A Generic Drug Plant Closure Portends Drug Shortages

A Generic Drug Plant Closure Portends Drug Shortages

The closing of a Teva Pharmaceuticals plant in California might spell shortages of 24 generic sterile injectable medication, together with important drugs, the vasodilator alprostadil; the antibiotic amikacin; chemotherapy medication bleomycin, dacarbazine, idarubicin, ifosfamide, mitoxantrone, streptozocin, and topotecan; and the hormone octreotide. In different information, a promising hair-loss drug and dietary dietary supplements.

CIDRAP:
Report: US Plant Closure Portends Drug Shortages—Some Critical 
In its first evaluation, the newly fashioned End Drug Shortages Alliance (EDSA) warns that the latest shuttering of a troubled Teva Pharmaceuticals manufacturing plant in Irvine, California, might have an effect on the provision of 24 generic sterile injectable medication, together with 5 important drugs for which the corporate had an over 15% market share. (Van Beusekom, 5/23)

Bloomberg:
Antibiotics Price Stalls Development To Counter Superbugs
As micro organism turn into more and more proof against antibiotics, the pipeline of medicine to counter so-called superbugs has nearly dried up. Only a couple of dozen are in medical trials at the same time as infections impervious to current remedies kill greater than 1.2 million folks a 12 months. The drawback is that the price of creating an antibiotic can attain $1.5 billion, and drugmakers don’t see a enough payoff. Three years after saying a technique to spice up funding in antibiotics, England is poised to fund a pair of recent medication by providing firms a hard and fast annual payment no matter how a lot—or how little—they’re used. The National Health Service plans to pay as a lot as £10 million ($12.6 million) a 12 months, or £100 million over a decade, for every drug. A authorities advisory group in April concluded a assessment confirming the advantages of a pair of medicine from Pfizer Inc. and Shionogi & Co., paving the way in which for the NHS to finalize contracts with the businesses. “There is an intention to maneuver ahead as rapidly as doable,” says David Glover, assistant head of medicines evaluation on the NHS. (Paton, 5/24)

On dietary dietary supplements —

Stat:
The FDA’s In The Dark About Thousands Of Dietary Supplement Ingredients
The firms that make dietary dietary supplements like nutritional vitamins and herbs have quietly launched 1000’s and 1000’s of recent substances with out telling the federal government, regardless of federal regulation requiring the disclosure. The Dietary Supplement Health and Education Act requires dietary complement makers to inform the Food and Drug Administration at any time when they introduce a “new dietary ingredient” into the market. The FDA doesn’t have approval authority prefer it does for conventional medicines, however the company is meant to get some concept of what a complement maker is promoting and why the corporate thinks the ingredient is secure. (Florko, 5/24)

Dallas Morning News:
North Texas Olympic Medalist Testifies H-E-B Supplement Made Her Fail Drug Test
After profitable the bronze medal for the United States on the 2016 Olympic Games, Jaqueline Galloway started the lengthy and arduous course of of coaching for her subsequent competitions. But a bottle of dietary supplements and a failed drug check sullied her status and dealt a swift kick to her taekwondo profession, Galloway testified Monday in a Collin County courtroom. She sued H-E-B, which owns Central Market in Plano the place she purchased a bottle of magnesium, calcium and zinc multivitamins in February 2019. The trial started this week. Galloway had taken the dietary supplements for simply over every week when she was given a random drug check. Her urine examined optimistic for ibutamoren, a substance on the U.S. Anti-Doping Agency’s listing of prohibited substances, and he or she was banned from competitors. (Williams, 5/23)

In different pharmaceutical information —

The Boston Globe:
Experimental Pill Prompts Some To Regrow A Nearly Full Head Of Hair
Concert Pharmaceuticals stated Monday that its experimental remedy for a extreme type of hair loss known as alopecia areata might restore a virtually full head of hair in about 30 to 40 p.c of individuals. The small Lexington firm is one of some corporations with medication within the superior phases of medical testing for the illness through which an individual’s immune system assaults their hair follicles, leading to patchy or complete hair loss. Although alopecia areata can generally clear up by itself in months, the situation typically lasts for years. There are not any remedies accepted for the illness. “Like many different autoimmune illnesses, it’s one which has not acquired a ton of consideration till comparatively just lately,” stated Concert Pharma chief govt Roger Tung. While creating the remedy, he has met individuals who endure extreme anxiousness and melancholy from spontaneously creating the situation. “This can actually screw up folks’s lives,” he stated. (Cross, 5/23)

Arizona Republic:
CMV And Herpes Are Latent Viruses That Could Help Create New Vaccines
Scientists and drug makers have been critically investigating a possible CMV vaccine for years. The concern is especially critical for pregnant folks, in addition to for these present process transplants (CMV infections may be lethal in immunocompromised folks). Moderna was capable of create an mRNA vaccine in opposition to SARS-CoV-2 so rapidly partially as a result of that they had already been engaged on a CMV vaccine utilizing the identical know-how for a number of years. Their CMV vaccine is now in Phase III medical trials. (Walling, 5/23)

KHN:
Tribal Pharmacy Dispenses Free Meds And Fills Gaps For Native Americans In The City 
Tucked away on a facet road close to downtown, the Mashkiki Waakaa’igan Pharmacy provides its Native American clientele the providers of any strange drugstore — it dispenses essential medicine and offers session on remedies. But there are two key variations: Every Mashkiki affected person will get prescriptions free of charge — with no out-of-pocket expense — and may entry care that’s acutely aware of cultural traditions. (Huggins and Mueller, 5/24)

This is a part of the KHN Morning Briefing, a abstract of well being coverage protection from main information organizations. Sign up for an electronic mail subscription.

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