FDA
Polyphor AG announced that the US Food and Drug Administration has designated murepavadin as a Qualified Infectious Disease Product in four additional indications; hospital-acquired bacterial pneumonia, acute bacterial skin and skin structure infection, bloodstream infection and complicated intra-abdominal infection.
There’s little doubt that Merck’s checkpoint inhibitor Keytruda (pembrolizumab) is about as close to a miracle drug as we get.
Since taking over the role of chief executive officer at Bothell, Wash.-based Alder BioPharmaceuticals in June 2018, Robert Azelby has maintained his focus on moving the company closer to launching its first commercial product in the migraine treatment space.
The agency approved Evenity on the basis of two Phase III clinical trials. The drug had been rejected in 2017 over safety concerns.
The U.S. Food and Drug Administration (FDA) approved ViiV Healthcare’s Dovato, a once-a-day, single-tablet combination of dolutegravir (DTG) and lamivudine (3TC) for HIV-1 in adults who had not received treatment before.
“Men with breast cancer have limited treatment options, making access to medicines such as Ibrance critically important,” stated Bret Miller, founder of the Male Breast Cancer Coalition.
Phase 1/2 pheNIX Trial Would Represent First PKU Gene Therapy to Enter the Clinic
Public perception of the industry can be a bit confusing. Life Science Leader recently pulled together several biopharma executives for a round table discussion of the biopharma industry’s public perception—generally bad—and what might be able to do about it.
The U.S. Food and Drug Administration (FDA) approved ADMA Biologics’ Asceniv to treat Primary Humoral Immunodeficiency Disease (PIDD or PI) in adults and adolescents.
The lynchpin to biotech and pharmaceutical drug development in the United States is arguably the greater Boston area, which includes the white hot square mile of talent and intellectual collaboration found in Kendall Square.
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