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Top Stories
Ongoing coronavirus outbreak prompts date change to ensure safety of trade show participants.
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Under the agreement, Roche will have access to Promedior's lead product candidate, PRM-15, a recombinant form of human pentraxin-2 that can possibly treat a range of systemic fibrotic diseases.
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Pharma-grade Precision at an Absolute Bargain
Up to 70% off for a limited time on our wide-mouth volumetric flasks. Rely on precise Class A volumetric tolerances for your preparations. Made from heavy-duty, leach-resistant borosilicate glass meeting USP Type I classification. We know your product is important. Trust us -- we are the standard. Contact DWK Life Sciences.
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Industry News
An evaluation by USP indicates bovine heparin is a potential alternative to porcine heparin.
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The National Institute for Health and Care Excellence (NICE) has issued guidance in Feb. 2020 stating that it does not recommend the combination therapy of pembrolizumab with axitinib for the treatment of advanced renal cell carcinoma in adults.
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Supplier News
The company has said that all three of its operating sites in China started back up on Feb. 12 and that it is closely monitoring the outbreak.
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The companies have entered into a global licensing and collaboration agreement to commercialize ReForm excipients used in biotherapeutic formulations.
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Bio/Pharma News
The Native Antigen Company has commercially introduced antigens that have been specifically derived from the Wuhan strain of novel coronavirus, now named Covid-19.
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ERS Genomics revealed that the European Patent Office (EPO) has rejected arguments filed in opposition to patent EP2800811, which is directed to the single-guide CRISPR/Cas9 gene editing system and covers uses in cellular and non-cellular settings.
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Regulatory News
The agency is taking steps to monitor the supply chain and assist in the development of treatments.
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FDA’s Center for Biologics Evaluation and Research is planning on publishing nine specific guidance documents on gene therapies in 2020.
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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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METHOD DEVELOPMENT
Analytical solutions are improving for raw material testing, drug product release process development, and more.
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ANALYTICS
Complex protein structures pose analytical challenges that can be addressed by advanced mass spectrometry technologies and workflows, which can be used to comprehensively characterize them.
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QUALITY/REGULATIONS
Data management is crucial in bio/pharmaceutical laboratory settings from discovery steps through clinical studies and varies based on the development phase.
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Expert input is needed for the bio-industry's most in-depth, global benchmarking and analysis study, which examines current global and regional trends affecting the bioindustry. Participants who complete the survey receive a free aggregated summary of the study results, a free whitepaper on the Top 15 Trends in Biopharmaceutical Manufacturing, and the opportunity to share insight about trends in biomanufacturing. For each completed survey, BioPlan Associates will contribute $10 (up to $3000) to a global health charity.
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February 23–26, 2020
March 1–5, 2020
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In Pharmaceutical Technology's ongoing Pharmacopoeia Compliance Series, experts explain the revision process for global and national pharmacopoeias, best practices for monitoring changes, and how to participate in revisions. Other features include FDA warning letters, building a quality culture, and essentials for DOE and QRM.
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