Remove tag accelerated-approvals
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bluebird bio wins back-to-back landmark FDA approvals for first-in-class gene therapies

Pharmaceutical Technology

After several setbacks, bluebird bio bounces back with two major FDA gene therapy approvals. Last month, Zynteglo (betibeglogene autotemcel), or beti-cel, was approved as a one-time potentially curative gene therapy for patients with beta-thalassaemia who require regular blood transfusions.

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The FDA and Aduhelm: WTF?

World of DTC Marketing

One agency FDA adviser, resigning from his committee post in protest, called it “probably the worst drug approval decision in recent U.S. Biogen’s Aduhelm won FDA approval after discovering that some patients on higher dosages had displayed improvement of.39 Not to mention the $56,000 annual price tag.

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EVERSANA and Amazon Web Services Introduce Transformative Medical & Regulatory Review AI Solution

PM360

The first solution, developed by EVERSANA leveraging AWS and AWS Partner TensorIoT , addresses a time-consuming and error-prone process in the industry—medical and regulatory content approvals. The complexity of this process across healthcare is a primary barrier to delivering personalized and timely customer experiences.

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What Tech Trends Do Life Sciences Marketers Need to Know About?

PM360

Another capability made possible by fine-tuning is the enhancement of content tagging. Content tagging has always been a labor-intensive task. Auto-tagging ensures that the right content efficiently reaches the right customers. For example, let’s consider approved email templates and key messages.

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3 Things Generative AI Can Do for Commercial Pharma Right Now

PM360

Accelerated Content Creation and Organization Personalized engagement is crucial for successful commercialization, especially as more physicians have come to expect it from their online interactions as consumers. Auto-tagging, a laborious task, is another area where generative AI/LLMs can assist.

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You can’t afford to get cancer

World of DTC Marketing

As cancer survival rates rise, so do the price tags of life-saving treatments. 11 of the 12 cancer drugs that the Food and Drug Administration approved in 2012 were priced at more than $100,000 per year. OPENING: American cancer patients spent more than $21 billion on their care in 2019. billion included out-of-pocket costs of $16.22

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Rare Disease Spotlight – tracing the rise of orphan drug designations over almost 40 years

Pharmaceutical Technology

For example, while orphan drug designations have more than doubled in the last decade compared to the previous one, only 16% of therapies with orphan tags have managed to gain FDA approval in some indications. Prior to the program, only 10 drugs were approved for a rare disease.