A Generic Drug Plant Closure Portends Drug Shortages
The closing of a Teva Pharmaceuticals plant in California could spell shortages of 24 generic sterile injectable drugs, including essential medications, the vasodilator alprostadil; the antibiotic amikacin; chemotherapy drugs bleomycin, dacarbazine, idarubicin, ifosfamide, mitoxantrone, streptozocin, and topotecan; and the hormone octreotide. In other news, a promising hair-loss drug and dietary supplements.
CIDRAP:
Report: US Plant Closure Portends Drug Shortages—Some Critical
In its first analysis, the newly formed End Drug Shortages Alliance (EDSA) warns that the recent shuttering of a troubled Teva Pharmaceuticals manufacturing plant in Irvine, California, could affect the availability of 24 generic sterile injectable drugs, including 5 essential medications for which the company had an over 15% market share. (Van Beusekom, 5/23)
Bloomberg:
Antibiotics Price Stalls Development To Counter Superbugs
As bacteria become increasingly resistant to antibiotics, the pipeline of drugs to counter so-called superbugs has virtually dried up. Only a few dozen are in clinical trials even as infections impervious to existing treatments kill more than 1.2 million people a year. The problem is that the cost of developing an antibiotic can reach $1.5 billion, and drugmakers don’t see a sufficient payoff. Three years after announcing a strategy to boost investment in antibiotics, England is poised to fund a pair of new drugs by offering companies a fixed annual fee regardless of how much—or how little—they’re used. The National Health Service plans to pay as much as £10 million ($12.6 million) a year, or £100 million over a decade, for each drug. A government advisory group in April concluded a review confirming the benefits of a pair of drugs from Pfizer Inc. and Shionogi & Co., paving the way for the NHS to finalize contracts with the companies. “There is an intention to move forward as quickly as possible,” says David Glover, assistant head of medicines analysis at the NHS. (Paton, 5/24)
On nutritional supplements —
Stat:
The FDA's In The Dark About Thousands Of Dietary Supplement Ingredients
The companies that make dietary supplements like vitamins and herbs have quietly introduced thousands and thousands of new ingredients without telling the government, despite federal law requiring the disclosure. The Dietary Supplement Health and Education Act requires dietary supplement makers to notify the Food and Drug Administration whenever they introduce a “new dietary ingredient” into the market. The FDA doesn’t have approval authority like it does for traditional medicines, but the agency is supposed to get some idea of what a supplement maker is selling and why the company thinks the ingredient is safe. (Florko, 5/24)
Dallas Morning News:
North Texas Olympic Medalist Testifies H-E-B Supplement Made Her Fail Drug Test
After winning the bronze medal for the United States at the 2016 Olympic Games, Jaqueline Galloway began the long and arduous process of training for her next competitions. But a bottle of supplements and a failed drug test sullied her reputation and dealt a swift kick to her taekwondo career, Galloway testified Monday in a Collin County courtroom. She sued H-E-B, which owns Central Market in Plano where she bought a bottle of magnesium, calcium and zinc multivitamins in February 2019. The trial began this week. Galloway had taken the supplements for just over a week when she was given a random drug test. Her urine tested positive for ibutamoren, a substance on the U.S. Anti-Doping Agency’s list of prohibited substances, and she was banned from competition. (Williams, 5/23)
In other pharmaceutical news —
The Boston Globe:
Experimental Pill Prompts Some To Regrow A Nearly Full Head Of Hair
Concert Pharmaceuticals said Monday that its experimental treatment for a severe form of hair loss called alopecia areata could restore a nearly full head of hair in about 30 to 40 percent of people. The small Lexington company is one of a few firms with drugs in the advanced stages of clinical testing for the disease in which a person’s immune system attacks their hair follicles, resulting in patchy or total hair loss. Although alopecia areata can sometimes clear up on its own in months, the condition often lasts for years. There are no treatments approved for the disease. “Like many other autoimmune diseases, it is one that has not received a ton of attention until relatively recently,” said Concert Pharma chief executive Roger Tung. While developing the therapy, he has met people who suffer severe anxiety and depression from spontaneously developing the condition. “This can really screw up people’s lives,” he said. (Cross, 5/23)
Arizona Republic:
CMV And Herpes Are Latent Viruses That Could Help Create New Vaccines
Scientists and drug makers have been seriously investigating a potential CMV vaccine for years. The concern is particularly serious for pregnant people, as well as for those undergoing transplants (CMV infections can be deadly in immunocompromised people). Moderna was able to create an mRNA vaccine against SARS-CoV-2 so quickly in part because they had already been working on a CMV vaccine using the same technology for several years. Their CMV vaccine is now in Phase III clinical trials. (Walling, 5/23)
KHN:
Tribal Pharmacy Dispenses Free Meds And Fills Gaps For Native Americans In The City
Tucked away on a side street near downtown, the Mashkiki Waakaa’igan Pharmacy offers its Native American clientele the services of any ordinary drugstore — it dispenses critical medication and provides consultation on treatments. But there are two key differences: Every Mashkiki patient gets prescriptions for free — with no out-of-pocket expense — and can access care that’s conscious of cultural traditions. (Huggins and Mueller, 5/24)
