Advenchen Laboratories LLC

LAS VEGAS, Jan. 26, 2024 /PRNewswire/ -- The surge in colposcopy device demand is mainly driven by a growing incidence of cervical disorders like cervical cancer and inflammatory alterations in the vulva, vagina, and cervix. Additionally, factors such as heightened awareness of early diagnosis, a growing embrace of advanced technologies, continuous product introductions and approvals, among others, collectively contribute to the overall expansion of the colposcopy devices market anticipated between 2023 and 2028. DelveInsight's Colposcopy Devices Market Insights report provides the current and forecast market analysis, individual leading colposcopy devices companies' market shares, challenges, colposcopy devices market drivers, barriers, trends, and key market colposcopy devices companies in the market. Key Takeaways from the Colposcopy Devices Market Report As per DelveInsight estimates, North America is anticipated to dominate the global colposcopy devices market during the forecast period. Notable colposcopy devices companies such as McKesson Medical-Surgical Inc., ZEISS, Olympus America, MEDGYN PRODUCTS, INC., Liger Medical, LLC., DYSIS Medical Inc, ATMOS MedizinTechnik GmbH & Co. KG, Ecleris, Optomic, Seiler Instrument Inc., Karl Kaps GmbH & Co. KG, Narang Medical Limited., SCHMITZ, Lutech, Centrel, Hunan Fude Technology Co., Ltd., Kernel Medical Equipment Co., Ltd., Delmont imaging, Biomedicinos, SCANER Science & Engineering center, and several others, are currently operating in the colposcopy devices market. In August 2021, DYSIS Medical Inc. launched DYSIS View, a compact and portable colposcope, which includes the company's innovative computer-aided cervical mapping technology that helps healthcare professionals detect cervical lesions more clearly. In April 2021, Liger Medical, LLC received FDA approval for IRIS Thermocoagulator and Digital Colposcope device. The device is intended for the destruction of human tissue with high temperatures by tissue contact with an electrically heated probe, and to provide magnified visualization of the tissues of the vagina, cervix, and external genitalia to aid in selecting areas for biopsy and diagnosing abnormalities as needed for a colposcopy exam. To read more about the latest highlights related to the colposcopy devices market, get a snapshot of the key highlights entailed in the Global Colposcopy Devices Market Report Colposcopy Devices Overview Colposcopy devices play a crucial role in the field of gynecology and women's health by providing a detailed and magnified examination of the cervix, vagina, and vulva. These specialized instruments are employed to investigate and diagnose abnormalities, such as cervical dysplasia or cancerous lesions, that may not be easily visible to the naked eye. During a colposcopic examination, a colposcope—an illuminated, binocular microscope—is used to magnify the cervical tissues, allowing healthcare professionals to detect any irregularities and take targeted biopsies if necessary. Additionally, colposcopy devices often incorporate advanced features, such as digital imaging and video capabilities, enhancing documentation and communication among healthcare providers. This non-invasive and highly effective diagnostic technique serves as a vital tool in the early detection and management of various gynecological conditions, ultimately contributing to improved outcomes for women's health. Colposcopy Devices Market Insights In 2022, North America dominated the colposcopy devices market, primarily due to the increasing incidence of cervical cancer and other factors. The region benefits from a robust healthcare infrastructure, a surge in product launches and approvals, and growing regulatory support for new healthcare products. As the prevalence of cervical cancer rises, there is a heightened demand for colposcopes, driving colposcopy devices market growth. The need for colposcopes is expected to escalate as more individuals undergo cervical cancer screening, necessitating investments by healthcare institutions to ensure swift and accurate diagnoses. The North American government has implemented initiatives to address cervical cancer, expanding insurance coverage for cervical screening examinations, particularly for low-income women. Efforts are also underway to integrate HPV vaccines into federal programs, further contributing to insurance coverage. These collective factors create a conducive environment for the growth of the colposcopy devices market in North America. To know more about why North America is leading the market growth in the colposcopy devices market, get a snapshot of the Colposcopy Devices Market Outlook Colposcopy Devices Market Dynamics The colposcopy devices market is experiencing a positive surge in product demand due to several factors, with a notable factor being the rise in cervical cancer cases. Additionally, there is an