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Israel set to be first country to vaccinate entire population against COVID-19
A new report has said that Israel is expected to be the first country in the world to vaccinate its population against COVID-19.
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Case study: Biochemistry company uses RMM analyser to streamline process control
See how a leading biochemistry company implemented Real-time Microbial Monitoring to streamline process control in their water system.
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FDA approves crizotinib for children with certain anaplastic large cell lymphomas
In a Phase I/II trial, 81 percent of paediatric patients with relapsed or refractory, systemic anaplastic large cell lymphoma achieved complete remission with crizotinib (Xalkori).
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Valneva may provide Europe with the only inactivated virus vaccine for COVID-19
The Europe Commission is currently in discussions to procure millions of doses of Valneva’s COVID-19 innactivated virus vaccine, VLA2001.
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Biopharma industry commits to working with regulatory agencies on COVID-19 vaccines
A statement from biopharmaceutical industry groups has said they plan to work with regulatory agencies to gather data on COVID-19 vaccines.
webinar
Comparing EMA and Health Canada CTA submission for Phase I trials to US FDA IND application
13 January 2021 | By Altasciences
Join us on 9 March 2021 at 14:00 GMT for an overview of a foreign health authority’s requirements for gaining approval to conduct an FIH clinical trial by comparing Health Canada and European Medicines Agency (EMA) Clinical Trial Authorisation (CTA) processes to that of the FDA IND submission.
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European Commission approves dispersible tablets to treat paediatric HIV
Marketing authorisation in the EU has been given to Tivicay (dolutegravir) dispersible tablets to treat HIV in certain paediatric patients.
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EMA receives authorisation application for AstraZeneca COVID-19 vaccine
The EMA has received a conditional marketing authorisation application for the Oxford-AstraZeneca COVID-19 vaccine.
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FDA approves Phase III trial of synthetic biological COVID-19 treatment
The international Phase III trial will evaluate whether a 14 day course of carrimycin can improve outcomes for COVID-19 patients with severe symptoms.
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UK’s MHRA approves Moderna’s COVID-19 vaccine
The MHRA has given the green light to the Moderna COVID-19 vaccine for use in the UK, making it the third to be approved in the country.
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European Commission approves Moderna’s COVID-19 vaccine
Moderna's COVID-19 vaccine has been approved in the EU with a conditional marketing authorisation by the European Commission.
article
Creating a COVID-19 Safety Toolkit for pharmaceutical businesses
Marta Kalas explains how to develop a COVID Safety Toolkit to ensure pharmaceutical businesses comply with changing regulations.
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NICE initiates new Innovative Licensing and Access Pathway for medicines
The new pathway developed by NICE for medicines to go from clinical trials to NHS patients is now in action.
video
On-demand webinar: Best practices for cleaning and disinfection
This on-demand webinar focuses on the importance of cleaning & disinfection, covering legal requirements & the global guidelines for disinfection in cleanrooms.
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European Commission approves first treatment for peanut allergy
Aimmune Therapeutics' PALFORZIA® has been approved by the European Commission as a treatment for peanut allergy.