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Lilly's Trulicity label updated to include use in combination with basal insulin for type 2 diabetes
Eli Lilly and Company has updated label of its once-weekly Trulicity (dulaglutide) to include use in combination with basal insulin for adults with Type 2 diabetes.
Drug Research > Drug Delivery > News
US FTC sues Shire ViroPharma for delaying generic entry of Vancocin
By PBR Staff Writer
The US Federal Trade Commission (FTC) has charged that Shire ViroPharma abused government processes via serial, sham petitioning to delay generics and maintain its monopoly over Vancocin HCl Capsules.
Drug Research > Drug Delivery > News
Soligenix's SGX301 secures PIM status from UK MHRA to treat cutaneous T-cell lymphoma
Soligenix has secured Promising Innovative Medicine (PIM) designation from the UK Medicines and Healthcare Products Regulatory Agency for SGX301 (synthetic hypericin) to treat cutaneous T-cell lymphoma (CTCL).
Drug Research > Drug Delivery > News
Spero Therapeutics acquires antibacterial candidates from Pro Bono Bio
Spero Therapeutics has acquired a next generation set of antibacterial candidates from Pro Bono Bio Ltd (PBB) to bolster its pipeline addressing the increased prevalence of multi-drug resistant forms of Gram-negative bacteria.
Drug Research > Drug Delivery > News
US Court Of Appeals affirms Cumberland's victory in patent litigation case
The US Court of Appeals for the Federal Circuit ruled in favor of Cumberland Pharmaceuticals in a patent case associated with its Acetadote product.
Drug Research > Drug Delivery > News
Cellestia Biotech raises CHF8m seed financing
Cellestia Biotech has raised CHF8m in funding from private investors and PPF Group to advance its lead anti-cancer compound CB-103 to clinical development stage.
Drug Research > Drug Delivery > News
Intrexon to buy clinical-stage gene delivery firm GenVec
Intrexon has agreed to acquire clinical-stage company GenVec which has developed the AdenoVerse gene delivery technology.
Drug Research > Drug Delivery > News
European Medicines Agency accepts to review Novelion’s MAA for metreleptin
The European Medicines Agency (EMA) has accepted for review Novelion Therapeutics' Marketing Authorization Application (MAA) for metreleptin as replacement therapy to treat complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy (GL) and in a subset of patients with partial lipodystrophy (PL).
Drug Research > Drug Delivery > News
EMA validates Validates Gilead’s MAA for chronic hepatitis C therapy
The European Medicines Agency (EMA) has validated and is assessing Gilead Sciences’ Marketing Authorization Application (MAA) for the investigational, once-daily, single tablet regimen of sofosbuvir 400 mg, velpatasvir 100 mg and voxilaprevir 100 mg (SOF/VEL/VOX) for the treatment of chronic hepatitis C virus (HCV)-infected patients.
Drug Research > Drug Delivery > News
aTyr Pharma's Resolaris secures FDA fast track status
The US Food and Drug Administration (FDA) has granted Fast Track designation for aTyr Pharma's Resolaris to treat limb girdle muscular dystrophy 2B (LGMD2B).
Drug Research > Drug Delivery > News
Mallinckrodt to pay $100m to settle US charges on drug pricing
By PBR Staff Writer
Mallinckrodt has agreed to pay $100m to settle the US Federal Trade Commission (FTC) and state charges that it illegally maintained its monopoly of specialty drug used to treat infants.
Drug Research > Drug Delivery > News

PBR Supplier Recommendations

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
Therapure Biopharma - Contract Protein Development and Manufacturing
Therapure Biopharma is a Contract Development and Manufacturing Organization (CDMO) that specializes in the development, scale up and manufacture of complex biologics. ... Drug Research > Drug Delivery > Suppliers
Vetter Pharma International - High-Quality Aseptically Pre-Filled Injection Systems
From preclinical development through commercial supply.... Drug Research > Drug Delivery > Suppliers
Polipharma Industries - Pharmaceutical Product Manufacturer
Polipharma Industries is a GMP-certified drug manufacturer established in 2003, whose core business is the manufacturing of pharmaceutical products. We provide activities and services such as: research & development, out-licensing, contract manufacturing, contract development, batch release, analytical services and clinical trials.... Drug Research > Drug Delivery > Suppliers
Alpex Pharma - High Quality Formulation Development & Manufacturing Company
Alpex Pharma is a pharmaceutical company active in the Production, Research and Development of ODT (Orally Dispersible Tablet) also known as ‘fast melt’ and effervescent tablets. Alpex Pharma has developed a unique proprietary covering ODT technology. High manufacturing capacity and advanced Research and Development technology make Alpex Pharma one of the most important companies of the world in the field of fast melt and effervescent tablets. The company has state-of-the-art manufacturing and Research and Development facilities covering 7000 square meters. ... Drug Research > Drug Delivery > Suppliers
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PBR White Paper Recommendations

1.5 Specific dsDNA Quantification UV/VIS-based cDrop™ Method vs Picogreen® Fluorescent Assay By Trinean
Precise quantification and normalization of isolated genomic DNA is critical for advanced molecular testing in life science research and molecular diagnostics. UV-Vis based quantification has long been the method of choice, mainly because of its convenience. However, determining the DNA concentration based on the absorbance at 260nm suffers from interference of components such as RNA, proteins and phenols. Alternative methods, such as the PicoGreen® based Quant-iT™ assay, based on fluorescence enhancement upon binding with dsDNA have been developed to address this issue.... Drug Research > Drug Delivery > White Papers 1.3 Micro-volume Protein Quantification using the DropSense96 Droplet Plate Reader By Trinean
The measurement of protein concentration in aqueous samples is an important assay in biochemistry research and protein production facilities. Spectrophotometric protein quantification assays are commonly used methods to rapidly determine the concentration of a protein. They utilize the direct UV absorbance of the protein at 280nm in combination with its extinction coefficient or an indirect dye-based methods like BCA, Lowry and Bradford assays.... Drug Research > Drug Delivery > White Papers 1.2 DropSense96 and its DropPlates, a Versatile Tool for Nucleic Acid and Protein Droplet Quantification By Trinean
As the demand for molecular tests increases, automated systems for biomolecule isolation and sample analysis are becoming popular. These facilitate integration of the complete molecular test in a full automatic set-up with liquid robots and bar-coded sample tracking resulting in a significant higher throughput while minimizing tedious manual repetitive tasks. The Trinean technology is a unique combination of the DropSense96 droplet plate reader, the 96well DropPlate microfuidic consumables and the DropQuant analytical software enabling direct quantification of small biomolecule samples in these high throughput, automated workflow.... Drug Research > Drug Delivery > White Papers 1.14 Droplet UV/VIS Quantification of Native Proteins in Biopharmaceutical Processing By Trinean
Biopharmaceuticals are mainly produced by microbial fermentation or in animal cell cultures. As a consequence, a cascade of procedures including purification and characterization are required throughout the processing chain to obtain the protein at the desired level of purity and potency. Within these processes, quantification of the protein of interest is mandatory at critical steps to maintain confidence in the processing results and fidelity in the end product.... Drug Research > Drug Delivery > White Papers 1.20 Quantification of His-tagged IgG antibodies after IMAC Ni-column purification By Trinean
Trinean introduces a new cDrop™ application suited for the quantification (OD280) of IgG antibodies and derivatives like Fab fragments during purification by IMAC Ni-columns using imidazole-containing buffers.... Drug Research > Drug Delivery > White Papers See more
1-15 of 2600 results