Bio Pharma Dive
JANUARY 28, 2022
The biotech will sell the roughly 50% stake it holds in a biosimilars joint venture to Samsung Biologics for as much as $2.3 billion — cash that analysts expect the drugmaker to invest in M&A.
Pharma Mirror
JANUARY 28, 2022
Singapore, Asia’s integrated healthcare company, Clearbridge Health Limite is pleased to announce that Labnovation Technologies, Inc.’s (“Labnovation”) COVID-19 Antigen Rapid (“ART”) Test Kit, which is imported by Clearbridge and registered for use in the Philippines, has been recently approved by the Food and Drug Administration (“FDA”) of the Philippines for self-testing.
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Bio Pharma Dive
JANUARY 28, 2022
The partners pulled their request after disagreeing with the FDA on post-approval studies for their immunotherapy Libtayo in cervical cancer. Incyte made a similar decision earlier this week.
pharmaphorum
JANUARY 28, 2022
Merck & Co has passed another milestone in its drive to move PD-1 inhibitor Keytruda earlier in the treatment pathway for cancer, with the European Commission approving use of the drug as post-surgery (adjuvant) therapy for renal cell carcinoma (RCC). Adjuvant treatment moves use of the drug into patients with earlier-stage cancer, a key strategy for Merck and other cancer immunotherapy companies as it expands the pool of patients eligible for treatment.
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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud
XTalks
JANUARY 28, 2022
Immunocore, a commercial-stage biotechnology company developing T cell receptor (TCR)-based immunotherapies in oncology, autoimmune and infectious diseases, has won approval from the US Food and Drug Administration (FDA) for its novel immunotherapy Kimmtrak (tebentafusp-tabn), making it the first approved treatment for unresectable or metastatic uveal melanoma and first TCR therapeutic to receive regulatory approval.
BioPharma Reporter
JANUARY 28, 2022
Cryoport, Inc. has entered into a partnership with specialized Belgian CDMO, Cell Matters, to deliver end-to-end cryopreservation services for leukapheresis derived therapies supporting both autologous and allogeneic cell therapies.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Scienmag
JANUARY 28, 2022
ATLANTA—An influenza vaccine administered through the nose and constructed with nanoparticles that enhance immune response offers strong protection against different influenza virus strains, according to researchers in the Institute for Biomedical Sciences at Georgia State University. Credit: Georgia State University ATLANTA—An influenza vaccine administered through the nose and constructed with nanoparticles that enhance immune response offers strong […].
Pharma Times
JANUARY 28, 2022
Collaboration of big hitters and introduction of innovation sparks pioneering HIV vaccination trial
Scienmag
JANUARY 28, 2022
Tokyo, Japan – Researchers from Tokyo Metropolitan University have succeeded in using nanowires of a transition-metal chalcogenide to make atomically thin “nanoribbons”. Bundles of nanowires were exposed to a gas of chalcogen atoms and heat which helped merge the threads into narrow strips. Nanoribbons are highly sought after for sophisticated electronic devices; given the scalability of […].
Pharma Times
JANUARY 28, 2022
Gene luminaries Oxford Biomedica reach agreement with Homology Medicines to develop super group
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Scienmag
JANUARY 28, 2022
Researchers from KTH Royal Institute of Technology and Stanford University have fabricated a material for computer components that enable the commercial viability of computers that mimic the human brain. Credit: Mahiar Hamedi Researchers from KTH Royal Institute of Technology and Stanford University have fabricated a material for computer components that enable the commercial viability of […].
Drug Channels
JANUARY 28, 2022
Today’s guest post comes from Fiza Bari, Senior Solutions Consultant and GTM Liaison at MMIT. Fiza discusses the impending influx of biosimilars and its effect on manufacturers, specifically in the immunology space. To learn more, sign up for MMIT’s Immunology Biosimilars webcast. It's a moderated discussion with payers on how the changing market might impact their management strategies in immunology.
Scienmag
JANUARY 28, 2022
Credit: Image credit: ESA/Hubble & NASA, J. Dalcanton, Dark Energy Survey, U.S. Department of Energy (DOE), Fermilab (FNAL), Dark Energy Survey Camera (DECam), Cerro Tololo Inter-American Observatory (CTIO), NoirLab/National Science Foundation/AURA, European Southern Observatory (ESO); Acknowledgment: J. Schmidt.
pharmaphorum
JANUARY 28, 2022
Eli Lilly has said it is seeking permission to build a new biopharmaceutical manufacturing facility in Ireland that will be used to produce active ingredients for its biologic medicines, including its new Alzheimer’s candidates. The pharma group has said the total investment in the proposed facility in Limerick would be more than €400 million ($445 million), and could create 300 jobs at the plant itself, with another 500 positions required while it is under construction.
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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.
