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Process & Production

FDA to review Samsung Bioepis’ BLA for biosimilar of Remicade By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted for review Samsung Bioepis' biologics license application (BLA) for SB2 (infliximab), an investigational biosimilar candidate of Janssen Biotech's Remicade.
Production & Manufacturing > Process & Production > News
European Medicines Agency accepts Sandoz' biosimilar rituximab regulatory submission Sandoz, a Novartis division, announced that the European Medicines Agency has accepted their Marketing Authorization Application for a biosimilar to Roche's EU-licensed MabThera (rituximab).
Production & Manufacturing > Process & Production > News FDA grants orphan drug designation to ANAVEX 2-73 to treat Rett syndrome The US Food and Drug Administration’s (FDA) Office of Orphan Product Development (OOPD) has granted Orphan Drug Designation (ODD) to Anavex Life Sciences' ANAVEX 2-73 for the treatment of Rett syndrome.
Production & Manufacturing > Process & Production > News
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FDA grants priority review to Genmab's sBLA for ofatumumab in combination with fludarabine and cyclophosphamide in relapsed CLL
The US Food and Drug Administration (FDA) granted Priority Review to Genmab's supplemental Biologics License Application (sBLA) for the use of ofatumumab (Arzerra) in combination with fludarabine and cyclophosphamide (FC) for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL).
Production & Manufacturing > Process & Production > News
FDA grants fast track status for Edge Therapeutics' EG-1962 to treat subarachnoid hemorrhage
The US Food and Drug Administration (FDA) has granted Fast Track designation to Edge Therapeutics' investigational product EG-1962 for the treatment of subarachnoid hemorrhage (SAH).
Production & Manufacturing > Process & Production > News
AstraZeneca's Selumetinib gets FDA orphan drug status for thyroid cancer
By PBR Staff Writer
AstraZeneca has received orphan drug designation from the US Food and Drug Administration for selumetinib as an adjuvant treatment of patients with stage III or IV differentiated thyroid cancer (DTC).
Production & Manufacturing > Process & Production > News
Sanitary Sifter Optimises Quality and Production in Pharmaceutical and Dietary Supplement Company
When Enzymatic Therapy stopped outsourcing and built its own FDA-approved manufacturing facility, the goal was to improve product quality, streamline production, and ramp up sales growth. A crucial step was selecting the right pharmaceutical sieving equipment to remove any agglomerates, oversize particles or contaminants from incoming raw dry materials.
Production & Manufacturing > Process & Production > Press Releases
HIgh Shear Bin Blender
IBC blenders have been for decades the best dry material blending technology available for 3,000 liter or smaller batch blending. This is due to the unparalleled blend uniformity capability, speed of blend and the fact that the blender itself has no product contact components that allows immediate product changeover. The only limitation with this technology has been that it is a low shear blending principle as it relies on the simple yet highly effective tumble action to produce homogeneous blends. On occasion high shear is required for batches with ingredients that tend to agglomerate during blending and that required a change to a blender with high shear blending principle; this is no longer necessary.
Production & Manufacturing > Process & Production > Products
Restricted Access Barrier System
Restricted Access Barrier Systems are rigid walls that provide a physical barrier between operators and the manufacturing process to prevent migration or segregation of product or to reduce operator exposure. Introduction or removal of materials can be done through glove ports or doors depending on the level of containment required. Come to Booth 1053 to see a barrier and discuss your containment or powder processing needs with our experts.
Production & Manufacturing > Process & Production > Products
Paratek receives favorable feedback from FDA for design of omadacycline oral-only skin infection phase 3 study
By PBR Staff Writer
Paratek Pharmaceuticals has received favorable feedback from the US Food and Drug Administration for the design of a planned oral-only phase 3 study of omadacycline to treat acute bacterial skin and skin structure infections (ABSSSI).
Production & Manufacturing > Process & Production > News
Allena’s investigational therapy wins FDA orphan drug status to treat pediatric hyperoxaluria
By PBR Staff Writer
Allena Pharmaceuticals has secured orphan drug designation from the US Food and Drug Administration (FDA) for its investigational therapy oxalate decarboxylase to treat pediatric hyperoxaluria.
Production & Manufacturing > Process & Production > News
FDA grants priority review for Eli Lilly's olaratumab to treat soft tissue sarcoma
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted priority review for Eli Lilly's olaratumab in combination with doxorubicin to treat patients with advanced soft tissue sarcoma.
Production & Manufacturing > Process & Production > News
Gilead Sciences receives positive CHMP opinion for Odefsey to treat HIV
By PBR Staff Writer
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for Gilead Sciences' fixed-dose HIV combination pill Odefsey featuring emtricitabine 200 mg, rilpivirine 25 mg, and tenofovir alafenamide (TAF) 25 mg.
Production & Manufacturing > Process & Production > News
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