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Press Releases from Kuick Resarch (821 total)

Dynport’s Plague vaccine receives orphan drug status from FDA

DynPort Vaccine Company LLC (DVC), a subsidiary of CSRA, announced that its plague vaccine has received orphan drug designation from US Food and Drug Administration. DVC is developing the recombinant rF1V plague vaccine on behalf of the U.S. Department of Defense (DoD). The vaccine is designed for pre-exposure prophylaxis to fight infection with Yersinia pestis, the causative agent of plague. DVC being a contractor for the Medical Countermeasure Systems Joint

Boehringer Ingelheim’s investigational anti-CD33 monoclonal antibody BI 836858 …

US Food and Drug Administration has announced orphan drug designation for Boehringer Ingelheim’s investigational anti-CD33 monoclonal antibody BI 836858 for the treatment of myelodysplastic syndromes (MDS). Boehringer Ingelheim is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with 145 affiliates and about 50,000 employees, committed to researching, developing, manufacturing and marketing novel treatments for

EMA grants orphan drug designation to Epidiolex® from GW Pharmaceuticals

GW Pharmaceuticals has announced that European Medicine Agency has granted orphan drug designation to its leading product candidate, Epidiolex® (cannabidiol or CBD) for effective treatment of the treatment of Lennox-Gastaut Syndrome (LGS), treatment-resistant, debilitating childhood-onset epilepsy. Additionally, the investigational drug has received orphan drug status in the treatment of LGS, Dravet syndrome, Tuberous Sclerosis Complex, and Infantile Spasms, each of which are severe infantile-onset, drug-resistant epilepsy syndromes. The EMA grants an

CAEL-101 from Fortress Biotech (FBIO) Receives Orphan Drug Designations for Amyl …

U.S. Department of Health & Human Services has confirmed the transfer of two U.S. Food and Drug Administration (FDA) Orphan Drug Designations for CAEL-101 (also known as 11-1F4) from Columbia University (“Columbia”) to Fortress’ subsidiary, Caelum Biosciences, Inc. (“Caelum”). The two Orphan Drug Designations include the use of CAEL-101 as a therapeutic agent for patients with AL amyloidosis, and the use of CAEL-101 as a radio-imaging agent in amyloidosis. Fortress

Gamida Cell Announces orphan drug designation for NiCord®

European Medicine Agency (EMA) has announced orphan drug status for NiCord® developed by Gamida cell, a leader in cellular and immune therapies for the treatment of cancer and orphan genetic diseases, to treat haematopoietic stem cell transplantation, also commonly known as bone marrow transplantation (BMT). Presently, the orphan drug is being evaluated internationally as a graft for bone marrow transplantation for patients with blood cancer who do not have a

EU Commission grants orphan drug status to ZX008 in Lennox Gastaut Syndrome

Zogenix Inc., a leading biopharmaceutical company dedicated to develop therapies to treat orphan and central nervous system (CNS) disorders, declared that European Commission has announced orphan drug designation for the company’s orphan medicinal product, ZX008 (fenfluramine) for effective treatment of Lennox Gastaut Syndrome (LGS), a refractory, debilitating childhood-onset epilepsy. Presently, the drug is being investigated under Phase 3 clinical trial program in Dravet syndrome, intractable, severe epilepsy that begins

FDA grants orphan drug designation to EnGeneIC for Targeted EDV™ Nanocells to …

US Food and Drug Administration has announced orphan drug status for EGFR-targeted, doxorubicin-loaded EDV Nano cells for the treatment of glioblastoma multiforme (GBM) the most aggressive form of brain cancer, developed by EnGeneIC Ltd., a clinical stage biopharmaceutical company focused on developing its proprietary EDV™ nanocell platform for targeted cyto-immunotherapy in cancer. FDA Orphan Drug Designation is granted to investigational therapies that address rare medical diseases or conditions that affect fewer

FDA announces orphan drug status for aNK Natural Killer Cell Therapy in Merkel C …

