Overall, last year can be considered quite a successful one in terms of new product approvals.
Overall, last year can be considered quite a successful one in terms of new product approvals. Nineteen products containing new biopharmaceutical molecular entities were approved in the United States and/or the European Union. These approval numbers are above average compared to the previous five years, which recorded a mean approval rate of 13 products. The 2013 annual approval rate was surpassed only in 2009, a year in which 20 new products came on the market.
Nineteen approvals, by any metric, is a healthy headline number. Digging a little deeper, however, reveals that just over two-thirds of these (a still credible 13 products) were genuinely new first time approvals. Six of the products, although newly approved in one region last year, had gained approval prior to that in the other region ).
Moreover, a significant difference in the absolute approval numbers was witnessed in the regions. A total of 16 approvals were recorded in Europe, while only five biopharmaceuticals came on the market in the US in that same period. This trend can partly be explained by Europe playing catch up in the case of some products; five of Europe’s 16 new approvals were already on the US market prior to 2013.
Those newly approved products that underpin particularly noteworthy technical, medical, or regulatory milestones are the focus a new Biopharm International article by Gary Walsh. Read it here.
Fake Weight Loss Drugs: Growing Threat to Consumer Health
October 25th 2024In this episode of the Pharmaceutical Executive podcast, UpScriptHealth's Peter Ax, Founder and CEO, and George Jones, Chief Operations Officer, discuss the issue of counterfeit weight loss drugs, the potential health risks associated with them, increasing access to legitimate weight loss medications and more.
MDMA Therapy for Mental Health Conditions: Do the Benefits Outweigh the Risks?
October 25th 2024Despite a recent FDA Complete Response Letter issued to Lykos for midomafetamine capsules for the treatment of post-traumatic stress disorder, experts believe that the future is bright for psychedelic drugs that treat mental health conditions.
The Transformative Role of Medical Information in Customer Engagement
October 3rd 2024Stacey Fung, Head of Global Medical Information at Gilead Lifesciences, delves into the evolving role of Medical Information (MI) in the pharmaceutical industry. Covering key topics like patient engagement through omnichannel strategies, combating misinformation, and leveraging AI to enhance medical inquiries, the conversation with Stacey highlights MI's critical role in ensuring patient safety and supporting drug development. She also shares her professional journey and tidbits for early career professionals on professional development.
The Impact of Artificial Intelligence on the Creation of Medicines
October 24th 2024Najat Khan, chief R&D officer, chief commercial officer, Recursion, and Fred Hassan, director, Warburg Pincus, discuss how artificial intelligence can help reduce healthcare costs at the 20th Annual Young & Partners Pharmaceutical Executive Summit held at the Yale Club of New York.