CHMP Backs 13 New Medicines, Maintains Negative Opinion of Sarepta’s Exondys

Europe – CHMP Backs 13 New Medicines, Maintains Negative Opinion of Sarepta’s Exondys

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday recommended thirteen new medicines for EU approval and reaffirmed...
NICE rejects Novartis’ CAR-T Kymriah for adult lymphoma

Europe – NICE rejects Novartis’ CAR-T Kymriah for adult lymphoma

The draft guidance recommends against its use for adults after two or more lines of systemic therapy, concluding that it is not cost effective...
NICE nod for Novartis’ targeted skin cancer combo

Europe – NICE nod for Novartis’ targeted skin cancer combo

Final draft guidelines are recommending the combination for use in patients with stage III BRAF V600 mutation-positive melanoma who have disease that has spread...
‘Streamlined’ medicines regulation promised in ‘No Deal’ Brexit scenario

UK – ‘Streamlined’ medicines regulation promised in ‘No Deal’ Brexit scenario

Warnings about the huge delays to supply chains and damage to the UK economy are being made across all sectors, but concerns about medicines...
Regulators Detail Challenges in Defining Orphan Conditions in EU

Europe – Regulators Detail Challenges in Defining Orphan Conditions in EU

A new commentary by European regulators and members of the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) in Nature Reviews Drug Discoveryprovides...
Good clinical practice for clinical trials

Europe – Good clinical practice for clinical trials

Overview Good clinical practice (GCP) is a set of internationally-recognised ethical and scientific quality requirements that must be followed when designing, conducting, recording and reporting...
Dismay as NICE rejects Roche’s MS drug Ocrevus

Europe – Dismay as NICE rejects Roche’s MS drug Ocrevus

The final appraisal document from the National Institute for Health and Care Excellence (NICE) has caused consternation among patients – and an immediate petition from the MS Society...
EC green-lights MSD’s Keytruda combo for lung cancer

Europe – EC green-lights MSD’s Keytruda combo for lung cancer

Specifically, the decision allows use of the combination in patients with metastatic non-squamous non-small cell lung cancer (NSCLC) who have no EGFR or ALK...
Les mauvais brevets limitent l'accès aux médicaments en Europe

Europe – Les mauvais brevets limitent l’accès aux médicaments en Europe

Les brevets pharmaceutiques peuvent être des obstacles à l'accès des patients au traitement dont ils ont besoin pour rester en vie et en bonne...
CHMP Backs 13 New Medicines, Maintains Negative Opinion of Sarepta’s Exondys

Europe – Pre-authorisation guidance

This guidance should be read in conjunction with the rules governing medicinal products in the European Union, volume 2, notice to applicants and pre-submission guidance documents. New or revised...

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