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Process & Production

China FDA accepts for review WuXi MedImmune's IND for monoclonal antibody By PBR Staff Writer
WuXi PharmaTech has announced that the China Food and Drug Administration (CFDA) has accepted to review WuXi MedImmune's investigational new drug (IND) application for new anti-IL6 monoclonal antibody for the treatment of rheumatoid arthritis.
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EMA validates Biogen and AbbVie's MAA for Zinbryta to treat multiple sclerosis By PBR Staff Writer
The European Medicines Agency (EMA) has validated Biogen and AbbVie's marketing authorisation application (MAA) for Zinbryta (daclizumab high-yield process), an investigational drug, to treat relapsing forms of multiple sclerosis (MS) in the European Union (EU).
Production & Manufacturing > Process & Production > News Adamis gets FDA complete response letter for epinephrine pre-filled syringe NDA By PBR Staff Writer
US-based Adamis Pharmaceuticals has received a complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding its new drug application (NDA) Epinephrine Injection USP 1:1000 0.3mg pre-filled single dose syringe (PFS) product, for the emergency treatment of acute anaphylaxis.
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EMA validates Biogen and AbbVie's MAA for Zinbryta to treat multiple sclerosis
By PBR Staff Writer
The European Medicines Agency (EMA) has validated Biogen and AbbVie's marketing authorisation application (MAA) for Zinbryta (daclizumab high-yield process), an investigational drug, to treat relapsing forms of multiple sclerosis (MS) in the European Union (EU).
Production & Manufacturing > Process & Production > News
Adamis gets FDA complete response letter for epinephrine pre-filled syringe NDA
By PBR Staff Writer
US-based Adamis Pharmaceuticals has received a complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding its new drug application (NDA) Epinephrine Injection USP 1:1000 0.3mg pre-filled single dose syringe (PFS) product, for the emergency treatment of acute anaphylaxis.
Production & Manufacturing > Process & Production > News
Eisai's thyroid cancer drug Lenvima gets positive opinion from EMA's CHMP
By PBR Staff Writer
Japan-based Eisai's UK subsidiary has received a positive opinion from the European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) for anticancer agent Lenvima (lenvatinib mesylate) to treat adult patients with progressive, locally advanced or metastatic differentiated thyroid carcinoma (DTC), refractory to radioactive iodine (RAI).
Production & Manufacturing > Process & Production > News
Takeda's NDA of Zafatek tablets gets approval in Japan to treat type 2 diabetes
By PBR Staff Writer
Takeda Pharmaceutical has received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for the new drug application (NDA) of Zafatek, a once-weekly DPP-4 (dipeptidyl peptidase-IV) inhibitor, for the treatment of people with type 2 diabetes.
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Kamada's GvHD treatment AAT gets European orphan drug status
By PBR Staff Writer
Israel-based Kamada has received orphan drug designation from the European Medicines Agency's (EMA) Committee for Orphan Medicinal Products (COMP) for its human intrevenous (IV) Alpha-1 Antitrypsin (AAT) to treat graft-versus-host disease (GvHD).
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Amgen seeks Japanese approval for Repatha to treat high cholesterol
By PBR Staff Writer
Amgen has submitted a new drug application (NDA) to the Japanese Ministry of Health, Labour and Welfare (MHLW) seeking marketing approval for its Repatha (evolocumab), an investigational fully human monoclonal antibody, to treat high cholesterol, a most common form of dyslipidemia.
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Dilaforette gets FDA orphan drug status for sevuparin to treat sickle-cell disease
By PBR Staff Writer
Swedish drug development firm Dilaforette has received orphan drug designation from the US Food and Drug Administration (FDA) for its polysaccharide drug, sevuparin (DF02), to treat patients with sickle-cell disease (SCD).
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Vaxil Bio's multiple myeloma drug ImMucin gets orphan drug status in Europe
By PBR Staff Writer
Israeli clinical stage biotechnology firm Vaxil Bio has received orphan drug designation from the European Medicines Agency (EMA) for ImMucin, to treat multiple myeloma (MM).
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Samsung submits MAA for infliximab biosimilar candidate to EMA
By PBR Staff Writer
Samsung Bioepis, a joint venture between Samsung Biologics and Biogen Idec, has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) seeking approval for its Remicade (Infliximab) biosimilar candidate, SB2.
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FDA approves Actavis' sNDA for SAPHRIS to treat manic or mixed episodes of bipolar I disorder
By PBR Staff Writer
US FDA has granted approval for Actavis' supplemental new drug application (sNDA) for SAPHRIS (asenapine) as monotherapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder in pediatric patients aged 10 to 17 years.
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