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FDA grants Imbruvica breakthrough therapy designation for cGVHD
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted a fourth Breakthrough Therapy designation (BTD) and an orphan drug designation for ibrutinib (Imbruvica) for the potential treatment of chronic graft-versus-host-disease (cGVHD) after failure of one or more lines of systemic therapy.
Production & Manufacturing > Process & Production > News
AcelRx Pharmaceuticals completes patient enrollment in remaining phase 3 studies of ARX-04
AcelRx Pharmaceuticals has completed patient enrollment in the two remaining Phase 3 studies of ARX-04 (sufentanil sublingual tablet, 30 mcg):
Contract Research & Services > Clinical Trials > News
Merck to develop vaccine manufacturing processes with International Vaccine Institute
Merck has entered a research agreement with the International Vaccine Institute (IVI) of Seoul, South Korea to help develop more robust, scalable vaccine manufacturing processes.
Production & Manufacturing > Manufacturing > News
Intensity Therapeutics raises $10m to fund clinical supplies manufacturing and phase I/II trials of INT230-6
Intensity Therapeutics, a privately held biotechnology company developing proprietary cancer immunotherapy products, has secured $10 million in new capital from a Series A preferred stock financing.
Production & Manufacturing > Manufacturing > News
Kitov's KIT-302 drug achieves manufacturing milestone ahead of planned NDA Filing with FDA
Kitov Pharmaceuticals announced that Dexcel Pharma, Kitov's manufacturing partner, has successfully completed an initial stability study for its lead drug candidate KIT-302.
Drug Research > Drug Delivery > News
Two additional phase 3 lipid-lowering trials of Bococizumab meet primary endpoints
By PBR Staff Writer
Pfizer has unveiled that two additional phase 3 bococizumab trials met their primary endpoints in patients at high and very high risk for cardiovascular events.
Contract Research & Services > Clinical Trials > News
Gilead Sciences’ Epclusa gets FDA approval to treat chronic Hepatitis C virus infection
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved Gilead Sciences’ Epclusa to treat adults with genotype 1-6 chronic hepatitis C virus (HCV) infection.
Regulatory Affairs > News
EMA and FDA accept for review Roche’s Ocrevus for two forms of multiple sclerosis
By PBR Staff Writer
The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have accepted to review Roche’s marketing applications for Ocrevus (ocrelizumab) to treat two forms of multiple sclerosis.
Production & Manufacturing > Process & Production > News
Onxeo advances development plan for first-in-class signal interfering DNA compound AsiDNA
Onxeo announced its plan for further development of AsiDNA, its first-in-class signal interfering DNA molecule which breaks the cycle of tumor DNA repair to induce cancer cell death.
Drug Research > Drug Discovery & Development > News
Sobi's Elocta approved in Switzerland to treat haemophilia A
Swedish Orphan Biovitrum AB announced that the Swiss Agency for Therapeutic Products, Swissmedic, has approved Elocta (rFVIIIFc) for the treatment of haemophilia A.
Regulatory Affairs > News
Bristol-Myers Squibb’s Opdivo gets FDA breakthrough therapy designation for advanced form of bladder cancer
Bristol-Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Opdivo for the potential indication of unresectable locally advanced or metastatic urothelial carcinoma that has progressed on or after a platinum-containing regimen.
Production & Manufacturing > Process & Production > News
Allergy Therapeutics announces findings from mEEC dose range finding study G204
Allergy Therapeutics announces findings from its exploratory Phase II dose-ranging study (G204) for the US GrassMATAMPL clinical development program and informs that the results did not determine a recommended dose for the Phase III trial.
Contract Research & Services > Clinical Trials > News
GW Pharmaceuticals’ Epidiolex succeds in late-stage study in Lennox-Gastaut syndrome
By PBR Staff Writer
GW Pharmaceuticals’ cannabis-derived epilepsy drug met the primary goal to reduce frequency of seizures in a phase 3 clinical trial.
Contract Research & Services > Clinical Trials > News
EMA committee recommends approval of Merck’s Keytruda for advanced NSCLC
By PBR Staff Writer
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of Merck’s Keytruda (pembrolizumab) to treat advanced or metastatic non-small cell lung cancer (NSCLC).
Production & Manufacturing > Process & Production > News
Sanofi, Boehringer Ingelheim to swap animal, consumer health assets
By PBR Staff Writer
Sanofi and Boehringer Ingelheim have signed contracts to exchange their respective animal health and consumer healthcare businesses.
Production & Manufacturing > Manufacturing > 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

Protein Storage and Stability Analysis Using the Zetasizer Nano ZSP By Malvern Instruments
Spidroins are a unique family of large, structural proteins that make up the bulk of spider silk fibres. The mechanical strength and elasticity of spider silk fibres have led to their successful use in the regeneration of peripheral nerves in rats [1], with the same properties giving the potential for use in a wide range of other applications [2,3,4]. The production of these proteins on an industrial scale, however, has only become possible fairly recently.... White Papers Using Differential Scanning Calorimetry to Inform and Accelerate Process Development for Protein Therapeutics By Malvern Instruments
The production and purification of immunoglobulins of the gamma isotype, particularly human IgG1, for diagnostic or therapeutic applications is now fairly routine. In the past decade IgE-based therapeutics have also gained momentum (1-3). IgE is important for host defense against parasites and for protective inflammation. Yet, IgE-mediated signaling through its receptors is also a focal point of inflammatory allergic disease (4). The constant region of IgE, is a homodimer containing duplicate pairs of three unique Ig-fold domains (Cε2, Cε3, and Cε4), and is responsible for binding its two receptors, FcεRI and CD23, also known as FcεRII.... White Papers Using Differential Scanning Calorimetry to Inform and Accelerate Process Development for Protein Therapeutics By Malvern Instruments
The production and purification of immunoglobulins of the gamma isotype, particularly human IgG1, for diagnostic or therapeutic applications is now fairly routine. In the past decade IgE-based therapeutics have also gained momentum (1-3). IgE is important for host defense against parasites and for protective inflammation. Yet, IgE-mediated signaling through its receptors is also a focal point of inflammatory allergic disease (4). The constant region of IgE, is a homodimer containing duplicate pairs of three unique Ig-fold domains (Cε2, Cε3, and Cε4), and is responsible for binding its two receptors, FcεRI and CD23, also known as FcεRII.... White Papers Evaluating Product Texture Using Oscillatory Testing on a Rotational Rheometer By Malvern Instruments
Formulating products to have both the correct functional and sensory attributes can be a difficult task. The latter in particular relies heavily on user feedback which can take considerable time and effort to attain. In addition it is not always easy to interpret such feedback in the context of material properties and hence rheological data.... White Papers 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 See more
1-15 of 54087 results