STAT

Under intense criticism, Gilead forsakes monopoly status for its experimental Covid-19 drug

Gilead Sciences has asked the FDA to rescind orphan drug designation for an experimental medicine being tested to combat #Covid-19.
Bottles of remdesivir in a hospital for COVID-19 patients in Wuhan.

In an unexpected move, Gilead Sciences (GILD) has asked the Food and Drug Administration to rescind orphan drug designation for an experimental medicine being tested to combat Covid-19. The request comes after intense criticism that it unfairly pursued a lucrative monopoly for remdesivir.

The designation, which offers a drug maker seven years of marketing exclusivity, drew immediate condemnation from consumer advocates because orphan status is reserved for medicines targeting rare diseases that afflict 200,000 or fewer people.  The

You’re reading a preview, subscribe to read more.

More from STAT

STAT2 min read
STAT+: Pharmalittle: We’re Reading About A Boy Dying In Pfizer Trial; AstraZeneca Yanking Covid Shot, And More
A young boy died in a clinical trial for an experimental Pfizer gene therapy for Duchenne muscular dystrophy, about a year after receiving the therapy.
STAT2 min read
STAT+: Pharmalittle: We’re Reading About A Roche Obesity Drug, An Experimental Lilly Insulin, And More
Roche disclosed that its recently acquired experimental obesity medication helped people lose a significant amount of weight in a Phase 1 trial.
STAT2 min read
STAT+: Pharmalittle: We’re Reading About FDA Dithering On Pharma Patents, WHO Pandemic Talks, And More
When it comes to a crucial controversy over patents for drug-and-device combination products, the FDA has been MIA.

Related Books & Audiobooks