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Sanofi and Google partner to improve diabetes treatment
Sanofi and Google will work together on new digital technology and tools for enhancing the management and treatment of diabetes.
QB3@953 signs collaboration agreement with GSK to identify early-stage drug discovery opportunities
QB3@953, a San Francisco incubator created by QB3, a University of California (UC) research institute and biotech accelerator, announced an agreement with pharmaceutical company GSK to identify and facilitate collaborations to translate early drug target concepts into medicines that benefit patients.
Drug Research > Drug Discovery & Development > News
RedHill Biopharma gets notice of allowance for new Israeli patent covering RHB-104 to treat Crohn's disease
RedHill Biopharma has received a Notice of Allowance from the Israeli Patent Office (ILPO) for a new Israeli patent No. 207420 covering the formulation of RHB-104, a proprietary and potentially groundbreaking antibiotic combination therapy in oral capsule formulation, with potent intracellular, anti-mycobacterial and anti-inflammatory properties.
Automation > IT & Software > News
Exelixis Announces First Regulatory Approval of Cobimetinib in Switzerland
Exelixis announced that Swissmedic, the Swiss licensing and supervisory authority of Switzerland, has approved cobimetinib for use in combination with vemurafenib as a treatment for patients with advanced melanoma.
Production & Manufacturing > Process & Production > News
Celyad enter into license agreement with Medisun for C-Cure in Greater China
By PBR Staff Writer
Belgian biopharmaceutical firm Celyad has entered into a new collaboration and distribution agreement with its Hong-Kong based partner, Medisun International Limited (Medisun) for C-Cure, its lead cardiac disease cell therapy candidate.
Contract Research & Services > Contract Services > News
ESC launches new concept for driving innovation in cardiovascular research with support from Boehringer
The European Society of Cardiology (ESC) announced the launch of the competitive medical research programme ‘ESC Grants for Medical Research Innovation’, exclusively supported by an independent grant from Boehringer Ingelheim.
Contract Research & Services > Contract Research > News
FDA approves new indication for Sunovion's Aptiom as monotherapy for partial-onset seizures
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted approval for Sunovion Pharmaceuticals' supplemental new drug application (sNDA) for Aptiom (eslicarbazepine acetate) as monotherapy to treat partial-onset seizures.
Production & Manufacturing > Process & Production > News
FDA approves Amgen's Repatha injection to treat certain patients with high cholesterol
By PBR Staff Writer
The US Food and Drug Administration has approved Amgen's Repatha (evolocumab) injection for some patients who are unable to get their low-density lipoprotein cholesterol (LDL-C) under control with the existing treatment options.
Drug Research > Drug Delivery > News
Perrigo acquires GlaxoSmithKline's OTC drugs portfolio for €200m
By PBR Staff Writer
Irish pharmaceutical company Perrigo has completed the acquisition of a portfolio of OTC brands in the European Economic Area (EEA), Brazil and Australia, from GlaxoSmithKline (GSK) for €200m.
Production & Manufacturing > OTC > News
Telesta secures BLA filing notification and priority review designation from FDA for MCNA
By PBR Staff Writer
Canadian biopharmaceutical firm Telesta Therapeutics has received its Biologics License Application (BLA) filing notification for MCNA from the US Food and Drug Administration (FDA).
Production & Manufacturing > Process & Production > News
MicuRX reports positive Phase II trial results for MRX-I to treat MRSA and VRE
By PBR Staff Writer
MicuRx Pharmaceuticals has reported positive top-line results from the first Phase II clinical trial for its lead drug MRX-I, an oral oxazolidinone antibiotic designed to treat drug-resistant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant Enterococcus (VRE).
Contract Research & Services > Clinical Trials > News
Bristol-Myers, QIMR to discover new immuno-oncology antibodies
By PBR Staff Writer
Bristol-Myers Squibb (BMS) has entered into a research collaboration and license agreement with QIMR Berghofer Medical Research Institute for the discovery of new therapeutic antibodies against an undisclosed immuno-oncology (I-O) target.
Drug Research > Drug Discovery & Development > News
WuXi PharmaTech's STA subsidiary gets first approval from Japanese regulatory authorities
WuXi PharmaTech (Cayman), a leading open-access R&D capability and technology platform company serving the pharmaceutical, biotechnology, and medical device industries, announced that its small-molecule process development and manufacturing subsidiary Shanghai SynTheAll Pharmaceutical (STA) received its first approval from the Japan PMDA for the manufacture of the GMP intermediate of a branded commercial drug in July.
Contract Research & Services > Contract Research > News
Horizon Pharma gets USPTO issuance of additional notice of allowance with claims covering Pennsaid 2%
Horizon Pharma received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for US patent application number 14/705,636 (US publication number 2015-0231263), entitled 'Diclofenac Topical Formulation' that covers Horizon's US approved product PENNSAID (diclofenac sodium topical solution) 2% w/w (PENNSAID 2%).
Production & Manufacturing > Process & Production > News
Symbiomix completes enrollment in second pivotal trial of SYM-1219 for bacterial vaginosis
Symbiomix announced the completion of patient enrollment in a Phase 3 clinical study, the second pivotal trial of SYM-1219, which is a single-dose, oral product candidate for the treatment of bacterial vaginosis (BV).
Contract Research & Services > Clinical Trials > News

