ADVANZ PHARMA’s Post

Exciting News From our Premier Sponsor! We're thrilled to celebrate the news announced at this weekend's Dermatology Summit: LEO Pharma has entered into a pivotal partnership with Gilead Sciences to develop novel therapeutic programs targeting inflammatory diseases. This landmark collaboration will accelerate the development of oral STAT6 inhibitors, potentially offering new hope for patients with atopic dermatitis, asthma, and COPD. The preclinical data showing STAT6's potential in treating inflammatory conditions represents an exciting step forward in our collective mission to advance dermatological science and patient care. As longtime supporters of dermatological innovation, we're particularly excited about the possibilities this partnership opens up for the development of both oral and topical treatments. The combined expertise of these two pharmaceutical powerhouses promises to accelerate the journey from bench to bedside. Congratulations to both teams on this momentous partnership! We look forward to seeing how this collaboration will shape the future of inflammatory disease treatment. #AdvancingDerm #BiotechNews #Pharmaceuticals (Read the Press Report at the 🔗 in comments)

Millions with geographic atrophy need help. The US has approved two treatments, but the EU has none. Why this matters.   More than 2.5 million Europeans are impacted by geographic atrophy   Europe’s vision crisis: GA patients neglected. Everyone I speak to about the wider ophthalmology industries talks about the innovation for treatments in the Retina space. There was a lot of excitement when both 𝐒𝐲𝐟𝐨𝐯𝐫𝐞 and 𝐈𝐳𝐞𝐫𝐯𝐚𝐲 received FDA approval.   And whilst Apellis Pharmaceuticals and Astellas Pharma fight it out for US market share, the EU remains without treatment options.   This week it was announced that Astellas have withdrawn its marketing authorisation application for ACP from the European Medicines Agency. In June, Syfovre received a negative opinion from the EMAs Committee for Medicinal Products for Human Use with the rejection being confirmed in September after re-examination.   The European retina community showed broad support for Syfovre, but the CMPH ruled that despite slowing the growth of GA lesions, there were not clinically meaningful benefits to patients whilst having safety risks linked to regular ocular injections.   Whilst Izervay (or ACP) differs from Syfovre, both target complement proteins in the immune system and it is also facing the strict standards of the EMA.   This news has huge financial impacts on both organisations and may mean that the European markets remain out of reach for a long time, despite their commitments to make treatments accessible worldwide.   There will be no consequences for patients currently in clinical trials, but there is now no expected timeline of when GA patients across Europe will receive beneficial treatments.   𝑨𝒏𝒅 𝒘𝒉𝒂𝒕 𝒘𝒊𝒍𝒍 𝒕𝒉𝒊𝒔 𝒎𝒆𝒂𝒏 𝒇𝒐𝒓 𝒇𝒖𝒕𝒖𝒓𝒆 𝒕𝒉𝒆𝒓𝒂𝒑𝒊𝒆𝒔?   Pharma giants such as Roche/Genentech (OpRegen), AstraZeneca (Danicopan) and Boehringer Ingelheim (BI 771716) all have therapies at different clinical phases. Whilst these varying treatments are a long way from being available on the global markets, they will surely have to face the same hurdles before GA patients can benefit.   To the experts in my network, I’d love to know your thoughts and opinions on the issue and what can be done to help more people with geographic atrophy. #geographicatrophy #maculardegeneration #retina #ophthalmology

Only put off until tomorrow what you are willing to die having left undone. **Merck Starts Late-Stage Study on Recently Acquired Ophthalmology Drug** In a significant development, Merck MRK has initiated the phase IIb/III BRUNELLO study on Restoret (MK-3000), a groundbreaking investigational Wnt agonist antibody. This study aims to tackle diabetic macular edema (DME), a common eye disease associated with diabetes. The BRUNELLO study will assess the safety and effectiveness of two different dosage levels of Restoret, namely high and low doses, in comparison to Roche’s RHHBY Lucentis (ranibizumab). The goal is to provide patients with a novel treatment option that can potentially improve their quality of life and vision outcomes. With the rising prevalence of diabetes worldwide, there is an urgent need for better therapies to address complications like DME. By investing in the development of Restoret, Merck demonstrates its commitment to advancing healthcare innovation and improving patient care. As an investor, it is essential to recognize the potential impact of groundbreaking medical advancements on the market. Investing in companies involved in cutting-edge research and development, like Merck, can lead to significant financial opportunities while contributing to the advancement of healthcare as a whole. Don't miss out on the chance to be part of this exciting journey. Take action now and consider allocating funds from your Health Savings Account (HSA) towards investments in the healthcare sector. Join the movement towards better health, wellness, and financial growth. #hsa #investing #healthcare #health #family #wellness 💪💰🌱👨⚕️🏥

It is a bright day for Prurigo Nodularis patients in the U.S, with the FDA approval of Galderma’s Nemolizumab. It is the first IL-31 inhibitor and the second biologic for PN joining Sanofi and Regeneron’s Dupixent in the U.S. We hope the NHS and NICE will follow suit soon and recognise that rare disease patients in the UK desperately need access to life saving treatments too. To date there is no dedicated treatment for PN approved in England by NICE. We need access just like patients of mainstream conditions, such as Atopic Dermatitis. Our lives matter too. #rare #pruritis Beacon for Rare Diseases GlobalSkin - International Alliance of Dermatology Patient Organizations Galderma Cambridge Rare Disease Network (CamRARE) https://lnkd.in/eRUR_yTP

In 2024, we saw a wave of groundbreaking biosimilar approvals across various therapeutic areas. The FDA granted approval to 19 biosimilars, including some firsts in ophthalmology, oncology, rheumatology and supportive care, highlighting the expanding range of treatment options for patients. Despite challenges like patent litigation affecting market entry for some products, these approvals may signal a promising future for greater accessibility and affordability in healthcare. Learn more here: https://lnkd.in/gCE3_7Wk #Biosimilars #Ophthalmology #Oncology #Rheumatology #Pharma #Biologics #FDAApprovals #ExecutiveSearch #BecauseTalentMatters

After the stunning results from the INDIGO trial (NCT04164901), this week, FDA approved #vorasidenib (Voranigo, Servier Pharmaceuticals) for adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation, following surgery including biopsy, sub-total resection, or gross total resection. Why is this important? This is the first #precision_medicine FDA approved for Grade 2 gliomas, it's a daily pill, and could be offered in substitution of radiation or chemotherapy until worsening of the disease. https://lnkd.in/gdqWHeTc

Priovant Therapeutics has started the CLARITY Phase 3 trial to test brepocitinib, a new drug for non-infectious uveitis (NIU), which can cause blindness. In earlier trials, brepocitinib showed promising results in reducing inflammation and improving vision. This new study will confirm its potential as a treatment for NIU, and the drug is also being tested for other autoimmune diseases like dermatomyositis. Learn more: https://lnkd.in/eGJwahCV #RetinaCare #EyeHealth #Ophthalmology #VisionCare #EyeCare #RetinaSpecialists #patientcentricity

The FDA approved teprotumumab-trbw (Tepezza; Amgen) in 2020 for treating thyroid eye disease (TED) following promising results from clinical trials. Although thousands of patients have received the monoclonal antibody, which targets the insulin-like growth factor 1 receptor, its use in clinical practice remains relatively new, and long-term real-world data remain limited. The results of 2 recent real-world studies show encouraging outcomes and indicate that the drug is performing well for a high percentage of patients with TED regarding the need for retreatments and intervention with orbital decompression. Read More: https://ow.ly/WcrM50U90sl