropriate for a bodybuilder or comic book superhero? Well, 25 years ago, researchers at Johns Hopkins University made it happen. By silencing a gene responsible for producing a protein called myostatin, they directed tiny mouse bodies to grow double the amount of lean muscle they would normally, leading to mice with bulky arms, defined pectorals, and an overall more substantial body mass. Now, biotech startups are hoping to use those findings to create what they believe will be better weight loss medications. (DeAngelis and Chen, 11/17)
Stat:
Questions And Answers On Casgevy, A New CRISPR-Based Therapy
History just happened. For the first time, a regulator has cleared a treatment using CRISPR, the gene-editing technology, for patients. The regulator is the United Kingdom’s Medicines and Healthcare products Regulatory Agency. The product is Casgevy, a treatment for sickle cell disease and beta thalassemia, two blood disorders. (Herper, Feuerstein, Trang and Boodman, 11/16)
KFF Health News:
Beyond Insulin: Medi-Cal Expands Patient Access To Diabetes Supplies
June Voros sprang from her couch as a high-pitched beep warned her that she needed a quick dose of sugar. Her blood sugar was plummeting, and the beep came from a continuous glucose monitor attached to her abdomen. The small but powerful device alerts Voros when her blood sugar is dangerously high or low. (Hart, 11/17)
