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Both Biocon and partners Samsung Bioepis/Biogen have reason to cheer: The FDA approved their respective #aflibercept #biosimilars, Yesafili™ (aflibercept-yszy) and Opuviz™ (aflibercept-jbvf) on May 20. The FDA approved both as #interchangeable biosimilars, which further confuses the issue of biosimilar interchangeability, both in terms of exclusivity and applicability. #Eylea #Regeneron #ranibizumab #Xbrane #Xlucane #Yesafili #Opuviz Amgen Celltrion Inc Formycon AG https://wp.me/p7gt6c-7uS

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Are all NSAIDs really the same? Check out the nuanced differences between ibuprofen and naproxen here! https://lnkd.in/gjFyMcjV #pharmacy #meded #NSAIDs #pharmacology

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You identify that Mahreen may be at risk of FH because of her age and high cholesterol level. You invite Mahreen into the consultation room. How would you open the conversation? What words and phrases could you use? Discuss case studies like this, and others, with our Genomics in pharmacy: an introduction to person-centred consultations e-learning programme: https://lnkd.in/d3Mw8u4h

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Calling all #caregivers, #healthcare insurance activists, and #LTC, #ALF, PAC, #MRDD directors and professional organizations!-And all our listeners!Learn about the importance of pharmacists, medication reviews, and quality outcomes on The Med List LIVE today at 6:00 PM ET. Kevin and Donna will be talking with Dr. Courtney Myers on how to optimizing care through optimizing medications! #MedStrong #MedStrongWorkbook #Deprescribing

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New Medicare physician fee schedule proposed rule includes provisions addressing Medicare drug inflation rebates, discarded drug refunds, hemophilia clotting factors, radiopharmaceuticals, immunosuppressive therapy, and HIV PrEP. Fortrea's policy experts can help with analysis of the proposed policies. https://lnkd.in/g-VtffJ3

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The Inflation Reduction Act makes significant changes to drug prices but does little to address patients’ out-of-pocket costs. The majority of Medicare patients – 85% – will continue to grapple with the pre-existing framework of high deductibles and substantial cost-sharing that existed prior to the IRA. Effective health reform should broaden its scope beyond merely list prices to make the system work better for patients. Read more about the other policies we are advocating for in Sanofi's 2024 Pricing Principles Report

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🏆 Another option for chronic inflammatory demyelinating polyneuropathy #CIDP has been US FDA approved from a priority review pathway. 💉 argenx's once-weekly SC-administered VYVGART Hytrulo has been cleared for use in adults with the condition. 🥇 This is the first and only anti-FcRN approved for this neuromuscular indication. 🤔 Insights/points to ponder wrt #competitive and #marketadvantages: 💉 Brand's approach to expanding indications via a differentiated MOA, ROA, and a faster administration time 🔬 Few treatment options in this space; not a crowded market 💪 Already established in another neuromuscular condition (gMG), so Argenx's specialty market has been 'warmed' 📈 Chronic/ongoing nature of this condition; positive financial outlook #CIDP #Argenx #Vyvgart #Neurology #NeuromuscularDiseases #Pharma #Healthcare

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SIDP members Kaylee Caniff, PharmD, BCIDP, Mohammed Al Musawa, PharmD, BCIDP, Mike Veve, PharmD, MPH and Michael Rybak, PharmD, MPH, PhD discuss how the diagnosis of #candidemia via T2Candida Panel resulted in overall better outcomes when compared to traditional blood culture utilizing DOOR analysis at #ESCMIDGlobal2024

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I am excited to see how this change will create greater efficiencies and shorten review timelines. This is a great, short read on upcoming sIRB changes!

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This is the first approval of an engineered T-cell therapy in solid tumor. Afami-cel was approved by the FDA for unresectable or metastatic synovial sarcoma, which occurs in about 400 patients per year in the US. In their single arm trial, the overall response rate was 43.2%, and the duration of response was 6 months. Ultimately, there aren't many other options for patients with this rare cancer. Solid tumors generally aren't as responsive to T cell therapy, but it's possible that we may make gains in areas where patients have few therapeutic options, like synovial sarcoma. #tecelra #sarcoma https://lnkd.in/ee9EMAdb

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How to avoid the dangers of duplicate subjects in clinical trials? Verified Clinical Trials' Kerri Weingard discusses this topic with Moe Alsumidaie of clinicaltrialvanguard.com. The issue of duplicate and professional research subjects is prevalent, making it a "must have" for all clinical trials. Check out the interview here: https://lnkd.in/dV--z-KQ Learn more at: https://lnkd.in/etwhixy #clinicaltrials #research #healthcare #professionalresearchsubjects

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This is a very interesting article on Saudi Arabia's significant strides toward becoming a regional hub for clinical trials, thanks to its robust infrastructure, favorable regulations, and strategic initiatives to attract global pharma. DISTILL has its HQ in Dubai and is very present in the MENA region. Our platform is well designed to streamline clinical trials, making data management efficient and secure, which is crucial for meeting the evolving regulatory standards and fostering innovation in clinical research. Ping me to know more about DISTILL EDC.   For further insights, read the full article here: https://lnkd.in/g5JGfsAP

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The potential of human gene editing to change the lives of those with genetic diseases cannot be understated. With substantial growth in therapies utilizing GE technologies, the FDA released a draft guidance on human gene therapy products in January 2024. In our latest Regulatory Navigator blog, we discuss key takeaways from the FDA's guidance on nonclinical assessment for investigational GE products. These include important considerations for future GE product development, such as using surrogates for testing, evaluating on- and off-target editing events, and characterizing toxicities.

