Seattle Genetics Announces Clinical Hold on Several Phase 1 Trials of Vadastuximab Talirine (SGN-CD33A)

Seattle Genetics | December 27, 2016

Seattle Genetics, Inc. (Nasdaq:SGEN), a global biotechnology company, today announced that it has received notice from the U.S. Food and Drug Administration (FDA) that a clinical hold or partial clinical hold has been placed on several early stage trials of vadastuximab talirine (SGN-CD33A) in acute myeloid leukemia (AML)

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Genetic testing uses laboratory methods to look at your genes, which are the DNA instructions you inherit from your mother and your father. Genetic tests may be used to identify increased risks of health problems, to choose treatments, or to assess responses to treatments.


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INDUSTRIAL IMPACT

Moderna and Thermo Fisher Scientific Announce Long-Term Strategic Collaboration

Moderna, Inc. | February 24, 2022

Moderna, Inc. a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, and Thermo Fisher Scientific Inc. the world leader in serving science, today announced a 15-year strategic collaboration agreement to enable dedicated large-scale manufacturing in the U.S. of Spikevax®, Moderna’s COVID-19 vaccine, and other investigational mRNA medicines in its pipeline. “Thermo Fisher continues to be a trusted partner, bringing a full range of products and services that have enabled us to deliver innovative medicines at an unprecedented speed and scale. We are pleased to further expand our collaboration with Thermo Fisher as a long-term manufacturing partner that will enable us to continue to build on our mRNA platform and pipeline.” Juan Andres, Moderna's chief technical operations and quality officer Over the past several years, Thermo Fisher has been partnering with Moderna to support its development pipeline with both clinical research and contract manufacturing services. This included the quick scale-up of aseptic fill-finish services and packaging of its COVID-19 vaccine. As part of this expanded agreement, Thermo Fisher will now provide dedicated capacity for a range of aseptic fill-finish services including lyophilized and liquid filling. In addition, the company will provide inspection, labeling and final packaging services. "Moderna’s innovation in mRNA technology has been pivotal in the global response to the pandemic and we are proud and privileged to support Moderna over the last decade,” said Michel Lagarde, executive vice president and chief operating officer of Thermo Fisher Scientific. “In expanding our strategic partnership, Moderna will further leverage our scale and depth of capabilities to continue to transform its mRNA platform and bring new breakthrough medicines to patients around the world." About Moderna In 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA) to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use of one of the earliest and most-effective vaccines against the COVID-19 pandemic. Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and auto-immune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. About Thermo Fisher Scientific Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

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RESEARCH

Lunaphore and Indica Labs announce partnership to provide complete technology solution for spatial biology and image analysis

