In an interview with Pharm Exec Associate Editor Don Tracy, Leonard Mazur, Co-founder, CEO, Citius Pharmaceuticals, offers an update on the recently accepted Biologics License Application for Lymphir by the FDA and other candidates currently in the Citius pipeline.
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FDA Approves Verona’s Ohtuvayre for the Maintenance Treatment of Chronic Obstructive Pulmonary Disease
Ohtuvayre is the first inhaled product with a novel mechanism of action for chronic obstructive pulmonary disease to be approved in 20 years.
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With CEO Turnover Rising to Record Levels, How Can Incoming, Existing Executives Build a Sustainable Role?
A Q&A with Russell Reynolds’ Global Lead of CEO & Executive Transition Practice, Ty Wiggins, PhD.
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CDC’s Advisory Committee Unanimously Recommends Vaxelis to Prevent Invasive Hemophilus Influenzae Type B in American Indian and Alaska Native Infants
The inclusion of Vaxelis in the CDC’s preferential recommendations is expected to influence vaccine administration strategies and public health policies in high-risk populations moving forward.
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FDA Issues Complete Response Letter to Merck and Daiichi Sankyo for Patritumab Deruxtecan for Advanced, Metastatic EGFR-Mutated Non-Small Cell Lung Cancer
The Complete Response Letter was issued as a result of inspection findings at a third-party manufacturing facility, unrelated to patritumab deruxtecan’s efficacy or safety in patients with advanced or metastatic EGFR-mutated non-small cell lung cancer.
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FDA Approves Genmab’s Epkinly to Treat Adults with Relapsed or Refractory Follicular Lymphoma After Two or More Lines of Systemic Therapy
Approval of Epkinly was based on results from the Phase I/II EPCORE trial in patients with relapsed or refractory follicular lymphoma who have already completed two or more lines of systemic therapy.
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Eli Lilly, OpenAI Strike Collaboration Agreement Seeking to Discover New Antimicrobials to Fight Drug-Resistant Bacteria
The collaboration with OpenAI is part of Lilly’s strategy to combat drug-resistant pathogens through its Social Impact Venture Capital Portfolio.
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FDA Accepts Otsuka and Lundbeck’s Supplemental New Drug Application for Brexpiprazole to Treat Adults with Post-Traumatic Stress Disorder
Results from three randomized clinical trials show safety and efficacy of a brexpiprazole-sertraline combination in adult patients with post-traumatic stress disorder.
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Advancing Bispecific Biologic Therapies for Solid Tumors and Blood Cancers
In an interview with Pharm Exec Associate Editor Don Tracy, Pedro Valencia, VP, Solid Tumor Pipeline Strategy & Execution, AbbVie, discusses how AbbVie is advancing the development of bispecific biologic therapies in both solid tumors and blood cancers.
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Novo Nordisk to Invest $4.1 Billion in Expanding Manufacturing Capabilities in the United States
Investment is expected to fund a new fill and finish manufacturing facility to enhance production of injectable treatments for obesity and chronic diseases.