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COVID-19 T cell test submitted for emergency use authorisation
In clinical testing, the T-SPOT.COVID test was found to agree with PCR test results in over 96 percent of samples taken within first 60 days of infection.
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Regs & Legs
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EMA concludes review of Lilly’s COVID-19 antibody therapies
The human medicines committee decided that there was significant evidence to endorse the use of a combination of bamlanivimab and etesevimab in outpatients at high risk of severe COVID-19.
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Interactive PDF: A quick guide to dissolution testing
What is dissolution testing, why is it critical, what to consider for your method validation? Learn more in this quick guide.
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EMA and Health Canada to make COVID-19 vaccine data open access
Starting with the publication of clinical data used to support the authorisations of the Moderna COVID-19 vaccine, EMA and Health Canada said they will continue the open access approach for all COVID-19 vaccines.
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Whitepaper: Making MS-based glycan analysis easier
Recent technological advances have made it easier to cope with the complexity of mass spectrometry (MS) based glycan analysis.
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EMA begins rolling review of Sputnik V COVID-19 vaccine
The EU regulator has begun reviewing preclinical and early trial data for Sputnik V, the COVID-19 vaccine developed by Russia.
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Interview: Current and future vaccine safety aspects
Key requirements to ensure patient safety in the present-day development and production of viral vaccines, and the challenges going forward.
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Whitepaper: Early product characterisation mitigates risks in biologics development
Product characterisation facilitates easier process design to ensure the biological drug attains critical product safety, purity, and potency.
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On-demand webinar: Key elements of a sterility assurance program
This on-demand webinar will provide aspects of a sterility assurance program for a pharmaceutical product. Sterility assurance begins at the early stages of product development and follows through the entire product lifecycle.
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EMA’s new guide to implementing IDMP data standards triggers the countdown to change
The IDMP data standards aim to standardise the submission of data on medicinal products. Remco Munnik, Associate Director at Iperion, has been working with the EU focus group creating the EU IDMP Implementation Guide version 2, published late February. He explains why pharma companies need to act now in response…
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COVID-19 treatments update: hydroxychloroquine and tocilizumab
Find out what the WHO has to say about the use of hydroxychloroquine in COVID-19 prevention and the results of a severe COVID-19 pneumonia trial with tocilizumab.
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Launch of generic oncology medications to improve treatment access in India
GlobalData suggests the recent approval of new generics in oncology should enhance access and adherence to cancer treatment by reducing costs borne by patients.
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FDA approves the Janssen COVID-19 Vaccine for emergency use
The FDA has issued an Emergency Use Authorization for the single-dose Janssen COVID-19 Vaccine, making it the third COVID-19 vaccine available for use in the US.
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EMA recommends six medications for approval in February meeting
The EMA’s committee adopted positive opinions of six medications, including two orphan drugs, and concluded its review of the use of REGN-COV2 – an investigational antibody therapy for COVID-19.
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EMA issues its requirements for adapting COVID-19 vaccines for viral variants
The European Medicines Agency has set out its guidelines for vaccine manufacturers adapting their approved COVID-19 vaccines to combat viral variants.