PBR Supplier Recommendations

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
PANalytical - Key Analytical Techniques and Products
PANalytical offers a wide range of key analytical techniques and products that are used in the pharmaceutical industry for research, development and quality control purposes. These rapid non-destructive analytical techniques such as near-infrared spectroscopy (NIR), X-ray diffraction (XRD) and X-ray fluorescence spectrometry (XRF) can be used for a large variety of (bio-)pharmaceutical applications including drug discovery, pre-formulation, formulation, stability testing and final product quality control. ... Automation > Laboratory Instrumentation > Suppliers
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PBR White Paper Recommendations

Exosomes and Microvesicles: Characterization by Nanoparticle Tracking Analysis By Malvern Instruments
NTA utilizes the properties of both light scattering and Brownian motion in order to obtain the particle size distribution of samples in liquid suspension. A laser beam is passed through the sample chamber, and the particles in suspension in the path of this beam scatter light in such a manner that they can easily be visualized via a 20x magnification microscope onto which is mounted a camera.... White Papers Differential Scanning Calorimetry: Theory and Practice By Malvern Instruments
The key benefit with DSC is that it is based on heat measurements and therefore allows the characterization of native biomolecules. Furthermore, the lack of spectroscopic readings means that the samples do not have to be optically clear. In addition, the characterization is not limited to the melting temperature (Tm), but it also provides data on the forces involved in folding of biomolecules and the mechanisms by which they unfold.... White Papers Ten Ways to…..Control Rheology by Changing Particle Properties (Size, Zeta Potential and Shape) By Malvern Instruments
Many common materials can be considered to be dispersions in which one substance (often particulate) is dispersed in another phase. These material types include adhesives, agrochemicals, cement, ceramics, colloids, cosmetics and personal care formulations, food and drink, mining and mineral slurries, paints, inks and surface coatings, pharmaceuticals and polymer systems.... White Papers Bioanalysis of Biosimilars By PRA Health Sciences
Assessment of biosimilarity during non-clinical and clinical trials requires specific bioanalytical procedures. The concentration of the biosimilars and their reference compounds is established using pharmacokinetic (PK) methods. Immunogenicity assays are used to determine and further characterize any anti-drug antibodies (ADA) formed during these studies. These analytical methods are pivotal for establishing similarity of biosimilar products as compared to their reference compounds.... Contract Research & Services > Contract Research > White Papers ECG Assessments During the Development of Oncology Compounds By PRA Health Sciences
Assessment of ECGs during the development of oncology compounds is challenging. Toxicity of these compounds often precludes the inclusion of healthy volunteers while a higher variability of ECG parameters in oncology patients can be expected due to disease, comedication, and co-morbidities. Recently, it was shown that the extraction of ECG data using the High Precision QT technique of iCardiac and Exposure Response analysis can result in a conclusive ECG assessment with a limited number of volunteers. Applying these techniques in a small-sized oncology study with dedicated PRA staff presents a unique opportunity for a conclusive and efficient cardiac safety assessment by ECG.... Contract Research & Services > Contract Research > White Papers See more
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