News
An inspection of a facility making Elevar’s rivoceranib uncovered deficiencies, leading the FDA to reject a combination therapy that includes the drug. The rebuff is the third strike for the partners after the agency issued manufacturing-related denials for the other drug in the combo.
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As antibody-drug conjugates advance and move into earlier lines of treatment, drug developers have to build gentler therapies that don’t just extend survival but improve it.
FDA’s rare disease decisions are strongest when the patient community has a voice in advisory committee decisions.
The lineup at the Alzheimer’s Association International Conference will provide critical insight into where the industry is headed with regard to targets being explored to vanquish the elusive neurodegenerative disease.
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Read our takes on the biggest stories happening in the industry.
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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Ex-FDA Neuroscience Director Billy Dunn was appointed to Prothena’s board of directors last week. Industry representatives and regulatory experts weigh in on the potential ethical implications.
Data from a Phase III trial of apraglutide for a type of short bowel syndrome with intestinal failure is expected by the end of the year. It is also in a Phase II study for acute graft-versus-host disease.
The 61-patient study met the primary endpoint of improved physiologic liver function and secondary endpoints, which included established non-alcoholic steatohepatitis biomarkers, Hepion reported Monday.
Sanofi and Regeneron reported positive results for the anti-inflammatory drug in a chronic obstructive pulmonary disease trial. The companies hope to see approval before a 2024 read-out of a second trial.
The topical treatment Vyjuvek got the FDA’s greenlight, making it the first redosable gene therapy and the first therapeutic for the rare skin disease dystrophic epidermolysis bullosa.
With Friday’s approval, Epkinly edges out Roche’s bi-specific antibody glofitamab, which is also being proposed for diffuse large B-cell lymphoma.
Crohn’s disease is Rinvoq’s seventh approved indication and could potentially help AbbVie weather declining sales for its blockbuster biologic Humira.
Blueprint Medicines, Indivior PLC and Lexicon Pharmaceuticals are all awaiting FDA decisions this week.
The regulator’s approval makes Miebo the first DED treatment that directly addresses tear evaporation. The drug is expected to hit U.S. markets in the second half of 2023.
According to the FDA, the majority of therapies prescribed for children were not tested in pediatric populations. The new guidance aims to change that.