Tag Archives: CHMP

Associazione Veneta Lotta alla Talassemia (AVLT) and the UK Thalassaemia Society (UKTS) Clarification on European Regulatory Status of LENTIGLOBIN™

(PRESS RELEASE) LONDON, 27-Mar-2019 — /EuropaWire/ — The LentiGlobin application for Conditional Marketing Authorization (cMAA) at the EMA from bluebird bio is still in the process of being reviewed by CHMP during their 25-28 March 2019 meeting. An opinion for … Read the full press release

Sandoz: EMA Committee for Medicinal Products for Human Use (CHMP) adopts positive opinion for marketing authorization of infliximab

Sandoz is seeking approval of biosimilar infliximab for use in all indications of its reference medicine across gastroenterology, rheumatology and dermatology Positive opinion is based on comprehensive clinical and non-clinical data that is expected to confirm that Sandoz biosimilar infliximab … Read the full press release

EU Committee for Medicinal Products for Human Use (CHMP) recommends EU approval of Roche’s Gazyvaro for people with previously treated follicular lymphoma

In the pivotal study, treatment with Gazyvaro plus bendamustine chemotherapy reduced the risk of disease worsening or death by 52 percent compared to bendamustine alone BASEL, 04-May-2016 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the EU … Read the full press release

AstraZeneca announces positive CHMP opinion recommending the approval of new antibiotic, CAZ AVI

LONDON, 02-May-2016 — /EuropaWire/ — AstraZeneca today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending the approval of a new antibiotic, CAZ AVI 2g/0.5g powder. CAZ … Read the full press release

Roche’s Perjeta recommended for approval in EU as pre-surgery breast cancer treatment

The Perjeta regimen is the first neoadjuvant (pre-surgery) breast cancer treatment recommended for approval in the EU based on the benefit in achieving pathological complete response (pCR) BASEL, 29-6-2015 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced … Read the full press release

European Medicines Agency recommends approval of first higher-strength insulin for treatment of patients with diabetes mellitus in the EU

London, 23-10-2012 — /europawire.eu/ — The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has made a recommendation to give marketing authorisation to insulin degludec, a new basal analogue insulin for the treatment of diabetes mellitus in adults. It … Read the full press release