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16-30 of 1873 results
Genentech gets FDA priority review for Zelboraf in Erdheim-Chester Disease
The US Food and Drug Administration (FDA) has accepted Genentech's supplemental New Drug Application (sNDA) and granted Priority Review for Zelboraf (vemurafenib) for Erdheim-Chester disease (ECD) with BRAF V600 mutation.
Production & Manufacturing > Process & Production > News
Janssen’s RA drug sirukumab fails to get FDA Advisory Committee nod
By PBR Staff Writer
Janssen Biotech has received a setback for its rheumatoid arthritis (RA) drug sirukumab after the Arthritis Advisory Committee of the US Food and Drug Administration (FDA) decided not to recommend its approval.
Production & Manufacturing > Process & Production > News
AstraZeneca's Acalabrutinib gets priority review from FDA for mantle cell lymphoma
AstraZeneca reported that the US Food and Drug Administration (FDA) has accepted and granted priority review for the New Drug Application (NDA) for its Bruton tyrosine kinase (BTK) inhibitor, acalabrutinib.
Production & Manufacturing > Process & Production > News
UK’s NICE invites Roche to submit CDF proposal for urothelial cancer drug
By PBR Staff Writer
The National Institute for Health and Care Excellence (NICE) has turned down Roche’s urothelial cancer drug atezolizumab citing the need for stronger evidence in clinical and cost effectiveness.
Production & Manufacturing > Process & Production > News
Amgen, Allergan submit BLA to FDA for biosimilar candidate to Herceptin
Amgen and Allergan have submitted a biologics license application (BLA) to the US Food and Drug Administration (FDA) for ABP 980, a biosimilar candidate to Herceptin (trastuzumab).
Production & Manufacturing > Process & Production > News
Galera gets Promising Innovative Medicines Designation for GC4419 in UK
Galera Therapeutics' GC4419 has secured a Promising Innovative Medicines (PIM) designation in the UK by the Medicines and Healthcare Products Regulatory Agency (MHRA) for the reduction of the duration or incidence of radiation and chemotherapy induced severe oral mucositis in head and neck cancer patients.
Production & Manufacturing > Process & Production > News
Kite Pharma seeks European approval for Axicabtagene Ciloleucel
Kite Pharma has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for axicabtagene ciloleucel as a treatment for patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL) who are not eligible for autologous stem cell transplant.
Production & Manufacturing > Process & Production > News
Eagle gets complete response letter from FDA on exertional heat stroke drug RYANODEX
Eagle Pharmaceuticals has received a Complete Response Letter from the US Food and Drug Administration (FDA) for its New Drug Application for RYANODEX (dantrolene sodium) for the treatment of exertional heat stroke (EHS), in conjunction with external cooling methods.
Production & Manufacturing > Process & Production > News
CHMP issues positive opinion for Daiichi Sankyo's LIXIANA label update
The European Committee for Medicinal Products for Human Use (CHMP) has recommended approval of a label update for Daiichi Sankyo Europe's LIXIANA, to provide guidance on its use in patients undergoing transoesophageal echocardiography (TEE)-guided and delayed cardioversion.
Production & Manufacturing > Process & Production > News
FDA advisory panel recommends Pfizer’s Mylotarg for acute myeloid leukemia
By PBR Staff Writer
Pfizer’s Mylotarg (gemtuzumab ozogamicin) has been recommended for approval by the US Food and Drug Administration’s (FDA) Oncologic Drug Advisory Committee (ODAC) to treat acute myeloid leukemia (AML).
Production & Manufacturing > Process & Production > News
Amicus plans to submit NDA to FDA for migalastat for fabry disease
Amicus Therapeutics has revealed its plans to file a new drug application (NDA) with the US FDA for the oral precision medicine migalastat for Fabry disease in the fourth quarter of the year.
Production & Manufacturing > Process & Production > News
BioMarin submits Pegvaliase BLA to FDA for treatment of phenylketonuria
BioMarin Pharmaceutical has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for pegvaliase, a PEGylated recombinant phenylalanine ammonia lyase enzyme product, to reduce blood phenylalanine (Phe) levels in adult patients with PKU who have uncontrolled blood Phe levels on existing management.
Production & Manufacturing > Process & Production > News
FDA accepts for filing Icon’s NDA for Dexycu drug therapy
The US Food and Drug Administration (FDA) has accepted for filing Icon Bioscience (IBI), recently submitted new drug application (NDA) for Dexycu (IBI-10090), a novel drug for treating inflammation associated with cataract surgery.
Production & Manufacturing > Process & Production > News
Pfizer gets CRL on Epogen biosimilar from FDA
By PBR Staff Writer
The United States Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Pfizer in connection with its biosimilar candidate to Amgen’s anemia drug Epogen (epoetin alfa).
Production & Manufacturing > Process & Production > News
Axovant’s dementia drug granted FDA fast track designation
Axovant Sciences’ investigational drug nelotanserin has secured fast track designation from the US Food and Drug Administration (FDA) for the treatment of visual hallucinations disorder in dementia with Lewy bodies (DLB).
Production & Manufacturing > Process & Production > News
16-30 of 1873 results