Search Results for “antibody” – Page 33 – media

GSK concludes Aiolos Bio acquisition for $1.4bn

GSK has successfully concluded the acquisition of Aiolos Bio in a deal that could reach $1.4bn, marking a significant expansion of GSK’s respiratory biologics portfolio. The agreement, signed last month, includes an upfront payment of $1bn and $400m in regulatory milestone payments. The acquisition introduces AIO-001, a long-acting anti-thymic stromal lymphopoietin (TSLP) monoclonal antibody, into GSK’s pipeline. The antibody is ready to enter Phase II clinical development. It targets adults with asthma and has the potential for extended dosing intervals, possibly every six months, due to its extended half-life and high potency. AIO-001 operates by attaching to the TSLP ligand, a key player in asthma inflammation, to hinder its signalling pathway. The acquisition significantly benefits the estimated 40% of severe asthma patients who suffer from low Type 2 (T2) inflammation. GSK’s commitment to respiratory diseases is further solidified with the addition of AIO-001, potentially redefining standard care for asthma patients. ...
- Source: drugdu
- 168
- February 20, 2024
Sanofi’s investigational frexalimab shows promise in relapsing forms of MS

Sanofi has announced that its investigational anti-CD40L antibody frexalimab has shown potential as a “high-efficacy therapy” for relapsing multiple sclerosis (MS), according to mid-stage results published in The New England Journal of Medicine. Affecting approximately 2.8 million people worldwide, MS is a disabling, neurological disease in which the immune system attacks the protective myelin sheath that covers the nerves and disrupts communication between the brain and the rest of the body. Relapsing forms of MS are characterised by clearly defined, but unpredictable, attacks of worsening neurologic function, followed by partial or complete recovery periods. Approximately 85% of patients are initially diagnosed with relapsing forms of MS, compared to 15% with progressive forms of the disease. Sanofi frexalimab has “a unique method of action with the potential to address both acute and chronic neuroinflammation in MS without causing lymphocyte depletion,” the company said. The phase 2 study of the candidate randomised ...
- Source: drugdu
- 103
- February 20, 2024
Hengrui’s anti-IL-17A Vunakizumab marketing application for ankylosing spondylitis indications accepted

Recently, Suzhou Shengdia Biopharmaceutical Co., Ltd., a subsidiary of Hengrui Pharmaceuticals, received the “Notice of Acceptance” issued by the National Medical Products Administration. The company submitted the Class 1 new drug Vunakizumab Injection (SHR-1314) The drug marketing authorization application was accepted by the NMPA. This product is used for adult patients with active ankylosing spondylitis whose conventional treatment is not effective. This application for marketing is based on a multi-center, randomized, double-blind, placebo-controlled adaptive seamless phase II/III clinical trial (SHR-1314-302). Research shows that Vunakizumab injection provides statistically significant and clinically meaningful improvements in active ankylosing spondylitis compared with placebo. At the same time, SHR-1314 injection is safe and well tolerated in the long-term treatment of patients with active ankylosing spondylitis. About SHR-1314-302 Research In November 2023, the main research endpoint of the Phase III clinical trial (SHR-1314-302) of SHR-1314 injection for the treatment of active ankylosing spondylitis in subjects with ...
- Source: drugdu
- 195
- February 20, 2024
Dragonfly and Gilead enter partnership for cancer therapy

Dragonfly Therapeutics has entered a clinical collaboration with Gilead Sciences to assess the potential of its investigational drug candidate DF1001 with the latter’s Trodelvy for two cancer indications. The study of the combination regimen will focus on metastatic breast cancer (mBC) and non-small cell lung cancer (NSCLC). DF1001 is designed to act on natural killer (NK) cells and T-cell activation signals, leveraging co-stimulation of NK receptor NKG2D and CD16 for NK cell activation. Trodelvy is a Trophoblast cell-surface antigen 2-directed antibody-drug conjugate. Dragonfly will maintain operational control of the trial, with the first patients receiving the combination treatment in the second quarter of 2024. Study sites are already operational in the US, Belgium, France, Denmark and the Netherlands. The study is set to expand, with additional sites in Europe, North America and Asia Pacific. Developed using Dragonfly’s TriNKET platform, DF1001 is being evaluated in adult patients for the treatment of ...
- Source: drugdu
- 172
- February 19, 2024
Regeneron and Sanofi’s Dupixent bags fifth drug label in Japan

Sanofi and Regeneron Pharmaceuticals have received yet another approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for Dupixent (dupilumab), this time as a treatment of chronic spontaneous urticaria (CSU). The Japanese agency approved Dupixent in CSU patients ages 12 and older whose symptoms are inadequately controlled by H1-antihistamines. This is the first approval for the therapy in this indication. Dupixent, a monoclonal antibody that inhibits the signalling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways, has been a high-grossing drug for Sanofi and Regeneron. In 2023, the therapy netted $11.59bn in global sales in 2023, as per Regeneron’s financials. GlobalData forecasts Dupixent sales to maintain their upward trajectory and generate $20.4bn in sales in 2030. Dupixent has been approved by the US Food and Drug Administration (FDA) and European Commission (EC) for five indications: atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis and prurigo nodularis. ...
- Source: drugdu
- 152
- February 19, 2024
Otsuka wins FDA breakthrough therapy designation for IgAN drug

