New FDA medical device framework to improve women’s health
The FDA’s Center for Devices and Radiological Health releases its strategic plan to improve medical device research and regulation for women.
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![The GlaxoSmithKline headquarters building in Brentford, west London, June 2018 [Credit: Willy Barton / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/GSK-3-300x278.jpg)
![The GlaxoSmithKline headquarters building in Brentford, west London, June 2018 [Credit: Willy Barton / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/GSK-3-e1624534468322.jpg)
Tony Wood to replace Dr Hal Barron as GSK’s CSO
Tony Wood will assume accountability for R&D across GSK’s portfolio and pipeline from Dr Hal Barron on 1 August 2022.
mRNA COVID-19 vaccines safe for pregnant women, finds EMA review
A review of studies involving 65,000 pregnancies suggests mRNA COVID-19 vaccines do not increase the risk of pregnancy complications.
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.
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.