Scienmag
JANUARY 28, 2022
DURHAM, N.C. – If you had to guess which part of the world has the highest levels of atmospheric mercury pollution, you probably wouldn’t pick a patch of pristine Amazonian rainforest. Yet, that’s exactly where they are. Credit: Melissa Marchese DURHAM, N.C. – If you had to guess which part of the world has the […].
pharmaphorum
JANUARY 28, 2022
The failure of the European Commission to locate text messages between its president Ursula von der Leyen and Pfizer chief executive Albert Bourla on procurement of COVID-19 vaccine has earned a rebuke from the EU Ombudsman. The messages were requested via a freedom if information request by journalist Alexander Fanta of netzpolitik.org, who was following up an article in the New York Times last year which suggested “personal diplomacy” had played a big part in the EU’s order f
Scienmag
JANUARY 28, 2022
Humans experience the world in three dimensions, but a collaboration in Japan has developed a way to create synthetic dimensions to better understand the fundamental laws of the Universe and possibly apply them to advanced technologies. Credit: Yokohama National University Humans experience the world in three dimensions, but a collaboration in Japan has developed a […].
Outsourcing Pharma
JANUARY 28, 2022
A representative from IQVIA discusses the particulars of the US agencyâs new draft document and shares what it might mean for clinical trial data evaluation.
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This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.
Scienmag
JANUARY 28, 2022
Three scientists from the Department of Energy’s Oak Ridge National Laboratory have been elected fellows of the American Association for the Advancement of Science, or AAAS, the world’s largest general scientific society and publisher of the Science family of journals. Credit: Laddy Fields/ORNL, U.S. Dept. of Energy Three scientists from the Department of Energy’s Oak […].
Drug Patent Watch
JANUARY 28, 2022
Annual Drug Patent Expirations for BRAFTOVI Braftovi is a drug marketed by Array Biopharma Inc and is included in one NDA. It is available from one supplier. There are thirteen…. The post New patent for Array Biopharma drug BRAFTOVI appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
JANUARY 28, 2022
Scientists repeatedly check the weather forecasts as they prepare aircraft for flight and perform last-minute checks on science instruments. There’s a large winter storm rolling in, but that’s exactly what these storm-chasing scientists are hoping for. Credit: NASA Scientists repeatedly check the weather forecasts as they prepare aircraft for flight and perform last-minute checks on […].
Drug Patent Watch
JANUARY 28, 2022
Annual Drug Patent Expirations for XARELTO Xarelto is a drug marketed by Janssen Pharms and is included in one NDA. It is available from three suppliers. There are four patents…. The post New patent for Janssen Pharms drug XARELTO appeared first on DrugPatentWatch - Make Better Decisions.
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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
Scienmag
JANUARY 28, 2022
Ikoma, Japan – All-polymer blend solar cells are expected to play an important role in the transition to clean energy technologies because they can be easily produced in large-scale flexible sheets. However, their performance has lagged behind that of more traditional silicon alternatives, as well as other organic solar cells. Credit: Hiroaki Benten Ikoma, Japan […].
Drug Patent Watch
JANUARY 28, 2022
Annual Drug Patent Expirations for VALTOCO Valtoco is a drug marketed by Neurelis Inc and is included in one NDA. There are five patents protecting this drug. VALTOCO drug price…. The post New patent for Neurelis Inc drug VALTOCO appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
JANUARY 28, 2022
Oak Ridge National Laboratory employees received Department of Energy Secretary’s Honor Awards from Secretary of Energy Jennifer Granholm in January as part of project teams spanning the national laboratory system. Credit: Jaimee Janiga/ORNL, U.S. Dept. of Energy Oak Ridge National Laboratory employees received Department of Energy Secretary’s Honor Awards from Secretary of Energy Jennifer Granholm […].
Drug Patent Watch
JANUARY 28, 2022
Annual Drug Patent Expirations for NUBEQA Nubeqa is a drug marketed by Bayer Healthcare and is included in one NDA. It is available from one supplier. There are seven patents…. The post New patent for Bayer Healthcare drug NUBEQA appeared first on DrugPatentWatch - Make Better Decisions.
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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.
Scienmag
JANUARY 28, 2022
Credit: USC/USC/Ella Maru Studio Could a new paradigm in digital health treat blinding disorders and possibly also be a conduit for treating other parts of the brain? A multi-disciplinary team of world-renowned researchers at USC are exploring this exciting possibility. Building on decades of knowledge, the success of the world’s first FDA-approved retinal […].
Drug Patent Watch
JANUARY 28, 2022
Annual Drug Patent Expirations for BIJUVA Bijuva is a drug marketed by Therapeuticsmd Inc and is included in one NDA. It is available from one supplier. There are nineteen patents…. The post New patent for Therapeuticsmd Inc drug BIJUVA appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
JANUARY 28, 2022
Pioneering University of Limerick, Ireland professor of surgery sheds light on a new order in the abdomen Credit: Alan Place Pioneering University of Limerick, Ireland professor of surgery sheds light on a new order in the abdomen Press release (25/1/22) LIMERICK, IRELAND: A pioneering University of Limerick professor of surgery whose groundbreaking research led to […].
Drug Patent Watch
JANUARY 28, 2022
Annual Drug Patent Expirations for TYRVAYA Tyrvaya is a drug marketed by Oyster Point Pharma and is included in one NDA. There are five patents protecting this drug. This drug…. The post New patent for Oyster Point drug TYRVAYA appeared first on DrugPatentWatch - Make Better Decisions.
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The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.
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