Kevin Conroy

We do not have a "drug formulary" at Mark Cuban Cost Plus Drug Company, PBC. There is no P&T, and there are no tiers or incentives to pad costs with drug rebates with preferred brands. We will sell every A-rated or biological in the Purple Book that is FDA approved from those manufacturers who will sell to us. Case in point: adalimumab. This one biological is 85%+ off from the innovator at Cost Plus (both through www.TeamCubanCard.com at a retail pharmacy near you and at costplusdrugs.com around $750/mo for most indications at cost plus for Yusimry) vs. nearly $7K per mo for most indications of the innovator. If plans just took this one biological off of their drug formularies and moved it to the lowest cost option without any rebates, it could save the #healthcare system billions of dollars. A dollar today in savings is worth more than a $1 maybe 9 months from now with a possible drug rebate. But they do not remove it. Why? #DrugRebates. With a bunch of pending breach of #fiduciaryduty lawsuits happening, plan sponsors would be wise to start thinking out of the box when it comes to #pharmacybenefits if they want to meet their duties, and that includes drugs and biologicals. Source on table: https://lnkd.in/gbZnWbm6

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How do we minimize the number of protocol amendments and increase the operational feasibility of our clinical trials? This article below points out the benefits of using data, conversations and real world data to enhance the feasibility of the protocol design and inclusion/exclusion criteria: 1) Are we being too strict on our criteria in order to "control" for data variability? 2) Do are criteria allow for the intended patient population in the real world (if not, they need to) 3) How realistic is your design in how the study sites actually work? How they see and treat patients? How is your company ensuring the design meets these requirements? https://lnkd.in/gzJzFd-3

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This is perhaps where the "U" turn for DTx starts? I'm not suggesting we will enter the highly bullish times of 2018-2021 but I think like a lot of technology cycles, this may serve as an inflection point as we look back on this 2-4 years from now. In addition to some of the additional coverage guidance around breakthrough treatments, we may see folks filing back into this space over the next 12-18 months. #dtx #digitaltherapeutics #FDA #reimbursement

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Once more into the IgA fray. We just learned Jade Bio and Aerovate will merge to focus on developing a potential “best-in-class” treatment for IgA nephropathy. Jade is the fourth spinout of Paragon Therapeutics, Inc. to go public via a reverse merger and the third this year, following Oruka Therapeutics and Crescent Biopharma. Paragon specializes in discovering promising new antibody drugs, which it then licenses to newly created companies to advance their development. In Jade’s case, JADE-001 targets a protein known as APRIL that’s thought to play a major role in the development of IgA nephropathy, which over time erodes kidney function. Jade aims to dose its drug every two months, compared to anti-APRIL antibodies being developed by Otsuka Pharmaceutical Companies (U.S.) and Novartis that are dosed once per month or once every two weeks. (Otsuka last week said its antibody, sibeprenlimab, succeeded in a Phase 3 trial, while Novartis expects data for its drug, zigakibart, in 2026.) The combined company will be named Jade Biosciences and will be led by Tom Frohlich, Jade’s current Chief Executive Officer (CEO). Jade’s existing Board of Directors will remain in place, chaired by Eric Dobmeier, former President and CEO of Chinook Therapeutics and current Venture Partner at Samsara BioCapital. Board members include Lawrence Klein, Ph.D., CEO of Oruka Therapeutics; Erin Lavelle, former Chief Operating Officer and Chief Financial Officer at ProfoundBio and Eliem Therapeutics; Chris Cain, Ph.D., Director of Research at Fairmount and Tomas Kiselak, Managing Member at Fairmount. IgAN has become a competitive area of drug development. • Novartis acquired Chinook Therapeutics last year • Biogen bought HI-Bio: A Biogen Company • Vertex Pharmaceuticals bought Alpine Immune Sciences, Inc. • Travere Therapeutics received full FDA approval this year • Calliditas Therapeutics's was first to market last fall There are 130,000 to 150,000 people who have IgAN in the U.S. Over time, their kidneys can no longer remove waste from the blood, leaving them at risk of progressing to end-stage renal disease (ESRD), which requires hemodialysis or kidney transplant. With the right focus on target therapies, patient access, physician engagement, and effective commercial strategies, we will see significant strides made in managing IgAN and improving outcomes for countless patients here in the U.S. and across the globe. *** What are you following in this space? What changes do you hope to see in the IgAN landscape over the next 3 to 5 years based on this flurry of positive results and investment? -- Sources: [1] Fierce: https://lnkd.in/eikyMsBs [2] Bio Dive: https://lnkd.in/ewDfgcJ3 [3] Jade PR: https://lnkd.in/eJ5xmesD [4] Novartis: https://lnkd.in/eYy72JzU [5] Otsuka: https://lnkd.in/ecQVvqku Photo: Jade Bio CEO Tom Frohlich Credit: Endpoints News