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Reviva Pharmaceuticals Announces FDA Alignment on Brilaroxazine Clinical Trials for NDA in Schizophrenia “We are pleased to receive positive feedback from the FDA and acceptance of a 4-week registrational study for our brilaroxazine program,” said Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva. “The FDA also clarified that our NDA submission could include two 4-week phase 3 studies showing efficacy and a 12-month long-term safety study. Importantly, we have already successfully completed and announced the results of our pivotal Phase 3 RECOVER trial in October 2023, and we are set to initiate our RECOVER-2 trial during this quarter. We expect topline data from our 1-year OLE trial in the fourth quarter of this year. Collectively, we expect to have completed all of the outlined NDA submission requirements by the third quarter of 2025.” RECOVER-2 is a global Phase 3, randomized, double-blind, placebo-controlled, multicenter, 4-week study designed to assess the safety and efficacy of brilaroxazine in approximately 450 patients with acute schizophrenia compared to placebo. Brilaroxazine will be administered at fixed doses of 30 mg or 50 mg once daily for 28-days. The primary endpoint is a decrease in Positive and Negative Symptoms Assessment total score compared to placebo from baseline to Day 28. Key secondary endpoints include clinical global impression (CGI) severity, positive and negative symptoms, social functioning, and cognition, and key biomarkers implicated in neuroinflammation. Reviva plans to initiate the first clinical site in this quarter (Q2-2024). #clinicaltrials #clinicalresearch

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⚔ Battle of the anti-#FcRNs in myasthenia gravis... 📑 Johnson & Johnson touts its recent nipocalimab PIII data showcased at the #EAN: European Academy of Neurology Conference, possibly competitively positioned well vs. argenx's #Vyvgart. ⏩ Forward looking: 👥 To leverage efficacy as a differentiator; across a range of antibody-positive gMG patients (i.e., MuSK+, anti-LRP4+, and anti-AChR+) 🗓 Regulatory filing est. by EOY #gMG #GeneralizedMyasteniaGravis #Clinical #MedicalAffairs #Nipocalimab #ActivitiesOfDailyLiving #Autoimmune #Neurodegenerative #Pharma #Healthcare

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Deciphera Pharmaceuticals to be Acquired by ONO Pharmaceutical For $2.4 Billion WALTHAM, Mass.--(BUSINESS WIRE)--Apr. 29, 2024-- Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer, today announced that it has entered into a definitive merger agreement with ONO Pharmaceutical Co., Ltd. (ONO), under which ONO will acquire all outstanding shares of Deciphera common stock for $25.60 per share in cash through a tender offer followed by a merger of Deciphera with a wholly-owned subsidiary of ONO (the “Acquisition”), for a total equity value of $2.4 billion. The boards of directors of both companies have unanimously approved the transaction. Together, ONO and Deciphera will accelerate their shared vision to deliver innovative new drugs and serve patients around the world. Deciphera brings specialized research and development capabilities in kinase drug discovery, well-established commercial and sales platforms in the United States and Europe, and global clinical development capabilities. https://lnkd.in/dY_hDwFT

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Will mRNA vaccines eventually be approved in melanoma? Updated data from the phase II KEYNOTE-942, which looked at pembrolizumab plus mRNA-4157 in resected melanoma, was presented at ASCO. Patients who received pembrolizumab plus the mRNA vaccine had prolonged relapse-free survival and distant metastases free survival, as well as numerically higher overall survival, when compared to patients who only received pembrolizumab. Melanoma is an immune responsive cancer, and we are seeing that mRNA vaccines may enhance the immune response in melanoma. This wasn't the only abstract looking at using other agents to enhance the immune response, either - there were abstracts looking at bicyclics (https://lnkd.in/ecPHfwke) and viral vectors (https://lnkd.in/er7cJnrB) as well, in combination with immunotherapy. All of these abstracts look promising, and hopefully some of them eventually make their way into clinical practice! #melanoma #keytruda #mRNA4157 https://lnkd.in/erfTzFwv

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Dive into our newest Peer Exchange series, where expert panel including Craig Beavers, PharmD, FACC, FAHA,FCCP,BCCP,CACP; Dave Dixon, PharmD, FACC, FAHA, FCCP, FNLA, BCACP, CLS; Joseph Saseen, PharmD, MNLA, FCCP, FAHA, BCPS, BCACP, CLS; Kate Phillips Cabral, PharmD, BCCP, FACC, FCCP; and Kelsey Norman, PharmD, BCCP, BCACP, BCPS, discussed the challenges of achieving LDL cholesterol targets. Enhance your understanding of statin therapy optimization and uncover the barriers to advancing heart health treatment. Start watching the ongoing episodes today: https://bit.ly/49Te1GD.

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