Unapproved Covid Test Kits Recalled By FDA
The Food and Drug Administration has accused Innova Medical Group of Pasadena, California, of falsifying data and distributing covid tests that lack regulatory approval. Meanwhile, a fact check finds that President Joe Biden is keeping his promise of increased covid testing.
Stat:
FDA Accuses Firm Of Distributing An Unapproved Covid-19 Test
The Food and Drug Administration announced a recall Thursday of a coronavirus rapid antigen test, accusing the company that makes the tests of distributing them without regulatory approval and using falsified data that inflates their performance. The agency announced a “Class 1 recall” — its most serious type, indicating that use of the tests may cause serious injuries or death — and fired off a warning letter to Innova Medical Group of Pasadena, Calif., saying an FDA investigation revealed serious problems in the company’s data, but also in its making unapproved rapid tests available to consumers in the United States. (McLaughlin, 6/10)
KHN and Politifact:
Biden Kept His Promise To Increase Covid-Testing Capacity, Even As Demand For Testing Drops
Before vaccinations were widely available, covid-19 tests were considered one of the few tools to help control the spread of the coronavirus. That’s why then-candidate Joe Biden promised during the 2020 presidential campaign to boost the United States’ testing capacity as one way he would “beat covid-19.” Specifically, Biden’s campaign website promised that, if elected, he would “double the number of drive-through testing sites” and “invest in next-generation testing, including at-home tests and instant tests, so we can scale up our testing capacity by orders of magnitude.” (Knight, 6/11)
In other pharmaceutical and biotech news —
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Vertex Shelves Drug For Inherited Lung Disease, Raising Concerns On Growth
Vertex Pharmaceuticals said Thursday that it would shelve an experimental protein “corrector” drug — the highest-priority medicine in the biotech’s pipeline — after it failed to achieve the goals of a small clinical trial involving patients with an inherited disorder that causes serious damage to the liver and lungs. The failure of the oral drug, called VX-864, is the second setback for Vertex and its effort to develop a treatment for patients with a genetic disease called alpha-1 antitrypsin deficiency, or AATD. The company’s first attempt, with a different drug, was shelved due to liver toxicity last year. (Feuerstein, 6/10)
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CRISPR Treatment For Blood Diseases Shows Promise In Small Study
Twenty-two patients with inherited blood disorders were free of severe pain and the need for transfusions months after receiving an experimental genome-editing medicine, more evidence the CRISPR-based treatment could be a functional cure. The therapy, jointly developed by Vertex Pharmaceuticals and CRISPR Therapeutics, is designed to treat sickle cell disease and beta-thalassemia by boosting the body’s production of hemoglobin. According to data from two clinical trials presented at the European Hematology Association annual meeting Friday, all patients in both studies have been free from symptoms of the diseases since their treatment and have not needed blood transfusions. (Garde, 6/11)
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In Potential Big Step, Bristol Says CAR-T Outperformed Stem Cell Transplant
The treatment known as CAR-T, in which white blood cells are genetically modified to attack blood cancer, is one of the most exciting and expensive in medicine. But it has not been directly compared to standard treatments in a randomized trial — until now. (Herper, 6/10)
Bloomberg:
Superbugs Fight Hinges On Struggling Small Biotechs: Report
The world has become dependent on small drugmakers to develop antibiotics that can prevent bacteria pandemics, even as these companies face funding shortfalls and bankruptcy risk, a new report said. About 75% of all late-stage antibiotics in the research and development pipeline came from small and medium-sized businesses, according to the Access to Medicine Foundation, an Amsterdam-based non-profit group. That’s after many larger pharmaceutical companies all but abandoned antibacterial research. This puts promising drugs at risk of being left stranded and impedes the fight against drug-resistant bacteria, the foundation said in a statement. (Gemmell, 6/10)
