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FDA approves Amgen's Repatha injection to treat certain patients with high cholesterol By PBR Staff Writer
The US Food and Drug Administration has approved Amgen's Repatha (evolocumab) injection for some patients who are unable to get their low-density lipoprotein cholesterol (LDL-C) under control with the existing treatment options.
Drug Research > Drug Delivery > News
Corium gets US patent for MicroCor transdermal system By PBR Staff Writer
The US Patent and Trademark Office issued US Patent No. 9,114,238, related to Corium International's new MicroCor transdermal system.
Drug Research > Drug Delivery > News Alvogen to buy four pharmaceutical products from Pfizer for US market By PBR Staff Writer
Alvogen has entered into a definitive agreement to acquire a portfolio of four pharmaceutical products from Pfizer for marketing in the US.
Drug Research > Drug Delivery > News
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Janssen submits extended MAA for paliperidone palmitate to EMA for schizophrenia treatment
By PBR Staff Writer
Johnson & Johnson company Janssen-Cilag International (Janssen) has submitted an extended marketing authorisation application (MAA) to the European Medicines Agency (EMA) for paliperidone palmitate once-every-three-months formulation to treat schizophrenia in adults.
Drug Research > Drug Delivery > News
Madison begins dosing in prostate cancer trial of MVI-816 and pembrolizumab combination
By PBR Staff Writer
US-based Madison Vaccines Incorporated (MVI) has started dosing in a clinical trial of its lead prostate cancer vaccine MVI-816 (pTVG-HP) in combination with pembrolizumab (Keytruda), a PD-1 inhibitor.
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Cempra's solithromycin gets FDA fast track status to treat CABP
By PBR Staff Writer
US-based pharmaceutical firm Cempra has received fast track designation from the US Food and Drug Administration (FDA) for solithromycin intravenous (IV) and capsules to treat community acquired bacterial pneumonia (CABP).
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Hemispherx extends strategic alliance with Armada for Alferon N Injection
Hemispherx Biopharma (HEB), announced that as the Company works toward the re-launch of Alferon N, it has extended its agreement with Armada Health Care (Armada) for two years (through August 14 2017) for the sales/marketing of Alferon N Injection, its Food and Drug Administration approved natural interferon, in the US.
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US FDA approves Baxter and Water Street’s Cefazolin injection 2gm for preoperative prophylaxis
By PBR Staff Writer
US-based Baxter International and Water Street Healthcare Partners’s Cefazolin Injection in Galaxy container (2g/100mL) has received approval from the US Food and Drug Administration (FDA).
Drug Research > Drug Delivery > News
G1 Therapeutics begins two Phase Ib/IIa trials of CDK4/6 inhibitor G1T28 in small-cell lung cancer
G1 Therapeutics, a clinical-stage oncology company, announced that it has initiated two Phase 1b/2a trials of the CDK4/6 inhibitor G1T28 in patients with small-cell lung cancer (SCLC).
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Hemispherx expands deal with Emerge to commercialize Alferon in Australia and New Zealand
By PBR Staff Writer
Hemispherx Biopharma has executed an agreement with Emerge Health to seek approval for Alferon N Injection in Australia and New Zealand and to start distribution of the product in both countries on a named-patient basis, where appropriate.
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Fresenius Kabi launches Cisatracurium Besylate Injection in US
By PBR Staff Writer
German health care firm Fresenius Kabi has launched Cisatracurium Besylate Injection, a new specialty injectable product, in three presentations in the US.
Drug Research > Drug Delivery > News
Immune Design, Merck to evaluate two immunotherapies with Keytruda to treat NHL and melanoma
By PBR Staff Writer
Immune Design has entered into partnership with the subsidiaries of Merck to evaluate the safety and efficacy of its oncology investigative agents, G100 and LV305 in combination with Merck's Keytruda (pembrolizumab) to treat patients with non-Hodgkin's lymphoma (NHL) and melanoma, respectively.
Drug Research > Drug Delivery > News
FDA grants fast track status for Marina's CEQ508 to treat familial adenomatous polyposis
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted fast track designation for Marina Biotech's investigational RNAi therapeutic, CEQ508, to treat familial adenomatous polyposis (FAP), for which currently there are no pharmaceutical approach available.
Drug Research > Drug Delivery > News
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