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1-15 of 1823 results
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
FDA accepts Intellipharmaceutics’ NDA for Rexista to treat moderate to severe pain
The US Food and Drug Administration has accepted for filing of Intellipharmaceutics International’s New Drug Application ("NDA") seeking authorization to market its Rexista abuse-deterrent oxycodone hydrochloride extended release tablets in the 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg and 80 mg strengths.
Production & Manufacturing > Process & Production > News
FDA grants priority review to Merck's Keytruda for two urothelial cancer indications
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted priority review to two supplemental biologics license applications that seek approval of Merck’s Keytruda for the treatment of locally advanced or metastatic urothelial cancer.
Production & Manufacturing > Process & Production > News
AbbVie's hepatitis C treatment under FDA priority review
By PBR Staff Writer
The US Food and Drug Administration has accepted under priority review AbbVie's new drug application (NDA) seeking approval of its once-daily pan-genotypic regimen of glecaprevir/pibrentasvir (G/P) to treat all major genotypes (1-6) of chronic hepatitis virus (HCV) infection.
Production & Manufacturing > Process & Production > News
Summit outlines phase 3 program for CDI antibiotic ridinilazole
By PBR Staff Writer
Drug discovery and development firm Summit Therapeutics has outlined plans for the design of the phase III programme for its C. difficile treatment, ridinilazole.
Production & Manufacturing > Process & Production > News
Emergent initiates phase 1b trial to assess broad-spectrum antiviral UV-4B for dengue
Emergent BioSolutions has commenced a Phase 1b multiple ascending dose study to assess the safety and tolerability of its novel antiviral candidate, UV-4B developed as a potential oral treatment for dengue viral infection.
Production & Manufacturing > Process & Production > News
1-15 of 1823 results