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Astellas Pharma reaches agreement with US Department of Justice Astellas Pharma US has reached an agreement with the US Department of Justice to resolve civil claims regarding the marketing of Mycamine (micafungin sodium) for injection.
Drug Research > Drug Delivery > News
European Medicines Agency alerts EU healthcare professionals after vials of falsified Herceptin identified The European Medicines Agency (EMA) has been informed that vials of the cancer medicine Herceptin (trastuzumab), thought to have been stolen in Italy, including from hospitals, have been tampered with and re-introduced under false credentials into the supply chain in some countries.
Drug Research > Drug Delivery > News Dicerna begins Phase I trial of DCR-MYC to treat solid tumors, hematological malignancies By PBR Staff Writer
US-based biopharmaceutical firm Dicerna Pharmaceuticals has started a Phase I dose-escalating clinical trial of its drug candidate DCR-MYC, (also known as DCR-M1711), in patients with solid tumors, multiple myeloma, or lymphoma.
Drug Research > Drug Delivery > News
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Lohmann Therapy System (LTS) - Transdermal Therapeutic Systems and Oral Thin Films
LTS is the market leader in alternative drug delivery systems, in the form of transdermal therapeutic systems and oral thin films. We develop and manufacture drug delivery systems that offer patients reliable therapeutic efficacy with total comfort and convenience.
Drug Research > Drug Delivery > Suppliers
Medac Pharma gets FDA approval for trade name Rasuvo for injectable MTX product
By PBR Staff Writer
US-based pharmaceutical firm Medac Pharma has received approval from the US Food and Drug Administration (FDA) for the name Rasuvo for its lead compound, MPI-2505, a subcutaneous injectable methotrexate (MTX) delivered in a ready-to-use autopen.
Drug Research > Drug Delivery > News
Transdermal Technologies
LTS’s research and development focuses on two new technologies to complement and expand the potential of alternative drug delivery systems. We are continually developing our TTS and OTF as well as microneedle technologies.
Drug Research > Drug Delivery > Products
Oral Thin Films for Drug Delivery
Oral thin films (OTF) are loaded with active substances which are used for drug delivery. They are taken orally and dissolve immediately in the mouth or are applied to the mucosa. For transmucosal films, the active substance enters the bloodstream directly via the oral mucosa, without having to first pass through the gastrointestinal tract.
Drug Research > Drug Delivery > Products
Drug Delivery via Transdermal Therapeutic Systems
Transdermal patches or transdermal therapeutic systems (TTS) are drug delivery systems that are applied directly to the skin. The active substance is absorbed by the skin and is distributed through the body transdermally via the bloodstream. This unique mode of administration has improved the simplicity of treatment for patients for almost 30 years.
Drug Research > Drug Delivery > Products
GlaxoSmithKline's Tanzeum gets FDA approval for type 2 diabetes treatment
By PBR Staff Writer
GlaxoSmithKline (GSK) has received approval from the US Food and Drug Administration (FDA) for its Tanzeum (albiglutide) subcutaneous injection to improve glycemic control, along with diet and exercise, in adult patients with type 2 diabetes.
Drug Research > Drug Delivery > News
FDA extends market exclusivity for BioMarin's Kuvan powder for oral solution and tablets
BioMarin Pharmaceutical has announced that the US Food and Drug Administration (FDA) granted KUVAN (sapropterin dihydrochloride) powder for oral solution and tablets a six-month pediatric exclusivity extension.
Drug Research > Drug Delivery > News
Impax resubmits NDA for Parkinson's disease drug Rytary to US FDA
By PBR Staff Writer
US-based Impax Pharmaceuticals, a division of Impax Laboratories, has resubmitted its new drug application (NDA) for Rytary (IPX066) to the US Food and Drug Administration (FDA), for the symptomatic treatment of Parkinson's disease (PD).
Drug Research > Drug Delivery > News
Alkermes' Phase III trial of schizophrenia drug aripiprazole lauroxil meets primary endpoint
By PBR Staff Writer
Irish based biopharmaceutical company Alkermes has reported positive topline results from a randomized, double-blind, placebo-controlled Phase III clinical trial of its new, long-acting injectable antipsychotic agent aripiprazole lauroxil for the treatment of patients with schizophrenia.
Drug Research > Drug Delivery > News
Vetter launches new clinical syringe packages
Vetter, a contract development and manufacturing organization, has introduced two clinical syringe packages that make it easier to start syringe development earlier in the drug development process.
Drug Research > Drug Delivery > News
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