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NICE approves gene therapy for spinal muscular atrophy
Zolgensma, a one-off, potentially curative treatment for type 1 spinal muscular atrophy, is set to become the most expensive drug ever approved for use on the UK’s NHS.
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Regulation & Legislation
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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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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.
whitepaper
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.
whitepaper
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.
whitepaper
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.
whitepaper
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.
video
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.
article
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…
news
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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Treatment for rare Duchenne muscular dystrophy mutation approved by FDA
The FDA conditionally approved Sarepta’s Amondys 45 (casimersen) after interim Phase III results indicated the treatment is reasonably likely to be of clinical benefit.
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EMA COVID-19 treatment evaluations update
The EMA has begun a rolling review of Celltrion’s regdanvimab (CT-P59) antibody for COVID-19 and assessing new data on Veklury (remdesivir).
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FDA grants Priority Review to Pfizer’s tick-borne encephalitis vaccine TicoVac™
If approved, TicoVac would be the first vaccine in the US to help protect adults and children from tick-borne encephalitis.
