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46-60 of 1873 results
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.
Production & Manufacturing > Process & Production > News
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).
Production & Manufacturing > Process & Production > News
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.
Production & Manufacturing > Process & Production > News
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.
Production & Manufacturing > Process & Production > News
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
Momenta announces FDA warning letter to contracted Glatopa’s fill/finish manufacturer
Momenta Pharmaceuticals has announced that Pfizer, Sandoz’s contracted Glatopa (glatiramer acetate injection) fill/finish manufacturing partner has received a warning letter from the FDA.
Production & Manufacturing > Process & Production > News
FDA plans to not to hold advisory committee meeting for Portola’s betrixaban NDA
The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) is not planning to hold an Advisory Committee meeting for Portola Pharmaceuticals' New Drug Application (NDA) for betrixaban.
Production & Manufacturing > Process & Production > News
Perrigo files for FDA approval for generic version of Valeant's acne gel
Perrigo said it has filed for the US Food and Drug Administration approval for clindamycin, benzoyl peroxide topical gel, the generic version of Onexton gel (clindamycin phosphate 1.2% and benzoyl peroxide 3.75%).
Production & Manufacturing > Process & Production > News
Ariad seeks European approval for NSCLC drug brigatinib
By PBR Staff Writer
Ariad Pharmaceuticals is seeking approval in Europe for brigatinib to treat adult patients anaplastic lymphoma kinase (ALK+) non-small cell lung cancer (NSCLC) who have been earlier treated with crizotinib.
Production & Manufacturing > Process & Production > News
46-60 of 1873 results