FDA
Target action dates for drugs sponsored by Sanofi, Boehringer Ingelheim and Disc Medicine have also been pushed back despite assurances of swift reviews under the FDA’s new Commissioner’s National Priority Voucher program.
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After a tumultuous year, experts call for stability while anticipating the first fruits of policies intended to expedite approvals for rare disease drugs.
The FDA’s announcement that it will phase out in vivo testing requirements for monoclonal antibodies marks a seismic shift. Here’s how industry can adapt.
Policy initiatives have come fast and furious at the FDA this year. While guidances on rare diseases and vaccines have consumed most of the ink, policy shifts aimed at improving FDA efficiencies and reshoring U.S. manufacturing also got some attention. Here, BioSpace rounds up more than a dozen initiatives relevant to the biopharma industry.
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The FDA’s approval marks the first personalized treatment targeting susceptible FGFR genetic alterations for patients with metastatic bladder cancer.
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.