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Approvals

New EU Nod For J&J/Genmab's Darzalex Brings It Closer To Rivals

The EU's CHMP has given the go ahead to extend the EU licence for Janssen/Genmab's Darzalex to include its use earlier in the treatment paradigm, bringing into line with the US label and its rivals.

Europe Drug Review Policy & Regulation
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Novartis Combo On Track To Be First Targeted BRAF NSCLC Therapy

The EU's CHMP has granted a positive opinion for Novartis' combo of MEK inhibitor Mekinist and BRAF inhibitor Tafinlar for BRAF-positive non-small cell lung cancer patients.

Approvals Commercial

AZ’s ZS-9 Targets Hyperkalemia Sector As It Nears EU Market

A potential near-blockbuster drug, AstraZeneca’s Lokelma (ZS-9), has received a positive opinion from Europe’s CHMP and, if approved, will soon have to justify best-in-class plaudits and a hefty acquisition price.

Approvals Market Intelligence

New FDA Revlimid Approval Extends Celgene's Myeloma Empire

Celgene is finally able to market its mainstay multiple myeloma therapy Revlimid for maintenance use after stem cell transplant, after the FDA further expanded its approved indications. The EU is set to follow suit following a CHMP positive opinion last month.

Approvals Policy & Regulation

Celltrion's Truxima First Biosimilar MAB In Oncology To Win EU Approval

Celltrion's version of Roche’s MabThera (rituximab), Truxima, has become the first biosimilar anticancer to win marketing authorization in Europe.

Approvals Biosimilars

Parsabiv Could Allow Amgen To Maintain Control Of Calcimimetics Market

Amgen's oral calcimimetic Sensipar faces generic competition in 2018, but the new intravenuous Parsabiv has advantages that could make it the more popular alternative.

Reimbursement Approvals

Pipeline Watch: Top-Line Tenapanor, Doravirine And Tofacitinib Results

Pipeline Watch has been updated to bring greater depth and detail to a potential therapeutic product’s progress through the R&D pipeline. The table brings you a snapshot of selected late-stage clinical trial events in the pharma and biotech industries.

Pipeline Watch Approvals
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