Indica Labs | May 13, 2022

Lunaphore, a Swiss life sciences company developing technology to enable spatial biology in every laboratory, and Indica Labs, a leading provider of computational pathology software and services, today announced a partnership to co-market an end-to-end solution that combines Lunaphore's flagship COMET™ spatial biology platform and Indica's HALO® and HALO AI™ digital pathology image analysis software. Lunaphore's COMET™ platform provides superior multiplex staining and image acquisition capabilities facilitating the automated detection of up to 40 separate spatial markers per tissue slide without human intervention. In contrast to other spatial biology solutions, COMET™ works with off-the-shelf, label-free antibodies and is designed to provide researchers with flexibility for their workflow. COMET™ has a wide range of research applications across immuno-oncology, neuroscience, and infectious diseases. Indica Labs' industry-leading HALO® and HALO AITM software enable fast, AI-based quantitative analysis of whole slide images. In combination with the COMET™ platform, the HALO Highplex FL module allows researchers to quantify an unlimited number of fluorescent markers and cell phenotypes defined by their biomarker expression. HALO Spatial Analysis and HALO AI deep learning classifiers are used in combination with Highplex FL to explore the distribution and spatial relationships between different cell phenotypes in the context of the tissue, such as tumor and immune cells. This additional spatial data is particularly important in immuno-oncology and neuroscience disease research. We are excited to partner with Lunaphore to address the growing needs of our research customers for highly multiplexed assays, Combining Lunaphore's superior multiplexing technologies upstream with our powerful AI-based analysis downstream, together we provide a streamlined workflow for high dimensional imaging and image analysis." Steven Hashagen, CEO of Indica Labs. Our partnership with Indica Labs is another key aspect of our strategy to combine our COMET™ technology with industry-leading image analysis technologies, Indica Labs' solutions are used by a large set of researchers in the field, thanks to their ease of use and analysis capabilities. Combining Indica's solutions with the class-leading capabilities of COMET™ will help us pursue our shared goal of making tissue image analysis easier and more accessible to labs around the world." Deborah Heintze, Chief Marketing Officer of Lunaphore. About Lunaphore Lunaphore Technologies S.A. is a Swiss company born in 2014 with the vision of enabling spatial biology in every laboratory. Lunaphore has developed a game-changing chip technology which can extract spatial proteomic and genomic data from tumors and transform any simple assay into multiplex spatial biology without complexity. Lunaphore empowers researchers to push the boundaries of research to ultimately develop the next generation personalized therapies. About Indica Labs Indica Labs is the world's leading provider of computational pathology software and image analysis services. Our flagship HALO® and HALO AI™ platform facilitates quantitative evaluation of digital pathology images. HALO Link™ facilitates research-focused image management and collaboration while HALO AP® enables collaborative clinical case review. Our Pharma Services team leverages all our image analysis platforms to partner with you to advance tissue-based research, clinical trials, and diagnostics.

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DIAGNOSTICS

RQ Bio Launches with Goal to Transform Treatment and Prevention of Viral Infectious Diseases Through Antibody Technologies

RQ Bio | May 17, 2022

RQ Bio today emerges from stealth mode announcing its launch as a new UK-based biotechnology company following the completion of a successful licensing deal with AstraZeneca for RQ Bio's existing mAbs against SARS-CoV-2. The Company, which is headquartered in London, is dedicated to developing treatments and preventative therapies based on potent broad-spectrum mAbs to provide instant and long-lasting immunity for vulnerable people at risk of severe disease or death from existing, emerging and new viral infections. To maximise and accelerate patient impact, the company will continue to be supported by its collaborations with its scientific co-founders, the University of Oxford and leading UK medical research charity LifeArc. Professor Gavin Screaton, Head of the Medical Sciences Division at the University of Oxford, will continue to advise in his capacity as scientific and medical co-founder, as will Clare Terlouw, Head of LifeArc Ventures and UK BIA board member, as a member of the Board of Directors. Our vision is to build on our successful debut with neutralising antibody therapy for SARS-CoV-2 and develop innovative medicines to address current and evolving unmet needs in other viral infectious diseases, By combining our expertise and innovative excellence in core areas we have created a smarter approach to antibody generation making us uniquely positioned to deliver fast patient impact." Hugo Fry, CEO of RQ Bio. LifeArc is committed to backing leading UK academics and scientists, and we were inspired to fund RQ Bio because of the exceptional group of founders who are so passionately dedicated to finding new treatments and preventative therapies in areas of high unmet patient need, LifeArc provided support from across the Charity, including the venture team, scientific labs and other in-house experts to help RQ Bio execute on its business plan, and we look forward to further supporting RQ Bio as it becomes a world-leading infectious disease company." Clare Terlouw, Head of LifeArc Ventures. About RQ Bio RQ Bio's mission has been to develop medicines based on potent broad-spectrum mAbs to provide instant and long-lasting immunity for vulnerable people at risk of severe disease or death from current and future variants of viral infections. RQ Bio has achieved this by combining innovative excellence in core areas to create a smarter approach to antibody generation. RQ Bio has multiple sources of leads and a deep collaboration with the University of Oxford. RQ Bio was founded by scientific experts previously involved with the UK BIA Antibody Taskforce, which worked to build a community of infectious disease antibody experts focussed on the development of rapid and efficient delivery of highly potent neutralising antibodies to help support the UK COVID-19 response. About AstraZeneca Licensing Deal Under the terms of the agreement, RQ Bio has granted AstraZeneca an exclusive worldwide licence to develop, manufacture and commercialise RQ Bio's exisiting early stage mAbs against SARS-CoV-2 and a right of first refusal to take an exclusive licence in respect of any additional mAbs against SARS-CoV-2. RQ Bio will receive upfront and milestone payments of up to $157 million and will be eligible to receive single digit royalties on sales. The successful licensing deal was supported by Oxford University Innovation (OUI), a wholly-owned subsidiary of the University of Oxford that manages the University's technology transfer and consulting activities, who worked efficiently and creatively with all parties on the corresponding technology licences and the filing of intellectual properties.

