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Andrew Baum, M.D. will play a vital role in advancing Pfizer’s long-term corporate strategic plan to maximize value for patients and shareholders. He will also be responsible for our portfolio analysis and prioritization functions, business development activities, strengthening our partnerships with the biotech ecosystem, and the commercial evaluation of our research pipeline.
A record 8,000 attendees are expected at this week’s 27th Annual Meeting of the American Society of Gene & Cell Therapy in Baltimore to discuss the opportunities and challenges facing the industry. Billed as the largest gathering of gene and cell therapy professionals, ASGCT 2024 starts tomorrow and will run through the end of the week, bringing together stakeholders from therapeutic developers and investors to patient advocates, policymakers and regulators.
FDA Commissioner Robert Califf has said that advisory committee meetings should focus more on discussion and be “less about the outcome,” but other agency officials recently advocated for retaining the vote on whether to approve a product under review.
The therapy is currently in late-stage development for the treatment of pulmonary arterial hypertension (PAH), which affects about 40,000 people in the United States.
BioNTech, which is investing money earned during the pandemic in cancer drug development, said in a statement that it is still targeting 2024 revenues in a range of 2.5 billion euros ($2.69 billion) to 3.1 billion euros.
In the dynamic realm where technology meets humanity, we are seeing a new frontier called digital twins. These AI-driven entities, also known as digital humans or synthetic clones, are reshaping the future of education, research, and training across nearly every sector, including the pharmaceutical and life sciences industries.
The deal was announced in February and Novo Nordisk Foundation has since refiled its application to the U.S. FTC seeking regulatory approval for it.
AstraZeneca’s blockbuster BTK inhibitor Calquence significantly improved progression-free survival when used as a frontline treatment in patients with mantle cell lymphoma, according to Thursday’s late-stage results.
Following strong Phase II data, Amgen is going all in on its next-generation obesity treatment MariTide, with plans to run a Phase III trial and a separate mid-stage study for diabetes.
The FDA’s authorization of therapies that fail their efficacy endpoints casts doubt on the regulator’s accelerated approval pathway, according to an article from David Rind, chief medical officer of the drug pricing non-profit Institute for Clinical and Economic Review, published in the Journal of the American Medical Association. In his viewpoint piece, Rind specifically called out Sarepta Therapeutics’ gene therapy Elevidys, which won the FDA’s accelerated approval in June 2023—despite falling short of its primary efficacy endpoint in two studies.
