Regeneron Says Experimental Therapy Shows Benefits For People With Moderate COVID Symptoms
The drugmaker says that its two-antibody cocktail, dubbed REGN-COV, lowered viral loads and improved symptoms for non-hospitalized patients in a small clinical trial. The therapy is also being tested in hospitalized patients with more severe symptoms. Regeneron says it is in early discussions with the FDA about possibly applying for emergency use authorization.
Regeneron Says Its Coronavirus Treatment Reduces Viral Levels, Improves Symptoms
Regeneron on Tuesday said its experimental two-antibody cocktail reduced viral levels and improved symptoms in non-hospitalized patients with mild-to-moderate Covid19, the disease caused by the novel coronavirus. When asked whether the company would apply for emergency use authorization from the U.S. Food and Drug Administration, the company said it plans to “rapidly” discuss the early trial results with regulatory agencies, including the U.S. Food and Drug Administration. (9/29)
Regeneron's Antibody Cocktail For Coronavirus: Early Data Shows Promising Results
The greatest improvements were seen in patients who hadn't already mounted a natural response to the infection, the company said. The results only involve 275 patients of the 1,000 they have enrolled in this particular trial, but appear "very promising," Dr. Jeanne Marrazzo, the director of the division of infectious diseases at University of Alabama at Birmingham, told CNN. (Christensen, 9/29)
In COVID vaccine development news —
Moderna COVID-19 Vaccine Appears Safe, Shows Signs Of Working In Older Adults
Results from an early safety study of Moderna Inc’s coronavirus vaccine candidate in older adults showed that it produced virus-neutralizing antibodies at levels similar to those seen in younger adults, with side effects roughly on par with high-dose flu shots, researchers said on Tuesday. The study, published in the New England Journal of Medicine, offers a more complete picture of the vaccine’s safety in older adults, a group at increased risk of severe complications from COVID-19. (Steenhuysen, 9/29)
The New York Times:
Will Pfizer's Vaccine Be Ready In October? Here's Why That's Unlikely.
And yet by all other accounts, the idea that it will be ready in October is far-fetched. Even if the vaccine shows promising signs in clinical trials — still a big if — the company will not have collected enough data by then to say with any statistical confidence that it is safe and effective. By repeating a date that flies in the face of most scientific predictions, [chief executive, Dr. Albert Bourla] is making a high-stakes gamble. If Pfizer puts out a vaccine before it has been thoroughly tested — something the company has pledged it will not do — it could pose a major threat to public safety. (Thomas, 9/30)
Johnson & Johnson Signs On Michigan's Grand River To Help With COVID-19 Vaccine Finishing Work
With all eyes on the hunt for a COVID-19 vaccine, drugmakers like New Jersey's Johnson & Johnson are scouring the market for manufacturing partners to help meet what would be global demand for their shots. With a couple already in hand, J&J is now turning to a Michigan CDMO to help keep up. Johnson & Johnson has partnered with Michigan's Grand River Aseptic Manufacturing (GRAM) to handle fill-finish duties for the New Jersey drugmaker's recombinant COVID-19 vaccine, the partners said last week. (Blankenship, 9/29)