BioprocessUpdates’ Post

Dr. Eduardo. E Chang likes this Article A new treatment option for some people with chronic obstructive pulmonary disease (COPD) may soon be available. That’s because a recent drug trial demonstrated that the already-established biologic medication Dupixent (dupilumab), jointly developed by drugmakers Sanofi and Regeneron, could improve lung function and significantly reduce COPD exacerbations (when symptoms worsen), which often lead to hospitalization. The drug is already approved for use in people with allergic asthma and eczema. #dupixent#COPD#biologics#lungImmunology

One of Wahi's Products RECOCOV™ (Patented). This product was formulated and designed from unique herbal ingredients against coronaviruses infections, mainly SARS-CoV-2, and regulates the immune system. Wahi Pharmaceutical Inc. research studies have shown that RECOCOV™ regulates the immune function during the sepsis- like condition and helps support from certain viral infection.#Wahipharmaceuticals #supplements #innovation #RECOCOV #WAHIPHARM #Medicine #Immunology #Immunesupport #Ethnopharmacology #Phytochemistry

EMA has recommended granting a marketing authorisation in the European Union (EU) for Fabhalta (iptacopan), an oral treatment for adults with paroxysmal nocturnal haemoglobinuria (PNH) who have haemolytic anaemia. The active substance of Fabhalta is iptacopan, a proximal complement inhibitor. Complement inhibitors are a type of immunotherapy used in the treatment of many inflammatory conditions that could be caused by deficiencies of the complement system, a part of the body's immune system. Iptacopan targets Factor B to selectively inhibit the alternative complement pathway and prevent the destruction of red blood cells within blood vessels (intravascular haemolysis) and in the liver and spleen (extravascular haemolysis). https://lnkd.in/drWCtYrA #Pharmacovigilance #Regulatoryaffairs

The global Travelers Diarrhea Treatment market was valued at US$ 785.4 million in 2023 and is anticipated to reach US$ 1007.4 million by 2030 witnessing a CAGR of 3.5% during the forecast period 20242030. The global pharmaceutical market is 1475 billion USD in 2022 growing at a CAGR of 5% during the next six years. In comparison the chemical drug market is estimated to increase from 1005 billion in 2018 to 1094 billion U. S. dollars in 2022. #TravelersDiarrheaTreatment #GlobalMarket #PharmaceuticalIndustry #Healthcare #Immunization #Antibiotics #NonAntibioticAgents #AntiMotilityAgents #AdultTravelersDiarrhea #ChildrenTravelersDiarrhea

🌟 Big News from EMA! 🌟 🔬 The European Medicines Agency (EMA) has just released its "Human Medicines Highlights 2023"! And guess what? They recommended a whopping 77 medicines for marketing authorization in 2023. Yes, you read that right – 77! 💊 👩🔬 Out of these, 39 are brand new active substances ready to make a debut in the European Union. 🇪🇺 Among these, we've got two groundbreaking vaccines to shield us from respiratory syncytial virus (RSV) 🛡️ and a trailblazing drug using CRISPR/Cas9 for rare blood disorders. 🧬 🎉 The highlights include: •Nine cancer warriors including Omjjara, Columvi, Tepkinly, and Elrexfio 🎗️ •Aqumeldi for heart failure in kids – a tiny yet mighty solution 💓 •Skyclarys, stepping up for Friedreich’s ataxia 🌟 •Arexvy, our new guard against RSV in adults over 60 🛡️ Plus, 17 orphan medicines tackling everything from cancer to Duchenne muscular dystrophy 🏥 🚀 Under the PRIME program, EMA gave a thumbs up to Elrexfio, Talvey, and Casgevy – all set to revolutionize cancer and sickle cell disease treatment. 🌈 💡 But wait, there's more! 77 extensions for indications were granted, with a focus on pediatric drugs. 🧒 🚫 On the flip side, three medicines didn't get the green light, including treatments for ALS, COVID-19, and fibrodysplasia ossificans progressive. 🔍 EMA doesn't just approve and forget; they keep an eagle eye on these meds for quality and safety. In 2023, they even updated recommendations for Adakveo, advised on fluoroquinolone antibiotics, and suggested a lower dose for Olumiant. Plus, they put a stop on over 350 generic drugs from Synapse Labs Pvt. Ltd. following inspection findings. 🌐 Dive into the full report for all the juicy details and stay tuned for what's shaping our health and medicine world! 🧪 #HealthcareInnovation #EMA2023 #Medicine #Pharmaceuticals #Biotech #Healthcare

