Clinical trials

Noxopharm Announces First COVID-19 Patient Treated in Veyonda® Study

Retrieved on: 
Thursday, October 8, 2020
Health, Infectious diseases, Hospitals, General Health, Clinical trials, Pharmaceutical, Biotechnology, Drug discovery, Pharmaceutical industry, Life sciences, Drug development, Health, COVID-19 drug development

As the number of COVID-19 cases and deaths continues to rise in most countries, Australian clinical-stage drug development company Noxopharm is pleased to announce treatment of the first patient with its lead pipeline candidate, Veyonda, in the Companys Phase 1 NOXCOVID-1 study.

Key Points: 
  • As the number of COVID-19 cases and deaths continues to rise in most countries, Australian clinical-stage drug development company Noxopharm is pleased to announce treatment of the first patient with its lead pipeline candidate, Veyonda, in the Companys Phase 1 NOXCOVID-1 study.
  • The NOXCOVID-1 trial will enroll up to approximately 40 patients, with enrollment due to be completed before the end of the year.
  • Noxopharm Limited (ASX:NOX) is an Australian clinical-stage drug development company focused on treating cancer with Veyonda, its lead drug candidate.
  • Noxopharm also has an active R&D program for additional drug candidates and is the major shareholder of U.S. biotechnology company Nyrada Inc. (ASX:NYR).

Merck Announces Week 96 Data from Phase 2b Study Evaluating Islatravir in Combination With Doravirine in Adults With HIV-1 Infection

Retrieved on: 
Thursday, October 8, 2020
FDA, Health, Infectious diseases, Clinical trials, Pharmaceutical, Biotechnology, Retroviridae, Organic compounds, Chemical compounds, Chloroarenes, Doravirine, Nitriles, HIV, Management of HIV/AIDS, Islatravir (MK-8591), Merck

At Week 96, at all dose levels, the combination of islatravir and doravirine maintained virologic suppression as measured by the number of study participants achieving HIV-1 RNA levels

Key Points: 
  • At Week 96, at all dose levels, the combination of islatravir and doravirine maintained virologic suppression as measured by the number of study participants achieving HIV-1 RNA levels
  • The numerically lower response rate for the 2.25 mg islatravir group was largely driven by discontinuations through Week 48.
  • A lower rate of drug-related adverse events (AEs) occurred in the islatravir groups (7.8%) compared with the DELSTRIGO group (22.6%) at Week 96.
  • No additional drug-related serious adverse events were reported in any group between Week 48 and Week 96.

Moderna Announces Updates on Respiratory Syncytial Virus (RSV) Vaccine Program

Retrieved on: 
Thursday, October 8, 2020
Medical Supplies, Health, FDA, Infectious diseases, Clinical trials, Pharmaceutical, Biotechnology, Vaccines, Medicine, Medical specialties, Health, Vaccination, Medical research, Moderna, Respiratory syncytial virus vaccine, Vaccine, Cancer vaccine, RTT, Moderna’s Prophylactic Vaccines Modality, Moderna

Under the terms of the agreement, Merck will complete the Phase 1 study and transition the program to Moderna.

Key Points: 
  • Under the terms of the agreement, Merck will complete the Phase 1 study and transition the program to Moderna.
  • Separately, Moderna also announced the initiation of dosing in the Phase 1 study of its solely owned RSV vaccine candidate (mRNA-1345).
  • With todays announcement, Moderna will have the right to also advance RSV vaccines in adults, either alone or in combination with other respiratory virus vaccines.
  • In 2016, Moderna and Merck entered into a collaboration for mRNA-4157, a personalized cancer vaccine candidate, which is currently being evaluated in a Phase 2 study.

Pfizer Announces Positive Phase 3 Top-line Results for Once-Weekly Investigational Long-Acting Human Growth Hormone to Treat Children with Growth Hormone Deficiency

Retrieved on: 
Thursday, October 8, 2020
Biotechnology, FDA, Health, Pharmaceutical, Clinical trials, Anatomy, Organ systems, Endocrine system, Growth hormones, Growth hormone therapy, Growth hormone deficiency, Growth hormone, Pituitary gland, Hypopituitarism, Pituitary adenoma, the Study, Somatrogon, Growth Hormone Deficiency, GENOTROPIN® (somatropin), OPKO Health, Inc., Pfizer Rare Disease

Somatrogon received Orphan Drug designation in the U.S. and the EU for the treatment of children and adults with growth hormone deficiency.

