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Pfizer's Prevenar 13 gets CHMP positive opinion for prevention of vaccine-type pneumococcal pneumonia in adults Pfizer announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending that the indication for Prevenar 13 (pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]) be expanded to include the prevention of pneumonia caused by the 13 pneumococcal serotypes in the vaccine in adults 18 years and older.
Drug Research > Drug Delivery > News
FDA committee recommends approval of Astellas' Cresemba By PBR Staff Writer
The US Food and Drug Administration’s (FDA) Anti-infective Drugs Advisory Committee voted unanimously to recommend approval of Astellas' investigational once-daily intravenous and oral broad-spectrum Cresemba (isavuconazonium) to treat invasive aspergillosis and mucormycosis.
Drug Research > Drug Delivery > News Boehringer launches Spiriva Respimat in US By PBR Staff Writer
Boehringer Ingelheim Pharmaceuticals has launched Spiriva Respimat (tiotropium bromide) Inhalation Spray in retail pharmacies across the US and will be available by prescription.
Drug Research > Drug Delivery > News
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FDA committee recommends approval of Astellas' Cresemba
By PBR Staff Writer
The US Food and Drug Administration’s (FDA) Anti-infective Drugs Advisory Committee voted unanimously to recommend approval of Astellas' investigational once-daily intravenous and oral broad-spectrum Cresemba (isavuconazonium) to treat invasive aspergillosis and mucormycosis.
Drug Research > Drug Delivery > News
Boehringer launches Spiriva Respimat in US
By PBR Staff Writer
Boehringer Ingelheim Pharmaceuticals has launched Spiriva Respimat (tiotropium bromide) Inhalation Spray in retail pharmacies across the US and will be available by prescription.
Drug Research > Drug Delivery > News
Novo Nordisk launches Xultophy in Switzerland to treat type 2 diabetes
By PBR Staff Writer
Danish pharmaceutical firm Novo Nordisk has launched its Xultophy (IDegLira) in Switzerland to treat people with type 2 diabetes.
Drug Research > Drug Delivery > News
FDA approves Fresenius' Neostigmine Methylsulfate Injection
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted approval for Fresenius Kabi to market its Neostigmine Methylsulfate Injection, a cholinesterase inhibitor.
Drug Research > Drug Delivery > News
FDA grants priority review for Janssen's schizophrenia treatment
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted Priority Review for Janssen Research & Development's new drug application (NDA) for three-month atypical antipsychotic paliperidone palmitate to treat schizophrenia in adults.
Drug Research > Drug Delivery > News
Johnson gets €100m from Europe's IMI to accelerate Ebola vaccine development
By PBR Staff Writer
Johnson & Johnson (JNJ) through a consortium, which includes research institutions and non-government organizations, is set to receive around €100m ($115m) from Europe's Innovative Medicines Initiative (IMI) to speed up the development of its Ebola vaccine regimen.
Drug Research > Drug Delivery > News
Aegerion completes acquisition of Myalept from AstraZeneca
By PBR Staff Writer
Aegerion Pharmaceuticals has completed the acquisition of AstraZeneca’s Myalept (metreleptin) for injection, an orphan drug product to treat complications of leptin deficiency in patients with generalized lipodystrophy (GLD).
Drug Research > Drug Delivery > News
All Wales Medicines Strategy Group recommends GSK’s COPD drug Incruse
By PBR Staff Writer
The All Wales Medicines Strategy Group (AWMSG) has recommended British drugmaker GlaxoSmithKline’s (GSK) Incruse Ellipta 55mcg (umeclidinium) for use in patients with chronic obstructive pulmonary (COPD) within NHS Wales.
Drug Research > Drug Delivery > News
Vical, AnGes partner for equine polyclonal antibody therapy against Ebola
By PBR Staff Writer
US-based Vical and Japanese biopharmaceutical company AnGes MG have partnered to develop and commercialize an equine polyclonal antibody therapy for patients with Ebola virus disease.
Drug Research > Drug Delivery > News
Allegro, Hanmi to develop and market Luminate in Korea and China
Allegro Ophthalmics and Hanmi Pharmaceutical have entered into a license agreement for Luminate (ALG-1001), Allegro’s Integrin Peptide Therapy that is currently in multiple Phase 2 studies in the United States for the treatment of vitreo-retinal conditions, in The Republic of Korea and the People’s Republic of China.
Drug Research > Drug Delivery > News
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