NantKwest, Inc. has recently received orphan drug designation from US Food and Drug Administration (FDA) for its leading drug candidate, activated natural killer (aNK) cell therapy for treatment of patients with advanced Merkel cell carcinoma. NantKwest, Inc. is a pioneering, next generation, clinical-stage Immunotherapy Company focused on harnessing the unique power of our immune system using natural killer (NK) cells to treat cancer, infectious diseases and inflammatory diseases. Presently the drug

EMA grants orphan drug designation to aTyr Pharma for the Treatment of Limb Gird …

European Medicine Agency has granted orphan drug designation to aTyr Pharma, Inc. (LIFE), a biotherapeutics company engaged in the discovery and development of Physiocrine-based therapeutics to address severe, rare diseases, for company’s novel product, Resolaris™ for the treatment of limb girdle muscular dystrophy (LGMD) patients. EMA orphan designation is intended to encourage development of medicines for the diagnosis, treatment, or prevention of life-threatening or chronically debilitating conditions that affect no more

FDA grants orphan drug designation to Miragen Therapeutics

Miragen Therapeutics, a leading biopharmaceutical company has announced that US Food and Drug Administration have granted orphan drug designation to its novel product, MRG-106 for the treatment of mycosis fungoides. The orphan drug designation is granted to investigational drugs intended to treat rare diseases affecting fewer than 200,000 people nationwide. The status has the potential to provide several benefits to developers, including tax credits for clinical trials costs, exemptions from certain

Prometic’s PBI-4050 receives FDA orphan drug status for Alström Syndrome

US Food and Drug Administration has announced orphan drug designation to orally active, anti-fibrotic, lead drug candidate, PBI-4050 Drug, for the treatment of Alstrӧm Syndrome (AS). The disease is chronically debilitating as it can cause permanent blindness, deafness, type 2 diabetes and life-threatening due to progressive organ failure. Presently, there is no satisfactory method to treat patients with AS. The company is investigating drug for its effect on multiple

European Union grants orphan drug designation to LSK BioPharma’s Apatinib

LSK BioPharma, a leading biopharmaceutical company announced that company’s novel small-molecule angiogenesis inhibitor, Apatinib is awarded with orphan drug designation from European Commission for the effective treatment of gastric cancer. EMA orphan designation is intended to encourage development of medicines for the diagnosis, treatment, or prevention of life-threatening or chronically debilitating conditions that affect no more than 5 in 10,000 people in the EU. Medicines that receive orphan designation are eligible

FDA grants orphan drug status to Sapience Therapeutics (ST-36)

Sapience Therapeutics, a leading biotechnonology company dedicated to develop therapies for complicated cancer cases, declared that US Food and Drug Administration (FDA) has awarded company’s novel product protein-based therapeutic ST-36, orphan drug designation for the treatment of glioma in patients. Gliomas are a form of malignant brain cancer that affect approximately 18,000 to 20,000 people annually in the U.S. Nearly 70 percent of gliomas are glioblastoma, the most deadly form of

Opko receives orphan drug designation for CUR-1916 in Dravet Syndrome

Opko Health Inc., a leading pharmaceutical company has announced that US Food and Drug Administration has granted orphan drug designation for company’s oligonucleotide-based AntagoNAT (CUR-1916) for the treatment of Dravet Syndrome. Presently, the syndrome does not own any of the approved treatment. Oligonucleotides are synthetic chemical compounds consisting of mixtures of modified DNAs and RNAs. Orphan drug status is granted to treatments for diseases that affect fewer than 200,000 people in

FDA orphan drug status given to Exelixis, Inc. (EXEL) for the Treatment of Hepat …

US Food and Drug Administration have granted orphan drug designation to Exelixis’ novel product cabozantinib for the treatment of hepatocellular carcinoma (HCC). A pivotal phase 3 trial (CELESTIAL) of cabozantinib is in process with patients suffering from advanced HCC. The FDA grants orphan drug designation to drugs and biologics that are intended for the treatment of rare diseases that affect fewer than 200,000 people in the U.S. Orphan drug status is

Annamycin from Moleculin receives orphan drug status for the Treatment of Acute …

Moleculin Biotech, Inc, a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, announced that company’s novel product, Annamycin (also known as “Liposomal Annamycin”), an anthracycline has been designated as orphan drug by the U.S. Food and Drug Administration (FDA) for the treatment of acute myeloid

