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Compounding pharmacies are facing a major challenge as the FDA removes Eli Lilly’s tirzepatide from the drug shortage list. The Outsourcing Facilities Association (OFA) has filed a lawsuit, calling this decision “reckless and arbitrary.” They argue the FDA didn't follow proper procedures or consider public input. This move could impact access to affordable medication options and affect compounding pharmacies that invested to meet patient demand. Read more about the ongoing legal battle and its implications for patients, providers, and the pharmaceutical landscape. #PharmaNews #CompoundingPharmacy #FDA #DrugShortage #Healthcare

🚨 **Lack of Transparency in Pharmacy Benefit Management Exposed** 🚨 A recent KFF survey highlights a crucial issue facing employers: a widespread lack of understanding of how Pharmacy Benefit Managers (PBMs) handle the funds intended for employees' medications. Despite the assurances from PBMs like CVS Caremark, Optum RX, and Express Scripts that 95% to 98% of rebates go back to employers, many businesses remain uncertain about the true flow of their money. 🔍 **Key Findings from the Survey**: - Only **19% of employers** believe they receive most of the rebates from PBMs. - A staggering **37% simply don’t know** how much of the rebates come back to them. - Even larger companies with dedicated teams struggle to make sense of these complex systems. These numbers reflect a real problem: confusion and frustration among employers about PBM practices and pricing policies. As the cost of employee health benefits continues to rise, understanding these financial dynamics becomes more critical than ever. 💡 As Mark Cuban recently pointed out, many companies might be losing money due to their lack of insight into PBM contracts. It's time for employers to push for greater transparency and accountability from their PBMs to ensure they’re getting the best possible value. 🗣️ **What can companies do?** 1. **Demand transparency**: Request detailed reports from your PBMs on how rebates are handled. 2. **Educate yourself**: Stay informed on how PBM agreements impact your bottom line. 3. **Explore alternatives**: Consider working with companies that offer transparent pricing models. 📉 Without clarity, companies may continue to face rising costs without understanding why. It's time to shed light on the inner workings of PBMs and take control of healthcare spending. #PBMs #HealthcareCosts #Transparency #EmployeeBenefits #PharmacyBenefitManagement #KFFSurveyhttps: //https://lnkd.in/gPYuaxX7

📢 **Healthy Competition: The Real Solution for Affordable Medicines** Today's announcement from CMS on price setting for a select few brand-name drugs might seem like progress, but the projected 22% savings can't compete with the benefits that generics and biosimilars bring to patients and the U.S. healthcare system. Generics and biosimilars drive down costs far more effectively, ensuring that patients have access to life-saving medications at a fraction of the price. The uncertainty created by current policies threatens this competition, ultimately hurting patients who rely on affordable options. The Association for Accessible Medicines, is urging policymakers to focus on removing barriers like patent thickets and PBM brand drug rebates, which delay access to these essential medicines. Let's prioritize healthy competition and proven solutions over ineffective price controls. #Healthcare #Pharma #Generics #Biosimilars #Policy #AffordableCare

**Top Biopharma Companies Hiring Now** If you're a life sciences professional seeking a new opportunity, BioSpace has identified 12 top biopharma companies currently hiring. Despite a 9.6% year-over-year decline in job postings as of July 2024, this is a significant improvement from June’s 23% drop, offering hope for job seekers. Here are the top companies to consider: 1. **AbbVie** 2. **Eli Lilly** 3. **Regeneron** 4. **Amgen** 5. **Takeda** 6. **Novo Nordisk** 7. **Daiichi Sankyo** 8. **Moderna** 9. **CSL** 10. **Gilead Sciences** 11. **Insmed** 12. **Resilience** Additionally, KlinEra Global Services is another company worth exploring for potential opportunities. For those looking to make a career move, our job search toolkit provides essential resources to help you succeed. Start your search today!

