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Genentech to Reintroduce Susvimo for Wet Age-related Macular Degeneration (AMD) Treatment

a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced the reintroduction of Susvimo® (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant for the treatment of people in the United States (U.S.) with wet, or...

PharmAbcine's Phase 1 Trial of PMC-403 for Neovascular Age-Related Macular Degeneration Advances to Single-Dose (4mg) and Multiple-Dose (3mg)

macular degeneration (nAMD), to the fourth single-dose group of 4mg and first multiple-dose group of 3mg in Phase 1 clinical trial. PMC-403 is a novel TIE2-activating antibody with the mechanism of stabilizing pathological and leaky blood vessels....

Kedrion Selected by Biotest to Distribute FDA-Approved Immunoglobulin Yimmugo® in the U.S

agreement, Biotest is expected to begin supplying Yimmugo® to Kedrion in Q4 2024, with a market launch planned for Q1 2025. The U.S. IG market is expected to grow by roughly 9% per year in the next eight years, representing an increasing patient...

FDA Grants Second Approval for EPKINLY® (epcoritamab-bysp) to Treat Relapsed or Refractory Follicular Lymphoma

(NHL) that arises from B-lymphocytes and is the second most common form of NHL accounting for 20-30% of all cases.2 About 15,000 people develop FL each year in the U.S.3 and it is considered incurable with current standard of care therapies.4...

CalciMedica Announces Positive Topline Data from Phase 2b CARPO Trial of Auxora™ in Acute Pancreatitis

results in multiple completed efficacy clinical trials. CalciMedica has completed a Phase 2b trial (called CARPO – NCT04681066) in AP with SIRS and a Phase 2b trial (called CARDEA – NCT04345614) in COVID pneumonia patients, continues to support the...

Hyundai Bioscience Develops Multi-Treatment for Mosquito-Borne Viral Infections, Including Dengue Feve

replication of these viruses. Currently, there is no treatment for dengue fever. The dengue virus has four serotypes (DENV-1, DENV-2, DENV-3, DENV-4), each with different IC50 values. The IC50 values for Zika, Chikungunya, and Yellow Fever viruses,...

Smart Cups Sets New Goals For Fundraising Round Amid Upcoming Partnerships And Continued Growth

honored by TIME Magazine, receiving high recognition for their proprietary technology with a Special Mention in TIME's 2021 Best Inventions. Led by CEO Chris Kanik, who is the season one winner of Gordon Ramsay's Food Stars on FOX, the Southern...

Rigaku Analytical Devices Partners with Leading Pharmaceutical Supplier

Rigaku Analytical Devices, a pioneer in developing handheld 1064 nm Raman analyzers, is pleased to announce distribution relationship Avantor, a leading provider of mission-critical products and services to the life sciences and advanced...

Indivior Publishes New Data Comparing Effectiveness of Intranasal Nalmefene (OPVEE 2.7mg) and IN Naloxone (4mg) in Synthetic Opioid Overdose Model

opioids, compared to a 4 mg dose of IN naloxone. Model simulations were performed using a validated translational model1 developed by the Division of Applied Regulatory Science in the US Food and Drug Administration's Center for Drug Evaluation and...

BioMarin to Present Data Showcasing VOXZOGO® (vosoritide)'s Impact on Bone Health and Quality of Life in Achondroplasia

BioMarin Pharmaceutical Inc. announced the presentation of new data from an investigator-led analysis of the Phase 2 111-205 study, which demonstrate that children with achondroplasia treated with VOXZOGO® experienced increases in bone length...

Qosina Introduces New iDOT™ Single-Use Sensor Bag Ports from Polestar Technologies

and pharmaceutical industries, has partnered with Polestar Technologies, a leader in optical sensing technologies since 1993, specializing in the monitoring of O2, CO2 and pH. Qosina is pleased to announce the addition of iDOT Single-Use Sensor Bag...

Immorta Bio Reports Successful Lung Cancer Growth Inhibition by Senolytic Immunotherapy SenoVax™

themselves with senescent cells, with negative correlations between the amount of senescent cells and patient survival1. Furthermore, increased resistance to cancer therapies such as chemotherapy2, radiation therapy3, and immunotherapy4 is...

FDA Accepts sBLA Filing of Leqembi® (lecanemab-irmb) for IV Maintenance Dosing in Early Alzheimer's Treatment

which can continue to cause neuronal injury. The sBLA is based on modeling of observed data from the Phase 2 study (Study 201) and its open-label extension (OLE) as well as the Clarity AD study (Study 301) and its OLE study. Alzheimer's disease is...

Agomab Receives FDA Orphan Drug Designation for AGMB-447 in Idiopathic Pulmonary Fibrosis

of ALK5. Agomab is evaluating AGMB-447 as a potential treatment for Idiopathic Pulmonary Fibrosis (IPF) in a Phase 1 clinical trial (NCT06181370). The FDA's Orphan Drug Designation program is designed to facilitate development of medicinal...

Lykos Therapeutics Provides Update on FDA Advisory Committee Meeting for Investigational MDMA-Assisted PTSD Therapy

on the question of whether the available data show that midomafetamine is effective in patients with PTSD. They also voted 1 yes to 10 no on the question of whether the benefits of midomafetamine with FDA's proposed risk evaluation and mitigation...

Thermo Fisher Scientific Introduces Innovative Mass Spectrometer to Advance Clinical Research

completion that supports significantly improved productivity. Compared to traditional technologies, Stellar MS achieves 10X the quantitative sensitivity while analyzing five times more compounds for proteomics, metabolomics, and lipidomics....

Bruker Launches Transformative neofleX MALDI-TOF System

fits on a bench-top. The neofleX Imaging Profiler MALDI-TOF/TOF mass spectrometer comes standard with Bruker’s proprietary 10 kHz smartbeam 3D laser for true pixel fidelity and with enhanced imaging detectors designed for longitudinal robustness,...

LIB Therapeutics Announces Positive Lerodalcibep Results from Two Phase 3 LIBerate Studies

included achievement of EAS / ESC LDL-C targets, and other lipid and apolipoproteins changes. Patients were randomized 2:1 to a single 300 mg once-monthly, subcutaneous dose of Lerodalcibep or placebo for 52 weeks. Approximately 85% of participants...

Orthofix Receives FDA 510(k) Clearance for Rodeo™ Telescopic Nail

leading global spine and orthopedics company, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market its Rodeo™ Telescopic Nail. The Rodeo Telescopic Nail is an innovative device indicated to...

Formosa Pharmaceuticals Strikes Licensing Deal with Tabuk Pharmaceuticals for Clobetasol Propionate Ophthalmic Suspension

Company ("Tabuk"), for exclusive rights to the commercialization of clobetasol propionate ophthalmic suspension, 0.05% (APP13007), a patented innovative medicine for the treatment of inflammation and pain following ocular surgery in key regions of...