FDA grants orphan drug designation to SB-913 Genome Editing Treatment for MPS II

Sangamo Therapeutics, Inc., a leading pharmaceutical company dedicated to develop gene therapies and therapeutic genome editing has recived orphan drug designation from US Food and Drug Administration for company’s genome editing product candidate, SB-913, for the treatment of Mucopolysaccharidosis Type II (MPS II), a rare lysosomal storage disorder. MPS II is caused by mutations in the gene encoding iduronate 2-sulfatase (IDS) enzyme. Using Sangamo’s zinc finger nuclease (ZFN) genome

DLBCL receives FDA orphan drug designation for eFT508

US Food and Drug Administration has announced orphan drug designation to eFT508, a highly selective inhibitor of MNK1 and MNK2 for the treatment of diffuse large B-cell lymphoma. The drug is developed by eFFECTOR Therapeutics. The company has initiated to evaluate the safety, pharmacokinetics, pharmacodynamics and antitumor activity of the agent in patients with B-cell hematologic malignancies. The company also is conducting a phase 1/phase 2 dose-escalation trial of eFT508

AstraZeneca’s NMOSD Drug receives orphan drug designation

April 18, 2017 Orphan Drug European Medicine Agency has Announced orphan drug designation for inebilizumab (earlier known as MEDI-551) developed by AstraZeneca PLC (AZN) for the treatment of neuromyelitis optica spectrum disorder (NMOSD). The drug has already received orphan drug status from US Food and Drug Administration (FDA). NMOSD, also called Devic’s disease, is a rare, autoimmune disorder of the central nervous system (CNS) that affects the functioning

Immune design receives orphan drug status for G100 Intratumoral therapy Candidat …

Immune Design, a biopharmaceutical company focused on developing drugs and therapies for oncology has declared receipt of orphan drug designation by US Food and Drug Administration (FDA) for its investigational therapy G100 for the treatment of follicular non-Hodgkin’s lymphoma. The product is currently in its discovery state containing potent synthetic small molecule toll-like receptor-4 (TLR-4) agonist, Glucopyranosyl Lipid-A (GLA). FDA grants orphan drug designation to those products like drugs and therapies

FDA grants orphan drug status to ZW25 for Gastric Cancer Treatment

US Food and Drug Administration has awarded orphan drug designation to Zymework’s leading product candidate, ZW25 for the treatment of gastric cancer and cancer of the gastroesophageal junction (GEJ). Presently, the dug is being examined under Phase 1 clinical trial in patients with advanced HER2 expressing cancers. ZW25 is a bio assisted antibody formulated to tie up with two non-overlapping epitopes of HER2 resulting in dual HER2 signal blockade, followed by

Protalex receives orphan drug designation for ITP

Protalex, a biopharmaceutical company dedicated to develop orphan drug or therapies for the effective treatment of patients with rare diseases, has recently announced that its novel drug candidate, PRTX 100 has been granted orphan drug designation by the US Food and Drug Administration (FDA) for the treatment of persistent, chronic immune thrombocytopenia (ITP). PRTX-100 is currently being evaluated in its Phase ½ trial in patients who have previously been treated with

Minoryx therapeutics announces orphan drug designation for MIN-102

Minoryx Theapeutics, a leading drug development company focused on developing orphan drugs for rare diseases recently, announced that US Food and Drug Administration (FDA) has granted orphan drug designation to its leading product candidate, MIN-102 for the treatment of patients with life threatening CNS disease with high unmet medical need. MIN-102 contains superior profile with selective PPAR gamma agonist for diseases linked with central nervous system. MIN-102 targets X-linked adrenoleukodystrophy

Tasquinimod from Active Biotech receives orphan drug status for multiple myeloma

US Food and Drug Administrations has granted orphan drug designation to Tasquinimod, investigational novel agent developed by Active Biotech, a leading biopharmaceutical company for the effective treatment for patients with multiple myeloma. Tasquinimod is an immunomodulatory, anti-metastatic and anti-angiogenic compound that affects the tumor’s ability to grow and spread. Multiple myeloma is an incurable form of blood cancer where the plasma cells in the bone marrow grow uncontrollably while other

