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🥁 𝗕𝗿𝗲𝗮𝗸𝗶𝗻𝗴 𝗡𝗲𝘄𝘀 𝗶𝗻 𝘁𝗵𝗲 𝗜𝗺𝗺𝘂𝗻𝗼𝗹𝗼𝗴𝘆 𝗦𝗲𝗰𝘁𝗼𝗿! 🧬 💉 Dupixent Approved in the EU as the First-Ever Targeted Therapy for Patients with COPD! 🔬 🟠 Yesterday (July 3), in a landmark decision, the European Medicines Agency (EMA) approved #Dupixent as the first biologic and targeted therapy for treating uncontrolled COPD, chronic obstructive pulmonary disease! 🟢 This marks a significant breakthrough after over a decade of limited treatment advancements for COPD patients. 𝘔𝘦𝘢𝘯𝘸𝘩𝘪𝘭𝘦, 𝘜.𝘚. 𝘳𝘦𝘨𝘶𝘭𝘢𝘵𝘰𝘳𝘴 𝘩𝘢𝘷𝘦 𝘱𝘰𝘴𝘵𝘱𝘰𝘯𝘦𝘥 𝘵𝘩𝘦𝘪𝘳 𝘥𝘦𝘤𝘪𝘴𝘪𝘰𝘯 𝘰𝘯 𝘋𝘶𝘱𝘪𝘹𝘦𝘯𝘵 𝘣𝘺 𝘵𝘩𝘳𝘦𝘦 𝘮𝘰𝘯𝘵𝘩𝘴, 𝘮𝘰𝘷𝘪𝘯𝘨 𝘵𝘩𝘦 𝘥𝘢𝘵𝘦 𝘧𝘳𝘰𝘮 𝘑𝘶𝘯𝘦 27 𝘵𝘰 𝘚𝘦𝘱𝘵𝘦𝘮𝘣𝘦𝘳 27! 🟡 Dupixent (#dupilumab) is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways. Unlike many treatments, it is not an immunosuppressant. The drug is being developed through a global collaboration between Regeneron and Sanofi, leveraging Regeneron's renowned VelocImmune® Technology! 🟢 Having been on the market for seven years, Dupixent has already secured approvals for treating eczema, asthma, and rarer conditions such as rhinosinusitis, eosinophilic esophagitis, and prurigo nodularis. Last year, it ranked No. 6 in global sales, generating a substantial $11.6 billion. 🟠 The European approval for Dupixent means it will now be accessible to over 200,000 COPD patients. COPD continues to be the third leading cause of death worldwide, making this approval a significant advancement in addressing a critical unmet need in respiratory care! #medicineapproval #pharmaindustry #biotechnology #biopharma #immunology #pulmonarydisease

New milestone for HI-Bio! 🚀 Our clinical-stage portfolio company today announced that the U.S. FDA has granted Orphan Drug Designation for Felzartamab for the Treatment of Antibody-Mediated Rejection (AMR) in Kidney Transplant Recipients. AMR is a major cause of kidney transplant failure, with late AMR affecting approximately 23,000 patients total in the U.S. There is no effective treatment for AMR and patient options are highly limited. HI-Bio is committed to advancing felzartamab across a spectrum of immune-mediated diseases, including IgA nephropathy, lupus nephritis and primary membranous nephropathy. This news comes 5 months after being granted Breakthrough Therapy by the FDA for Felzartamab in primary membranous nephropathy (PMN). Congratulations to Hi-Bio team for this new milestone 👏 Read more 👉 https://lnkd.in/eiG8EraB #FasterForThePatient #immunology #FDA #lifesciences #biopharma

The FDA approved Roche’s Piasky (crovalimab-akkz) to treat patients aged 13 and older with paroxysmal nocturnal hemoglobinura (PNH) and a body weight of at least 40kg, according to documents posted to the agency’s website on June 20, 2024. The US clearance of both intravenous and subcutaneous formulations of the anti-C5 recycling monoclonal antibody (mAb) follows approvals earlier this year in China and Japan. PiaSky is a pH-dependent binding humanized anti-complement (C5) monoclonal antibody. PiaSky uses Chugai’s Recycling Antibody® technology. Unlike conventional antibodies that bind to an antigen only once, crovalimab has been engineered to bind to the antigen repeatedly, enabling low dose subcutaneous administration every four weeks. This is the second approval for a drug using the recycling antibody technology following Enspryng® for the treatment of neuromyelitis optica spectrum disorder (NMOSD).

