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Titan Pharmaceuticals wins FDA approval for Probuphine to treat opioid dependence
The US Food and Drug Administration has approved Titan Pharmaceuticals' Probuphine (buprenorphine) implant, the first product for the long-term maintenance treatment of opioid dependence in clinically stable patients on 8 mg or less a day of oral buprenorphine.
Regulatory Affairs > News
Integral Molecular develops B-Cell cloning technology to discover rare antibodies against membrane proteins
Integral Molecular has developed an ultra high-throughput microfluidic B-cell cloning technology that can interrogate tens of millions of immune cells (B-cells), enabling deep mining of entire immune repertoires to discover rare and diverse monoclonal antibodies for therapeutic purposes.
Automation > IT & Software > News
Faron expands development strategy for novel immunotherapy drug candidate, Clevegen
Faron Pharmaceuticals has expanded the development strategy for Clevegen, its novel cancer immunotherapy drug candidate.
Drug Research > Drug Discovery & Development > News
Symbiomix reports positive results for SYM-1219 in bacterial vaginosis
By PBR Staff Writer
Symbiomix Therapeutics' SYM-1219 (secnidazole) has achieved statistically and clinically significant results across all primary and secondary endpoints in phase 3 trial for bacterial vaginosis (BV).
Contract Research & Services > Clinical Trials > News
FDA approves CSL Behring's single-chain Afstyla for hemophilia A
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved CSL Behring's Afstyla [Antihemophilic Factor (Recombinant) Single Chain] to treat adults and children with hemophilia A.
Regulatory Affairs > News
Roche’s phase III study of Gazyva meets primary endpoint early
By PBR Staff Writer
Roche's Gazyva drug demonstrated superior progression-free survival compared to Mabthera/Rituxan in people with previously untreated follicular lymphoma in the phase III Gallium study that met its primary endpoint early.
Contract Research & Services > Clinical Trials > News
Dow Corning to present webinar on effective silicone-based topical formulations
Dow Corning will present an educational webinar titled, “Effective Silicone-based Topical Formulations – How to Improve Efficacy and Patient Compliance,” on June 7 at 10 a.m. EDT.
News
Dr. Reddy’s Laboratories acquires six OTC brands
Dr. Reddy’s Laboratories has acquired a portfolio of over-the-counter (OTC) brands in the cough-and-cold, pain, and dermatology categories.
Production & Manufacturing > OTC > News
Serial BioPharma Entrepreneurial Team launches drug development firm Arrivo BioVentures
Serial BioPharma Entrepreneurial Team has launched Arrivo BioVentures, a drug development company, with $49m in committed funding.
Drug Research > Drug Discovery & Development > News
Allied-Bristol Life Sciences completes ABLS II drug candidate feasibility programme
Allied-Bristol Life Sciences (ABLS), its partnership with Bristol-Myers Squibb Company (BMS), has completed the drug candidate feasibility programme at ABLS II, LLC (ABLS II), and approved up to $15m to fund further development of the lead optimisation programme.
Drug Research > Drug Discovery & Development > News
Baxalta unveils positive phase 1 results for BAX 930, investigational recombinant ADAMTS13 to treat hTTP
Baxalta has reported positive results from a Phase 1 open-label, dose escalation study assessing the safety and pharmacokinetic (PK) profile of BAX 930, an investigational recombinant ADAMTS13 for the treatment of patients with severe hereditary thrombotic thrombocytopenic purpura (hTTP).
Drug Research > Drug Delivery > News
Seattle Genetics starts phase 3 trial of vadastuximab talirine for newly diagnosed AML patients
By PBR Staff Writer
Seattle Genetics has started a phase 3 trial of vdastuximab talirine (SGN-CD33A) for patients with newly diagnosed acute myeloid leukemia (AML).
Contract Research & Services > Clinical Trials > News
FDA advisory committee backs approval of Sanofi treatment for adults with type 2 diabetes
By PBR Staff Writer
A US Food and Drug Administration's (FDA) committee recommended the approval of Sanofi's new drug application (NDA) for the investigational fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide to treat adults with type 2 diabetes.
Production & Manufacturing > Process & Production > News
Alkermes starts phase 1 trial of immuno-oncology drug candidate ALKS 4230
By PBR Staff Writer
Biopharmaceutical firm Alkermes has started a phase 1 clinical study of its immuno-oncology drug candidate, ALKS 4230.
Contract Research & Services > Clinical Trials > News
Redx Pharma reaches pre-clinical proof of concept stage with oncology lead
Redx Pharma has reached pre-clinical proof of concept stage with an oncology lead that has the potential to treat leukaemia and other blood cancers.
Drug Research > Drug Discovery & Development > News

PBR Supplier Recommendations

SchuF Valves- Innovative, custom valve solutions for the pharmaceutical industry
The SchuF group, inventor of the bottom outlet valve, manufactures custom, flush-mounted valves that eliminate dead space in the reactor outlet nozzle. The main features and benefits of SchuF valves include the following;... Suppliers
Bruker Optics - Fourier Transform Infrared, Near Infrared and Raman Spectrometers
Bruker Optics is the leading manufacturer and worldwide supplier of fourier transform Infrared (FTIR), near infrared and raman spectrometers for a number of industries and applications, such as pharmaceutical and life sciences.... Automation > Laboratory Instrumentation > Suppliers
LABORATORIOS INIBSA - Pharmaceutical Contract Manufacturing Company
LABORATORIOS INIBSA is a pharmaceutical contract manufacturing company. We have more than 60 years' experience and belong to the INIBSA GROUP. INIBISA supplies products and services to Biotools, Inibsa Dental and Inibsa Hospital, as well as other pharmaceutical companies through our contract manufacturing division. From our facilities in Lliçà de Vall, 20km from Barcelona LABORATORIOS INIBSA currently supplies more than 50 countries worldwide.... Production & Manufacturing > Manufacturing > Suppliers
SHL Healthcare - Developer and Manufacturer for Equipment Solutions
SHL Healthcare develops and manufactures equipment solutions for home, hospital and long-term care use with a focus on patient comfort and functionality. Our broad range of products include medical slings, rehabilitation beds, pressure mattress systems, lifting equipment, medical soft goods and a variety of related accessories. ... Suppliers
SHL Group - Pen Injectors, Autoinjectors and Inhaler Systems
SHL is a privately-owned developer, designer and manufacturer of advanced drug delivery devices.... Regulatory Affairs > Suppliers
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PBR White Paper Recommendations

Improved library preparation with the NEBNext® Ultra II DNA Library Prep Kit for Illumina™® By New England Biolabs
Here we demonstrate the utility of the NEBNext Ultra II DNA Library Prep Kit for DNA library construction from a variety of sample types and for a number of applications. ... White Papers 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 Discovery & Development > 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 Discovery & Development > 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 Discovery & Development > 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 Discovery & Development > White Papers See more
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