NantCell receives FDA orphan drug status for Ganitumab Monoclonal Antibody Thera …

NantCell, Inc., part of the NantWorks ecosystem of companies, has been granted orphan drug designation from US Food and Drug Administration (FDA) for the company’s Ganitumab, Insulin Growth Factor-1R (IGF-1R) Monoclonal Antibody Therapy for the treatment of Ewing Sarcoma. Ganitumab is a fully human monoclonal antibody directed against IGF-1R that is being investigated in a Phase III human clinical trial. Mechanism of action of the monoclonal antibody is described as IGF-1R

EU grants orphan drug status to Strekin’s STR001 for Sudden Sensorineural Hear …

European Medicine Agency (EMA) has granted orohan drug designation to Sterkin AG, a clinical stage biopharmaceutical company’s development candidate STR001 for the treatment of patients with Sudden Sensorineural Hearing Loss. FDA and EMA grants orphan drug designation to those products like drugs and therapies that treat rare diseases. The administration defines rare diseases as those affecting fewer than 200,000 people in United States. Orphan drug designation provides certain financial benefits such

India Cosmetic Surgery Market Sales Revenue Opportunity Report 2016

India is viewed as one of the most progressive countries for cosmetic surgical procedures and this trend is expected to continue in the near future. This is mainly due to the fact that cosmetic surgery has evolved beyond the traditional concept of being a ‘risky or ‘impractical procedure that was demanded by women who were overly conscious about their appearance. Today, people in India understand that cosmetic surgery is a

Private Hospital Services Market In India Sales Revenue Opportunity Report

Over the years the share of the private sector in the provision of health care delivery has increased to more than 75% of all outpatient care and about 60% of all in-patient care. The presence of private sector is widespread across the entire Indian healthcare landscape from providing healthcare delivery services, entry of corporate groups in managing and creation of healthcare infrastructure and imparting quality medical education. Download Report: https://www.kuickresearch.com/report-Private-Hospital-Services-Market-In-India.php For Report

India Biosimilar Market Analysis Sales Revenue Opportunity Report

As the number of patent expiries of biologic drugs is increasing, Indian companies are developing biosimilar manufacturing capabilities. Firms are developing their capabilities by either forming partnerships with R&D-intensive firms or outsourcing to upcoming Indian contract research organizations (CROs). Domestic manufacturers have a cost advantage (lower facility and development costs) than peers in developed countries. Moreover, Indian firms seem keen on repeating their successes achieved in developing and commercializing biosimilars.

China Healthcare Market Analysis Sales Revenue Opportunity Report

Healthcare system in China is witnessing series of transformation driven by government backed reform process and increasing private sector participation. Although China healthcare market is fraction of the developed markets, it is actually witnessing double digit growth in recent years. However, within the Chinese healthcare market landscape,there still exists huge difference between the tier one cities and the rural areas. Within the city, there exist huge difference in the level

India Genetic Testing Market Sales Revenue Opportunity Report

India is witnessing an accelerating shift towards the prevalence of non-communicable diseases, having secured third position in congenital malformations and genetic disorders as the commonest causes of mortality in neonates in cities. The ability to identify these non-communicable diseases at an early stage lies within the genetic screening segment. Genetic screening, however, is still in its infancy and there are many challenges that need to be overcome in order to

India Stem Cell Banking Market Sales Revenue Opportunity Report

Stem Cell Banking has emerged as new opportunity of healthcare services provider in Indian market. The market is still in nascent stage of development and valued at more than INR 400 Crore (US$ 70 Million) in 2013. The current stem cell preservation level for new born baby is below 1% and hence there exists immense opportunity for stem cell preservation service providers to grow exponentially in coming years. With

India Specialty Clinics Market Sales Revenue Opportunity Report 2016

Specialty clinics are emerging out of the general hospitals as a universal trend. Globally, niche specialties are being catered to by specialty clinics. The share of single specialty clinics, though is small, is rapidly growing in India. The market for specialty clinics is highly fragmented in India, with the presence of many small and niche players. However, the popularity of these clinics is increasing day-by-day. In 2012, specialty clinics accounted

