FDA
Regulators on both sides of the Atlantic are pushing for the withdrawal of the rare disease treatment that accounted for just 1% of Amgen’s 2025 revenue. Nevertheless, Amgen continues to defend the medicine, which was acquired in the $3.7 billion buyout of ChemoCentryx.
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Last month, the FDA launched TrialBlazer, intended to streamline the IND path and bring early clinical trials and medical innovation home to the U.S. It’s a start, but new agency leadership must see it through.
Significant leadership instability at the FDA—compounded by continued workforce attrition—led to a slight slowdown in overall regulatory productivity in the first half of this year, but the agency has been catching up of late.
Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech 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.