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€7.7 million has been awarded to IMPACTIVE by the European Commission to study mechanochemistry as a sustainable method for synthesising active pharmaceutical ingredients (APIs).
Elizabeth Anne Wright, Head of the EU regulatory life sciences team at law firm Cooley, and associates Jessica Koffel and Edward Turtle look ahead at EU regulatory milestones for the life sciences sector in 2023. Five key areas of potential change include: clinical trials, medical devices, pharmaceutical legislation, class actions…
Dupixent® has been approved by European Commission as the first and only targeted medicine indicated for eosinophilic esophagitis.
The European Commission has approved Enhertu in the EU as the first HER2-directed therapy for patients with HER2-low metastatic breast cancer.
The Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) have stated it is closely monitoring and responding to the current EU antibiotic shortages.
Tezspire is the first biologic approved in Europe for severe asthma with no phenotype or biomarker limitation, says AstraZeneca EVP.
Xofluza® offers the first novel mechanism of action for an influenza antiviral to be approved by the European Commission in almost 20 years.
Patients in the EU with an advanced prostate cancer will benefit from a newly approved Lynparza-based treatment combination for the first time.
Ebvallo™ is the first authorised allogeneic T-cell immunotherapy and has been approved for EU patients with relapsed or refractory Epstein‑Barr virus positive post‑transplant lymphoproliferative disease.
Gene therapy etranacogene dezaparvovec has been granted a positive opinion by the CHMP as a haemophilia B treatment for adults in Europe.
Dupixent®, the first and only targeted medicine for prurigo nodularis has been approved by the EC for adults with a moderate-to-severe form of the condition.
The European Commission has approved Pluvicto® as the first targeted radioligand therapy for advanced prostate cancer, based on significant results from the Phase III VISION trial.
Comirnaty® has been authorised by the MHRA as a vaccine to protect against Covid-19 for individuals from six months to four years old.
The European Commission has granted the first paediatric marketing authorisation for Gilead's low-dose Biktarvy® HIV tablet.
A patient-centric legal framework intends to return clinical trial data to study participants, ready for re-use in further research or healthcare practice.
