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China Food and Drug Administration approves SciClone and BTG's DC Bead SciClone Pharmaceuticals and its partner BTG has announced that the China Food and Drug Administration has approved the registration of DC Bead for the embolization of malignant hypervascularized tumors.
Drug Research > Drug Delivery > News
FDA approves TWi Pharma's generic megestrol acetate 125mg/ml oral suspension By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved TWi Pharmaceuticals' abbreviated new drug application (ANDA) for megestrol acetate 125mg/ml oral suspension, which is the generic equivalent to Par Pharmaceutical's Megace ES.
Drug Research > Drug Delivery > News Madison Vaccines' MVI-816 to be used in clinical trial of a new combination to treat metastatic prostate cancer By PBR Staff Writer
Madison Vaccines Incorporated (MVI), a clinical stage biopharmaceutical company, has said its lead product candidate MVI-816 (pTVG-HP) will be used in a clinical trial testing a two-pronged immunotherapy approach to treat metastatic prostate cancer.
Drug Research > Drug Delivery > News
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FDA approves Fresenius Kabi's Kabiven and Perikabiven for parenteral nutrition
By PBR Staff Writer
The US Food and Drug Administration has granted approval for Fresenius Kabi's Kabiven and Perikabiven, which are intravenously infused solutions of lipids, dextrose, amino acids and electrolytes in three-chamber parenteral nutrition (PN) bags.
Drug Research > Drug Delivery > News
Bavarian Nordic secures order to supply IMVAMUNE smallpox vaccine in Canada
Bavarian Nordic has signed two contracts with the Canadian authorities for the delivery of a total of 65,700 doses of IMVAMUNE smallpox vaccine
Drug Research > Drug Delivery > News
Ipsen to start second resupply of Increlex in the US in September
Ipsen has announced that a new supply of Increlex (mecasermin [rDNA origin] Injection) will be available starting in September 2014.
Drug Research > Drug Delivery > News
Alkermes submits NDA to FDA for schizophrenia drug aripiprazole lauroxil
By PBR Staff Writer
Ireland-headquartered biopharmaceutical firm Alkermes has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) seeking approval for aripiprazole lauroxil to treat schizophrenia.
Drug Research > Drug Delivery > News
Alexion starts eculizumab trail for post-kidney replacement DGF prevention
By PBR Staff Writer
US-based Alexion Pharmaceuticals has began dosing in a single, multinational, placebo-controlled clinical trial to evaluate the efficacy and safety of eculizumab (Soliris) to prevent delayed graft function (DGF) after kidney transplantation in adult patients who are at increased risk of DGF.
Drug Research > Drug Delivery > News
Softigel - Manufacturers of Softgel Pharmaceutical Products
Softigel develops and manufactures softgel (soft gelatin) capsules, advanced drug delivery technologies, nutritional supplements, as well as veterinary, cosmetic and pharmaceutical products. Softgels are an effective delivery system for oral drugs, especially those with low solubility and/or permeability (BCS classes II, III and IV). We are Procaps' stategic business division for contract manufacturing services.
Drug Research > Drug Delivery > Suppliers
Mylan launches generic version of Precedex injection
By PBR Staff Writer
Mylan has launched its new dexmedetomidine hydrochoride injection, 100 mcg (base)/mL after receiving the final approval from the US Food and Drug Administration (FDA) for the product’s Abbreviated New Drug Application (ANDA).
Drug Research > Drug Delivery > News
FDA approves Lilly and Boehringer’s Basaglar insulin glargine injection
By PBR Staff Writer
The US Food and Drug Administration (FDA) has offered tentative approval for Basaglar insulin glargine injection, which is jointly developed by Eli Lilly and Boehringer Ingelheim, signifying its compliance with all the regulatory needs for approval.
Drug Research > Drug Delivery > News
Fresenius Kabi launches Acetylcysteine Solution 10% in multiple doses
By PBR Staff Writer
Fresenius Kabi, a Germany-based health care company, has launched Acetylcysteine Solution, USP, 10% in multiple doses 4mL, 10mL and 30mL vials.
Drug Research > Drug Delivery > News
Mallinckrodt completes acquisition of Questcor Pharmaceuticals
Mallinckrodt, a leading global specialty pharmaceutical company, has announced that it has completed its acquisition of Questcor Pharmaceuticals in a cash and stock transaction valued at approximately $5.8 billion.
Drug Research > Drug Delivery > News
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