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BIOTECHNOLOGY
Medical Device News Magazine reports breaking biotechnology news in addition to medical device news.
CHMP Recommends Evrysdi ® for Babies Under Two Months Old with Spinal Muscular Atrophy
"The CHMP opinion represents another important milestone in the development of Evrysdi," said Matthew B. Klein, M.D., Chief Executive Officer, PTC Therapeutics. "Presymptomatic babies are an important patient group that deserve access to oral, at-home administered treatments early in the disease."
SunHo Announces First Patient Dosed in Phase I/II Clinical Trial of a Potential First-in-class Immunocytokine IBB0979
Dr. Liusong Yin, the Executive Director, Chief Executive Officer and Chief Science Officer of SunHo, "We focus on innovative immunocytokines to build the next leading global biopharma of immunotherapy, and to bring perceivable benefits and affordable medicine to patients worldwide, by innovation and collaboration."
Lytix Biopharma Announces Presentation of Interim Data from ATLAS-IT-05 Study at ESMO 2023
In ATLAS-IT-05, a Phase II study, LTX-315 is given to patients with advanced melanoma in combination with the immune checkpoint inhibitor pembrolizumab (Keytruda), a market leading approved immunotherapeutic antibody. In the abstract interim efficacy and safety data from the first patients enrolled in the Phase II study are presented.
PrecisionLife Identifies First Detailed Genetic Risk Factors for Long COVID and Common Mechanisms with ME/CFS and other Complex Diseases
This analysis opens the door for new precision diagnostic and therapeutic approaches to address the massive unmet medical need affecting the lives of millions of patients reports PrecisionLife.
PathogenDx’s New Rapid, Single Test Detects Salmonella and 13 Serotypes in Poultry as Foodborne Illness Remains a Significant Threat to Public Health in the...
“Salmonella outbreaks are a huge issue facing poultry producers, particularly when you look at the astronomical risk and costs associated with an outbreak,” said PathogenDx Co-founder and CEO Milan Patel. “For every confirmed case of Salmonella, another 30 go undetected. In fact, the Centers for Disease Control and Prevention (“CDC”) estimates that each year one in six Americans – or 48 million people – get sick, 128,000 are hospitalized and 3,000 die of foodborne diseases.
Grifols Meets Enrollment Target in Phase 3 Study of Two Dose Regimens of Prolastin®-C in Patients with Emphysema Due to Alpha-1-Antitrypsin Deficiency
“While alpha-1 patients currently benefit from recommended AAT augmentation therapy, we hope to show clinical evidence of benefit with the current approved dose and a greater impact by doubling the single dose to 120 mg/kg weekly,” said Sandra Camprubi, Grifols Senior Director Clinical Operations. “We look forward to providing topline data from this study in 2026 and evaluating the next regulatory steps to provide emphysema patients impactful treatment options for alpha-1.”
Harbour BioMed Announces 2023 Interim Results Positive Profit Alert with the Enhancement of Value Driven by Innovation
Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed, commented: "The performance of HBM in the first half of 2023 serves as validation of our global strategy, which emphasizes global innovation and collaboration. This has demonstrated our strong momentum in growth and development.
The Caris Precision Oncology Alliance Welcomes The Broad Institute of MIT and Harvard
The Broad Institute joins Caris' extensive network of leading cancer institutions and research consortia committed to improving patient outcomes through innovations in precision medicine.
Broughton Launches E&L Testing Service for Pharma | Ensuring Product Safety and Managing Risk
As part of the service, Broughton will offer expert advice on the new ICH guidance, which covers harmonizing E&L study design and implementing ICH Q14 quality-by-design method development best practices.