EMD Serono became the third major drugmaker to sign a “Most Favored Nation” pricing deal with the Trump administration, pledging to align U.S. drug prices with those in other wealthy nations and offer discounted IVF medications through the new TrumpRx program. In return, the company will receive a three-year tariff exemption and has been selected for the Commissioner’s National Priority Voucher (CNPV) pilot, under which it will submit its fertility drug, Pergoveris, for review. https://lnkd.in/debxSi7N #NAVLINDaily #PharmaPolicy #IVF #TrumpRx
EMD Serono signs 'Most Favored Nation' deal with Trump administration
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Edoxaban’s Journey Shows How Targeted Pharmacology and Real-World Data Converge - Abedalrahman Maen Addassi Daiichi Sankyo | FDA https://lnkd.in/eKdxFSpE #Anticoagulation #Bleeding #DaiichiSankyo #DeepVeinThrombosis #DVT #Edoxaban #FactorXaInhibitor #Health #Hemorrhage #HemostasisToday #Medicine #OralAnticoagulant #PE #PulmonaryEmbolism #Savaysa
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A new milestone in contraceptive innovation DMPA-SC (Subcutaneous Medroxyprogesterone Acetate 104 mg); listed in the UNFPA global procurement catalogue, this development marks a major step toward diversifying the DMPA-SC supply landscape and strengthening global supply chain resilience. The DMPA-SC injectable empowers women with three-month protection option. It is EMPOWERING, EASY TO USE & CONVENIENT potentially eliminates the need for frequent visits to healthcare providers This advancement opens new possibilities for regional manufacturing collaboration, particularly for Pakistan’s pharmaceutical and biotech sector. By investing in next-generation contraceptive technologies and local fill-finish capacity, Pakistani manufacturers can position themselves as future suppliers for global reproductive health programs while advancing women’s access domestically. Congratulations to the Incepta Pharmaceuticals Ltd. and partners for achieving this milestone; a promising signal for stronger, more inclusive supply chains and expanded contraceptive choice worldwide. #DMPASC #ContraceptiveChoice #ReproductiveHealth #SupplyChain #InceptaPharmaceuticals #PakistanPharma #UNFPA #WomenEmpowerment #HealthcareInnovation #SelfCare #DKTPakistan
A historic achievement for Incepta Pharmaceuticals Ltd.! 🏆 We are thrilled to announce that our Medroxyprogesterone Acetate Suspension for Subcutaneous Injection (MEDOGEN SUBQ) has been WHO Prequalified — becoming the world’s first-ever generic self-injectable contraceptive to receive this prestigious recognition! This groundbreaking milestone not only underscores Incepta’s commitment to innovation and global quality standards, but also celebrates the technological advancement and manufacturing excellence of Bangladesh’s pharmaceutical industry on the world stage. MEDOGEN SUBQ offers 12–14 weeks of reliable protection against pregnancy, empowering women everywhere with greater freedom, choice, and confidence in family planning. At Incepta, we are proud to deliver high-quality, affordable, and life-changing healthcare solutions — because everyone deserves access to better health, everywhere. 🌏 #InceptaPharmaceuticals #GlobalMilestone #PharmaInnovation
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People didn't initially know what he was talking about when the President blurted something about a lower #price for #Ozempic to open an event about fertility drugs. But when they figured it out, Novo Nordisk and Eli Lilly and Company stock prices tumbled. https://lnkd.in/eb5SnChJ
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🇺🇸 White House makes new ‘most favored nation’ deal. Expanding Access. Strengthening Health Security. President Donald Trump announced a major new agreement with EMD Serono, Inc. (Merck KGaA) to lower the cost of IVF treatments by 42–79%, marking one of the most sweeping fertility drug pricing initiatives to date under the Most Favored Nation framework. The deal secures “massive discounts” on fertility medications, which will be available through the TrumpRx direct-to-consumer hub in early 2026 — and includes a commitment from EMD Serono to sell all future drugs at “most favored nation” prices. In exchange, the company’s U.S.-manufactured ingredients and products will be exempt from upcoming pharma tariffs — a clear signal that domestic production and affordability are now inseparable priorities for the nation’s health security strategy. The White House also announced: 🧬 Negotiations to lower GLP-1 drug prices from Novo Nordisk and Eli Lilly 💊 A new FDA “National Priority Voucher” program to accelerate U.S. review of essential drugs like Pergoveris, which EMD Serono will manufacture domestically ✅ At LifeScienceX, we see this as further proof that infrastructure, pricing reform, and reshoring are converging — building a more resilient, equitable healthcare ecosystem where life-saving and life-creating medicines are made and accessible in the U.S. #LifeScienceX #HealthSecurity #Reshoring #Biomanufacturing #PharmaInfrastructure #IVF #DrugPricing #MadeInAmerica Read the full article below: https://lnkd.in/gb6Ex5EH