https://lnkd.in/gHm-4q3Y We present a retrospective study on the treatment outcomes of severely immunocompromised patients with persistent COVID-19. The study analyzed data from 14 patients who received a combination of tixegavimab/cilgavimab and antiviral medications. Response was evaluated based on symptom improvement, PCR cycle-threshold values, and C-reactive protein levels. Eleven patients achieved complete clinical and virological resolution, while three showed partial responses. The study suggests a potential association between non-response and tixegavimab/cilgavimab neutralization. The findings underscore the need for tailored treatment approaches and further research on optimal strategies for managing persistent COVID-19, as well as the development of antivirals and variant-specific monoclonal antibodies.

#FDA Approves #Biosimilar #Ustekinumab-aekn(#Selardsi) for #PsO, #PsA #Alvotech and #Teva announced the US Food and Drug Administration (FDA) approval of its ustekinumab (Stelara) biosimilar, ustekinumab-aekn (Selardsi), for the treatment of moderate to severe plaque psoriasis (PsO) and active psoriatic arthritis (PsA) in both adults and pediatric patients aged ≥ 6 years. Ustekinumab is a humanized #immunoglobulin G1k (#IgG1k) monoclonal antibody used to treat psoriatic arthritis, Crohn disease, ulcerative colitis, and plaque psoriasis. IgG1k antibodies bind to the p40 protein subunit utilized by #biotechnology #monoclonalantibody #immunology

GSK’s Depemokimab has the potential to be the first approved “ultra-long-acting biologic” with a six-month dosing schedule for severe asthma. Depemokimab has demonstrated statistically significant and clinically meaningful reductions in exacerbations over 52 weeks vs. placebo in the phase III SWIFT trials. Six-month dosing (just 2 injections per year) could simplify treatment to support millions of patients with severe asthma. For more information click the link below. https://lnkd.in/dFkFkBup #Asthma #longactingbiologic #GSK #innovations #SWIFTtrial #PhaseIIItrial

EMA APPROVED DUPIXENT First approval of Dupilumab (Dupixent; Sanofi) for COPD patients. Dupixent as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils. The approval covers patients already on a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA) and a long-acting muscarinic antagonist (LAMA), or on a combination of a LABA and a LAMA if ICS is not appropriate. The EMA is the first regulatory authority in the world to approve Dupixent for COPD patients. Additional submissions are under review with other regulatory authorities around the world, including in the US, China, and Japan. #dupixent #dupilumab #COPD https://lnkd.in/dzfeWzfk

Phase 4 XEMBIFY�� study on subcutaneous immunoglobulin achieves positive topline results.      Our phase 4 trial evaluating a biweekly dosing option for Grifols’ subcutaneous immunoglobulin (SCIg), XEMBIFY®, has met its primary endpoint demonstrating comparable total immunoglobulin levels when administering the product every two weeks compared with weekly. Label extension in the U.S. to include a biweekly dosing option would provide more flexibility and convenience for patients with primary immunodeficiencies.    For more information, see the press release.   #WeAreInnovation #clinicaltrials #immunology

Managing Variants of COVID-19 In light of the ever-changing data surrounding the continued emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants, the understanding of the spectrum of COVID-19 and optimal management continues to develop, challenging healthcare professionals to stay abreast of the most current information with the potential to affect clinical decision-making. To mitigate the overall health burden associated with this devastating pandemic, providers must have current knowledge of the latest practice-changing information about recommended therapeutic and preventive strategies in the context of evolving variants that have varying effects on COVID-19 vaccines and therapeutics. www.cmezone.com/MM221

EMA approval of Sanofi/Regeneron’s Dupixent fills biologic gap in COPD: GlobalData. Dupixent, a monoclonal antibody (mAb) targeting interleukin-4 (IL4) and interleukin-13 (IL13) pathways, has been approved by the EMA as the first biologic for uncontrolled chronic obstructive pulmonary disease (COPD) patients. It is to be used specifically as an add-on maintenance treatment, given alongside the standard of care (SoC), with a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA) and a long-acting muscarinic antagonist (LAMA), or on a combination of a LABA and a LAMA. The approval is set to improve the treatment landscape for COPD and offer patients a treatment option with potential to improve quality of life.