LabCorp Gets Home COVID Test Approved
The FDA issues an emergency use authorization for a COVID test that can be purchased without a prescription. Erectile dysfunction drug is recalled; Amazon's new band gets a mixed review.
LabCorp said on Wednesday that it has received Emergency Use Authorization for an over-the-counter version of its COVID-19 home test. With the EUA, LabCorp is able to sell the test kit directly to consumers without requiring a prescription. The kit is the first over-the-counter at-home collection kit for SARS-CoV-2 to receive EUA. (Bonislawski, 12/10)
In other pharmaceutical and biotech news
Pharmaceutical distributor AvKare issued a voluntary recall of 100 mg tablets of both sildenafil,an erectile disfunction medication, and trazodone, an antidepressant, after a mix-up led to some of the prescription drugs being packaged together. These products have been recalled due to a product mix-up of the listed two separate products inadvertently packaged together during bottling at a 3rd party facility, the company said in a Wednesday announcement. (Pitofsky, 12/10)
Arguing the Food and Drug Administration is precluding competition for biosimilar manufacturers, Boehringer Ingelheim has petitioned the agency to alter its interpretation of the word strength found in a federal law that has made it possible to sell these medicines. The move reflects a wonky, behind-the-scenes dispute that, nonetheless, holds potentially great significance for the burgeoning growth of biosimilar treatments in the U.S., which is expected to reach $80 billion in aggregate sales over the next five years, according to one recent forecast. (Silverman, 12/10)
Amazon has a new health-tracking bracelet with a microphone and an app that tells you everything thats wrong with you. You havent exercised or slept enough, reports Amazons $65 Halo Band. Your body has too much fat, the Halos app shows in a 3-D rendering of your near-naked body. (Fowler and Kelly, 12/10)
A new biotechnology company was launched Thursday in Cambridge with $81 million in funding, joining a growing number of biotechs in the area that are based on an emerging field in cell biology. Faze Medicines will work on biomolecular condensates, which it believes can be studied to develop drugs that could slow, halt, or reverse certain diseases. Condensates are membrane-less organelles, or clusters of molecules such as proteins and nucleic acids, that help cells perform vital functions. (Gardizy, 12/10)