Key Points: 
  • Somatrogon received Orphan Drug designation in the U.S. and the EU for the treatment of children and adults with growth hormone deficiency.
  • Growth hormone deficiency is a rare disease characterized by the inadequate secretion of growth hormone from the pituitary gland and affects one in approximately 4,000 to 10,000 people.
  • Growth hormone should not be used to increase height in children after the growth plates have closed.
  • Growth hormone should not be used in children with Prader-Willi syndrome who are very overweight or have severe breathing problems.

Knopp Biosciences NIH-Funded Pain Program Advances to Second Year of HEAL Award to Discover Non-Opioid Treatments for Chronic Pain

Retrieved on: 
Thursday, October 8, 2020
Health, Other Science, Clinical trials, Research, Science, Pharmaceutical, Biotechnology, Perception, Branches of biology, Nociception, Pain, Acute pain, Neuropathic pain, Chronic pain, Opioid, Peripheral neuropathy, Neurological disorder, Epilepsy

Knopp has developed a discovery platform of proprietary molecules directed to a non-opioid biological target linked to chronic pain caused by damage to nerves.

Key Points: 
  • Knopp has developed a discovery platform of proprietary molecules directed to a non-opioid biological target linked to chronic pain caused by damage to nerves.
  • Growing scientific evidence suggests that selectively activating key Kv7 channel subtypes can control nerve-cell hyperexcitability associated with chronic pain.
  • Knopp Biosciences is a privately held drug discovery and development company focused on delivering breakthrough treatments for immunological and neurological diseases of high unmet need.
  • Knopps preclinical Kv7 platform is directed to small molecule treatments for developmental and epileptic encephalopathies, other rare epilepsies, neuropathic pain, and tinnitus.

NEC OncoImmunity AS and Oslo University Hospital Team Up to Develop a Diagnostic for COVID-19 Using Artificial Intelligence

Retrieved on: 
Thursday, October 8, 2020
Technology, Biotechnology, Health, Pharmaceutical, Oncology, Research, Software, Infectious diseases, General Health, Hospitals, Genetics, Science, Data management, Clinical trials, Articles, Medical specialties, Health, Occupational safety and health, Clinical pathology, Epidemiology, Serology, COVID-19 pandemic, Coronavirus disease, COVID-19 testing, NEC OncoImmunity AS, NEC Corporation, Oslo University Hospital

The project will develop a novel T-cell diagnostic for the current COVID-19 pandemic to complement the current serological tests.

Key Points: 
  • The project will develop a novel T-cell diagnostic for the current COVID-19 pandemic to complement the current serological tests.
  • Reliable diagnostic tests to identify immune individuals are critical to overcome the ever-looming threat of COVID-19.
  • Oslo University Hospital is owned by the South-Eastern Norway Regional Health Authority (HS) and delivers specialist healthcare services to patients all over Norway.
  • Oslo University Hospital is Norways largest hospital with around 20,000 employees and is responsible for a significant proportion of the medical research and the education of medical personnel in the country.

Gilead Sciences Signs Joint Procurement Agreement With the European Commission for Veklury® (remdesivir)

Retrieved on: 
Thursday, October 8, 2020
Biotechnology, Manufacturing, FDA, Health, Pharmaceutical, Research, Other Manufacturing, Infectious diseases, Hospitals, Science, Clinical trials, Articles, European Union, Antivirals, Specialty drugs, COVID-19, Nucleotides, Remdesivir, Gilead Sciences, European Economic Area, European Union response to the COVID-19 pandemic, Procurement, Veklury (remdesivir), Gilead Sciences

Gilead Sciences (Nasdaq: GILD) and the European Commission today signed a joint procurement agreement (JPA) that will enable rapid and equitable access to Veklury (remdesivir), the first antiviral drug proven to be effective for the treatment of COVID-19 in the European Union (EU).

