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New Tools for Biopharma Development Take Center Stage on the Malvern AAPS 2015 Booth
New tools from Malvern that answer to specific analytical challenges in biopharma development will take center stage at this year’s AAPS Annual Meeting and Exposition, in Orlando, USA (Orange County Convention Center, 25 - 29 October 2015). Alongside Malvern’s established analytical suite for both large and small molecule development will be a range of complementary and orthogonal characterization technologies with proven value for accelerating innovator and generic product development.
Press Releases
Are You A Good Fit for Custom Powder Systems?
What I'm looking for as Senior VP of Technology for candidates for employment in the design field is a sincere interest in how machines work. I think that’s the basis for most everybody who's succeeded and done really well here -- a true interest in machinery, how it works. If you were the kid that started taking your parents' appliance apart at the age of three, you're probably going to fit really good here.
Production & Manufacturing > Manufacturing > Press Releases
Dako announces FDA approval of new companion diagnostic for lung cancer
By PBR Staff Writer
Dako, an Agilent Technologies company and a worldwide provider of cancer diagnostics, today announced the U.S. Food and Drug Administration (FDA) approval of a new companion diagnostic assay that can reveal whether a patient with advanced non-small cell lung cancer (NSCLC) is likely to respond to a new form of treatment.
FDA approves Keytruda for treatment of patients with metastatic non-small cell lung cancer whose tumors express PD-L1 with disease progression on or after platinum-containing chemotherapy
By PBR Staff Writer
Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA (pembrolizumab) monotherapy, the company’s anti-PD-1 (programmed death receptor-1) therapy, at a dose of 2 mg/kg every three weeks, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 as determined by an FDA-approved test and who have disease progression on or after platinum-containing chemotherapy.
Woodley Equipment to Attend Global Site Solutions Summit, Florida, USA
The Global Site Solutions Summit is taking place at Amelia Island, Florida on 8 – 11th October 2015. This is the 10th annual event of the Society for Clinical Research Sites which aims to bring together Study site executives, Sponsors and CRO’s from across the globe.
Contract Research & Services > Clinical Trials > Press Releases
Woodley Equipment to Attend ICSE Exhibition, Madrid, Spain
Woodley Equipment is attending ICSE Exhibition taking place on 13th - 15th October 2015 in Madrid, Spain. ICSE connects the pharmaceutical industry with outsourcing solution providers.
Contract Research & Services > Clinical Trials > Press Releases
Anthera starts Phase 3 study of Sollpura pancreatic enzyme replacement therapy
By PBR Staff Writer
Anthera Pharmaceuticals has started a Phase 3 study on Sollpura (liprotamase) in patients with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis.
Contract Research & Services > Clinical Trials > News
FDA approves treatment combination of Gilead’s Letairis with Tadalafil for PAH
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved the use of Gilead Sciences’ Letairis (ambrisentan) in combination with tadalafil to treat pulmonary arterial hypertension (PAH).
Regulatory Affairs > News
Ultragenyx seeks marketing authorization for Ace-ER tablets in Europe
By PBR Staff Writer
Ultragenyx Pharmaceutical has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for aceneuramic acid prolonged release (Ace-ER; UX001) tablets indicated for patients with GNE Myopathy.
Regulatory Affairs > News
FDA accepts Sandoz's BLA for biosimilar Etanercept
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted Sandoz's regulatory submission for Etanercept, a biosimilar to Amgen's Enbrel drug.
Regulatory Affairs > News
Vernalis buys US rights of Moxatag from Pragma Pharmaceuticals
By PBR Staff Writer
Vernalis has acquired the US rights of Moxatag amoxicillin extended-release tablets from Pragma Pharmaceuticals.
Contract Research & Services > Contract Research > News
Karo Bio acquires OTC products manufacturer Swereco
Karo Bio has acquired the shares in Swereco Group.
Production & Manufacturing > OTC > News
Theralase completes GMP manufacture of second batch of lead drug
Theralase Technologies has completed manufacture of a second batch of its lead Photo Dynamic Compound (PDC), TLD-1433 in compliance with Good Manufacturing Practice (GMP) standards.
Production & Manufacturing > Manufacturing > News
Pharmalink raises funds to advance Nefecon development to treat kidney disease
By PBR Staff Writer
Pharmalink has raised SEK100m (€10.5m) to advance the development of Nefecon as a new treatment for kidney disease.
Drug Research > Drug Discovery & Development > News
Neon Therapeutics secures $55m to develop neoantigen-based cancer immunotherapies
By PBR Staff Writer
Immuno-oncology firm Neon Therapeutics has secured $55m in initial funding to develop neoantigen-based cancer immunotherapies.
Drug Research > Drug Discovery & Development > News

