whitepaper
Whitepaper: Transmissible disease defense unit
The use of flexible mobile biocontainment and test units to prevent the spread of transmissible diseases.
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Biologics
whitepaper
Case study: Oxygen monitoring during shelf life
A stability study that provides an opportunity to extend the product shelf life, by optimising the formulation and/or product packaging.
news
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.
news
First person enrolled in Phase I oncolytic virus trial
The Phase I/IIa trial of BT-001 will assess the safety and efficacy of the virus’ dual mode of action in solid tumours.
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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Tezepelumab significantly reduces exacerbations of severe asthma
In a Phase III trial, tezepelumab was shown to meaningfully reduce annualised asthma exacerbation rates in a range of patients with severe, uncontrolled asthma.
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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.
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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).
news
FDA approves more flexible transportation conditions for Pfizer-BioNTech COVID-19 vaccine
Based on new stability data, the US regulator will allow COMIRNATY® to be transported and stored at standard pharmaceutical freezer temperatures for up to two weeks.
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New variant-specific mRNA COVID-19 vaccine to enter clinical trials
Moderna has shipped the trial material for its mRNA-1273.351 vaccine candidate to the US National Institutes of Health for Phase I trials.
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Ide-cel provides lasting remissions in multiply-relapsed myeloma
BMS and bluebird bio have applied to the FDA for approval of ide-cel as a standard therapy for relapsed or refractory multiple myeloma based on positive Phase II trial results.
news
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.
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Sanofi and GSK start Phase II study of their COVID-19 vaccine candidate
The dose finding study will assess the safety, reactogenicity and immunogenicity of the companies’ investigational COVID-19 vaccine in 720 participants.
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Patient dosed with first Lassa fever vaccine to reach human trials
The first trial participant has been given INO-4500 in Ghana - INO-4500 is a DNA vaccine candidate being developed to protect against Lassa fever.
