Remove tag regulatory-market
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Drug Regulatory Affairs Certificate Institutes in India

Pharmatutor

Drug Regulatory Affairs Certificate Institutes in India. Historical Overview of Pharmaceutical Industries and Regulatory Affairs:During 1950s, multiple tragedies i.e., sulfanilamide elixir, vaccine tragedy and thalidomide tragedy have resulted in substantial increase of legislations for drug products quality, safety and efficacy.

Safety 59
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Cannabinoids receptors: popular preclinical target but banned in 137 countries

Pharmaceutical Technology

Collectively, cannabinoid receptors (CB1 and CB2) are currently the most popular targets in preclinical stage of development, with 391 drugs tagged in total. Despite the current popularity of cannabinoid receptors, the regulatory landscape is challenging and complex. This is closely followed by CB2 receptors in second place.

Medical 98
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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. As we came together with AWS, it became clear we could make a real impact in the medical and regulatory review process for branded materials.

Medical 52
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What Tech Trends Do Life Sciences Marketers Need to Know About?

PM360

To discover how technology is affecting the jobs of life sciences marketers we turned straight to the source—our readers. Casey Cronin Life sciences marketers have a unique opportunity to connect with target audiences on an individual level and foster brand safety through AI advancement. Here are the best responses.

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J&J gets first approval for multiple myeloma bispecific Tecvayli

pharmaphorum

Johnson & Johnson has its first worldwide regulatory approval – in the EU – for Tecvayli, one of two much-anticipated bispecific antibodies the drugmaker has developed for patients with multiple myeloma. Tecvayli previously scored a priority medicines (PRiME) designation from the EMA and a breakthrough-therapy tag from the FDA.

FDA 95
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3 Things Generative AI Can Do for Commercial Pharma Right Now

PM360

In commercial, issues related to Medical, Legal, and Regulatory (MLR) review compliance will need to be carefully managed as well. Auto-tagging, a laborious task, is another area where generative AI/LLMs can assist. Auto-tagging helps the right content get delivered to the appropriate customers. This is a brave new world.

Pharma 97
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Axsome bounces back as FDA clears depression drug

pharmaphorum

Auvelity isn’t the first NMDA-targeting antidepressant to reach the market. The biotech hasn’t revealed much information about the reasons for the delay in getting approval, but said in an SEC filing in June this year that it had agreed to “post-marketing commitments” proposed by the FDA, without going into details.

FDA 90