increasing demand for advanced colposcopy instruments to support treatments as healthcare professionals and patients become more aware of the benefits of minimally invasive procedures. These instruments often incorporate cutting-edge technology such as advanced optics and high-resolution imaging systems, enhancing visualization and accuracy during colposcopy examinations. The necessity for such devices is motivated by the goal of improving diagnostic precision, ensuring patient comfort, and enabling early detection of cervical anomalies. Consequently, the growing awareness of minimally invasive diagnostics is expected to drive the demand for colposcopy devices in the forecast period. Furthermore, the colposcopy devices market is likely to be influenced by increasing research and developmental activities, product launches, approvals, and other strategic initiatives. Nevertheless, challenges such as patient discomfort and anxiety during colposcopy examinations, the high costs associated with colposcopy devices and procedures, and other factors may impede the growth of the colposcopy devices market. Get a sneak peek at the colposcopy devices market dynamics @ Colposcopy Devices Market Dynamics Analysis Colposcopy Devices Market Assessment Colposcopy Devices Market Segmentation Colposcopy Devices Market Segmentation By Product: Optical and Digital Colposcopy Devices Market Segmentation By Portability: Stationary and Handheld Colposcopy Devices Market Segmentation By End User: Hospitals, Ambulatory Surgical Centers, and Others Colposcopy Devices Market Segmentation By Geography: North America, Europe, Asia-Pacific, and Rest of World Porter's Five Forces Analysis, Product Profiles, Case Studies, KOL's Views, Analyst's View Which MedTech key players in the colposcopy devices market are set to emerge as the trendsetter explore @ Colposcopy Devices Companies Table of Contents Interested in knowing the colposcopy devices market by 2028? Click to get a snapshot of the Colposcopy Devices Market Trends Related Reports Womens Health Market Womens Health Market Insights, Epidemiology, and Market Forecast – 2028 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key women's health companies including AbbVie Inc., Abbott, Eli Lilly and Company, Agile Therapeutics®, Willow Innovations, Inc., Pfizer Inc., LUPIN, AstraZeneca, Torrent Pharmaceuticals Ltd., Bayer AG, Renovia Inc., Hologic, Inc, BD, Koninklijke Philips N.V., Danaher, The Feminina Group Inc., Chiaro Technology Ltd., Redcliffe Hygiene Private Limited, AceWin Co., Ltd., Pigeon Corporation, among others. 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Ovarian Cancer Pipeline Ovarian Cancer Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key ovarian cancer companies, including IMV, Elucida Oncology, Chia Tai Tianqing Pharmaceutical Group, Precigen, Inc, Glycotope GmbH, Sonnet Biotherapeutics, Allarity Therapeutics, Adimab, Mersana Therapeutics, Genentech, Genmab, Merck, OncoQuest, IMPACT Therapeutics, among others. Cervical Cancer Pipeline Cervical Cancer Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key cervical cancer companies, including Regeneron Pharmaceuticals, Jiangsu Hengrui Medicine, Akeso Biopharma, Celgene, MedImmune, Henlix Biotech, Zeria, Advaxis, Akeso Biopharma, AnGes, Advenchen Laboratories, Jiangsu Chia Tai Tianqing Pharmaceutical, Ono Pharmaceuticals, InnoMab, BeiGene, Agenus, Ludwig Institute for Cancer Research, EMD Serono, Merck, Apollomics, Immunitor, Genentech, among others. About DelveInsight DelveInsight is a leading Business Consultant, and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Contact Us Shruti Thakur [email protected] +91-9650213330 SOURCE DelveInsight Business Research, LLP

Pictured: The earth as seen from space/iStock, digitalmazdoor In November 2023, the FDA announced it was investigating the “serious risk” of malignancies in patients who have been treated with BCMA- or CD19-directed autologous CAR-T cell immunotherapies. The announcement has garnered attention from regulatory authorities and industry leaders in regions including South Korea, the EU and the U.K. Chimeric antigen receptor (CAR) T cell therapy was developed more than three decades ago by Carl June, an immunologist at the University of Pennsylvania who wanted to circumvent the adverse effects of bone marrow transplants used in treating blood cancers. Today, six CAR T cell therapies—Novartis’ Kymriah, Johnson & Johnson/Janssen’s Carvykti, Bristol Myers Squibb’s Abecma and Breyanzi and Gilead/Kite’s Tecartus and Yescarta—have been approved for various blood cancers and 217 more are in Phase II clinical trials and later stages of development for different cancers. All six approved therapies are covered under the FDA’s safety investigation. Tightening Global Regulations A European Medicines Agency (EMA) representative told BioSpace in an email that "a thorough review of all available evidence