Russia Clinical Trial Market Sales Revenue Opportunity Report Analysis

The Russian clinical trial market accounts for a significant share in the global clinical trial market. The country has got the population and the prevalence of diseases which cater as a good pool of subjects for conducting the studies. The high quality of the regulations followed in the Russian market for clinical trials has led to better optimization of the studies. The Russian clinical trials market enjoys high speed of

Singapore Clinical Trial Market Sales Revenue Opportunity Report Analysis

Singapore has off late come to become the nucleus of clinical research activities in the Asia-Pacific region. The country is a natural hub for manufacturers and clinicians. It also possesses one of the best healthcare infrastructure networks in the entire region. Singapore is the third largest market in Asia for conducting clinical trials. The national government has been extremely supportive in developing clinical research activities and maintaining high immunization rates.

Brazil Medical Device Market Sales Revenue Opportunity Report 2018

Being one of the largest economies in Latin America and being visualized as one of the key upcoming healthcare hubs, Brazil has come a long way. It has secured a very high position amongst emerging countries as far as its economic growth is considered and has been ranked as one of the largest medical devices market in Latin America. Much can be interpreted with this exponential growth specially the changing

Saudi Arabia Medical Device Market Sales Revenue Opportunity Report 2018

Accounting for nearly 50% of the total Middle East market, the Saudi Arabian medical devices market is estimated around US$ 1.1 Billion in 2013 and is expected to surpass USD 1.6 Billion by 2018, by registering a growth of 9% CAGR. The medical device sector is being anticipated to represent a strong growth in the coming years owing to overall increase in the health care spending, growing penetration by the

Indian In Vitro Diagnostics Market Sales Revenue Opportunity Report 2018

The Indian IVD market is valued at more than US$ 500 Million, and is expected to surpass US$ 1.5 Billion by 2018 growing steady at a CAGR of 20%. This remarkable growth can be attributed to increased healthcare awareness, desire to undergo preventive health checkups, availability of disease specific tests, corporate setups promoting health focus of employees, and drift from manual to semi-automated and automated equipment. Emergence of new concepts

India IVF Treatment Market Sales Revenue Opportunity Report 2018

India has a large population of 1.22 Billion people and infertility in the country is rising at a rapid rate (about 30 Million couples suffer from infertility). Infertility or the inability to have children refers to a range of disorders some of which affect the male, and some the female, and contribute to childlessness in a couple. There is also something called unexplained infertility, where doctors are unable to provide

US Cancer Vaccine Market Sales Revenue Opportunity Report 2018

Cancer vaccines are a viable option for treating many types of cancers which in the present day do not have effective treatments. Therapeutic cancer vaccines and Prophylactic cancer vaccines are the two broad segments into which the cancer vaccines market is categorized. Therapeutic or Treatment vaccines are targeted at treating an existing cancer by strengthening the body’s natural defences against the cancer and the Prophylactic or Preventive vaccines are used

Global Orphan Drug Market Sales Revenue Opportunity Report 2018

The global pharmaceutical industry has been experiencing a slow growth in recent years owing to many factors such as expiration of patents, competition from generic drugs segment, exhausting pipelines, and an increasingly stringent regulatory framework. It is most likely that many blockbuster drugs would lose their exclusivity in the next 5 year horizon. Download Report: https://www.kuickresearch.com/report-Global-Orphan-Drug-Market-Outlook-2018.php For Report Sample Contact: neeraj@kuickresearch.com or +91-11-47067990 "Global Orphan Drug Market Outlook 2018" Table of Contents 1. Introduction to

South Korea Biosimilar Market Sales Revenue Opportunity Report

South Korea has emerged as one of the strategic location for the development of biosimilars on the global level. Among the various emerging countries identified for development of biosimilars, South Korea is one of the most promising countries where pharmaceutical companies have identified huge investment potentials for the drug development process. One of the major reasons for the attractiveness of South Korea is the end of patent protection for some