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🇺🇸 White House makes new ‘most favored nation’ deal. Expanding Access. Strengthening Health Security. President Donald Trump announced a major new agreement with EMD Serono, Inc. (Merck KGaA) to lower the cost of IVF treatments by 42–79%, marking one of the most sweeping fertility drug pricing initiatives to date under the Most Favored Nation framework. The deal secures “massive discounts” on fertility medications, which will be available through the TrumpRx direct-to-consumer hub in early 2026 — and includes a commitment from EMD Serono to sell all future drugs at “most favored nation” prices. In exchange, the company’s U.S.-manufactured ingredients and products will be exempt from upcoming pharma tariffs — a clear signal that domestic production and affordability are now inseparable priorities for the nation’s health security strategy. The White House also announced: 🧬 Negotiations to lower GLP-1 drug prices from Novo Nordisk and Eli Lilly 💊 A new FDA “National Priority Voucher” program to accelerate U.S. review of essential drugs like Pergoveris, which EMD Serono will manufacture domestically ✅ At LifeScienceX, we see this as further proof that infrastructure, pricing reform, and reshoring are converging — building a more resilient, equitable healthcare ecosystem where life-saving and life-creating medicines are made and accessible in the U.S. #LifeScienceX #HealthSecurity #Reshoring #Biomanufacturing #PharmaInfrastructure #IVF #DrugPricing #MadeInAmerica Read the full article below: https://lnkd.in/gs49twzN
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🤝 Pfizer has acquired Metsera for up to $7.3 billion, strategically positioning itself at the forefront of developing next-generation obesity and metabolic disorder treatments. 💊 Metsera's key asset, MET-097i, is a novel dual GLP-1/glucagon agonist that has shown an average 14% weight loss over 12 weeks with significantly improved tolerability compared to existing GLP-1s. 📈 This acquisition allows Pfizer to aggressively compete in the lucrative and rapidly growing obesity market, aiming to deliver more effective, accessible, and tolerable therapeutic options worldwide. #Sherringford #TheHealthcareCurator #HealthcareCuratedContent #HealthcareLearningPlatform #IMG #providers #nursing #medicine https://lnkd.in/eT8X-6Me Read More 👇 https://lnkd.in/eT8X-6Me
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FDA Clears Simponi (Golimumab) for Children with Ulcerative Colitis The U.S. Food and Drug Administration (FDA) has approved Simponi (Golimumab) for the treatment of children aged two years and older with moderately to severely active ulcerative colitis (UC) who weigh at least 15 kg. https://lnkd.in/d44Ec-3T #Simponi #Golimumab #UlcerativeColitis #PediatricUC #FDAApproval #JohnsonAndJohnson #InflammatoryBowelDisease #IBD #PediatricGastroenterology #BiologicTherapy #TNFInhibitor #ClinicalResearch #DrugApproval #MedicalAdvancements #Pharmacally #TheraSpace #Gastroenterology #AutoimmuneDisease #ClinicalTrials #FDA2025
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Medication Spotlight!!🌻 ANTIHYPERTENSIVE DRUG.🚨 "Tab Moxon" appears to be a brand name for a medication containing the active ingredient moxonidine. It is an antihypertensive drug used to treat high blood pressure (hypertension). 👉🏻Some facts about Moxonidine (the active ingredient in Tab Moxon) include: -It is a centrally acting antihypertensive medication. -It works by relaxing and widening blood vessels, which makes it easier for the heart to pump blood. -It can be used when other medications like thiazides, beta-blockers, and ACE inhibitors are not suitable or effective. -It is not a blood thinner. -Common side effects can include dry mouth, headache, dizziness, and sleepiness. -It is generally not recommended for use in pregnant or breastfeeding women, or in children and adolescents under 18. -It should not be stopped abruptly without consulting a doctor, as this can cause a sudden increase in blood pressure.
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Lots of information provided at the #RAPSConvergence #Pediatric session! Go check out the slides. Here's a teaser with some highlights from the panel: 🌎 US, EU, and now UK all REQUIRE drug developers to perform pediatric clinical trials if there is an identified need.* *with some exemption (e.g., oncology and orphan drugs in the US, but not the EU) 🚸 Who qualifies as a ped? It's different based on location: 🇺🇸 0-16 years old 🇪🇺 0-18 years old ♊ While there are similarities between US and EU regulations, there are subtle and important distinctions between waivers deferrals, PSPs and PIPs, timelines, etc. Don't assume satisfying requirements for one will fulfill your obligations for the other! ☎️ Recommended approach: make a plan and get feedback from FDA and EMA before moving forward (this is a theme of the conference). Get feedback & regulatory alignment on at least: 🔸Unmet Need 🔹Standard of Care Comparison 🔸Benefit over SoC Suggested Process: Draft Plan ➡️ Internally hone into mature plan 🔁 Get FDA/EMA feedback ➡️ Execute #RAPS2025 #RAPSConvergence2025 #RegulatoryAffairs #ClinicalAffairs #Pharma #ClinicalTrials #DMD
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LucidQuest YouTube > Trending in Endocrinology: Diabetes distress, denosumab, and more: Endocrinology highlights this fortnight: EASD releases the first guideline on diabetes distress, promoting routine screening and structured support. CHMP issues a positive opinion on AVT03, a denosumab biosimilar, while Health Canada approves Celltrion’s STOBOCLO and OSENVELT, intensifying competition. FDA clears Palsonify, paltusotine, the first once-daily oral SST2 agonist for acromegaly. Revvity and Sanofi advance a four-plex T1D autoantibody test toward global submissions. New analyses link hypothyroidism to higher SIBO risk. Icovamenib shows 52-week HbA1c durability signals. Zydus gains Canadian approval for liothyronine tablets for patients. http://dlvr.it/TNXG7D Subscribe for more! #LucidQuest #PharmaCI
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