John Gomez

BioPharma Sector highlights at your fingertips.

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340B Industry Colleagues: Bristol Meyers Squibb will unlawfully begin restricting 340B pricing for covered entities next week. Until legislation is (hopefully) passed forcing the pharmaceutical manufacturer to fold on their increased restrictions, the best approach is to directly share concerns with BMS. Send the following email to [email protected] : “To whom it may concern,   I am reaching out today on behalf of my covered entity regarding 340B price access to Bristol Meyers Squibb products.   The most recent policy notice issued on 9/3/2024 is deeply troubling and concerning for my covered entity’s access to 340B pricing and our ability to stretch scarce federal resources.   The increased data submission required fields in conjunction with the 14-day date of dispense window are entirely unattainable at the most basic level of 340B qualification and ordering processes. Two of the new claim information fields in particular are inaccessible under typical and compliant 340B qualification practice - Product Serialization Number and Wholesale Invoice Number are not assigned by our wholesalers until a purchase order is fulfilled. As you know, 14 days is not nearly enough time to expect all qualified dispenses to reach package size for order placement and purchase order fulfillment.   Covered entities desire to work with Bristol Meyers Squibb to ensure our 340B program is compliant and complete integrity is met. At its core, the recent requirements are unreasonable and unfathomable for covered entities to abide by and efficiently submit conforming claim information via the 340B ESP platform.   Thank you.”  

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Nektar: Q1 Earnings Snapshot 🏥💼💰 Investing in healthcare companies for your HSA account? Don't miss out on Nektar's Q1 earnings results! 📈👀 Summary: Nektar, a leading biopharmaceutical company, recently released its Q1 earnings report, highlighting impressive growth and potential for investors. 🚀📊 Despite the challenging economic climate, Nektar achieved strong financial performance with substantial revenue increases and promising development milestones. 💪💸 Key Highlights: 1️⃣ Revenue Surge: Nektar reported a significant increase in revenue compared to the same period last year, demonstrating the company's ability to drive sales and deliver innovative healthcare solutions. 💼💰💼 2️⃣ Promising Pipeline: The earnings report showcased Nektar's robust portfolio of potential breakthrough drugs, indicating exciting future prospects and opportunities for long-term growth. 🌟✨ 3️⃣ Health Impact: Nektar's cutting-edge therapies are targeted at improving patient outcomes, reinforcing the organization's commitment to revolutionizing healthcare and positively impacting lives. 🌍❤️ Inspiration & Call to Action: With Nektar's impressive Q1 performance, investing in their future success could be a game-changer for your HSA account! Don't let the Fear of Missing Out (FOMO) hold you back from seizing this opportunity to align your investments with your values and financial goals. 📈🚀 Take action now and consider adding Nektar to your investment portfolio, unlocking the potential for both financial gains and positive impact on global health and wellness. 💪💼✨ #HSA #investing #healthcare #health #family #wellness

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Motilent are back from the American College of Gastroenterology Congress in Philadelphia! Our team had a great time reconnecting with partners and meeting future collaborators from across the field. Our booth was buzzing with conversations, and we’re grateful for the opportunity to engage with so many people across #lifesciences, #biotechs, and leading academic institutions and community clinics. 👉Intestinal Ultrasound (IUS) excitement! One of the hottest topics at #ACG2024 was the increasing focus on #IntestinalUltrasound (#IUS) and #IUStraining. The enthusiasm around the Pennsylvania Convention Center was great to see, with many exciting discussions on how this technology is shaping #patientcare and where It could evolve. While the session lineup may not have fully captured the excitement we experienced it firsthand on the booth! Those who we spoke with about the International Bowel UltraSound (IBUS) Group e-learning platform we'll send over the information when it's available. 👉The Shift Toward Transmural Healing: It was great to hear the growing conversations around what happens to the #bowel beyond mucosal appearance and symptoms, a shift in how we approach #IBD care. We’re looking forward to advancing the ways we get patients into long-term remission through monitoring the different aspects of IBD in addition to established tests like endoscopy. 👉Motility Insights: Though not as high-profile as IUS this year, motility is a favourite topic on the booth for us! We had insightful discussions around motility in the stomach and bowel, exploring ways to quantify movement and look at gastric emptying. Touching on both IBS and other disease areas. A lack of clear care pathways and reimbursement holds back routine use but the need is there and growing with the side effects from #GLP1.  Thanks to everyone who stopped by our booth and shared their insights with us! Stay tuned for an announcement tomorrow on where to catch us next! Picture: Simon, Luke, Gethin and Beth packing up the booth after the conference.

