NA to NAM ratio as a biomarker for cell therapy sterility
Study shows nicotinic acid (NA) to nicotinamide (NAM) ratio enables detection of early-stage microbial contaminations in cell therapy products.
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Transpire Bio signs with Recipharm for inhaled medicine development
Under the agreement, Recipharm will help advance two inhaled medicines intended for asthma and chronic obstructive pulmonary disease (COPD).
Grünenthal to buy NebidoTM testosterone treatment from Bayer for €500m
Privately-owned Grünenthal estimates the Nebido brand will add about €100 million to its EBITDA in 2023.
Dupixent® delivers histological remission for paediatric EoE patients
Phase III trial data shows Dupixent® (dupilumab) has the potential to improve signs of eosinophilic oesophagitis (EoE) and support healthy weight gain in children with the condition.
Research calls for regulators to accelerate the approval of antibiotics
Report by One Health Trust says acknowledging antimicrobial resistance in regulatory frameworks for accelerated drug approval could improve access to new antibiotics.
![Photo of affected lot - PROPOFOL Injectable Emulsion, USP (contains benzyl alcohol) 100 mL Single Patient Use, Glass Fliptop Vial. Lot DX9067 [Credit: Pfizer].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Propofol-recall-300x278.jpg)
![Photo of affected lot - PROPOFOL Injectable Emulsion, USP (contains benzyl alcohol) 100 mL Single Patient Use, Glass Fliptop Vial. Lot DX9067 [Credit: Pfizer].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Propofol-recall-e1657792683882.jpg)
Hospira recalls lot of Propofol Injectable Emulsion
The voluntary US-wide recall of Lot DX9067 of Propofol Injectable Emulsion, USP is due to the possible presence of visible particulate with potentially harmful effects.
Pilot scheme to analyse raw trial data launched by EMA
The pilot will assess whether analysing raw clinical trial data is beneficial to regulatory decision making on marketing authorisation and post-authorisation applications.
Afrigen to collaborate with NIAID on mRNA vaccine research
The research collaboration will enable the sharing of technical skills and materials to expedite Afrigen’s goal of mRNA vaccine production.
Nipah virus vaccine enters Phase I trial
The investigational mRNA-1215 vaccine developed to prevent Nipah virus – a bat-borne disease of pandemic potential, will be evaluated for safety, tolerability and immunogenicity.
AstraZeneca to acquire TeneoTwo and its blood-cancer therapeutic
AstraZeneca announces plans to acquire TeneoTwo and its CD19/CD3 T-cell engager, TNB-486, in a deal worth up to $1.2bn.
ViiV, Roche and Pfizer top in ESG, according to patients
Survey reveals that many patients feel pharma company’s environmental, social, governance (ESG) activities are irrelevant to them.
Ensuring adequate sanitisation: disinfectant-resistant microbes in cleanrooms
Here, EPR summarises a paper that asks whether cleanroom sanitisation procedures are adequate, discussing the emerging problem of microbial resistance to disinfectants.
CEPI provides $30m to advance novel coronavirus vaccine
The Coalition for Epidemic Preparedness Innovations (CEPI) has partnered with a consortium of research and technological institutions to fund the development of a novel vaccine to provide protection against COVID-19, as well other SARS-like Betacoronaviruses.
Aurobac Therapeutics launched to fight antimicrobial resistance
Aurobac Therapeutics SAS - a €40m joint venture between Boehringer Ingelheim, Evotec and bioMérieux - has been launched to create the next generation of antimicrobials and diagnostics to fight antimicrobial resistance (AMR).
Microbial risks presented by aging facilities
Here, EPR summarises the microbial contamination concerns that may arise from aging facilities presented in an article by Tim Sandle.