The FDA approved Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab), designed for treating rare diseases like paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). We should also note that Soliris is also indicated to treat patients with generalized myasthenia gravis, an autoimmune disease affecting muscle control, and neuromyelitis optica spectrum disorder, a rare inflammatory disease affecting the optical nerves and spinal cord. Interchangeable biosimilars are continuing to make an impact. With Bkemv, we now have 53 approved biosimilar in the U.S. with 13 of them approved as interchangeable biosimilars. This approval hopefully continues to demonstrate and drive advancement in the treatment of rare diseases and the progress in healthcare accessibility and innovation. #FDA #Biosimilar #HealthcareInnovation #Pharmaceuticals #RareDiseases #PatientCare #DrugApproval #ClinicalResearch #HealthcareAccessibility

Take our #AllergyQuiz The use of biologics revolutionized the management of asthma, due to their higher capacity to prevent loss of lung function and minimize the toxicity of some treatments such as those associated with oral corticosteroids. Although biologics have a greater ability to control asthma symptoms and reduce the frequency of acute exacerbations, less attention has been paid to achieving asthma remission. In relation to this, what percentage of clinical remission plus lung function improvement has been achieved for treatment of patients with severe asthma with mepolizumab after 12 months? Check the correct answer by reading the original article by Dennis Thomas and colleagues. doi.org/10.1111/all.15867 Options: A) 29.3% B) 25.2% C) 22.8% D) 19.1% #Allergy_journal Share your answer in the comment section below. We will post the answer after 3 days. journalallergy.com

Brief insights into the molecular causes of Long Covid following SARS-CoV-2 infection, and the prophylactic measures available to mitigate its risk, including vaccines, viral inhibitors, and metformin. The review also highlights the gaps in Long Covid research, such as the need for precise biomarkers to diagnose the condition and monitor the effectiveness of therapeutic treatments. #COVID19 #longcovid #health #globalhealth #publichealth #medicine #biotechnology #pharmaceuticals #FDA #WHO #CDC #vaccines #clinicaltrials #immunology https://lnkd.in/gzH6CKNx

𝐄𝐌𝐀 𝐀𝐩𝐩𝐫𝐨𝐯𝐞𝐬 𝐃𝐮𝐩𝐢𝐱𝐞𝐧𝐭 𝐟𝐨𝐫 𝐔𝐧𝐜𝐨𝐧𝐭𝐫𝐨𝐥𝐥𝐞𝐝 𝐂𝐎𝐏𝐃 The European Medicines Agency (EMA) has approved Dupixent (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) with raised blood eosinophils. This approval, the first globally for Dupixent in COPD, allows patients on ICS/LABA/LAMA or LABA/LAMA regimens to benefit from this new therapy. Additional submissions are under review in the US, China, and Japan. Key Highlights: Landmark Approval: Dupixent is the first biologic approved to target an underlying cause of COPD, improving lung function and reducing exacerbations. Clinical Data: Based on the Phase 3 BOREAS and NOTUS studies, which showed a 30-34% reduction in moderate or severe exacerbations and significant improvements in lung function and quality of life. Safety Profile: Consistent with existing indications, with common side effects including injection site reactions, conjunctivitis, and back pain. Industry Reactions: Tonya Winders Tonya Winders, CEO, Global Allergy & Airways Patient Platform: “This marks a new era in COPD treatment, providing hope for patients with limited treatment options.” Paul Hudson Paul Hudson, CEO, Sanofi: “Dupixent’s approval changes the landscape for over 200,000 EU patients with uncontrolled COPD.” George D. Yancopoulos george yancopoulos, President, Regeneron: “This approval redefines COPD treatment, demonstrating unprecedented improvements in clinical trials.” About COPD: COPD is a leading cause of death globally, characterized by progressive lung function decline, persistent cough, mucus production, and breathlessness. Despite smoking cessation, many patients continue to suffer from this debilitating disease. #Dupixent #COPD #EMAApproval #Biologics #RespiratoryHealth #Sanofi #Regeneron