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Process & Production

Boehringer's BLA for idarucizumab gets FDA priority review By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted priority review for Boehringer Ingelheim Pharmaceuticals' biologics license application (BLA) for idarucizumab.
Production & Manufacturing > Process & Production > News
FDA grants orphan drug status for AstraZeneca's selumetinib to treat uveal melanoma By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted AstraZeneca an orphan drug designation (ODD) for the MEK inhibitor selumetinib, to treat uveal melanoma, a rare disease.
Production & Manufacturing > Process & Production > News FDA approves Sandoz's Glatopa for multiple sclerosis treatment By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted approval for Sandoz's Glatopa, the first generic version of Teva’s Copaxone (glatiramer acetate injection) 20mg/ml one-time-daily multiple sclerosis (MS) therapy.
Production & Manufacturing > Process & Production > News
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Baxter submits NDA to Japanese authorities seeking approval for BAX 855 to treat hemophilia A
By PBR Staff Writer
Baxter International has submitted a new drug application (NDA) to Japan's Ministry of Health, Labour and Welfare (MHLW) seeking approval for BAX 855, an investigational, extended half-life recombinant factor VIII (rFVIII) treatment based on ADVATE for patients over 12 years of age with hemophilia A.
Production & Manufacturing > Process & Production > News
FDA grants fast track status for ARCA biopharma's Gencaro to prevent atrial fibrillation
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted fast track designation for ARCA biopharma's Gencaro for the prevention of atrial fibrillation/atrial flutter in a genetically modified heart failure population.
Production & Manufacturing > Process & Production > News
FDA grants fast track status for Exelixis’ carcinoma drug cabozantinib
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted fast track designation for Exelixis' cabozantinib to treat patients with advanced renal cell carcinoma (RCC) who have received one prior therapy.
Production & Manufacturing > Process & Production > News
MedImmune gets FDA fast track status for MEDI8897 to prevent LRTI caused by RSV in infants
By PBR Staff Writer
AstraZeneca's global biologics R&D arm MedImmune has received fast track designation from the US Food and Drug Administration (FDA) to develop MEDI8897, an investigational recombinant human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody (mAb).
Production & Manufacturing > Process & Production > News
FDA grants priority review for Shire's lifitegrast NDA to treat dry eye disease in adults
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted for filing Shire's new drug application (NDA) as well as granted a priority review designation for lifitegrast, which is deisgned to treat dry eye disease in adults.
Production & Manufacturing > Process & Production > News
Boehringer seeks FDA approval for Pradaxa to treat DVT and PE
By PBR Staff Writer
Boehringer Ingelheim Pharmaceuticals has submitted a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) for Pradaxa for the prophylaxis of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have had primary elective total hip replacement surgery.
Production & Manufacturing > Process & Production > News
Amgen's Vectibix in combination with FOLFIRI gets European approval to treat mCRC
By PBR Staff Writer
Amgen has received approval from the European Commission (EC) for a new use of Vectibix (panitumumab) as first-line treatment in combination with FOLFIRI to treat adults with wild-type (WT) RAS metastatic colorectal cancer (mCRC).
Production & Manufacturing > Process & Production > News
We Invite You to Visit us on Booth N°17: MEDELPHARM & ADVANTEST
Looking at MEDELPHARM Process technologies and ADVANTEST Terahertz spectroscopy analysis systems.
Production & Manufacturing > Process & Production > Press Releases
Medelpharm Corporate Flyer
| By Medelpharm
After over 70 years of deep-rooted passion for high precision engineering, Medelpharm now put the design and development of R&D tablet presses and tableting technologies in the focus of its operations.
Production & Manufacturing > Process & Production > White Papers
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.
Production & Manufacturing > Process & Production > News
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