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Biosimilar version of Humira approved in Europe

A biosimilar version of AbbVie Inc.’s blockbuster arthritis drug Humira, produced by a joint venture of Biogen Inc. and Samsung Biologics, was approved by EU regulators.

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EU approves breast cancer drug Kisqali

Novartis AG’s Kisqali (ribociclib) received European Union approval as first-line treatment for a tough-to-treat breast cancer.

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AbbVie Receives CHMP Positive Opinion for Humira

The EMA’s CHMP granted a positive opinion for Humira (adalimumab) for the treatment of chronic non-infectious anterior uveitis in pediatric patients from 2 years of age.

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EU medicines agency recommends approval of Novartis leukemia drug Rydapt

ZURICH (Reuters) – A European Medicines Agency (EMA) panel recommended on Friday approval of a new Novartis drug to be used against a tough-to-cure form of blood cancer as the Swiss drugmaker makes headway on refreshing its oncology portfolio. The EMA’s Committee for Medicinal Products for Human Use (CHMP) backed Rydapt against acute myeloid leukemia […]

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IDMP & the Emperor’s new clothes

The fact that the European Medicines Agency again pushed back the deadline for ISO IDMP (Identification of Medicinal Products) compliance has not stopped the life sciences technology and services industry from promoting IDMP software and solutions.

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Kamada Withdraws MAA For Inhaled Alpha-1 Antitrypsin

Kamada Ltd. withdrew the Marketing Authorization Application (MAA) for its proprietary inhaled Alpha-1 Antitrypsin therapy for the treatment of Alpha-1 Antitrypsin Deficiency with the EMA.

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EU Approves Brineura for CLN2 Disease

The European Commission granted marketing authorization for BioMarin Pharmaceutical’s Brineura for the treatment of tripeptidyl peptidase 1 (TPP1) deficiency.

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Votubia receives EU approval for new indication

Novartis broadened the indications for its Votubia drug with EU approval of its use to treat refractory partial-onset seizures in patients with tuberous sclerosis complex.

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New drug approvals fall to six-year low in 2016

2016 turned out to be a disappointing one for new drug approvals with the U.S. Food and Drug Administration clearing just 22 new medicines for sale, the lowest number since 2010 and sharply down on 2015’s tally of 45.

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Richter withdraws biosimilar marketing application

Hungarian pharma firm Richter withdrew a marketing application for a biosimilar drug from the EMA in anticipation of a possible negative assessment.

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