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FDA OK’s Gilead Sciences’s hepatitis C drug

The U.S. Food and Drug Administration (FDA) has approved updated labeling for Gilead Sciences’s Epclusa (sofosbuvir 400mg/velpatasvir 100mg), the first all-oral, pan-genotypic, once-daily single tablet regimen (STR) for the treatment of adults with chronic hepatitis C virus (HCV) infection, to include use in patients co-infected with HIV.

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New EU approval for AstraZeneca’s certain breast cancer treatment

AstraZeneca today announced that the European Commission (EC) has approved Faslodex (fulvestrant) for certain metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy.

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Quantum Genomics raises €8.2 Million, could double it

Quantum Genomics, a biopharmaceutical company focused on cardiovascular diseases, has a completed placement and a capital increase, including the removal of preferential subscription rights, reserved for a category of beneficiaries.

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Ablynx’s Nanobody Fast Track listed by the US FDA, third phase study report in 2017

Ablynx was granted Fast Track designation for caplacizumab, by the that the U.S. Food and Drug Administration (FDA). That’s the company’s first-in-class anti-von Willebrand factor (vWF) Nanobody developed for the treatment of acquired thrombotic thrombocytopenic purpura (aTTP).

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Verona Pharma doses first patients for its respiratory disease treatment

Verona Pharma, a respiratory disease-focused drugmaker, said on Wednesday that the first patients have been dosed in a Phase 2b clinical trial testing RPL554 as a maintenance treatment for chronic obstructive pulmonary disease (COPD). Verona Pharma expects to report top-line data from this trial in the second half of 2018.

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Midatech wraps up pre-clinical liver cancer programm, human studies in 2018

Midatech Pharma has prepared its candidate MTD119 (previously MTR104) for advanced liver cancer for the clinical testings, in a pre-clinical programme that included three subcutaneous or orthotopic liver cancer xenograft models treated with the active cytotoxic compound maytansine conjugated with Midatech’s gold nanoparticle (GNP) technology.

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Cellectis granted European RNA-guided endonucleases patent, more patents on the way

Cellectis, a French clinical-stage biopharmaceutical company focused on developing immunotherapies based on gene-edited CAR T-cells (UCART), on Tuesday announced a patent grant by the European Patent Office, for the invention of using RNA-guided endonucleases, such as Cas9 or Cpf1 for the genetic engineering of T-cells.

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Valneva cleared for the only currently active clinical stage Lyme vaccine candidate

Valneva on Monday said that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its Lyme disease vaccine candidate VLA15.

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Sanofi, Regeneron seek European approval for approval in Europe for Dupinext to treat adults with atopic dermatitis

Sanofi and Regeneron Pharmaceuticals, on Friday announced that the European Medicine Agency`s Committee for Medicinal Products for Human Use has adopted a positive opinion for the marketing authorization of Dupixent.

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The first targeted treatment for newly diagnosed certain Leukemia in the EU

Novartis on Friday said that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of Rydapt (midostaurin) for the treatment of adults with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation-positive.

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