Drug Approval Services
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Manufactured by Hebei Lingding Biotechnology Co., Ltd.based in CHINA
Minoxidil sulphate was the first drug approved by the FDA for the treatment of androgenetic alopecia (hair loss). Before that, minoxidil had been used as vasodilator drug prescribed as oral tablet to treat high blood pressure, with side effects that included hair growth and reversal of male baldness. In the 1980s, UpJohn Corporation came ...
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Manufactured by Quanterix Corporationbased in USA
With the Simoa Accelerator Laboratory as your pharma service technology solution of choice, you can expand the limits of biomarker exploration and dramatically accelerate the timeline to drug ...
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based in CANADA
and over-the-counter drug products approved for sale in ...
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Manufactured by Regis Technologies Inc.based in USA
Regulatory agencies have acknowledged impurities, especially potential genotoxic impurities (PGIs), as a high priority in the drug development approval process. Since impurities found in pharmaceutical drug substances can potentially exhibit pharmacological activity, there are reporting, identification, and qualification thresholds dictated by ...
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Manufactured by Emmaus Medical, Incbased in USA
of the agreement, Emmaus Life Sciences and Cellseed will conduct clinical trials to seek Food and Drug Administration approval for use by patients in the United States. ...
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Manufactured by Soteria Medical BVbased in NETHERLANDS
Prostate cancer is the most common cancer, other than non-melanoma skin cancer, and the second leading cause of cancer-related death in men in the United States. Prostate cancer incidence rates rose dramatically in the late 1980s, when screening with the prostate-specific antigen (PSA) test, which received initial U.S. Food and Drug ...
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Manufactured by BOC Sciencesbased in USA
Composed of an assortment of twenty-one libraries including FDA-approved drug library, natural product library, and anti-cancer compound library, among others, the bioactive screening libraries at BOC Sciences are ready-to-use chemical libraries for drug discovery, lab drug screening, drug target identification, ...
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Manufactured by SAGA Diagnostics ABbased in SWEDEN
gene mutations which arise randomly and due to environmental exposures. Increasingly, these mutations can be targeted by approved drugs as well as dozens of therapeutics currently in development around the ...
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by elminda Ltd.based in ISRAEL
CNS drugs exhibit the lowest approval success rates due to multiple challenges such as lack of efficacy in early and advanced stages of development, Poor target selection / engagement, poor translation from pre-clinical models and disease heterogeneity. BNA may contribute in CNS research and drug development by adding new objective ...
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based in USA
CureMatch provides a scored and ranked listing of the most well-adapted personalized medicine treatment options. The comprehensive analysis considers commonly used treatments, as well as targeted therapy, immunotherapy, hormone therapy, and newly approved oncology drugs. These options are presented either alone (monotherapy) or in ...
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Manufactured by Alfa Chemistrybased in USA
and Drug Administration (FDA) has approved ifosfamide only for testicular cancer. A study analyzed the therapy outcomes of 39 patients with testicular cancer who were treated with ifosfamide as a monotherapy from 1970-1977. The results showed that 16/39 patients (41%) were tumor-free after chemotherapy and operation and 6 of them survived for more than ...
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by Natera, Inc.based in USA
Why partner with Signatera for your clinical trial? Clinically validated across multiple solid tumors, Signatera has shown to predict relapse in >98% of patients without further treatment. Experienced team with Global reach: CE Mark, three FDA Breakthrough Device Designations, 8 Non-Significant Risk (NSR) determinations. >60 Natera IP assets covering ctDNA MRD and ...
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Manufactured by Cellworks Research India Private Limitedbased in
Accelerate drug development timelines, reduce risks and lower costs. Our biosimulation platform predicts human clinical response to investigational drug candidates YEARS earlier than traditional development ...
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based in GERMANY
The path to approval for generic topical products can be challenging. bioskin can help you to optimally plan and implement a development strategy: Vasoconstrictor assays according to FDA guidance: Bioequivalence of topical corticosteroids in Europe and the USA is assessed using the vasoconstrictor or human skin blanching assay as ...
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based in BELGIUM
Aiming at optimizing your clinical development strategy, our expert consultants develop the innovative strategies and capabilities needed to launch products with the greatest potential for commercial success and improved patient outcomes. ...
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based in GERMANY
Act beyond human and experimental limitations. Knowledge to advance game-changing therapies from idea to market. The world's biomedical knowledge at your fingertips. Reliable predictions to anticipate risks. Interlinked data to find new targets and design novel drugs. Real-world evidence to evaluate success. These capabilities ...
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Manufactured by Ascendia Pharmaceuticalsbased in USA
A 505(b)(2) drug development project represents a streamlined regulatory strategy for many pharmaceutical products today. The provisions of 505(b)(2) were created to avoid unnecessary duplication of studies already performed on a previously approved product. A 505(b)(2) new drug application contains full safety and effectiveness ...
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based in USA
Photodynamic therapy, also called PDT, is a cancer treatment that uses light energy to kill cancer cells. First, the doctor administers a photosensitizer, a type of drug that makes cells sensitive to certain wavelengths of light. Then the cancer cells are exposed to light, causing a reaction that kills cancer cells nearby. In clinical ...
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Manufactured by NeuroOne Medical Technologies Corporationbased in USA
Neurons communicate through electrical and chemical signals. The specific properties of the neurons composing a brain area and their connections with neurons in other brain areas, define the function of a brain area (e.g. language, vision, ...
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Manufactured by MedGenome Inc.based in USA
Profiling the Tumor Microenvironment: Using a genomics based approach to analyze the tumor microenvironment can provide unique insights beyond IHC and FACS methods. OncoPeptTUME deeply interrogates RNA-Seq data sets to produce high resolution mapping of the tumor microenvironment using proprietary cell type specific gene expression signatures. OncoPeptTUME provides a critical assessment of the ...
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