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Revolo Biotherapeutics President & CEO Woody Bryan, Ph.D. made a bold decision to pivot the route of administration for his company's lead #peptide candidate in allergic diseases. On this week's episode of the #businessofbiotech, Woody and I discuss what happens at the intersection of patient centricity, enabling science, and #biotech business strategy. Tune in and subscribe wherever you listen to podcasts, or check out the videocast at utm_source=linkedin&utm_medium=social&utm_campaign=MSPutm_source=linkedin&utm_medium=social&utm_campaign=MSP Bioprocess Online Life Science Connect

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When investors think your gene therapy isn't good enough... That's what Lexeo is feeling right now on LX2006 for cardiomyopathy associated with Friedreich's Ataxia. Their Ph1/2 trial saw 50% of patients (8 total in the trial) experience a reduction of 10% in left ventricular mass index. There are only a handful of companies developing therapies for Friedreich's Ataxia, let alone the heart-related components of this rare disease. While Lexeo was optimistic about the data and taking it to discuss a future pivotal study with regulators, the market was not, knocking the stock down at present ~25%. The public markets are brutal with earlier stage companies. Depending on capital needs, it can be a bit easier to not be public when you're early in development. Regardless, another piece of positive news for AAV as it slowly comes out of its winter. Lines up with our beginning of the year predictions below! https://lnkd.in/drRreSCd

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Repeal the FDA Rule on LDTs Please let’s all standup for patients right Rep. Brad Finstad (R-MN) and Rep. Dan Crenshaw (R-TX) have introduced H.J. Res 145 in the House of Representatives, which would repeal the Food and Drug Administration final rule on Laboratory Developed Tests (LDTs). If the resolution passes the House of Representatives and Senate, and is signed into law, the FDA rule would be negated. If the FDA is permitted to implement this rule, it will create a costly, dual regulatory structure that overlaps with the Centers for Medicare and Medicaid Services in overseeing LDTs. ADLM is concerned that it will stifle innovation and limit patient access to vital laboratory tests. The association continues to assert, along with many others in the healthcare community, that changes to LDT oversight should occur within the current CLIA regulatory structure. ADLM requests that you send an email to your Representative urging them to cosponsor H.R. Res. 145, thereby supporting this effort to prevent the rule from taking effect. The type and level of LDT oversight is a decision for Congress, not the FDA. You will get a separate notice about a similar effort in the Senate. Please respond to that request as well. Click the link below to log in and send your message: https://lnkd.in/gaxAzm_V You are receiving this email because you signed up for alerts from American Association for Clinical Chemistry. Click here to unsubscribe from this mailing list.

