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Mylan launches generic version of Apresoline injection in US Mylan announced the US launch of Hydralazine Hydrochloride Injection USP, 20 mg/mL, which is a generic version of Novartis' Apresoline Injection, 20 mg/mL.
Drug Research > Drug Delivery > News
Concert Pharmaceuticals unveils CTP-543 to treat alopecia areata Concert Pharmaceuticals has announced its next product candidate, CTP-543, for the treatment of alopecia areata.
Drug Research > Drug Delivery > News Veristat acquires UK-based CRO, Spero Oncology Veristat, a full service Clinical Research Organization (CRO), is expanding its clinical research offerings into Europe through the acquisition of UK-based CRO, Spero Oncology.
Drug Research > Drug Delivery > News
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Heritage Pharmaceuticals issues product safety warning counterfeit drug product BiCNU
Heritage Pharmaceuticals announced that it recently became aware of the existence of a counterfeit drug product labeled as BiCNU (Carmustine for Injection) 100mg that has been sold and distributed outside of the US.
Drug Research > Drug Delivery > News
Ocular completes end-of-phase 2 review with FDA for OTX-TP for glaucoma and ocular hypertension
Ocular Therapeutix has completed its End-of-Phase 2 review with the US Food and Drug Administration (FDA) for its OTX-TP (sustained release travoprost) product candidate for the treatment of glaucoma and ocular hypertension.
Drug Research > Drug Delivery > News
Chinese Patent Office plans to grant patent relating to Immunicum's cancer immune primer INTUVAX
The Chinese Patent Office (SIPO) intends to grant a patent relating to Immunicum's cancer immune primer, INTUVAX.
Drug Research > Drug Delivery > News
Galapagos reports 20-week results from FITZROY study with JAK1 inhibitor filgotinib in Crohn's disease
Galapagos reported 20-week results from its FITZROY study with the investigational, selective JAK1 inhibitor filgotinib in Crohn's disease.
Drug Research > Drug Delivery > News
Tris Pharma launches DYANAVEL XR oral suspension, CII to treat Children with ADHD
Tris Pharma has launched DYANAVEL XR (amphetamine), CII, the first and only extended-release liquid amphetamine for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children aged 6 years and older.
Drug Research > Drug Delivery > News
FDA finds no finds no deficiency with Heron Therapeutics' Sustol NDA
By PBR Staff Writer
The US Food and Drug Administration (FDA) has indicated that there are no substantive deficiencies in Heron Therapeutics' new drug application (NDA) for Sustol (granisetron) Injection (extended release) to treat acute and delayed chemotherapy-induced nausea and vomiting (CINV).
Drug Research > Drug Delivery > News
WHO expert panel recommends use of Sanofi Pasteur's dengue vaccine in endemic countries
By PBR Staff Writer
The World Health Organization's (WHO) strategic advisory group of experts had recommended the use of Sanofi Pasteur's Dengvaxia dengue vaccine in endemic countries.
Drug Research > Drug Delivery > News
Shire submits NDA to FDA for new formulation of Vyvanse CII as chewable tablets
Shire has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for a new, alternate formulation of Vyvanse (lisdexamfetamine dimesylate) as a chewable tablet for patients who may have difficulty swallowing or opening a capsule.
Drug Research > Drug Delivery > News
Sample Processing for the UK Biobank Genotyping Project
UK Biobank is a health research charity which has collected and/or generated a wide range of biological samples and data on 500,000 participants aged 40-69 years old (at baseline). Data and samples are available for use by bona-fide researchers to investigate aetiology of disease.
Drug Research > Drug Delivery > Case Studies
Precise Nucleic Acid Quantification Using Lab-on-a-chip Spectroscopy and the cDrop Quantification Algorithm
Precise quantification and quality control of isolated genomic DNA is critical for the success of downstream applications such as next-generation sequencing. Traditionally, two quantification methods have been used routinely: (1) UV/Vis spectroscopy and (2) fluorescence-based assays (i.e. PicoGreen) that utilize DNA intercalating agents.
Drug Research > Drug Delivery > Case Studies
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