GSK to invest $100M in Montana vaccine manufacturing site

biopharmadive | April 24, 2019

The British drugmaker is acting in part to address a shingles vaccine shortage that has captured nationwide attention. Demand for GSK’s Shingrix (zoster vaccine recombinant), approved in 2017, quickly outstripped supply and forced shipping delays and order limits last year. The Centers for Disease Control and Prevention is cautioning patients that the delays are likely to continue through this year. And AARP has offered advice to its members on how best to find the vaccine, including staying in close touch with the local pharmacy. Even with the shortages, Shingrix became one of GSK’s most important growth drivers in its first full year, beating analysts’ early expectations. The vaccine chalked up sales of 784 million pounds, or about $1 billion, last year and ended 2018 with 98% market share, GSK reported in February.

Spotlight

Over the past several years, the U.S. healthcare system has experienced seismic shifts. We have witnessed transformations in coverage, care delivery, new technologies and outcomes-based reimbursement. We have also seen notable growth in the U.S. biosimilars market: the FDA approval of several biosimilar products, health plans and pharmacy benefit managers identifying coverage models and providers adding available biosimilars to their treatment plans for patients. While the biosimilar market continues to develop, we expect that the next year will bring another strong phase of growth and market maturity for biosimilars. We anticipate additional regulatory and legal activity surrounding these agents across a range of therapeutic areas.

Spotlight

Over the past several years, the U.S. healthcare system has experienced seismic shifts. We have witnessed transformations in coverage, care delivery, new technologies and outcomes-based reimbursement. We have also seen notable growth in the U.S. biosimilars market: the FDA approval of several biosimilar products, health plans and pharmacy benefit managers identifying coverage models and providers adding available biosimilars to their treatment plans for patients. While the biosimilar market continues to develop, we expect that the next year will bring another strong phase of growth and market maturity for biosimilars. We anticipate additional regulatory and legal activity surrounding these agents across a range of therapeutic areas.

Related News

NCCN Oncology Research Program and Puma Biotechnology, Inc. Collaborate to Research on Neratinib in Various Cancers

National Comprehensive Cancer Network | October 16, 2020

The National Comprehensive Cancer Network® (NCCN®) Oncology Research Program (ORP) today announced plans to evaluate neratinib, a type of tyrosine kinase inhibitor (TKI) that works as a dual inhibitor of the epidermal growth factor receptor 1 (EGFR) and human epidermal growth factor receptor 2 (HER2). The research funding is supported by a $2-million grant from Puma Biotechnology, Inc. Projects may include pre-clinical, translational and clinical trials. They will focus on treatment of: Pediatric tumors(including neurofibromatosis Type 2 and progressive Vestibular Schwannoma). Early-stage and metastatic breast cancer, including those with HER2+ brain metastases. Other HER2-amplified tumors. EGFR-mutated glioblastoma multiforme. Specific research areas will be determined by a group of cancer research experts from NCCN Member Institutions who form a Request for Proposals (RFP) Development Team.

Read More

Research Solutions Announces Partnership with BIO Business Solutions to Bring One-Click Scientific Literature Access to the Biotech Industry

Research Solutions | October 12, 2020

Research Solutions/Reprints Desk (NASDAQ: RSSS), a pioneer in providing cloud-based workflow solutions for R&D driven organizations, today announced that it has partnered with BIO Business Solutions to help life sciences companies save time and money on scholarly literature access via its award-winning Article Galaxy research platform. Operated by the Biotechnology Innovation Organization (BIO), BIO Business Solutions is the industry's largest cost savings purchasing program. More than 4,500 member companies worldwide—including biotechnology and biopharmaceutical firms, medical device firms, academic institutions, state biotechnology centers, and related organizations—together save more than $511 million annually through the BIO Business Solutions® program.

Read More

MEDTECH

CellCarta expands its biomarker capabilities for clinical trials by adding Olink technology to its global services

CellCarta | September 01, 2021

CellCarta and Olink Proteomics AB announced today a strategic collaboration to offer Olink® Target 96 & Target 48 to pharmaceutical and biotech customers, advancing targeted protein biomarker quantification in clinical studies. CellCarta is a global leader in precision medicine and with more than 20 years of experience in mass spectrometry the company continues to invest in the field of proteomic biomarkers to better understand diseases and support therapeutic development projects. With the acquisition of the first Olink® Signature Q100 instruments and the collaborative support of Olink, CellCarta becomes the first global clinical CRO to offer the technology. "Complementing our mass spectrometry platforms with the Proximity Extension Assay (PEA) technology from Olink will allow us to support our clients with comprehensive proteomic services for their clinical studies. As the translational medicine community is turning to multi-omic analysis to address challenging questions in therapeutic development, we see Olink coupling with our other platforms (immune monitoring, histopathology, genomics) to create additional value for our clients." said Nick Wright, President and Global COO of CellCarta. The Olink platform offers an unmatched high-multiplex technique to quantify protein biomarkers using minimal clinical sample volume, with exceptional sensitivity and specificity, while covering a broad dynamic range. Differing from other multiplex protein detection platforms, Olink's PEA technology provides high specificity by avoiding cross-reactivity binding or interference at signal readout with its dual recognition approach with matched pairs of antibodies labeled with complementary DNA oligos. Olink fills the need for a robust technology that elevates clinical proteomics and is a must in a field driven by low abundant biomarkers, such as immuno-oncology. Through this collaboration, CellCarta will bring the Q100 platform into its CAP/CLIA laboratories to address the need for proteomic biomarkers for clinical trials and support multi-omics analysis with its CellEngineTM software. CellCarta's global footprint, with sites in the US, Canada, Belgium, Australia, and China, will allow for rapid deployment of the platform and support clients in their global clinical programs. "We are excited to enter this strategic collaboration with CellCarta to broaden the access to our protein biomarker solutions. CellCarta is well positioned in the pharma services market as a leading specialty CRO and is a logical choice for this collaboration to elevate the analysis of proteomic biomarkers in clinical trials specimens. Enabling proteomic analysis along with other key technologies in clinical biomarker programs will increase their value and achieve insights which only true multi-omic analyses can provide", said Jon Heimer, CEO of Olink Proteomics. About Olink Olink Holding AB (publ) (Nasdaq: OLK) is a company dedicated to accelerating proteomics together with the scientific community, across multiple disease areas to enable new discoveries and improve the lives of patients. Olink provides a platform of products and services which are deployed across major biopharmaceutical companies and leading clinical and academic institutions to deepen the understanding of real-time human biology and drive 21st century healthcare through actionable and impactful science. The company was founded in 2016 and is well established across Europe, North America and Asia. Olink is headquartered in Uppsala, Sweden About CellCarta CellCarta is a leading provider of specialized precision medicine laboratory services to the biopharmaceutical industry. Leveraging its integrated analytical platforms in immunology, histopathology, proteomics and genomics, as well as related specimen collection and logistics services, CellCarta supports the entire drug development cycle, from discovery to late-stage clinical trials. The company operates globally with 10 facilities located in Canada, USA, Belgium, Australia, and China.

Read More