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🚨 The #FDA's latest draft guidance on accelerated approvals takes aim at "dangling" approvals—products still marketed despite failed confirmatory trials. The agency is now mandating tighter timelines (2-4 years for oncology), more transparency in withdrawal processes, and public involvement. 🕵️‍♂️ This marks a shift from flexibility to rigor, signaling that the accelerated pathway is no longer a free pass. For #biopharma, it's both a challenge and an opportunity to align trial strategies earlier. Is this the FDA tightening the reins—or just evolution in regulatory science? FDA website: https://lnkd.in/gqc-z-5e #pharmanews #breakingnews

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Life Sciences-This Week: November 22, 2024 · Revvity Expands Partnership with Genomics England to Enhance UK Genomic Research ·  10x Genomics and Beckman Coulter Life Sciences Introduce Automated Single Cell Assay Solution ·  Leader Life Sciences to Distribute Bio-Techne Products in GCC Region ·  Halozyme, Inc. Proposes €2 Billion All-Cash Acquisition of Evotec   SUBSCRIBE to be notified of new episodes and watch prior episodes. https://lnkd.in/gkgVPgUs #LifeSciences #News #SAMPS

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Life Sciences-This Week: November 22, 2024 ·  Revvity Expands Partnership with Genomics England to Enhance UK Genomic Research ·  10x Genomics and Beckman Coulter Life Sciences Introduce Automated Single Cell Assay Solution ·  Leader Life Sciences to Distribute Bio-Techne Products in GCC Region ·  Halozyme, Inc. Proposes €2 Billion All-Cash Acquisition of Evotec   SUBSCRIBE to be notified of new episodes and watch prior episodes. https://lnkd.in/gkgVPgUs #LifeSciences #News

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Interesting development to watch: outcomes-based agreements for cell and gene therapies, tying Medicaid payments to improved health outcomes for this typically underserved population. https://lnkd.in/g3QXifut

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Thank you Mary Lou Jepsen for a great article and also for the commitment to and leadership of open-source innovation with Openwater.health. Biopharma and biotechnology trailblazers, particularly those navigating mid-small-micro cap waters, face tremendous challenges across the board. And, not just in development. Certainly in development stages, the FDA is trying to keep pace with completely new frameworks they must consider and review. Developers must adapt to these learning curves and survive the process. If they do, the challenges often continue after approval. With desperately needed rare disease innovations, such as gene therapies, we are seeing business model issues hit developers and patient access. As the industry turns its attention to the Holy Grail of mass market ultra blockbusters, it's possible, if not probable, that more and more rare disease development programs will get shelved due to seemingly insurmountable challenges. "Go it alone" or waiting for the lucrative deal isn't a realistic option for too many developers. For many of us who care deeply about these underserved populations, throwing up our hands and giving up simply isn't an acceptable option. Patients and their families with few to no options are waiting for their miracle. #raredisease #biotech #innovation

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GreatPoint Ventures portfolio company Truvian Health is revolutionizing the healthcare industry with its innovative approach to blood testing. The company's recent achievement of raising $74 million is a testament to its potential and the confidence investors have in its mission. Truvian Health aims to make blood testing accessible to everyone, everywhere, which is a game-changer in both convenience and healthcare outcomes. This significant investment will accelerate the development and deployment of Truvian's advanced blood testing technology, making it possible for individuals to receive accurate and timely health information without the need for traditional lab visits. The technology promises to be a disruptive force in the industry, offering fast, affordable, and reliable blood test results that can be conducted virtually anywhere. I'm incredibly excited about investing in Truvian Health because the company is at the forefront of a major shift in healthcare. Their commitment to accessibility and innovation aligns perfectly with the growing demand for personalized and convenient health solutions. The successful funding round not only highlights the company's solid business model but also its potential for significant growth and impact in the healthcare sector. Investing in Truvian Health is not just a financial opportunity; it's a chance to be part of a movement that will transform how people manage their health. https://lnkd.in/g7ZBtTMz

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OMG Guardant Health CEO AmirAli Talasaz wrote an apology (oops I mean "clarification") for his Elonesque-tech-bro challenge to bet $1M Exact's CEO Kevin Conroy that Exact's upcoming CRC blood test data would be bad: "I understand this public action has caused confusion and even upset some cancer patients, advocates and others. I want to take a moment to clarify my intentions." He then goes on with his "clarification" and it's just a bunch of ass-covering about this being just another bold step in his righteous crusade for good data quality in clinical trials. Classic non-apology apology. Not a great lesson in accountability for Guardant's patients, employees, or investors. For heaven's sake, why can't these people simply apologize when they screw up? 🤯🤯🤯

