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31-45 of 1845 results
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
FDA clears Audentes’ IND application for AT342 to treat Crigler-Najjar syndrome
Audentes Therapeutics’ investigational new drug (IND) application for AT342, its gene therapy product candidate, to treat Crigler-Najjar Syndrome has been cleared by the US Food and Drug Administration (FDA).
Production & Manufacturing > Process & Production > News
CHMP issues positive opinion for Amgen's adalimumab biosimilar
By PBR Staff Writer
Amgen has received positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for adalimumab biosimilar candidate, ABP 501, to treat several inflammatory diseases.
Production & Manufacturing > Process & Production > News
EMA’s CHMP backs Pfizer's Xeljanz for rheumatoid arthritis
By PBR Staff Writer
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of Pfizer's Xeljanz to treat rheumatoid arthritis (RA).
Production & Manufacturing > Process & Production > News
AbbVie's hepatitis C treatment under accelerated review by EMA
By PBR Staff Writer
The European Medicines Agency (EMA) has validated AbbVie's marketing authorization application (MAA) for a new hepatitis C treatment.
Production & Manufacturing > Process & Production > News
FDA grants orphan drug designation to Concert's cystic fibrosis treatment
By PBR Staff Writer
Concert Pharmaceuticals has secured orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for CTP-656 to treat cystic fibrosis.
Production & Manufacturing > Process & Production > News
EMA validates Validates Gilead’s MAA for chronic hepatitis C therapy
The European Medicines Agency (EMA) has validated and is assessing Gilead Sciences’ Marketing Authorization Application (MAA) for the investigational, once-daily, single tablet regimen of sofosbuvir 400 mg, velpatasvir 100 mg and voxilaprevir 100 mg (SOF/VEL/VOX) for the treatment of chronic hepatitis C virus (HCV)-infected patients.
Production & Manufacturing > Process & Production > News
Abeona gets orphan drug status in EU for ABO-101 gene therapy in Sanfilippo syndrome type B
Abeona Therapeutics has secured orphan drug designation from the European Medicines Agency (EMA) Committee for Orphan Medicinal Products for its gene therapy program ABO-101 for children impacted by Sanfilippo syndrome type B (MPS IIIB).
Production & Manufacturing > Process & Production > News
ProMetic's alstrom syndrome treatment gets orphan drug status in Europe
The European Commission has granted orphan drug designation to ProMetic Life Sciences' PBI-4050 drug for the treatment of Alström Syndrome.
Production & Manufacturing > Process & Production > News
31-45 of 1845 results