Big Pharma Sharma

🚨 New Post Alert: TIGIT – Too Legit to Quit? Or Just Can’t Hit? 🚨 In the latest analysis from Big Pharma Sharma, I dive deep into the polarizing TIGIT landscape. 🧬 The post examines: 👉The TIGIT "Phase 3 Graveyard," where several key trials have been terminated or suspended 👉 The remaining hope in ongoing Phase 3 trials, with pivotal readouts expected from Roche, Gilead Sciences, Arcus Biosciences, Merck, iTeos Therapeutics, and more 👉 A timeline of upcoming results that could determine whether TIGIT is a legitimate player in immuno-oncology or just another overhyped target Find out more in the full post! 📝 🔗 in Comments ⤵

🔍 Rethinking Immuno-Oncology Failures as New Hope for Autoimmune Diseases 🔍 Not every immuno-oncology target has been a home run. But what if some of the "misses" in oncology—targets like CD40L and OX40—could offer breakthroughs in a different setting? Enter inverse-I/O: the strategy of targeting immune pathways for suppression rather than activation, with promising Phase 3 studies already underway for CD40L and OX40L in autoimmune diseases. The latest post explores: 👉 The potential of inverse-I/O targets like CD40L and OX40L to address autoimmune needs 👉 How companies like Sanofi and Amgen are leading the way with advanced Phase 3 programs 👉 Why “flipping the script” on I/O targets could reveal untapped therapeutic opportunities Dive into the details on how inverse-I/O could reshape immune-targeted therapies and open doors for novel treatments in autoimmune and inflammatory diseases. L1nk in the comments!

#ESMO24 delivered several impactful data readouts, and in my latest post, I break down three key insights that are reshaping the competitive dynamics in the oncology space: 💡 Replimune RP1 Data: With strong efficacy and a favorable safety profile, RP1 in melanoma has the potential to compete directly with cell therapies due to its easier administration and community-based treatment options. This could shift the treatment paradigm in melanoma. 💡 TIGIT’s Mixed Signals: Despite promising data from iTeos Therapeutics and GSK, the TIGIT landscape remains clouded with uncertainty. While new results show some clinical benefit, it’s hard to trust anything in this field outside of overall survival data —keeping the field in a holding pattern. 💡 PD-1 + LAG-3 Combinations: Regeneron fianlimab (combined with Libtayo) is emerging as a potential leader in PD-1 + LAG-3 therapy, with data suggesting it may be more potent than Bristol Myers Squibb Opdualag. This combination could expand beyond melanoma and help reshape the immunotherapy landscape. In my full post, I delve deeper into the implications of these data readouts and how they could impact the future of oncology. Check it out (l*nk in comments) and subscribe to my Substack for more in-depth analysis!

#ESMO24 delivered several impactful data readouts, and in my latest post, I break down three key insights that are reshaping the competitive dynamics in the oncology space: 💡 Replimune RP1 Data: With strong efficacy and a favorable safety profile, RP1 in melanoma has the potential to compete directly with cell therapies due to its easier administration and community-based treatment options. This could shift the treatment paradigm in melanoma. 💡 TIGIT’s Mixed Signals: Despite promising data from iTeos Therapeutics and GSK, the TIGIT landscape remains clouded with uncertainty. While new results show some clinical benefit, it’s hard to trust anything in this field outside of overall survival data —keeping the field in a holding pattern. 💡 PD-1 + LAG-3 Combinations: Regeneron fianlimab (combined with Libtayo) is emerging as a potential leader in PD-1 + LAG-3 therapy, with data suggesting it may be more potent than Bristol Myers Squibb Opdualag. This combination could expand beyond melanoma and help reshape the immunotherapy landscape. In my full post, I delve deeper into the implications of these data readouts and how they could impact the future of oncology. Check it out (l*nk in comments) and subscribe to my Substack for more in-depth analysis!

🚨 Ivonescimab beats Keytruda in head-to-head trial! 🚨 At this year’s #WCLC2024, Akeso and Summit Therapeutics, Inc. Phase 3 HARMONi-2 data showed ivonescimab outperformed Keytruda in 1L NSCLC patients. But beyond the data itself, there’s a bigger discussion happening around China’s role in global drug development. Can we still afford to write off 🇨🇳 China-only data? Or should we see it as a critical opportunity for early clinical proof-of-concept (PoC)? In my latest post, I explore: ▶ The impressive efficacy data from HARMONi-2 ▶ Caveats and questions about the study’s design ▶ Broader implications for China’s growing role in clinical research and drug development, and how leading companies like Merck and AstraZeneca are capitalizing on this. Read the full analysis to learn why dismissing Chinese data could be a missed opportunity. 📝 Full post linked in the comments!