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Caris Life Sciences 𝗮𝗻𝗱 COTA 𝗧𝗲𝗮𝗺 𝗨𝗽 𝘁𝗼 𝗔𝗱𝘃𝗮𝗻𝗰𝗲 𝗖𝗮𝗻𝗰𝗲𝗿 𝗧𝗿𝗲𝗮𝘁𝗺𝗲𝗻𝘁𝘀 𝘄𝗶𝘁𝗵 𝗥𝗲𝗮𝗹-𝗪𝗼𝗿𝗹𝗱 𝗗𝗮𝘁𝗮. 𝗟𝗲𝗮𝗱𝗶𝗻𝗴 𝗽𝗿𝗲𝗰𝗶𝘀𝗶𝗼𝗻 𝗺𝗲𝗱𝗶𝗰𝗶𝗻𝗲 𝗰𝗼𝗺𝗽𝗮𝗻𝘆 𝗖𝗮𝗿𝗶𝘀 𝗟𝗶𝗳𝗲 𝗦𝗰𝗶𝗲𝗻𝗰𝗲𝘀 𝗮𝗻𝗱 𝗼𝗻𝗰𝗼𝗹𝗼𝗴𝘆 𝗱𝗮𝘁𝗮 𝗲𝘅𝗽𝗲𝗿𝘁 𝗖𝗢𝗧𝗔, 𝗜𝗻𝗰. 𝗮𝗿𝗲 𝗷𝗼𝗶𝗻𝗶𝗻𝗴 𝗳𝗼𝗿𝗰𝗲𝘀 𝘁𝗼 𝗶𝗺𝗽𝗿𝗼𝘃𝗲 𝗰𝗮𝗻𝗰𝗲𝗿 𝗱𝗿𝘂𝗴 𝗱𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁. This collaboration will combine Caris' massive dataset of genetic, imaging, and other molecular data with COTA's real-world data on patient treatments and outcomes. This rich resource will be a boon for researchers, giving them new insights to develop more effective and personalized cancer therapies. 𝙃𝙚𝙧𝙚'𝙨 𝙬𝙝𝙖𝙩 𝙩𝙝𝙞𝙨 𝙢𝙚𝙖𝙣𝙨 𝙛𝙤𝙧 𝙘𝙖𝙣𝙘𝙚𝙧 𝙧𝙚𝙨𝙚𝙖𝙧𝙘𝙝: • 𝘔𝘰𝘳𝘦 𝘱𝘰𝘸𝘦𝘳𝘧𝘶𝘭 𝘥𝘢𝘵𝘢 𝘱𝘭𝘢𝘵𝘧𝘰𝘳𝘮 - By combining their strengths, Caris and COTA are creating a unique platform for researchers. This platform will offer a comprehensive view of cancer at the molecular level and how it responds to treatments in real-world settings. • 𝘍𝘢𝘴𝘵𝘦𝘳 𝘥𝘳𝘶𝘨 𝘥𝘦𝘷𝘦𝘭𝘰𝘱𝘮𝘦𝘯𝘵 - With a clearer understanding of cancer and patient responses, researchers can design better clinical trials and accelerate the development of new drugs. • 𝘐𝘮𝘱𝘳𝘰𝘷𝘦𝘥 𝘱𝘢𝘵𝘪𝘦𝘯𝘵 𝘰𝘶𝘵𝘤𝘰𝘮𝘦𝘴 - Ultimately, this collaboration aims to deliver more effective personalized treatments to patients, improving their prognosis and quality of life. #cancerresearch #precisionmedicine #realworlddata #oncology #drugdiscovery 

