Shanghai, June 14, 2024, WuXi Biologics (“WuXi Bio”) (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), announced it has been named to the 2024 MSCI ESG Leaders Indexes. This marks the second consecutive year the company has been included in the indexes for its outstanding sustainability performance. MSCI, a leading investment research firm, provides stock indexes and portfolio performance analytics to institutional investors. Its ESG Leaders Indexes are designed to represent the performance of companies with high ESG ratings relative to their sector peers. The index suite utilizes MSCI’s award-winning ESG Research and ESG Ratings to identify companies that have demonstrated an ability to manage their ESG risks and opportunities and are therefore eligible for inclusion. In 2023, WuXi Biologics received an AAA rating from MSCI for outstanding performance in Key Issues of Climate Change, Corporate Governance, Talent Development, and Product Safety & Quality, on its rating ...
On June 13, 2010, AbbVie and Future Gen Biopharm announced the signing of a license agreement to co-develop FG-M701, a next-generation TL1A antibody in preclinical development for the treatment of inflammatory bowel disease (IBD). FG-M701 is a fully human monoclonal antibody targeting TL1A, a clinically validated target for inflammatory bowel disease. Uniquely engineered to have potentially best-in-class functional properties compared to first-generation TL1A antibodies, FG-M701 is designed to provide improved efficacy and reduced dosing frequency in the treatment of inflammatory bowel disease. Dr. Jonathon Sedgwick, Senior Vice President and Global Head of Discovery Research at AbbVie, said that the prevalence of inflammatory bowel disease continues to rise, and many people with ulcerative colitis and Crohn’s disease do not respond to current therapies. AbbVie’s mission is to raise the standard of care by pursuing transformative therapies to help more patients with autoimmune diseases achieve remission. We look forward to working with ...
Minister Sridhar Babu inaugurated Innovera Pharma’s latest site in New Jersey, USA, during his recent visit. The new facility is expected to expand Innovera Pharma’s research, development, and production capabilities. The roots of this collaboration were established during a key meeting at the World Economic Forum (WEF) in Davos, Switzerland wherein Telangana CM Revanth Reddy and Sridhar Babu led a delegation earlier this year. These discussions paved the way for the company to invest in Telangana. Solidifying this partnership, within 30 days of the announcement, a ceremony was held on February 22, 2024, in Suryapet, Telangana. This event marked the commencement of a project aimed at enhancing local manufacturing capabilities and infrastructure. The partnership highlights how regional governments can support enterprises in scaling their operations globally. By fostering such alliances, this active partnership not only strengthens Innovera’s global presence but also reinforces Telangana’s strides to develop the pharmaceutical and biotechnology ...
Pfizer announced that CIFFREO, a Phase 3 global, multicentre, randomised, double-blind, placebo-controlled study evaluating the investigational mini-dystrophin gene therapy, fordadistrogene movaparvovec, in ambulatory patients with Duchenne muscular dystrophy (DMD) did not meet its primary endpoint of improvement in motor function among boys 4 to 7 years of age treated with the gene therapy compared to placebo. The primary endpoint in the final analysis was assessed by change in the North Star Ambulatory Assessment (NSAA) a year after treatment. Key secondary endpoints, including 10-metre run/walk velocity and time to rise from floor velocity, also did not show a significant difference between participants treated with fordadistrogene movaparvovec and placebo. The overall safety profile of fordadistrogene movaparvovec in the CIFFREO trial was manageable, with mostly mild to moderate adverse events, and treatment-related serious adverse events generally responding to clinical management. Pfizer will continue to closely monitor all participants enrolled in the study and ...
The amyotrophic lateral sclerosis (ALS) market across the 8MM (8MM: the US, France, Germany, Italy, Spain, the UK, Japan, and Canada) is projected to grow at a compound annual growth rate (CAGR) of 15 per cent from $317 million in 2019 to $1.28 billion in 2029, forecasts drugdu. The key opinion leaders (KOLs) interviewed by drugdu identified the greatest unmet needs within the ALS space. These entail earlier diagnosis, disease-modifying therapies (DMTs), identification of biomarkers, and efficacious first-line treatment options. However, the consensus amongst them is that the need to diagnose ALS early and the development of DMTs is imperative for any change to take place within the treatment space. Momna Ali, Healthcare Analyst at drugdu, comments, “Due to the variety in the presentation of ALS development and symptoms, there have been historical difficulties in diagnosing patients in a timely manner. Pharmaceutical companies have an opportunity to educate physicians both ...
