Drug Designation Equipment
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by Vybionbased in USA
INT41 has received Orphan Drug Designation from the FDA for Huntington’s disease. IND enabling studies for INT41 Gene Therapy for Huntington’s disease are in place following a preIND meeting with the FDA in in February 2022 in response to the briefing book prepared by our consultants at Latham BioPharm, a world class consulting ...
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Manufactured by Confo Therapeuticsbased in BELGIUM
With its unique antibody-based technology, Confo Therapeutics aims to overcome the current limitations of GPCR drug discovery in order to fully realize the potential of GPCRs as drug ...
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PremiumManufactured by Powder Systems Limited (PSL)based in UNITED KINGDOM
The MSR™ MicroSphere Refiner is a cGMP piece of equipment that allows drug developers and manufacturers to complete a wide range of aseptic processes with their microspheres at various scales. It is a one-of-its-kind solution has been developed and refined over decades following a Quality-by-Design (QbD) approach, taking into ...
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PremiumManufactured by Powder Systems Limited (PSL)based in UNITED KINGDOM
The LabMSR system is a GLP piece of equipment that has been developed to enable global drug manufacturers to generally replicate, at R&D scale, some of the process benefits of PSL’s full scale production MicroSphere Refiners (MSR). Due to their characteristics and properties, polymeric microspheres have traditionally been ...
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based in ITALY
The PPI-FIT (Pharmacological Protein Inactivation by Folding Intermediate Targeting) technology, of which Sibylla is the exclusive licensee, is a paradigm shift in rational drug design. The basic task of drug design is to find a small molecule able to bind a biological target -such as a protein- so to modulate or block its ...
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Manufactured by Tonix Pharmaceuticals Holding Corp.based in USA
TNX-2900, Tonix’s proprietary potentiated intranasal oxytocin is in the pre-Investigational New Drug (IND) stage as a candidate for the treatment of Prader-Willi syndrome (PWS) and non-organic failure to thrive disease. TNX-2900 has been granted Orphan Drug Designation (ODD) in the US by the FDA for the treatment of ...
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based in TAIWAN
encapsulation may be the key to generating an entirely new type of therapy. By incorporating careful attention to delivery characteristics from the earliest stages of drug design, TLC can expand possibilities for molecules that could lead to an effective therapy. TLC388, currently in development for indications within oncology, is an example of a ...
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Manufactured by Notitia Biotechnologiesbased in USA
NM108 is an investigational botanical drug that is designed to treat diseases by promoting the growth of either the existing or replenished Foundation Guild™ bacteria in a patient's gut microbiome. NM108 is currently in phase 2 trial as well as available for Expanded Access (compassionate ...
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Manufactured by Vivesto ABbased in SWEDEN
of adult patients with first relapse of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer. Apealea has also received orphan drug designation from the US regulatory authority FDA for the treatment of epithelial ovarian cancer, which could entail several potential benefits, including seven years of ...
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Manufactured by Alfa Chemistrybased in USA
Introducing fluorine atom(s) into bioactive organic compounds has become a leading strategy for drug design and lead optimization. In drug synthesis strategy, fluorine is frequently employed to modify biologically relevant properties such as metabolic stability, basicity, lipophilicity and bioavailability. Additionally, the binding ...
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Manufactured by Notitia Biotechnologiesbased in USA
BM306 is an investigational live biotherapeutic product that contains the Foundation Guild™ bacteria in a defined consortium. This investigational drug is designed to treat diseases by replenishing the missing or extinct Foundation Guild™ bacteria in a patient's gut ...
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Manufactured by Wuhan HSD Technology Development Co., Ltdbased in CHINA
Phenylpiracetam hydrazide, also known as fonturacetam hydrazide, is a designer drug that is a derivative of phenylpiracetam in which the amide group is replaced with a hydrazide group. It was first reported by a Russian research group in 1980 as part of a series of chemical compounds investigated as anticonvulsants. In an electroshock ...
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Manufactured by Cellphire Therapeutics, Inc.based in USA
. Thrombosomes has also been given orphan drug designation for the treatment of Acute Radiation Sickness by the U.S. Food and Drug ...
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Manufactured by Rea Tapebased in SOUTH KOREA
THIN GENTLE SILKY FABRICs: REA Tape Premium is made from 100% rayon. LATEX FREE: Is 100% latex free. DRUG FREE: Is 100% free from any medical substances or pharmaceutical drugs. HYPOALLERGENIC: Is designed to minimize the possibility of an allergic response. BREATHABLE: Allows freely for the passage of air and moisture. JAPANESE MEDICAL GLUE: ...
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Manufactured by Rea Tapebased in SOUTH KOREA
100% PURE COTTON: Is made from 100% pure natural cotton fibers. LATEX FREE: Is 100% latex free. DRUG FREE: Is 100% free from any medical substances or pharmaceutical drugs. HYPOALLERGENIC: Is designed to minimize the possibility of an allergic response. BREATHABLE: Allows freely for the passage of air and moisture. JAPANESE MEDICAL GLUE: Uses ...
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Manufactured by Rea Tapebased in SOUTH KOREA
100% PURE COTTON: Is made from 100% pure natural cotton fibers. LATEX FREE: Is 100% latex free. DRUG FREE: Is 100% free from any medical substances or pharmaceutical drugs. HYPOALLERGENIC: Is designed to minimize the possibility of an allergic response. BREATHABLE: Allows freely for the passage of air and moisture. JAPANESE MEDICAL GLUE: Uses ...
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Manufactured by Nemerabased in FRANCE
Our portfolio of disposable pens includes variable and fixed dose devices for automatic and manual drug administration, combining modern design with high intuitiveness of use for multidose therapies. Nemera offers three disposable pen injector development platforms with wide customization and drug capability options, to serve fulfilling of ...
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Manufactured by Kala Pharmaceuticals, Inc.based in USA
AMPPLIFY Drug Delivery Technology is designed to enhance penetration through the mucus barrier and deliver increased concentration of drug to the target ocular tissue. AMPPLIFY Drug Delivery Technology has been shown to improve delivery of loteprednol etabonate compared to traditional suspension eyedrops without ...
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Manufactured by Seres Therapeutics, Inc.based in USA
SER-287 is an investigational, oral, biologically-derived microbiome therapeutic for the treatment of ulcerative colitis (UC). SER-287 is a consortium of multiple bacterial spores manufactured by fractionating and purifying targeted bacteria from stool of healthy human donors. SER-287 has been granted Fast Track designation and Orphan ...
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by Theramx Inc.based in SOUTH KOREA
Drug delivery platform technology designed to maximize efficacy while simultaneously minimizing side effects of existing drugs by delivery to desired ...
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