is ongoing" by the Pharmacovigilance Risk Assessment Committee (PRAC), an EMA arm that assesses and monitors medicines. “This includes the 23 cases of various types of T-cell lymphoma or leukemia that were present in EudraVigilance at the time of signal validation,” the representative said, adding that these cases overlap with ones reported to the FDA. In a statement emailed to BioSpace, Janine Jolly, deputy director of benefit/risk evaluation at the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA), said the regulator is aware that the FDA and the EMA’s PRAC are investigating a signal of serious risk of T-cell malignancy following treatment with BCMA-directed or CD19-directed autologous CAR T cell immunotherapies. She noted that secondary malignancies are considered a potential risk for products in this class. However, she said the MHRA “will consider this issue further and communicate any new advice to healthcare professionals and patients upon completion of our review.” An FDA representative told BioSpace in an email that while the potential risk of developing secondary malignancies is indeed labeled as a class warning in the U.S. prescribing information for approved CAR T cell immunotherapies, “the FDA’s safety communication describes reports specifically of T-cell malignancy.” Further east, South Korea announced in December 2023 that it is monitoring the side effects of the two CAR T cell therapies approved in that country, Kymriah and Carvykti. “The Korean regulatory agencies will now be more focused on receiving expansive data regarding malignancies as well,” said Sasmitha Sahu, a pharma analyst at GlobalData who covers immunology and oncology, in a GlobalData report. Sahu told BioSpace that South Korea’s Ministry of Food and Drug Safety (MFDS) appears to design its regulatory policies based on FDA guidelines. However, unlike in the U.S. and Europe, where there are observatory units for tracking CAR T cell therapy’s adverse effects, South Korea does not yet have such checkpoints in place because the medicines were recently approved in the country. “It is not clear what kind of active steps the South Korean agencies have taken, but they have definitely directed hospitals where these CAR T cell therapies are administered to closely track incidents or the appearance of secondary malignancies,” Sahu said. “The mandated monitoring of all the reporting of any suspected adverse reactions, including T-cell malignancies [and] adverse effects, may lead to the creation of a similar dedicated registry for patients who are administered CAR-T therapies.” The FDA requires 15 years of patient follow-up for all approved CAR-T therapies to monitor their long-term safety profile. Following the reports of T cell malignancies in patients who had previously received CAR-T therapies, the regulator recommended life-long surveillance. “Monitoring [CAR T cells] could slow down the regulatory enthusiasm across all the regions,” Sahu said. “It may prompt the need to do a cautious wait-and-watch approach and may elicit further changes in the regulatory approval process.” In an email to BioSpace, a representative for Gilead said, “We are confident in the overall benefit-risk pro both Yescarta and Tecartus, having treated 17,700 patients to date in both clinical trials and the commercial setting. There is no evidence to date that treatment with Yescarta or Tecartus has a causal role in the development of malignancies of T-cell origin.” In a similar vein, the FDA representative said, “The overall benefits of these products continue to outweigh their potential risks for their approved uses.” A global group of cancer and cell therapy leaders concluded the same in a commentary recently published in Nature, while stressing that more information is needed. Perception: Pros and Cons Shriya Das, a biotech professional who managed one of Advenchen Laboratories’ Phase I and II oncology clinical trials in South Korea and Japan, said that while current clinical trials will go ahead as planned, it may take longer to fill them. “Everybody reads newspapers, everybody is aware of what's happening. Recruitment could slow down because patients and potential participants could get a scare about trying a new investigational treatment.” Das additionally noted that the therapies will face stronger scrutiny by regulatory authorities moving forward. However, she said, even if the FDA does find concerning evidence, the investigation could provide valuable data and insights for developing more-effective and safer treatments, ultimately leading to better patient outcomes. Another benefit of the FDA’s investigation is that it will build the public’s confidence in regulatory authorities, Das said, as patients will see that medicines are still monitored after approval. Patience Asanga is a Nigeria-based freelance science journalist who writes about the environment, biotechnology and life sciences.