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Personalized treatments are shaking up old norms, and if you’re guiding M&A moves or advising clients, you need insights that make sense right now, not next year. Our carousel highlights the practical side of patient-focused medicine, showing where smaller biotech players, sharper data tools, and gene-level approaches lead to tangible outcomes and better decisions. No rambling, no empty buzzwords. Instead, simple, straightforward perspectives you can use from an industry expert - Dr. Tong Dai. Give it a scroll, then catch the full Q&A, or reach out to speak with one of our experts. Let’s turn these insights into forward steps for your next big call! 🔗 Full Q&A: https://lnkd.in/eBHzVe43 🚀 Speak to an expert: https://lnkd.in/ePdBM_rn

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PharmStars alumni startups enjoyed an informative and engaging 🗣️ session with a panel of experts: Brendan O'Leary, FDA alumni and Digital Health Consultant, Neroli Anderson, Head of Operations at TeleMedC, and Marc Aafjes, founder and CEO of Deliberate AI and a PharmStars Spring 2022 alumni. Our panel was moderated by Shrawan Patel, MD, PharmStars' Head Mentor and co-founder and himself an expert in Software as a Medical Device (SaMD).   The panel discussion revolved around the “When?” “How?” and “If?” of securing FDA approval for digital health innovations. And of course, on communications!   When? Planning an approval strategy should be part of product development. There will be delays (especially for novel products), so start early.   How? All the panelists agreed the FDA is very helpful in the process -- so work with them. Whether you will take the "de novo" route (new technology, which will require clinical data) or the "510K" route (showing equivalency to existing technology), you will have challenges. Don’t be fooled: the effort gap between these pathways is not as big as you might think.   How? Use the Q-Submission process (written request for feedback to guide product development and application) to advance your submission. But don’t surprise the FDA - stick to the process reviewed in the Q-Sub and use the detailed feedback they provide.   If? There are several advantages to pursuing a regulated product but not all innovations have the option of being regulated. The FDA's website has a self-guided questionnaire to help determine whether to seek regulation or not.   Communication? Email the FDA inbox to ask questions. 90% of the inquiries receive relevant responses within 14 days, which can be quicker than the Q-Sub program. But don’t ask questions if you don’t want to hear the answers. Use a consultant to inquire if you are unsure what path you will follow.   Thanks again to our panelist and moderator for a fascinating and educational discussion! Please visit our website at www.PharmStars.com to learn about joining a future cohort so you, too, can also enjoy the benefits of being a PharmStars alum.   #PharmStars #Startup #Accelerator #DigitalHealth #Regulation #FDA #pharma #biopharma #PharmStarsAlumni #innovation #acceleratorprogram

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💥 Unveiling the REAL expectations from Service Providers in the Clinical Trial Industry! 💼 Dive into the insights shared by our dynamic panelists at the 20th BioPharma Clinical Trials Nexus in San Diego! 🔍 #ClinicalTrials #IndustryInsights #FlippingTheDialogue 💪

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Stifel’s weekly biopharma update, with data partly compiled by DealForma, highlights industry uncertainty from U.S. Election volatility, steady IPO activity, subdued M&A, and promising obesity drug developments, with new research linking sugar addiction to obesity management. Check out Stifel’s report. https://hubs.ly/Q02X2RCt0

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📈 Exact Sciences Stock Surges on Higher Medicare Pricing for Cologuard Plus! 💡 Big news in the world of diagnostics! Exact Sciences' next-gen Cologuard Plus test has been priced at $592 by CMS—16% higher than the original Cologuard test ($508). This unexpected decision has sent Exact Sciences' stock soaring, rising by as much as 11% on Tuesday. Here's why it matters: ✅ FDA-Approved Innovation: Cologuard Plus, approved just last month, uses advanced methylation testing on three genes (LASS4, LRRC4, PPP2R5C) to detect colorectal cancer. ✅ Higher Reimbursement Rate: After CMS initially proposed pricing it the same as the original Cologuard, the final rate reflects a more nuanced framework combining three Septin 9 tests ($192 each) and a FIT test ($15). ✅ Launch Timeline: The test is set to go live commercially in Q1 or Q2 2025, with new CMS pricing effective Jan. 1, 2025. 💡 Why the Buzz? This pricing clarity reduces investor uncertainty and sets the stage for a potential 10% price increase from commercial payors, according to Evercore ISI analyst Vijay Kumar. With Medicare fee-for-service patients representing 15-20% of the Cologuard population, this is a major win for Exact Sciences! As diagnostics evolve, better tools for early cancer detection like Cologuard Plus can lead to healthier futures. This news isn’t just about pricing—it’s about progress. 💬 What do you think of the role of innovative pricing frameworks in supporting better healthcare solutions? #HealthcareInnovation #Diagnostics #ExactSciences #CologuardPlus #CancerScreening #Medicare #StockMarket

