FDA grants priority review to tumour drug selumetinib

Pharmaceutical Technology | November 15, 2019

The US Food and Drug Administration (FDA) has awarded priority review status for AstraZeneca and MSD (Merck)’s selumetinib to treat neurofibromatosis type 1 (NF1) and symptomatic, inoperable plexiform neurofibromas (PNs) in children. If approved, selumetinib would be the first drug for paediatric patients aged three years and above with NF1 plexiform neurofibromas, said the companies. Selumetinib inhibits the MEK enzyme involved in the RAS/MAPK cell-signalling pathway, which is linked to cancer cell growth and proliferation in a variety of tumour types. AstraZeneca and MSD agreed to jointly develop and commercialise the drug worldwide. The new drug application (NDA) submitted to the FDA is supported by positive data from the SPRINT Phase II Stratum 1 clinical trial, which was funded under the National Cancer Institute (NCI) Cancer Therapy Evaluation Programme (CTEP).

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Sino Pharmaceutical Equipment Development (sinoped) Co,Ltd. is a large-scale production enterprise specializing in R&D, production, sales and service of pharmaceutical machinery.

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Sino Pharmaceutical Equipment Development (sinoped) Co,Ltd. is a large-scale production enterprise specializing in R&D, production, sales and service of pharmaceutical machinery.

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USP Introduces Analytical R&D to Optimize Continuous Manufacturing Technologies

US Pharmacopeia | January 04, 2023

The United States Pharmacopeia (USP) has announced the launch of the USP Advanced Manufacturing Technology Lab in Richmond, Virginia, as a part of its launch of a suite of R&D analytical solutions. These analytical lab services will aid drug manufacturers in adopting advanced manufacturing technologies, such as pharmaceutical continuous manufacturing (PCM), to increase geographic diversity in pharmaceutical manufacturing and support medicine supply chain resilience. The new R&D analytical solutions will include analytical lab services that take advantage of USP's in-house scientific expertise and cutting-edge facilities at the USP Advanced Manufacturing Technology Lab in Richmond, as well as its headquarters in Rockville, Maryland. These capabilities will be utilized to characterize materials and qualify and develop ways to help ensure the quality of PCM-based medicines. PCM involves a continuous flow of materials through a process pipeline in which two or more unit operations are directly connected and the sequential transformation of those materials. As the input materials are fed in, the process output, such as an active pharmaceutical ingredient or drug product, is collected, and the complete procedure is carried out in a single facility. USP's emphasis on R&D analytical solutions and PCM-specific quality assessments is part of a broader set of activities aimed at addressing the problems of PCM adoption and bolstering pharmaceuticals' supply chain resilience. Consulting services provided by a USP company, Pharmatech Associates, Inc., can assist manufacturers with decision-making and problems associated with PCM adoption. Pharmatech Associates consulting services, which operate independently of USP's standards-setting processes, provide manufacturers interested in PCM and other advanced manufacturing technologies with technical, business, and regulatory strategies, workforce training, and equipment and process design. About The U.S. Pharmacopeia (USP) USP is a non-profit, independent scientific organization that provides safe, high-quality pharmaceuticals. The organization has strived to establish confidence in the world's drugs, dietary supplements, and foods for more than two centuries. It protects patient safety and enhances global health via rigorous science and the establishment of public quality standards.

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PHARMACY MARKET, PHARMA TECH

Jazz Pharmaceuticals Maintains Exclusive Rights to Develop and Sell Zymeworks' Zanidatamab

Jazz Pharmaceuticals plc and Zymeworks Inc. | December 28, 2022

Jazz Pharmaceuticals plc and Zymeworks Inc. recently informed that the former has chosen to keep its exclusive rights to develop and sell Zymeworks' Zanidatamab in key markets, such as the U.S., Europe, and Japan, as part of the license and collaboration agreement made in October 2022. A pivotal trial in previously treated HER2-amplified biliary tract tumors (BTC) found that 41.3% (95% CI: 30.4, 52.8) of recruited patients with HER2-amplified and expressing (IHC2+ and 3+) illness achieved an objective response as judged by independent central review. The median response length was 12.9 months (95% CI: 5.95 to not attained). In this trial, Zanidatamab's safety profile was similar to what had been found in previous studies of monotherapy, while no new safety signals were found. Jazz Pharmaceuticals stated that the compelling top-line clinical data from the pivotal study in patients with BTC demonstrated the transformative potential of Zanidatamab. This big win gives the company more confidence that it can make this medicine better for cancer patients who have big unmet needs. Even though its main focus will be on the ongoing clinical trials for BTC and GEA, these data will add to the growing amount of evidence that Zanidatamab is effective against a wide range of HER2-expressing cancers. Zymeworks expressed that the collaboration with Jazz is going well, which will speed up the global development of Zanidatamab in many types of cancer and may give patients with hard-to-treat cancers and few treatment options access to a basic HER2-targeted drug. Jazz will pay Zymeworks $325 million to exercise its option to develop and sell Zanidatamab in all countries except Asia-Pacific in the fourth quarter of 2022. About Jazz Pharmaceuticals Jazz Pharmaceuticals, founded in 2003 and located in Dublin (Ireland), innovates to improve the lives of patients and their families. The company transforms biopharmaceutical discoveries into innovative medications to reimagine what's possible. About Zymeworks Zymeworks develops next-generation multifunctional biotherapeutics. Zanidatamab is a new Azymetric™ HER2-targeted bispecific antibody being examined in numerous Phase 1, Phase 2, and pivotal clinical trials globally as a targeted therapeutic option for patients with HER2-positive solid tumors. Zanidatamab Zovodotin (ZW49) is a bispecific antibody-drug combination in Phase 1 clinical development. It combines Zanidatamab's unique design and antibody framework with Zymeworks' ZymeLink™ linker-cytotoxin.

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PHARMACY MARKET

Nephron and Sharps Announce Manufacturing and Research Partnership

Nephron Pharmaceuticals Corporation | November 15, 2022

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