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Teikoku gets FDA acknowledgment of receipt for Docetaxel Injection By PBR Staff Writer
Teikoku Pharma USA (TPU) has received an acknowledgment of the receipt from the US Food and Drug Administration (FDA) for a 505(b)(2) new drug application (NDA) for Docetaxel Injection Concentrate, Non-Alcohol Formula.
Drug Research > Drug Delivery > News
FDA approves Sanofi Pasteur's Quadracel vaccine for children four to six years of age By PBR Staff Writer
Vaccines division Sanofi Pasteur has secured approval from the US Food and Drug Administration (FDA) to use Quadracel vaccine for active immunization against diphtheria, tetanus, pertussis and poliomyelitis in children four through six years of age.
Drug Research > Drug Delivery > News Emergent to advance development of next-generation anthrax vaccine NuThrax By PBR Staff Writer
Emergent BioSolutions has secured a $31m contract from the US Department of Health and Human Services' (HHS') Biomedical Advanced Research and Development Authority (BARDA) to advance the development of its next generation anthrax vaccine candidate, NuThrax.
Drug Research > Drug Delivery > News
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Merck’s Phase III KEYNOTE-006 trial of melanoma drug Keytruda meets co-primary endpoints
By PBR Staff Writer
Merck has reported positive results from the Phase III trial (KEYNOTE-006) evaluating Keytruda (pembrolizumab) compared to ipilimumab in the first-line treatment of patients with unresectable stage III or IV advanced melanoma with no more than one prior systemic therapy.
Drug Research > Drug Delivery > News
Pharmalink buys Synartro's product candidate to treat inflammation associated with osteoarthritis
By PBR Staff Writer
Swedish specialty pharmaceutical firm Pharmalink acquired a new therapeutic product candidate from Synartro, a research and development (R&D) company, to treat inflammation associated with osteoarthritis.
Drug Research > Drug Delivery > News
AstraZeneca reports positive results from PT003 Phase III PINNACLE trials in COPD
By PBR Staff Writer
AstraZeneca has reported positive top-line results from the Phase III PINNACLE program of PT003, a twice-daily fixed-dose combination of glycopyrronium and formoterol fumarate, to improve lung function in patients with chronic obstructive pulmonary disease (COPD).
Drug Research > Drug Delivery > News
Stability Issues Related to Soft Gelatin Capsule Development
Stability issues are a challenge and never ending concern for formulators. The reactivity of formulations depends on many factors but it is generally recognized that labile drugs in aqueous forms are sometimes the worst cases and in this regard, this should be a true statement for the development teams which work with SGC´s.
Drug Research > Drug Delivery > Press Releases
Emergent completes proof-of-concept production of new Ebola vaccine
By PBR Staff Writer
US-based Emergent BioSolutions has completed proof-of concept manufacturing of a modified vaccinia Ankara (MVA) Ebola Zaire vaccine candidate (MVA EBOZ).
Drug Research > Drug Delivery > News
NICE approves Roche's blood cancer drug Gazyvaro
By PBR Staff Writer
The UK's National Institute for Health and Care Excellence (NICE) has issued a positive final appraisal determination (FAD) recommending Roche's Gazyvaro (obinutuzumab) for routine use on the National Health Service (NHS).
Drug Research > Drug Delivery > News
Bayer seeks European approval for Eylea to treat myopic CNV
By PBR Staff Writer
Bayer HealthCare has submitted a marketing authorisation application (MAA) to European Medicines Agency (EMA) seeking approval for aflibercept solution for intravitreal injection to treat patients in the European Union (EU) with myopic choroidal neovascularization (myopic CNV).
Drug Research > Drug Delivery > News
United Therapeutics gets FDA approval for Unituxin to treat pediatric high-risk neuroblastoma
By PBR Staff Writer
US-based biotechnology firm United Therapeutics has received approval from the US Food and Drug Administration (FDA) for its chimeric biologic antibody Unituxin (dinutuximab) Injection (formerly called ch14.18) to treat pediatric patients with high-risk neuroblastoma.
Drug Research > Drug Delivery > News
Hospira recalls a lot of magnesium sulfate in 5% dextrose injection
By PBR Staff Writer
Hospira has issued a voluntary recall of one lot of Magnesium Sulfate in 5% Dextrose, Inj., USP, 10mg/mL following reports of an incorrect barcode on the primary bag labeling.
Drug Research > Drug Delivery > News
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