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MEDICAL

ImmunoTek Bio Centers First to Launch VeinViewer® Technology for Plasma Donations

ImmunoTek Bio Centers | April 27, 2022

Donating plasma is now easier, thanks to a smart new tool allowing technicians to see the map of veins inside a plasma donor's arm. ImmunoTek Bio Centers proudly announces its two divisions – ImmunoTek Plasma and Freedom Plasma – are the first blood plasma collection centers to use this groundbreaking technology. The VeinViewer®, developed by Christie Medical Holdings, has had great success in hospitals and medical clinics, and recently in pilot programs with ImmunoTek. Using the VeinViewer® in a plasma donation setting provides phlebotomists with real-time images of the donor's veins before needle insertion. The VeinViewer® uses direct projection vein illumination to identify vein patterns and display them on a patient's skin. As part of plasma donation, a needle is inserted into the donor's arm to withdraw blood that is then separated into individual parts during a process called plasmapheresis. Being able to easily see where the donor's veins are located helps phlebotomists as they insert the needle to begin the process. Our technicians found that using the VeinViewer® provides a clear look at a donor's veins before the needle is inserted. The ability to see this image increases their accuracy, makes the donation process faster, and reduces the likelihood of reinserting the needle, We are proud to be the first plasma collection company to offer this next-level service for our donors." Blair McKinney, Chief Operating Officer of ImmunoTek Bio Centers. We are delighted ImmunoTek selected Christie's leading vascular visualization technology to aid in establishing a comfortable environment and efficient encounter for donors." Paul Damiani, Christie Medical Holdings, Inc President. ImmunoTek has created an unparalleled donation ambiance and we look forward to integrating the unmatched VeinViewer for an even better donor experience." Lisa Kaufman, Vice President at Christie. The United States provides 2/3 of the world's supply of plasma, which is used to make critical life-saving medicines and plasma-based therapies. Blood plasma is in great demand and the need for it increases 6-8 percent yearly. Increasing plasma donations helps meet the need for plasma around the world. ABOUT IMMUNOTEK BIO CENTERS, LLC ImmunoTek Bio Centers LLC is the fastest-growing independent plasma collection center operator in the United States and is a global leader in developing a reliable plasma supply chain for biotech companies. Since its inception in 2013, ImmunoTek has built and operated more than 50 plasma collection centers, most of which are or are in the process of becoming FDA-licensed and EU-certified, with nearly 40 additional centers in progress. ABOUT CHRISTIE MEDICAL HOLDINGS, INC. Christie Medical Holdings is a medical device manufacturer based in Lake Mary, FL, USA. Our market-leading, VeinViewer® Vision2 and Flex systems, are near-infrared, vascular imaging devices that allow clinicians to clearly see accessible vasculature as a real-time HD image, projected directly on the surface of the patient's skin. Since its invention, VeinViewer has transformed over the years into the current innovative models found in over 50 countries to accurately and safely illuminate veins up to 10 mm deep. It is the only vein finder of its kind that can positively impact the entire Pre-, During- and Post-access procedure through proven clinical and cost-saving results.

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Spotlight

Genetic testing uses laboratory methods to look at your genes, which are the DNA instructions you inherit from your mother and your father. Genetic tests may be used to identify increased risks of health problems, to choose treatments, or to assess responses to treatments.

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