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FDA approves first Stelara biosimilar, Wezlana

European Pharmaceutical Review

The US Food and Drug Administration ( FDA) has approved Wezlana (ustekinumab-auub) as a biosimilar to Johnson & Johnson’s Stelara (ustekinumab). The evidence also demonstrated that Wezlana met the other legal requirements to be interchangeable with Stelara at the pharmacy level, without consulting the prescriber.

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Sanofi and AstraZeneca’s RSV antibody shows mettle in real-world results

Pharmaceutical Technology

Nirsevimab is still undergoing regulatory review in the US, with the US Food and Drug Administration (FDA) accepting the Biologics License Application (BLA) for nirsevimab in January 2023. A further potential sum of €440m is dependent on whether regulatory and sales-related milestones are hit.

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THINK Surgical Receives FDA 510(k) Clearance for TMINI Miniature Robotic System

Legacy MEDSearch

Food and Drug Administration (FDA). THINK Surgical designed the TMINI robotic handpiece in collaboration with Sagentia Innovation, an R&D consultancy based in Cambridge, U.K. About Sagentia Innovation Sagentia Innovation is a science and engineering R&D consultancy based in Cambridge, U.K.

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Cardiovascular Medical Device Sales With Marc Toth

Evolve Your Success

In this episode, Samuel Adeyinka interviews Marc Toth , who shares his entrepreneurial journey in the cardiovascular medical device sales industry. We are corporate with $150 million in sales for corporate but I’ve been here since the beginning. The foods are put on the trays, then go up to the person who has a diabetic diet.

Medical 52
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Hemosonics Awared FDA 510(k) Clearance for Quantra® Hemostasis System with QSTAT® Cartridge

Legacy MEDSearch

Food and Drug Administration (FDA) for the Quantra Hemostasis System with QStat Cartridge. Over the past 17 years, we have built one of the strongest networks of device professionals ranging from sales, marketing, research & , quality & regulatory, project management, field service, and clinical affairs.

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New quality requirements for tobacco products

European Pharmaceutical Review

1 In the EU, the Tobacco Products Directive (2014/40/EU) governs “the manufacture, presentation and sale of tobacco and related products”. He is currently a CMC consultant with an interest in impurities and safety‑based limits. References Smoking, Drinking and Drug Use among Young People in England, 2021. Internet] OJEU.

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Private Patient Advocacy: The Medical Sales Rep’s Role In The Nursing World With Antra Boyd And Karen DiMarco, Part 2

Evolve Your Success

In part two of our interview with Antra Boyd and Karen DiMarco, we get more of their perspective of the medical sales industry, specifically the role they believe a medical sales rep plays and its importance to their role as nurses. To listen to the first part, check it out at The Medical Sales Podcast. Sales can be pushy.