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Fresenius Kabi launches Glucagon for injection in US Fresenius Kabi announced today the introduction of Glucagon for Injection in the United States. Fresenius Kabi is a global health care company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition.
Drug Research > Drug Delivery > News
Sanofi and Regeneron's Praluent gets FDA approval to treat high LDL cholesterol in adults By PBR Staff Writer
The US FDA has approved Sanofi and Regeneron Pharmaceuticals' Praluent (alirocumab) Injection as an adjunct to diet and maximally tolerated statin therapy to treat adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease (ASCVD).
Drug Research > Drug Delivery > News GSK gets EMA Committee positive opinion for its malaria candidate vaccine Mosquirix By PBR Staff Writer
GlaxoSmithKline (GSK) has received positive scientific opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for its malaria candidate vaccine Mosquirix, also known as RTS,S, in children aged six weeks to 17 months.
Drug Research > Drug Delivery > News
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Eagle Pharmaceuticals’ RTU Bivalirudin NDA accepted for filing by FDA
Eagle Pharmaceuticals has announced that the 505(b)(2) New Drug Application (NDA) for its novel ready-to-use bivalirudin product (RTU bivalirudin) has been accepted for filing by the US Food and Drug Administration (FDA).
Drug Research > Drug Delivery > News
Novavax reports positive results from Phase I Ebola GP vaccine trial
By PBR Staff Writer
US-based clinical-stage vaccine company Novavax has reported positive top-line data from a Phase I clinical trial of its Ebola virus glycoprotein (GP) recombinant nanoparticle vaccine candidate adjuvanted with Matrix-M.
Drug Research > Drug Delivery > News
Lysogene, Alcyone Lifesciences enter collaboration for mucopolysaccharidosis type IIIA
Alcyone Lifesciences, a leader in neural intervention systems for neurological conditions and targeted drug delivery, and Lysogene, a privately held biotechnology company and leader in recombinant adeno-associated virus (rAAV) based gene therapy for the CNS, have entered into a collaboration.
Drug Research > Drug Delivery > News
Isis Pharmaceuticals begins Phase I/IIa trial of ISIS-HTT to treat patients with Huntington's disease
By PBR Staff Writer
US-based Isis Pharmaceuticals has started a Phase I/IIa clinical trial of ISIS-HTT, a Gen. 2.0+ antisense drug, for the treatment of patients with Huntington's disease (HD), a rare genetic neurological disease.
Drug Research > Drug Delivery > News
Asahi Kasei gets approval for Xiaflex in Japan to treat Dupuytren's Contracture
By PBR Staff Writer
Asahi Kasei Pharma has received approval for its regulatory application from the Japanese Pharmaceutical and Medical Device Agency (PMDA) for Xiaflex (collagenase clostridium histolyticum) to treat patients with Dupuytren's contracture in Japan.
Drug Research > Drug Delivery > News
StemCells treats first patient in Phase II HuCNS-SC trial for dry AMD
By PBR Staff Writer
US-based StemCells has completed transplantation of the first subject in its Phase II Radiant trial of its HuCNS-SC platform technology (purified human neural stem cells) at the Retina Foundation of the Southwest.
Drug Research > Drug Delivery > News
Delcath gets FDA orphan drug status for melphalan to treat cholangiocarcinoma
By PBR Staff Writer
US-based Delcath Systems has received orphan drug designation from the US Food and Drug Administration's (FDA) Office of Orphan Products Development (OOPD) for melphalan to treat cholangiocarcinoma.
Drug Research > Drug Delivery > News
Ipsen gets FDA approval for Dysport for Injection to treat upper limb spasticity in adults
By PBR Staff Writer
Ipsen Biopharmaceuticals has received approval from the US Food and Drug Administration (FDA) for its supplemental Biologics License Application (sBLA) for Dysport (abobotulinumtoxinA) to treat upper limb spasticity (ULS) in adult patients.
Drug Research > Drug Delivery > News
Hospira gets FDA nod to launch generic bivalirudin for injection in US
By PBR Staff Writer
Hospira had received approval from the US Food and Drug Administration (FDA) to launch bivalirudin for injection, a generic version of The Medicines Company's Angiomax.
Drug Research > Drug Delivery > News
Rexahn gets patent in Japan for new targeted cancer drug delivery platform
Rexahn Pharmaceuticals, a clinical stage biopharmaceutical company developing best-in-class therapeutics for the treatment of cancer, announced that it was issued patent number 5749273 from the Japanese Patent Office entitled "Polymeric Systems for the Delivery of Anticancer Drugs" for the company's novel CPMA drug delivery platform.
Drug Research > Drug Delivery > News
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