Neena Brizmohun
Deputy editor of Pink Sheet/Scrip/Medtech Insight. Interested in science, pharma and medtech. All views expressed are my own.
Articles
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2 weeks ago |
insights.citeline.com | Neena Brizmohun
AMR-Targeting Drug Secures EMA PRIME Designation Antabio’s next-generation, broad-spectrum antibacterial, MEM-ANT3310, has made it onto the European Medicines Agency’s priority medicines scheme. The company says its product is designed to make a significant impact on the growing problem of antimicrobial resistance. MEM-ANT3310 is a next-generation, broad-spectrum antibacterial (Shutterstock)
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2 weeks ago |
insights.citeline.com | Neena Brizmohun
New Measures Cut Israel’s Drug Approval Time To Just 70 DaysIsrael has introduced a new framework to expedite the marketing approval of medicines, make the country a more attractive destination for drug registration and help reduce drug prices through market competition. Israel's new framework seeks to shorten drug registration timelines (Shutterstock)
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3 weeks ago |
insights.citeline.com | Neena Brizmohun
Industry Benefits As EU CTIS Hits Global Data Sharing MilestoneThe EU Clinical Trials Information System has achieved primary registry designation in the International Clinical Trials Registry Platform in a move that is expected to reduce regulatory burden for companies and help them lower compliance costs by aligning with publication requirements in medical journals. CTIS has been designated a primary registry in the International Clinical Trials Registry Platform (Shutterstock)
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3 weeks ago |
insights.citeline.com | Neena Brizmohun
Early Randomization Among Advice On How To Meet Both EMA & HTA NeedsNewly published insights from a series of European Medicines Agency workshops can guide drug developers in designing development plans that meet the needs of both regulators and health technology assessment bodies. Regulatory-HTA body collaboration early at the design stage and throughout the entire product lifecycle is key (Shutterstock)
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3 weeks ago |
insights.citeline.com | Neena Brizmohun
Mysimba Passes EU Safety Probe, But Currax Must Address Long-Term Heart RisksThe weight management drug, Mysimba, continues to demonstrate a positive benefit-risk balance but the data available are not sufficient to fully determine the cardiovascular safety beyond 12 months. Meanwhile, Currax this month announced the publication of a peer-reviewed study of Mysimba that followed patients for over 4.7 years and found no evidence of excess cardiovascular risk.
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RT @ScripRegVibha: Looking forward to the DIA Europe 2022 meeting tomorrow. Some great sessions listed on the agenda, especially on EU Clin…
RT @ScripRegMaureen: This free-to-view article from @PharmaPinkSheet sister publication @Genericbulletin highlights the off-patent industry…