After a high-profile failure in an Alzheimer’s related agitation trial earlier this week, Otsuka has garnered a positive update with a breakthrough therapy designation for its rare kidney disease drug sibeprenlimab. The US Food and Drug Administration (FDA) designation is for sibeprenlimab’s use in immunoglobulin A nephropathy (IgAN), sometimes referred to as Berger’s disease, a disorder that occurs when antibody immunoglobin A builds up in the kidneys, leading to inflammation and damage. This results in blood and protein in urine, as well as high blood pressure and kidney failure over time. The FDA made the decision following positive results from the Phase II ENVISION trial (NCT04287985), announced in November 2023. The 155-patient study evaluated the dose response of different doses of sibeprenlimab by measuring proteinuria or high levels of protein in the urine. Data from the trial, published in The New England Journal of Medicine, showed that after 12 months, ...
- Source: drugdu
- 90
- February 19, 2024
US lawmakers urge administration to take action against Wuxi

In a letter to the US Departments of Treasury, Defense, and Commerce, four lawmakers have expressed their concerns regarding biotech WuXi AppTec and its subsidiary WuXi Biologics’ supposed ties to the Chinese military. The 12 February letter from Chairman Mike Gallagher (R-WI), Senator Bill Hagerty (R-TN), Ranking Member Raja Krishnamoorthi (D-IL), and Senator Gary Peters (D-MI) asked that the administration add Wuxi to US government control lists given the biotech’s alleged ties to the Chinese Communist Party (CCP) and involvement in the CCP genocide of Uyghurs in Xinjiang, Reuters first reported. In addition, the letter alleges that the biotech is “closely affiliated” with the People’s Liberation Army (PLA), claiming that the biotech’s chairman and CEO Dr. Li has “personally commended CCP branch work in the company and has called on Party branches and members to play an active role in the company.” Lawmakers also claim that CEO Chen Zhisheng of ...
- Source: drugdu
- 106
- February 16, 2024
Electrochemical Sensors with Next-Generation Coating Advances Precision Diagnostics at POC

Current point-of-care (POC) diagnostic technologies are typically limited to measuring a single disease biomarker or several biomarkers from the same class of molecules, such as various RNAs, proteins, or antibodies. However, the ability to measure multiple biomarkers from different molecular classes could provide a more comprehensive understanding of a disease’s state, severity, progression, and individual variations in its development. Electrochemical biosensors, which convert the chemical signal of a biomarker found in a small biofluid sample (like blood, saliva, or urine) into an electrical signal proportional to the biomarker’s amount, could potentially address many diagnostic challenges at the point of care. These sensors can be assembled into multiplexed arrays to detect different biomarkers, and recent advances have overcome the challenge of “biofouling” – the degradation of electrode surfaces by nonspecific biological molecules in samples – through the development of thin antifouling coatings. Now, researchers at Wyss Institute at Harvard University (Boston, ...
- Source: https://www.labmedica.com/clinical-chemistry/articles/294800220/electrochemical-sensors-with-next-generation-coating-advances-precision-diagnostics-at-poc.html
- 124
- February 14, 2024
FDA grants breakthrough status to J&J’s nipocalimab for HDFN

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation (BTD) to Johnson & Johnson’s (J&J) nipocalimab for alloimmunised pregnant people at increased risk of increased severe haemolytic disease of the foetus and newborn (HDFN), which can cause life-threatening anaemia. This investigational therapy is the only one in the clinics for the condition, which occurs when the blood types of the pregnant individual and the foetus are incompatible. Nipocalimab is a fully human, aglycosylated, effectorless, monoclonal antibody designed to hinder the neonatal fragment crystallisable receptor (FcRn) and reduce levels of circulating immunoglobulin G antibodies. The regulator granted BTD based on findings from the proof-of-concept, open-label Phase II UNITY clinical trial of the therapy. The multicentre, international, non-blinded trial assessed nipocalimab’s efficacy, safety, pharmacodynamics and pharmacokinetics. The study met this primary endpoint with 54% of pregnant subjects. A small number of severe adverse events were reported in the study. ...
- Source: https://www.pharmaceutical-technology.com/news/fda-breakthrough-jj-nipocalimab/?cf-view
- 111
- February 14, 2024
AstraZeneca posts 81% rise in FY 2023 profit after tax

AstraZeneca has reported a significant 81% rise in profit after tax, reaching $5.96bn for the fiscal year (FY) 2023 from $3.29bn in the previous year. Despite a $3.73m decline in the sales of Covid-19 medicines, the company’s total revenue for the full year 2023 grew by 6% to $45.81bn, up from $44.35bn in FY 2022. Excluding Covid-19 medicines, AstraZeneca saw a 15% increase in total revenue. The company experienced growth across oncology, where revenues rose by 21%, cardiovascular, renal and metabolism (a rise of 18%), respiratory and immunology (a rise of 10%) and rare disease (a rise of 12%). Reported earnings per share (EPS) stood at $3.84, an 81% increase from the $2.12 reported in the previous year. Core EPS, a key profitability measure, rose 15% to $7.26. The company’s earnings before interest, taxes, depreciation and amortisation also saw a notable increase of 47% ...
- Source: https://www.pharmaceutical-technology.com/news/astrazeneca-fy-2023-profit-after-tax/?cf-view
- 175
- February 12, 2024

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