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31-45 of 1862 results
FDA grants Pfizer’s Lorlatinib breakthrough designation for NSCLC
The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Pfizer’s lorlatinib for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC), who were earlier treated with one or more ALK inhibitors.
Production & Manufacturing > Process & Production > News
uniQure’s gene therapy for severe hemophilia B gets PRIME designation in Europe
uniQure’s AMT-060 investigational gene therapy in patients with severe hemophilia B, has been granted PRIME designation by the European Medicines Agency (EMA).
Production & Manufacturing > Process & Production > News
EMA's CHMP recommends approval for Kevzara for rheumatoid arthritis
The European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Sanofi and Regeneron Pharmaceuticals’ Kevzara (sarilumab) for treating adult patients with moderately to severely active rheumatoid arthritis after adopting a positive opinion for its for its marketing authorization.
Production & Manufacturing > Process & Production > News
Biosimilars to rituximab, etanercept recommended for approval in Europe
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of both Sandoz' biosimilars rituximab and etanercept to treat the same indications as their respective reference medicines.
Production & Manufacturing > Process & Production > News
Sawai to buy Upsher-Smith’s generic pharmaceuticals business for $1.05bn
By PBR Staff Writer
Japan-based Sawai Pharmaceutical has agreed to acquire Upsher‐Smith’s generic pharmaceuticals business from its parent firm Acova for around $1.05bn.
Production & Manufacturing > Process & Production > News
Novartis gets FDA breakthrough therapy status for CTL019 to treat r/r DLBCL
By PBR Staff Writer
Novartis has secured breakthrough therapy status from the US Food and Drug Administration (FDA) for its investigational chimeric antigen receptor T cell (CAR-T) therapy, CTL019, to treat adult patients with relapsed and refractory (r/r) diffuse large B-cell lymphoma (DLBCL), who have failed two or more prior therapies.
Production & Manufacturing > Process & Production > News
FDA advisory committee to review Puma’s NDA for neratinib
The US Food and Drug Administration (FDA) has scheduled Puma Biotechnology’s New Drug Application (NDA) for neratinib for discussion by the Oncologic Drugs Advisory Committee (ODAC) on 24 May 2017.
Production & Manufacturing > Process & Production > News
Icon Bioscience submits NDA to FDA for anti-inflammatory drug Dexycu
Icon Bioscience has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for its lead pipeline product Dexycu (IBI-10090).
Production & Manufacturing > Process & Production > News
Active Biotech’s tasquinimod gets FDA orphan drug status for multiple myeloma treatment
The US Food and Drug Administration (FDA) has granted orphan drug designation to Active Biotech’s investigational novel agent, tasquinimod, for multiple myeloma treatment.
Production & Manufacturing > Process & Production > News
FDA grants priority review for Lynparza for maintenance setting in ovarian cancer patients
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted AstraZeneca’s new drug application (NDA) for Lynparza (olaparib) tablets (300mg twice daily) for use in platinum-sensitive, relapsed ovarian cancer patients in the maintenance setting.
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FDA grants orphan drug status to Boehringer's BI 836858 to treat MDS
Boehringer Ingelheim has secured orphan drug designation from the US Food and Drug Administration (FDA) for its anti-CD33 monoclonal antibody, BI 836858, to treat myelodysplastic syndromes (MDS).
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FDA grants priority review to Enasidenib for IDH2-Mutant AML
The US Food and Drug Administration (FDA) has accepted under priority review Celgene's new drug application (NDA) seeking approval of enasidenib to treat patients with relapsed/refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase 2 (IDH2) mutation.
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FDA grants priority review for EMD Serono's avelumab for metastatic urothelial carcinoma
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted priority review for EMD Serono's biologics license application (BLA) of avelumab to treat metastatic urothelial carcinoma (mUC).
Production & Manufacturing > Process & Production > News
EMA's CHMP recommends approval of Novartis’ Tafinlar in combination with Mekinist
The Committee for Medicinal Products for Human Use (CHMP) has recommended approval to the European Medicines Agency (EMA) of Novartis’ Tafinlar (dabrafenib) in combination with Mekinist (trametinib) as therapy for advanced or metastatic non-small cell lung cancer (NSCLC) patients whose tumors express the BRAF V600 mutation.
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AstraZeneca gets positive CHMP recommendation for hyperkalaemia drug
By PBR Staff Writer
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of AstraZeneca’s ZS-9 (sodium zirconium cyclosilicate) to treat hyperkalaemia.
Production & Manufacturing > Process & Production > News
31-45 of 1862 results