Rare Disease Clinical Outcome Assessment Consortium launched
The Rare Disease Clinical Outcome Assessment (COA) Consortium aims to advance patient-focused assessment of clinical benefit in treatment trials for rare diseases.
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SAHPRA and USP to increase availability of safe health products in South Africa
SAHPRA and US Pharmacopeia have signed a Memorandum of Understanding to expand access to quality-assured health products in South Africa.
ACG introduces Smart Connected Product to enable remote machine monitoring in real-time
New solution improves machine efficiency, prevents breakdowns, lowers costs and reduces risks whilst providing anytime, anywhere remote monitoring.
Have your say on future UK clinical trial legislation
The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a public consultation on far-reaching proposals to revise the clinical trial legislation in the UK.
Enhertu granted Priority Review for HER2-positive breast cancer
US FDA grants Enhertu Priority Review based on promising trial results in certain patients with HER2-positive breast cancer.
![Gilead sign at their headquarters in Silicon Valley, California USA[Credit: Michael Vi/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Gilead-2-300x278.jpg)
![Gilead sign at their headquarters in Silicon Valley, California USA[Credit: Michael Vi/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Gilead-2-e1642427117214.jpg)
Gilead joins the Association of the British Pharmaceutical Industry
With the Association of the British Pharmaceutical Industry (ABPI), Gilead Sciences will work to tackle health crises and shape international trade and regulation.
Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, January 2022
The EMA’s pharmacovigilance committee (PRAC) began reviewing terlipressin containing medicines and recommended updates to COVID-19 vaccine safety information.
Promising results for COVID-19 and pneumococcal vaccine co-administration
Pfizer reveals co-administering its Prevnar 20™ pneumococcal vaccine and a booster dose of Comirnaty® COVID-19 vaccine was safe and immunogenic.
Accelerating Clinical Trials in the EU (ACT EU) initiative launch
The new ACT EU initiative seeks to transform how clinical trials are initiated, designed and run in the European Union.
NICE recommends Rinvoq® for adults with active psoriatic arthritis
AbbVie’s Rinvoq® (upadacitinib) will be available on the NHS in England and Wales for adults with active psoriatic arthritis, following NICE approval.
![Takeda logo on a building in San Diego, California 2020 [Credit: Michael Vi/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Takeda-1-300x278.jpg)
![Takeda logo on a building in San Diego, California 2020 [Credit: Michael Vi/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Takeda-1-e1641995614300.jpg)
Takeda to acquire Adaptate for novel T-cell engager technology
Takeda’s acquisition of Adaptate Biotherapeutics will enhance efforts to develop cell engager therapies for solid tumours.
Keytruda® promising in adjuvant treatment of lung cancer
MSD/Merck reveals Keytruda® (pembrolizumab) significantly improved disease-free survival in adjuvant treatment of non-small cell lung cancer (NSCLC) patients.
Kaftrio® with ivacaftor approved by EC to treat children with cystic fibrosis
Children with cystic fibrosis aged six to11 years could benefit from Kaftrio® in combination with ivacaftor, as a treatment targeting the underlying cause of the disease.
Graft engineering sees potential to reduce GVHD risk in leukemia patients
New study shows risk of developing graft-versus-host disease (GVHD) in leukaemia patients reduced by removing naïve T cells from donor blood used for stem cell grafts.
Ensovibep shows promise as an antiviral for COVID-19
Phase II trial data suggests ensovibep (MP0420) significantly reduces SARS-CoV-2 viral load and reduces hospitalisation and death due to COVID-19.
