European Commission expands approval of Alexion’s eculizumab

Alexion Pharmaceuticals’ eculizumab has been approved by the European Commission for the treatment of neuromyelitis optica spectrum disorder (NMOSD), extending its current marketing authorisation. NMOSD is a rare, devastating, complement-mediated disorder of the central nervous system characterised by relapses, also referred to as attacks. Previously known as Devic’s Disease, NMOSD is often confused with other

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AZ’s breast cancer treatment gains approval from European Commission

AstraZeneca and MSD‘s Olaparib has been approved by the European Commission for the treatment of germline BRCA-mutated HER2-negative metastatic breast cancer. The approval allows for the first PARP inhibitor approved in Europe for patients with this difficult-to-treat disease, and the third EU approval for Olaparib. The European commission made the approval based on data from

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European Commission approved AZ’s treatment for locally advanced, unresectable NSCLC

AstraZeneca’s durvalumab has been approved in Europe for the treatment of locally-advanced, unresectable non-small cell lung cancer (NSCLC). The decision enables doctors to prescribe the drug for adults with stage III NSCLC whose tumours express PD-L1 on ≥1% of tumour cells and whose disease has not progressed following platinum-based chemotherapy and radiation therapy (CRT). The

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Pfizer’s treatment for ulcerative colitis approved in Europe

European Commission has approved Pfizer’s Xeljanz (tofacitinib citrate) for ulcerative colitis (UC), meaning it is the first oral therapy and Janus kinase inhibitor to be approved for this patient population. The drug is now approved for three indications in the EU, which also includes rheumatoid arthritis and psoriatic arthritis. “Until now, people living with moderately

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European Commission approves Amgen’s Repatha for reducing cardiovascular risk

The EC has decided to expand the scope of Amgen’s PCSK9 inhibitor Repatha to include the reduction of cardiovascular risk in adults with established atherosclerotic cardiovascular disease (CVD). The treatment can be used to reduce cardiovascular risk by lowering low-density lipoprotein cholesterol (LDL-C) levels – as an adjunct to correction of other risk factors. The

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Boehringer gains first biosimilar approval within EU for Cyltezo

Boehringer Ingelheim has recently won its first biosimilar approval in Europe with authorisation of Cyltezo for a variety of chronic inflammatory conditions, which includes rheumatoid arthritis, psoriatic arthritis, Crohn’s disease and ulcerative colitis. Cyltezo is a biosimilar of AbbVie’s Humira, an anti-TNF monoclonal antibody that pulls in annual sales of approximately $15 billion across its

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Gilead gains EU approval for Hep Combination Treatment – Vosevi

Gilead Sciences obtained a big achievement with its Hepatitis C treatment Vosevi (drug which comprises of Sofosbuvir/Velpatasvir/Voxilaprevir) becoming the first and only single tablet regimen for patients who have previously failed therapy with direct-acting antivirals (DAA). The drug was approved to treat adults with genotype 1-6 chronic hepatitis virus (HCV) infection as a 12-week regimen

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Soliris approved by European Commission to treat adults with gMG, will be picked up by Germany first

Alexion has won new European indication for its ultra-orphan drug, Soliris, and has picked Germany to be its first launch market. Soliris received the green light from the European Commission to treat adults with generalised myasthenia gravis (gMG), who are anti-acetylcholine receptor antibody-positive. The extended indication for the first-in-class inhibitor was based on the back

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