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EMA to investigate HPV vaccine for severe side effects, complex regional pain syndrome and postural orthostatic tachycardia syndrome

July 13, 2015 | By Eric Sagonowsky While the European Medicines Agency said it "does not question that the benefits of HPV vaccines outweigh their risks," on Monday it announced a safety review of the shots that have thus far failed to live up to expectations partly due to safety concerns and a sex-related stigma.…

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Considerations For Compliance With CTIS Submissions Under The EU-CTR

This article outlines the process for sponsors in transitioning from an EU-CTD to an EU-CTR CTIS submission process. It provides guidance on...

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Pfizer, BioNTech's updated booster protects against Omicron in human trial

Pfizer and its German partner BioNTech said their COVID-19 vaccine booster, adapted for the BA.4 and the BA.5 subvariants, generated a strong immune response and was well tolerated in testing on humans.

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Pfizer, BioNTech Find Updated COVID Booster Protects against Omicron in Trial

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Looming challenges for Europe's cell and gene therapy space

In spite of logistical obstacles from Brexit and the COVID-19 pandemic, Europe’s CGT market is catching up to that of the U.S. 

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4th COVID vaccine dose significantly boosts immunity, UK study finds

The study results will help immunization committees decide whether to expand booster programs to wider populations.

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U.S. Dragging Its Feet on Biosimilar Approvals, Pharmacist Says

Introduction of biosimilars falling behind that of other countries

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'Vaccinated, recovered or dead': Europe fights COVID-19 wave — and itself

‘Vaccinated, recovered or dead’: Europe fights COVID-19 wave — and itself

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'Vaccinated, recovered or dead': Europe fights Covid-19 wave - and itself

More than half the world's Covid-19 deaths this month were reported in Europe.. Read more at straitstimes.com.

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WHO Approval for Covaxin delayed again

WHO Approval for Covaxin delayed again
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