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Venture investment in biopharma and medtech companies hits new highs in Q2. Learn more from our experts Kathryn McDonough and Skip Kelly on the latest trends and insights in our reports, powered by DealForma: https://lnkd.in/en4rSKRf #JPMInnovationEconomy

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So much movement has happened in the oncology liquid biopsy market in the first six months of 2024. We've captured that and more in our third edition of the Oncology LBx Market Report. With updated content around the following (and not limited to): - Market sizing, segmentation, and forecast - Our internal database of LBx companies and their offerings, evaluated the latest performance data from key players - Incorporated the latest trends in the LBx market, based on interviews with experts and secondary research - Assessed new / current offerings and expected future portfolio developments - Evaluated emerging, high-growth applications in depth, elucidating both quantitative and qualitative market divers, moderators, and trends: (MRD, monitoring, early detection) - Developed deep-dive profiles of select key competitors Want to be notified when it's available? Sign up here: https://lnkd.in/euT9db7K #LiquidBiopsy #Oncology #PrecisionMedicine

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Taking place October 8-10 in Boston, MA & virtual, the 2024 #ExecutiveDecisionMaking event offers two distinct and unique programs led by top pharma and biotech leaders—Program & Portfolio Management and Strategic Resource Management. Take advantage of our early deadline extension and register by August 2nd and gain new tools and organizational strategies to optimize project planning, portfolio insights and decision making; and align resource planning, allocation, and capacity management with portfolio prioritization. » Access industry expertise, insights, and best practices for strategic decision-making » Explore cutting-edge approaches to resource management and portfolio management » Connect and collaborate with your peers and SMEs in the pharma and biotech sectors » Benefit from real-life case studies and success stories that you can apply to your organization » Discover new technologies and processes that enhance efficiency, and drive better outcomes » Advance your professional growth with fresh perspectives, new skills, and an expanded network https://lnkd.in/e8C_kMeB

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Marvellous medicine: Second only to AI for its ability to generate investor hype, biotech offers opportunity and risk in equal measure. Read our latest Spectrum report to learn how our investment teams view the sector: https://lnkd.in/ekcsK9VG #biotech #lifesciences #equities #privateequity Martin T. Henry Biddle, CFA, FCA Christopher Mankiewicz Jordan Stuart Capital at risk. For professional investors only.

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𝗪𝗶𝘁𝗵 $𝟯𝗕 𝗳𝘂𝗻𝗱𝗶𝗻𝗴 𝗿𝗼𝘂𝗻𝗱, 𝗕𝗮𝗶𝗻 𝘀𝗲𝘁 𝘁𝗼 𝗺𝗮𝗸𝗲 𝗺𝗼𝗿𝗲 𝗯𝗶𝗼𝘁𝗲𝗰𝗵 𝗯𝗲𝘁𝘀 Bain Capital Life Sciences (BCLS) has emerged as a major player in biotech investing, securing increasing amounts of funding for its initiatives. On Tuesday, the eight-year-old firm announced raising $3 billion for its fourth funding round, with $2.5 billion from new and existing investors and $500 million from its partners. Bain Capital Life Sciences Fund LP (BCLS) plans to use this fund to invest globally in transformative medicines, medical devices, diagnostics, and life sciences tools targeting unmet medical needs. The firm's previous funding rounds were $720 million in 2017, $1.1 billion in 2019, and $1.9 billion in 2021. https://lnkd.in/gD58TkNm

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