DUBLIN, July 14, 2023 /PRNewswire/ -- The "Leiomyosarcoma - Pipeline Insight, 2023" clinical trials has been added to ResearchAndMarkets.com's offering. "Leiomyosarcoma - Pipeline Insight, 2023" report provides comprehensive insights about 10+ companies and 10+ pipeline drugs It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. The companies and academics are working to assess challenges and seek opportunities that could influence Leiomyosarcoma R&D. The therapies under development are focused on novel approaches to treat/improve Leiomyosarcoma. Leiomyosarcoma Emerging Drugs Chapters This segment of the Leiomyosarcoma report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases. Leiomyosarcoma: Pipeline Development Activities The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Leiomyosarcoma therapeutic drugs key players involved in developing key drugs. Pipeline Development Activities The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Leiomyosarcoma drugs. Leiomyosarcoma Emerging Drugs ADI PEG20: Polaris Group ADI-PEG 20 is a first-in-class therapeutic approach to deplete arginine and starve cancer cells. Because arginine is one of the 20 amino acids that are essential for protein synthesis and survival of cells, some cancer cells become dependent upon the external supply of arginine to survive and grow. ADI-PEG 20 is designed to deplete the external supply of arginine, which causes arginine-dependent cancer cells to die while leaving the patient's normal cells unharmed. Currently, it is in Phase III stage of clinical trial evaluation to treat Leiomyosarcoma. AL-3818: Advenchen Laboratories AL3818 is a novel small molecule PTK inhibitor being developed by Advenchen Laboratories. Advenchen Laboratories is conducting a Phase III study to evaluate the safety and efficacy of AL3818 (anlotinib) hydrochloride in the treatment of metastatic or advanced alveolar soft part sarcoma (ASPS), leiomyosarcoma (LMS), and synovial sarcoma (SS). Leiomyosarcoma: Therapeutic Assessment This segment of the report provides insights about the different Leiomyosarcoma drugs segregated based on following parameters that define the scope of the report, such as: Phases Late stage products (Phase III) Mid-stage products (Phase II) Early-stage product (Phase I) along with the details of Pre-clinical and Discovery stage candidates Discontinued & Inactive candidates Route of Administration Products have been categorized under various ROAs such as Oral Parenteral intravenous Subcutaneous Topical. Molecule Type Products have been categorized under various Molecule types such as Monoclonal Antibody Peptides Polymer Small molecule Gene therapy Product Type Leiomyosarcoma Report Assessment Pipeline Product Profiles Therapeutic Assessment Pipeline Assessment Inactive drugs assessment Unmet Needs Key Players Merck Advenchen Laboratories Trillium Therapeutics PTC Therapeutics PharmaMar Philogen EMD Serono Incyte Corporation Clovis Oncology, Inc. Key Products Avelumab AL3818 Pembrolizumab TTI-621 PTC596 ET-743 L19-hTNF M6620 Itacitinib Rucaparib For more information about this clinical trials report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets