Top Stories
A US District Judge in the Southern District of Florida held that the US Stem Cell Clinic of Weston, FL and US Stem Cell of Sunrise, FL adulterated and misbranded a stem cell drug product made from a patient's adipose tissue.
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FDA is supporting the development and marketing of OTC therapies, including CBD products, by proposing new rules and an expanded review office and promoting digital technologies.
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Industry News
The US Pharmacopeial Convention released new and revised standards for compounding nonsterile medicines, sterile medicines, and radiopharmaceutical drugs.
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The company is voluntarily recalling Amikacin Sulfate Injection, USP, 1g/4 mL (250mg/mL), and Prochlorperazine Edisylate Injection, USP, 10mg/2mL (5mg/mL), to the consumer level because microbial growth was detected.
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Specialty CDMO Launches New Website
Ascendia Pharmaceuticals' new website – www.ascendiapharma.com – details how the specialty CDMO meets complex drug development needs. It outlines Ascendia Pharma's sophisticated formulations developed using advanced manufacturing processes in a state–of–the–art R&D and cGMP facility. Ascendia's development services, including analytical testing/validation; pre–formulation development and modeling; formulation; proof–of–concept; and optimization, are explained. Its suite of three technologies – AmorSol, EmulSol, and NanoSol – are detailed, as well. Visit
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Supplier News
By connecting manufacturing processes and logistics technology, GE Healthcare and World Courier look to accelerate the development of advanced therapies.
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MilliporeSigma awarded its Advance Biotech Grant to three US companies that are focused on traumatic brain injury, vaccine development, and chronic pain.
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Exclusive Video from Interphex 2019
Laser Printing: Progress Beyond Traditional Ink
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Sponsored by: Qualicaps
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Bio/Pharma News
The agency says Novartis drug is the first PI3K inhibitor to be approved for treating breast cancer.
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A new facility to be built in the Philadelphia Navy Yard will support commercial production for autologous tumor-infiltrating lymphocyte cell therapy products from Iovance Biotherapeutics.
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Regulatory News
Prestige BioPharma has announced that the EMA has accepted its marketing authorization application for HD201 (Tuzune) for review.
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As part of its work to combat the opioid crisis, the agency is considering fixed-quantity, unit-of-use blister packaging for certain immediate-release opioid analgesics.
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QA/QC
Quality cannot be verified through testing, especially at the limit of detection, and no test method can confirm the absence of a microbe or particle.
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ANALYTICS
Leachable silicone oil may have an effect on large-molecule APIs, making it important to establish a robust analytical method to detect and quantify the substance.
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MANUFACTURING
Although continuous approaches offer significant benefits for some products and processes, batch manufacturing is not going away any time soon.
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ASEPTIC/STERILE PROCESSING
A one-size-fits-all approach to monitoring practices and results is never appropriate, given the diversity of practice within the pharmaceutical industry.
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Events
June 12–13, 2019
June 18–20, 2019
September 10–11, 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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