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Top Stories
Through the agreement, Roche will gain full rights to the company’s portfolio of molecules for fibrotic diseases, most notably PRM-151, Promedior’s lead product candidate.
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The new company name, Viatris, derives from Latin and represents the company’s main goals.
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Industry News
A clinical-stage company that was spun out of the VUB university in Belgium, eTheRNA immunotherapies, has revealed it will be participating in an EU research project aimed at developing off-the-shelf mRNA nanomedicines.
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NICE has issued a positive recommendation for GW Pharmaceuticals’ Epidyolex (cannabidiol) oral solution for the treatment of seizures in patients with a rare form of childhood-onset epilepsy.
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Supplier News
The companies will acquire Orflo’s two flagship products, the Moxi Z and the Moxi Go.
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The new center will handle the delivery of novel and high-quality therapeutics by providing expertise in critical analytical processes and specialized workflows.
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2019 PDA Quality Week | Dec. 9-13 | Washington, DC
The Week is comprised of three individual, but contiguous events designed to educate you on all aspects of QRM. Each offering provides a different perspective, starting with a focus on the emerging regulatory landscape, framing the requirements and objectives of the regulations that govern this important but elusive concept.
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PRODUCT SPOTLIGHT |
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Put our labware through its paces
Only the best laboratory glassware meets USP, EP and ASTM quality standards. That’s all DWK sells! Store your formulations with security in containment solutions by DWK Life Sciences. Ask your rep in for a special offer – discount prices and more!
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Bio/Pharma News
Norwegian clinical-stage immunoncology company, Lytix Biopharma, has entered into a clinical collaboration with US-based Iovance Biotherapeutics.
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The recent approval by FDA of Vumerity (diroximel fumarate), a new drug for treating multiple sclerosis, has a triggered a $150-million milestone payment from Biogen to Alkermes.
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Regulatory News
Roche’s ADC, Kadcyla, has been recommended for approval in the EU for for the adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment.
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FDA issued a warning letter to the company for obtaining over-the-counter drugs made by foreign manufacturers that violated federal law.
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OUTSOURCING
Contract manufacturers are making strategic partnerships and expanding services in the last quarter of 2019.
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QUALITY SYSTEMS
An effective quality control unit is independent from manufacturing and ensures current standards are followed.
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MANUFACTURING
PATH’s Microarray Patch Center of Excellence aims to accelerate transdermal patch technology for public health needs.
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Renishaw has developed the Virsa Raman Analyser using its expertise in optical design and detector technologies. It combines the power of laboratory–grade Raman with the convenience of a transportable unit. Use Renishaw's latest high-performance Raman spectroscopy system, to take your spectroscopic analysis away from the confines of the laboratory microscope to new samples and environments.
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Events
November 25–26, 2019
December 4–5, 2019
December 9–11, 2019
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eBOOKS
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The editors explore novel technologies for the formulation, manufacture,
purification, and delivery of sterile small- and large-molecule drugs including single-use systems, facilities and equipment, contamination issues, and process analytics.
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