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LESS THAN 2 WEEKS AWAY, REGISTER NOW! (There is no cost to register) Register here 👇🏾👇🏾👇🏾 https://lnkd.in/epBSVG7G So far almost 100 people have signed up to hear how Aanika Biosciences, Inc. Biosciences, Inc. can bundle insurance coverage with novel technology. Working with us can: 1) Mitigate the adoption of new biologics or other technologies if you are a farmer / food company 2) Allow farmers and food companies to obtain simpler and less restrictive insurance coverage 3) And if you're developing new technologies in the food/ag space, can shorten your sales cyles differentiate your product! ***We will also be discussing a new application of insurance coverage bundled with our biotags which is just awesome, for lack of a better word*** This is a "can't miss" event if you're in the food / ag space. Jamie Richards, PhD Amol Deshpande Daniel J. Luciano, PhD Gurleen Sahansra Sam Pilkington #agriculture #foodsafety #cropprotection #biotechnology #insurance

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The collaboration between Virpax Pharmaceuticals Inc. (Nasdaq:VRPX) Pharmaceuticals and the National Center for Advancing Translational Sciences (NCATS) heralds a significant advancement in pain management research. Focused on the development of NES100, an intranasal peptide targeting acute and chronic non-cancer pain, this partnership utilizes innovative nanotechnology to enhance the delivery of enkephalin to the brain. By leveraging Molecular Envelope Technology (MET) and a specialized device, NES100 aims to provide analgesic effects without the adverse events commonly associated with opioids. This extended collaboration underscores the shift towards non-opioid alternatives for pain management, crucial in addressing the opioid crisis. The research aligns with the NIH’s HEAL initiative, emphasizing the national commitment to combat opioid addiction. The potential of NES100 lies in offering a non-addictive pain treatment, potentially transforming pain therapy and improving outcomes for individuals with chronic pain conditions. NES100's development presents a promising avenue for pain management, offering a safer alternative to traditional opioids. If proven effective in clinical trials, NES100 could emerge as a valuable tool for patients seeking pain relief. The intranasal delivery method not only enhances convenience but also holds the promise of improved patient adherence and treatment efficacy. 𝐑𝐞𝐚𝐝 𝐌𝐨𝐫𝐞: https://lnkd.in/dwMpJZf8 Gerald W. Bruce Matt Barnes

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ShangBay’s portfolio company Skyhawk Therapeutics, Inc., a clinical-stage biotechnology company developing novel small molecule therapies designed to modulate critical RNA targets, today announced that the Company will deliver a poster presentation highlighting preclinical data that support SKY-1214 as a potential treatment for relapsed/refractory (R/R) multiple myeloma (MM) and non-Hodgkin's lymphoma (NHL) at the upcoming 66th American Society of Hematology (ASH) Annual Meeting taking place December 7-10, 2024 in San Diego, California.

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UniQure and the Hunt for a Huntington's disease therapy... The company out this morning with two year (!!) data on AMT-130 showing slowing of the disease by 80%. Leveraging AAV5, this asset is one of several AAV-based therapies in development for Huntington's. A range of serotypes are utilized, including AAV1 and AAVrh10 from the likes of Voyager and AskBio (Bayer). Of course, this is in addition to oligo-based development candidates (e.g., Ionis, WaVe, Atalanta). UniQure just recently sold off their manufacturing site to Genezen who plans to build an gene therapy center of excellence (and continue manufacturing drug product for UniQure). I'd imagine that will help fund (what is these days) a fairly broad pipeline of development candidates. What do you think about AAV development? Or oligo development for that matter? Reach out and let us know! #AAV #drugdevelopment #investing

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