Key Points: 
  • Gilead Sciences (Nasdaq: GILD) and the European Commission today signed a joint procurement agreement (JPA) that will enable rapid and equitable access to Veklury (remdesivir), the first antiviral drug proven to be effective for the treatment of COVID-19 in the European Union (EU).
  • The JPA enables participating countries in the EU and the European Economic Area (EEA) and the UK to purchase Veklury for both real-time demand and stockpiling needs, coordinated by the European Commission.
  • The agreement covers purchases of Veklury over the next six months and has the option to be extended.
  • All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

NILEMDO® significantly lowers cholesterol in people with familial hypercholesterolaemia shows new analysis presented at EAS 2020

Retrieved on: 
Thursday, October 8, 2020
Health, Clinical trials, Research, Science, Pharmaceutical, Cardiology, Biotechnology, Lipids, Lipid metabolism disorders, Drugs, Medical specialties, Familial hypercholesterolemia, Low-density lipoprotein, Hypercholesterolemia, Statin, Bempedoic acid, Cholesterol, Bempedoic acid/ezetimibe, Lipid-lowering agent, NILEMDO®, NUSTENDI®, Daiichi Sankyo

Bempedoic acid reduced low-density lipoprotein cholesterol (LDL-C) by 22.3% compared to placebo in people with heterozygous familial hypercholesterolaemia (HeFH) taking maximally tolerated statins with or without other lipid-lowering therapies (LLTs).

Key Points: 
  • Bempedoic acid reduced low-density lipoprotein cholesterol (LDL-C) by 22.3% compared to placebo in people with heterozygous familial hypercholesterolaemia (HeFH) taking maximally tolerated statins with or without other lipid-lowering therapies (LLTs).
  • "The results from data presented at EAS 2020 demonstrate that bempedoic acid provides clinically meaningful LDL-C lowering with a good safety profile when added to background LDL-C lowering medications in patients with HeFH.
  • The 88th EAS Congress was held as a virtual event due to travel restrictions.
  • Efficacy and Safety of Bempedoic Acid in Patients with Heterozygous Familial Hypercholesterolemia: Analysis of Pooled Patient-level Data From Phase 3 Clinical Trials.

MyBio Offers Most Accurate Covid-19 Antigen Test on the Global Market with 99% Accuracy Rate

Retrieved on: 
Thursday, October 8, 2020
Other Manufacturing, Research, Infectious diseases, Clinical trials, Manufacturing, General Health, Pharmaceutical, Health, Science, Other Science, Medicine, Articles, Health, Medical tests, Zoonoses, Medical terminology, Rapid antigen test, Coronavirus disease, Virus, ELISA, COVID-19 testing

Award-winning Kilkenny-based life sciences company MyBio has partnered with German manufacturer MLab GmbH to bring the most accurate Covid-19 antigen test available globally to the Irish market.

Key Points: 
  • Award-winning Kilkenny-based life sciences company MyBio has partnered with German manufacturer MLab GmbH to bring the most accurate Covid-19 antigen test available globally to the Irish market.
  • The test establishes whether a person has the virus with an accuracy rate of 99%.
  • The low-cost, rapid antigen test is analysed on-site without additional equipment or a laboratory setting, producing results in 15 minutes.
  • The test will enable easier detection of asymptomatic carriers of the virus and contact tracing of those who may have already been exposed.

Neuromod Publishes Results of Large-Scale Tinnitus Clinical Trial in Peer-Reviewed Top-Tier Scientific Journal

Retrieved on: 
Thursday, October 8, 2020
Medical devices, Health, Clinical trials, Research, Science, Biotechnology, Branches of biology, Health, Medicine, Audiology, Auditory perception, Occupational safety and health, RTT, Symptoms, Tinnitus, Clinical, Neuromodulation, Medical research, Neuromod Devices Limited, Lenire®, Science Translational Medicine

The clinical trial was conducted between 2016 and 2019 and was designed to track changes in tinnitus symptom severity.

Key Points: 
  • The clinical trial was conducted between 2016 and 2019 and was designed to track changes in tinnitus symptom severity.
  • The study was conducted at the Wellcome Trust-HRB Clinical Research Facility, St. Jamess Hospital, Dublin, Ireland and the Tinnituszentrum of the University Regensburg, Germany.
  • A Medical Research Organization (NAMSA, Minneapolis, Minnesota, USA) guided and assisted the close-out process of Neuromods clinical trial.
  • Lenire is the first non-invasive bimodal neuromodulation tinnitus treatment shown to soothe and relieve tinnitus in a large-scale clinical trial.