🔍Exploring the Future of GLP-1 Therapies Beyond Diabetes and Obesity 💉 I've been closely tracking the expansion of GLP-1 agonists, a drug class that’s already revolutionized treatments for Type 2 Diabetes and Obesity. But the story doesn’t end there. My latest analysis reveals where the future of GLP-1 drug development is heading—and it’s more diverse and bigger than you might think. From NAFLD/MASH to Renal Disease to Heart Failure, GLP-1 therapies are making inroads into a variety of other large markets outside of Obesity and Type 2 Diabetes. What stands out most is the strong focus on metabolic and cardiovascular diseases, but emerging indications like CNS disorders (including Alzheimer’s and Parkinson’s) are also gaining traction and underscore the broad and multi-pronged effects of this class of medicines. The chart below breaks down the breadth of clinical development efforts across different phases in non-Obesity and non-T2DM GLP-1 clinical trials, underscoring the growing potential of GLP-1 therapies to address a wide range of unmet medical needs. 🔗 Dive deeper into the data and explore the full analysis in my latest Substack post (link in comments) What stands out to you about clinical development in this space? What is the next area where GLP-1s can make a meaningful impact? What challenges will we need to wrestle with as a society and industry if we live in a world where a large plurality of people are on these medicines? Let me know your thoughts and musings in the comments! #biotech #pharma #GLP1 #drugdevelopment #Obesity #T2D

💡 This week’s post is a bit different than my usual. A discussion between Vivek Ramaswamy and Balaji Srinivasan that centered around the FDA and their desire to potentially dismantle it caught my ear. 🕵♀️ I went through their respective claims and provided my perspective point-by-point. The short story is that it is easy to destroy things. Building is hard. While the FDA has its deficiencies, simple uninstalling it would be harmful to patients’ lives and is overall unrealistic. ⚖ Many of the systems and rules we are forced to operate under are before our time. We didn’t ask for all of them and perhaps many need to be modernized to fit the changing state of drug development and clinical practice. 🏡 Much like when you buy new home, you have a few choices. You can either live in the home you bought and “make it work” with your anachronistic appliances, old wallpaper, and worn exterior. You can completely demolish that home and build something anew - but where do you live in the meantime? The middle path is often the best path, which in this analogy is remodeling your home to fit your needs. ➕ In the same vein, its easy to just say we are going to press the “delete” button on government regulation, but that rhetoric is negative and destructive. We need to be more focused on positivity and how we can remodel, modernize, and optimize regulation so that it is pro-innovation AND pro-patient. Hope you enjoy this one! Link in comments. 👇

🚨 New Post Alert! 🚨 This week on Big Pharma Sharma, I delve into the evolving landscape of IgA nephropathy (IgAN). Discover why this market is capturing significant attention, the current treatment paradigms, the key players involved, and how the competitive dynamics in this field are set to make it a Big Pharma battleground. Recent acquisitions by Biogen, Vertex, and Novartis signal a growing focus on IgAN from Big Pharma players, with AstraZeneca, Roche, and Otsuka also deeply invested in late-stage studies. In my latest post, I explore: ▶ Who are the major players in the IgAN market? ▶ How is the treatment paradigm expected to shift? ▶ What strategies will companies use to succeed in this competitive space? ▶ Predictions for the future Don't miss out on this deep dive [ 🔗 in comments]! Companies and topics discussed: #IgAN #Nephrology #Biotech #Pharma Vera Therapeutics, Inc. Novartis, AstraZeneca,Roche, Ionis Pharmaceuticals, Inc., Travere Therapeutics, Calliditas Therapeutics,Vertex Pharmaceuticals, Biogen, Otsuka Pharmaceutical Companies (U.S.) Follow Big Pharma Sharma for more weekly insights and analysis from an insider’s perspective on the biotech and pharma industry.

🚨 New Post Alert! 🚨 This week on Big Pharma Sharma, I delve into the evolving landscape of IgA nephropathy (IgAN). Discover why this market is capturing significant attention, the current treatment paradigms, the key players involved, and how the competitive dynamics in this field are set to make it a Big Pharma battleground. Recent acquisitions by Biogen, Vertex, and Novartis signal a growing focus on IgAN from Big Pharma players, with AstraZeneca, Roche, and Otsuka also deeply invested in late-stage studies. In my latest post, I explore: ▶ Who are the major players in the IgAN market? ▶ How is the treatment paradigm expected to shift? ▶ What strategies will companies use to succeed in this competitive space? ▶ Predictions for the future Don't miss out on this deep dive [ 🔗 in comments]! Companies and topics discussed: #IgAN #Nephrology #Biotech #Pharma Vera Therapeutics, Inc. Novartis, AstraZeneca,Roche, Ionis Pharmaceuticals, Inc., Travere Therapeutics, Calliditas Therapeutics,Vertex Pharmaceuticals, Biogen, Otsuka Pharmaceutical Companies (U.S.) Follow Big Pharma Sharma for more weekly insights and analysis from an insider’s perspective on the biotech and pharma industry.

🚨 New Post Alert! 🚨 This week on Big Pharma Sharma, I delve into the evolving landscape of IgA nephropathy (IgAN). Discover why this market is capturing significant attention, the current treatment paradigms, the key players involved, and how the competitive dynamics in this field are set to make it a Big Pharma battleground. Recent acquisitions by Biogen, Vertex, and Novartis signal a growing focus on IgAN from Big Pharma players, with AstraZeneca, Roche, and Otsuka also deeply invested in late-stage studies. In my latest post, I explore: ▶ Who are the major players in the IgAN market? ▶ How is the treatment paradigm expected to shift? ▶ What strategies will companies use to succeed in this competitive space? ▶ Predictions for the future Don't miss out on this deep dive [ 🔗 in comments]! Companies and topics discussed: #IgAN #Nephrology #Biotech #Pharma Vera Therapeutics, Inc. Novartis, AstraZeneca,Roche, Ionis Pharmaceuticals, Inc., Travere Therapeutics, Calliditas Therapeutics,Vertex Pharmaceuticals, Biogen, Otsuka Pharmaceutical Companies (U.S.) Follow Big Pharma Sharma for more weekly insights and analysis from an insider’s perspective on the biotech and pharma industry.