India Specialty Clinics Market Sales Revenue Opportunity Report 2018

Specialty clinics are emerging out of the general hospitals as a universal trend. Globally, niche specialties are being catered to by specialty clinics. The share of single specialty clinics, though is small, is rapidly growing in India. The market for specialty clinics is highly fragmented in India, with the presence of many small and niche players. However, the popularity of these clinics is increasing day-by-day. In 2013, specialty clinics accounted

UAE Diabetes Market Opportunity Sales Revenue Opportunity Report 2018

UAE, with one of the highest rates of Type 2 diabetes represents significant societal costs, in relation to morbidity, mortality and also lost productivity coupled with a huge burden on the healthcare system. It has been observed that the high prevalence of diabetes in the UAE is gradually taking its toll on the overall health of the nation and also risking the country’s economic well-being. Download Report: https://www.kuickresearch.com/report-UAE-Diabetes-Market-Opportunity-Analysis-2018.php For Report Sample Contact: neeraj@kuickresearch.com

Europe Orphan Drug Market Sales Revenue Opportunity Report 2018

The concept of rare diseases and the idea that a special attention needs to be given to this sector has been taking shape in Europe since the 1990s. ever since then the political aspects and initiatives related to orphan medicinal products have been emerging at both the EU level and at the level of member states individually. Download Report: https://www.kuickresearch.com/report-Europe-Orphan-Drug-Market-Outlook-2018.php For Report Sample Contact: neeraj@kuickresearch.com or +91-11-47067990 "Europe Orphan Drug Market Outlook 2018" Table

US Proton Therapy Market Sales Revenue Opportunity Report

Proton beam therapy is seen as the next great leap forward in treating cancer with radiation. It has been found that proton therapy is beneficial for tumors surrounded by sensitive structures such as the eye, brain, and spinal cord, where the organs are sensitive and there is high potential for radiation damage. Proton therapy is also very useful in childhood cancer treatment due to the high risk of long-term side

Non Hodgkin Lymphoma Therapeutics Market Sales Revenue Clinical Trials Pipeline …

The market for Non Hodgkin Lymphoma has significant unmet medical necessities in terms of demand for innovative drugs and novel technologies. This is one of the major factors behind the market witnessing rapid growth in Non Hodgkin Lymphoma segment. Past few decades have witnessed an increased level of activity with regards to development of new identification systems and drug mechanisms. In recent years, there have been an increasing number of

Breast Cancer Vaccine Sales Revenue Clinical Trials Pipeline Report

“Global Breast Cancer Vaccine Clinical Trial Insight” Report Highlight: * Global Breast Cancer Vaccine Market Overview * Global Breast Cancer Vaccine Clinical Pipeline by Company, Phase & Country * Mechanism of Breast Cancer Vaccine & Personalized Cancer Vaccines * Detailed Clinical Insight on Breast Cancer Vaccine Pipeline: 35 Vaccines * Majority in PHASE-I Clinical Trial: 12 Vaccines * Highest Clinical Phase is PHASE-III: 2 Vaccines (NeuVax & OBI-822) Download Report: https://www.kuickresearch.com/report-Global-Breast-Cancer-Vaccine-Clinical-Trial-Insight.php For Report Sample Contact: neeraj@kuickresearch.com or +91-11-47067990 "Global Breast

UAE IVF Treatment Market Sales Revenue Opportunity Report 2018

UAE has been projected as one of the upcoming IVF market meeting all international health expectations and standards in terms of quality of services provided without discrimination. It bears a potential to become a hub for promoting medical tourism keeping in mind the recent changes that have been introduced by the government, healthcare facilities that meet international standards and the well qualified doctors that are willing to serve here. Download Report: https://www.kuickresearch.com/report-UAE-IVF-Treatment-Market-Outlook-2018.php For

Ebola Virus Vaccine Market Sales Revenue Clinical Trials Pipeline Report

Ebola virus infection, which was previously called Ebola hemorrhagic fever was discovered in 1976. The infection caused due to ebola virus originates from four different strains of ebola virus. These viruses generally are known to affect non-human primates, and are transmitted from wild animals to the humans and among the latter, it is known to spread through human-to-human transmission. The natural hosts of ebola virus are Fruit bats, which

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