As the industry awaits the first Medicare drug prices negotiated under the Inflation Reduction Act (IRA), experts are divided on the long-term impact. While some believe the effects will be minimal—especially for drugs nearing the end of exclusivity—others warn of potential unforeseen consequences. Despite these concerns, pharma leaders like those from Bristol Myers Squibb and Novartis are confident they can navigate the changes without significant financial harm. With more drugs set for negotiation in 2027, the true impact of the IRA on the industry remains to be seen. Follow CSuitePharma for ongoing insights and updates on these developments. #PharmaNews #InflationReductionAct #DrugPricing #Biopharma

📢 Key Takeaways from the Latest Study on TNF Inhibitors for Rheumatic Diseases 📢 A recent study published in *The Journal of Rheumatology* reveals no significant long-term survival differences between subcutaneous biosimilar and originator TNF inhibitors. This finding offers reassurance for clinicians considering biosimilars, particularly when used alongside methotrexate, which was linked to higher retention rates. Biosimilars, more frequently prescribed as first-line treatments, demonstrated a lower discontinuation rate compared to originators, highlighting their effectiveness and safety in real-world practice. This study is crucial for guiding treatment decisions and shaping policies on biosimilar use in rheumatology. #Rheumatology #Biosimilars #TNFinhibitors #HealthcareResearch #ClinicalPractice https://lnkd.in/gEmz-pRt

The White House is set to announce the results of its first Medicare negotiations on the prices of 10 prescription drugs, marking a significant step in the Biden administration’s efforts to lower healthcare costs. This announcement, which comes just before the second anniversary of the Inflation Reduction Act, underscores the administration’s commitment to easing the financial burden on older Americans by leveraging Medicare’s newfound authority to negotiate drug prices. The impact of these negotiations, slated to take effect in 2026, could bring substantial savings to patients and set a precedent for future drug pricing reforms. As President Biden and Vice President Harris prepare to highlight this milestone in Maryland, the administration’s focus on reducing drug costs is clear. With plans to expand the program to include more medications in the coming years, this initiative not only addresses a critical voter issue but also solidifies a key component of the Democratic platform as Harris looks to carry this momentum into the upcoming election. https://lnkd.in/dxdjsR-y

**Baxter to Sell Kidney Care Segment to Carlyle for $3.8 Billion** Baxter International Inc. (NYSE: BAX) will sell its Kidney Care segment to Carlyle for $3.8 billion. The segment will be renamed Vantive. Baxter expects to receive $3.5 billion in cash, with net after-tax proceeds of around $3 billion. This sale is part of Baxter's strategy to streamline operations and enhance shareholder value. Carlyle, in partnership with Atmas Health, will lead Vantive with Chris Toth as CEO. The transaction, pending regulatory approval, is expected to close in late 2024 or early 2025. Baxter plans to use the proceeds to reduce debt and drive growth.

🚨 **Biosimilar Medicine Development** 🚨 A recent article highlights the significant impact of regulatory requirements on patient access to biosimilar medicines. It argues that the current demand for bridging studies—where the same biologic reference product (RP) must be compared in different regions—is an unnecessary barrier. These studies often duplicate existing data, increasing costs and delaying patient access to crucial treatments. The article calls on health authorities to streamline the approval process by waiving these redundant studies when RPs are scientifically and regulatorily proven to be identical. By doing so, global access to affordable biosimilars could improve, benefiting patients worldwide. **Key Takeaway:** Regulatory policies should evolve to support faster and more cost-effective biosimilar development, ensuring patients have quicker access to life-saving medicines.

🚨 **FDA Hits Aurobindo's Eugia with Severe OAI Classification** 🚨 The FDA has issued an "Official Action Indicated" (OAI) classification to Eugia, a unit of Aurobindo, following an inspection of its Bhiwadi Unit II facility. This designation highlights significant compliance issues and potential public health hazards. Key Issues: - Failure to prevent microbial contamination - Manual interventions compromising aseptic conditions - Inadequate review of manufacturing discrepancies This marks the fifth Form 483 for Eugia within a year, underscoring persistent regulatory challenges. Aurobindo remains committed to improving compliance and ensuring product safety for U.S. and European markets. #FDA #Aurobindo #Pharmaceuticals #RegulatoryCompliance #PublicHealth