PBR Supplier Recommendations

Source BioScience - Provider of Laboratory Services and Products
Source BioScience is a leading provider of state of the art laboratory services and products. ... Suppliers
JRS Pharma - Bringing Health Science to Life
JRS Pharma offers a complete portfolio of excipients and coatings, along with technical expertise and biopharma services. Our product portfolio provides our customers with a wide range of solutions for the development and manufacture of oral dosage forms. With over 135 years of experience, 7 R&D centers, 31 production sites, and 25 sales offices, we are dedicated to serving the health science industry worldwide. ... Suppliers
Munters - Your Perfect Climate
Munters is the global leader in energy efficient climate control. Munters provide temperature and humidity climate solutions to assist manufacture and storage of products and create comfortable indoor environments. The company was established over 65 years ago and with over 3,000 employees in 30 offices worldwide.... Suppliers
Bürkert Fluid Control Systems - Manufacturer of Measuring, Control and Regulation Systems for Liquids and Gases
The company group Bürkert Fluid Control Systems, founded in 1946 by Christian Bürkert, is a manufacturer of measuring, control and regulation systems for liquids and gases, with headquarters in the southern German town of Ingelfingen. The company which has been family owned since its foundation has got an export ratio of 80%.... Suppliers
Axol - Succeed with Axol Your Human Cell Culture Specialists
Axol specializes in human cell culture, including extensive expertise in cellular reprogramming and lineage-specific differentiation of iPS cells. We have a passion for great science, delivering postdoctoral level support and providing innovative future products to help our customers advance faster in their research. Whether you would like ready-made cells from our portfolio of cell types and disease backgrounds, or need a customized project tailored to your research, we are here for you. ... Suppliers
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PBR White Paper Recommendations

Supporting the pharmaceutical industry with 21 CFR Part 11 compliance readiness.... Automation > Laboratory Instrumentation > White Papers Enhanced Sampling and Calibration Procedures for the Analysis of Residual Oxygen in Nitrogen Purged Pharmaceutical Packaging by GC-TCD By Butterworth Laboratories Ltd
In recent times there has been a large increase in the type and number of products packaged using Modified Atmosphere Packaging (MAP) procedures. The majority of these processes concern the removal of oxygen from packaging systems in order to reduce oxidative degradation of the product and increase shelf life. Whilst most of the historical development of MAP took place within the food industry, over the last 20 years there has been a large growth in its application within the pharmaceutical sector.... White Papers Sciences Radiolabelling Brochure By Almac
Trust Almac with your 14C radiolabelling requirements and we will offer advice on the most appropriate label position for your molecule, including synthetic feasibility and metabolic stability.... White Papers Commerical Packaging By Almac
- Complementary US and UK operations, - Quality-driven, flexible packaging solutions, - Market leader for product launch of niche / orphan drug products, - Solid oral dose and biopharmaceutical packaging, - Packaging and artwork design, - Full serialisation and 2D matrix barcoding solutions.... White Papers Providing an Unparalleled Range of Contract Pharmaceutical Development and Manufacturing Services Globally for Over 40 Years By Almac
Only we can combine the expertise from our range of specialised services to provide you with the right solutions to help you develop and commercialise your products.... White Papers See more
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