The Trinity Challenge has announced the winners of its second competition (the Trinity Challenge on Antimicrobial Resistance), aimed at tackling the escalating threat of antimicrobial resistance (AMR). The awarded projects focus on addressing critical data gaps in communities and lower-income countries, which are disproportionately impacted by antibiotic-resistant infections. IIIT-Delhi announces that the project “AMRSense: Empowering Communities with a Proactive One Health Ecosystem,” led by Prof Tavpritesh Sethi in collaboration with CHRI-PATH, 1mg.com, and ICMR, has secured the joint second prize. The project shares this honor with “OASIS: OneHealth Antimicrobial Stewardship for Informal Health Systems,” also from India. Each joint second prize winner will receive £600,000 in funding over the next three years. All winners will also benefit from ongoing post-award innovation and scaling support. AMRSense addresses the challenges of engaging, motivating, and training community health workers (CHWs) in AMR surveillance and management, compounded by the lack of a comprehensive data ...
Drugdu.com expert’s response: The benefits and impacts of requiring an EU Representative for CE certification can be summarized as follows: Benefits : 1.Communication Bridge: An EU Representative serves as an intermediary between manufacturers and EU authorities, effectively communicating and handling technical, regulatory, and after-sales issues related to products. This bridging role significantly simplifies the communication process between manufacturers and EU authorities, improving the efficiency of problem-solving. 2.Compliance Assurance: Through an EU Representative, manufacturers can ensure their products meet EU regulatory requirements, mitigating the risk of compliance violations due to unfamiliarity with local regulations. The EU Representative’s familiarity and understanding of EU regulations can provide manufacturers with guidance and support in terms of compliance. 3.Clear Responsibility: In the event of product issues, EU authorities can directly contact the EU Representative to take prompt action, such as product recalls. This clear responsibility approach enhances the efficiency of problem resolution, reducing delays ...
Current prostate cancer (PCa) screening protocols typically begin with prostate-specific antigen (PSA) testing, which, if elevated, may lead to further assessment using multiparametric magnetic resonance imaging (mpMRI). Now, a cost-effectiveness analysis has revealed that using biparametric magnetic resonance imaging (bpMRI) as an initial screening tool is less cost-effective than the traditional approach of first-line PSA testing followed by mpMRI. This conclusion held true even when assuming no cost for bpMRI, indicating that the financial savings do not compensate for the drawbacks of using the first-line MRI approach. A team of researchers from Fred Hutchinson Cancer Center (Seattle, WA, USA), in collaboration with other institutions, developed a microsimulation model to compare the effectiveness and cost-efficiency of first-line bpMRI versus first-line PSA with reflex mpMRI for prostate cancer screening. The study showed that initiating screening with MRI significantly increased the incidence of false positives, unnecessary prostate biopsies, and overdiagnoses, without a corresponding ...
A computer program powered by artificial intelligence (AI) and trained on nearly half a million tissue images can effectively diagnose cases of adenocarcinoma, the most prevalent type of lung cancer. The computer program developed and tested by researchers at NYU Langone Health (New York, NY, USA) provides an unbiased, detailed, and reliable second opinion for patients and oncologists regarding the presence of the cancer and the possibility and timing of its return, also known as its prognosis. This is because the program incorporates structural features of tumors from 452 adenocarcinoma patients, who are among the more than 11,000 patients in the U.S. National Cancer Institute’s Cancer Genome Atlas. Importantly, the program operates independently and is “self-taught,” deciding by itself which structural features are most critical for assessing the severity of the disease and its impact on tumor recurrence. In their research, the algorithm, known as histomorphological phenotype learning (HPL), successfully ...
Don Tracy, Associate Editor The cobas is classified as a four-in-one molecular test that can identify SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus from a single nasopharyngeal or anterior nasal swab sample. The FDA has granted Emergency Use Authorization (EUA) to Roche’s cobas liat SARS-CoV-2, Influenza A/B & respiratory syncytial virus (RSV) nucleic acid test. According to the company, it is a four-in-one molecular test, defined as an automated multiplex RT-PCR assay that can detect SARS-CoV-2, influenza A, influenza B, and RSV from a nasal swab sample. Additionally, Roche reported that full results can be expected in 20 minutes via a compact analyzer.1 “Diagnostics play a critical role in the fight against respiratory illness,” said Matt Sause, CEO, Roche Diagnostics, in a press release. “We are proud to provide this innovative test to address the significant burden placed on healthcare systems. Now, healthcare professionals will be able to ...
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