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Phase III study FINE-ONE will evaluate the efficacy and safety of finerenone versus placebo in delaying the progression of chronic kidney disease (CKD) in adults with CKD and type 1 diabetes (T1D) CKD affects up to 40% of people with T1D A quarter of people with CKD associated with T1D progress to end-stage kidney disease Only limited treatment options are available for people with CKD and ...
ByBayer AG
The W.A. de Vigier Foundation promotes and supports innovative entrepreneurial spirit in Switzerland. Since 1987, the goal of the foundation has been to invigorate emerging companies, providing support to young entrepreneurs, who stand out in the country's innovation-rich startup environment. Today, the De Vigier Award is one of the most respected prizes for young entrepreneurs in Switzerland, ...
MedTech Innovator is the leading program for medical devices, digital health and diagnostic companies and is the largest accelerator for life science companies globally. Every year, start-ups from all over the world are invited to present their solution and vision for a chance to be selected to join the MedTech Innovator Accelerator. The program culminates in a competition for a grand prize of ...
MorphoSys AG (FSE: MOR; NASDAQ: MOR) today announced that preliminary results from the ongoing Phase 1/2 study (NCT04104776) of tulmimetostat (CPI-0209) monotherapy in heavily pretreated patients with advanced cancers showed responses or disease stabilization in five cohorts with evaluable patients. Tulmimetostat is an oral, investigational next-generation selective dual inhibitor of EZH2 and ...
Data from the MANIFEST trial show durable improvements in both spleen volume and symptom score beyond 24 weeks with pelabresib in combination with ruxolitinib for JAK inhibitor-naïve patients An exploratory analysis of biomarkers from the MANIFEST trial indicates the potential for disease modification MorphoSys AG (FSE: MOR; NASDAQ: MOR) today announced results from analyses of the ...
Zuranolone 50 mg demonstrated a clinically meaningful and statistically significant improvement in depressive symptoms at Day 15, the primary endpoint, and at Days 3, 28, and 45, key secondary endpoints as previously reported Newly presented data offered additional insight into the SKYLARK Study and further demonstrated the rapid improvements in depressive symptoms observed in the clinical ...
Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), announced today that clinical data from multiple internal and partnered programs were presented at the recent 2022 Annual Meeting of the American Academy of Ophthalmology (AAO), the world's largest association of eye ...
Broomfield, Colorado, 10/3/2022. Aktiv Pharma Group (Aktiv) today announced a procurement contract award from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). Under this contract (number 75A50122C00082), awarded under the 2004 Project ...
The Funding Will Accelerate Development of an Intramuscular Formulation of ENA-001, a Novel Agnostic Respiratory Stimulant, for the Potential Treatment of Community Drug Overdose and as a Medical Countermeasure for Mass Casualty Events. The Funding Supports Development of an Intramuscular ENA-001 From Pre-Clinical Toxicology Through Filing for Approval in the United States Enalare Therapeutics ...
Broomfield Colorado 6/25/2022. Aktiv Pharma Group (Aktiv) announced today a grant award from the U.S. Department of Defense (DOD) Defense Health Agency (DHA) Joint Program Committee 6/Combat Casualty Care Research Program (JPC-6/CCCRP) [1] for the continued development of a tranexamic acid (TXA) autoinjector, targeting proposed indications related to prehospital treatment of severe bleeding. ...
Cingulate Inc. (NASDAQ: CING), a clinical-stage biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, today announced completion of the formulation study for its third asset, CTx-2103, for the management of anxiety-related disorders. The study was ...
Frontier Biotechnologies announced that the Azerbaijan Republic Ministry of Health approved Aikening® (Albuvirtide), the first long-acting intravenous infusion for the treatment of HIV-1 infection in adults. Aikening® is a new fusion inhibitor given once weekly, used in combination dual therapy to treat people living with HIV who have failed initial treatment. The approval of ...
Design and rationale of the phase 1/2a open label, multicenter study of the AFM24 monotherapy in patients with advanced EGFR-expressing solid tumors Design and rationale of the phase 1/2a study of AFM24 in combination with atezolizumab in patients with advanced EGFR-expressing solid tumors Design and rationale of the phase 1/2a study of AFM24 in combination with SNK01 autologous natural ...
CAMBRIDGE, Mass., May 19, 2022 (GLOBE NEWSWIRE) -- Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to XMT-2056, the ...
Post hoc analyses conducted in patient populations at greater risk of progression to severe disease or death suggests that SNG001 may have an important clinical effect on top of standard of care Synairgen plc (LSE: SNG), the respiratory company developing SNG001, an investigational formulation for inhalation containing the broad-spectrum antiviral protein interferon beta, today announces the ...
Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that it has enrolled the first subject in the 48-week Phase 2 MOMENTUM trial evaluating the safety and efficacy of pemvidutide1 in subjects with obesity or overweight. Pemvidutide is a novel, investigational GLP-1/glucagon dual receptor agonist under development for the treatment of obesity and ...
Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, today announced publication of key results from its Phase 3 SPOTLIGHT trial of F-rhPSMA-7.3 in recurrent prostate cancer in an abstract being presented at the ASCO 2022. Genitourinary Cancers Symposium (ASCO GU). F-rhPSMA-7.3 is an investigational ...
B244 reduced patients’ WI-NRS score by an average of 34.3% and achieved clinically meaningful 4-point itch response Lesional severity (appearance) improved for IGA and EASI Results were achieved in 4 weeks Safe and well tolerated with no SAEs and no single adverse event occurred in greater than 1% of the active group. AOBiome Therapeutics, a clinical stage biotechnology company ...
Synairgen plc (LSE: SNG), the respiratory company developing SNG001, a formulation for inhalation containing the broad-spectrum antiviral protein interferon beta, today announces that the international Phase 3 SPRINTER trial of SNG001 in patients hospitalised with COVID-19 did not meet its primary or key secondary efficacy endpoints. SNG001 demonstrated a favourable safety profile and was well ...
Results from the Phase III ARASENS trial evaluating darolutamide plus androgen deprivation therapy (ADT) and docetaxel showed a statistically significant increase in overall survival with a reduction in the risk of death by 32.5% compared to ADT plus docetaxel (HR=0.68, 95% CI 0.57-0.80; P Consistent benefits were also seen across secondary endpoints, which are of key relevance to patients, ...
ByBayer AG