The fourth quarter of 2024 is critical for the biotech industry, with 5 major FDA approval decisions on the horizon. These upcoming verdicts could impact everything from treatments for #cancer to #rarediseases 🧬 Stay ahead of the latest in #biotech and learn how these #FDA decisions could shape the future of healthcare.
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Nintedanib: A Novel Therapeutic Approach for Idiopathic Pulmonary Fibrosis. Recent studies has shown that Nintedanib has significant efficacy in the treatment of NSCLC (Non-small cell Lung Cancer), Ovarian cancer and IPF (Idiopathic Pulmonary Fibrosis). At Pharmaffiliates, we believe that every new drug molecule is a step towards a healthier world. Together, we can make a difference. Fast-track your research with our trusted & high quality Nintedanib reference standards, pharmaceutical impurities and related compounds. 𝐓𝐨 𝐯𝐢𝐞𝐰 𝐜𝐨𝐦𝐩𝐥𝐞𝐭𝐞 𝐥𝐢𝐬𝐭 𝐨𝐟 𝐍𝐢𝐧𝐭𝐞𝐝𝐚𝐧𝐢𝐛 𝐢𝐦𝐩𝐮𝐫𝐢𝐭𝐢𝐞𝐬, 𝐀𝐏𝐈 𝐬𝐭𝐚𝐧𝐝𝐚𝐫𝐝𝐬 & 𝐫𝐞𝐥𝐚𝐭𝐞𝐝 𝐜𝐨𝐦𝐩𝐨𝐮𝐧𝐝𝐬 - https://lnkd.in/gBXDmqQR #research #ReferenceStandards #Pharmaffiliates #AnalyticalChemistry #DrugDiscovery #drugresearch #Impurities #contractresearch #cro #cdmo #stableisotopes #intermediates #pharmaceutical #research #researchanddevelopment #analyticalchemistry #drugdevelopment #qualitycontrol #qc #drugdiscovery #pharmacokinetic #CMC #impurityqualification #Pharmacodynamics #drugmanufacturing #healthcareinnovation #pharmamanufacturing #api #activepharmaceuticalingredient #Nintedanib
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Biocon Biologics successfully developed and launched the world’s first biosimilar Trastuzumab for patients of HER2-positive metastatic breast cancer in India in 2014. Our biosimilar Trastuzumab was the first to be approved by the U.S. Food and Drug Administration (FDA). Today, our biosimilar Trastuzumab is offering millions of breast and gastric cancer patients across the globe access to a more affordable treatment option. Our three commercialized biosimilars for cancer, Trastuzumab, Pegfilgrastim and Bevacizumab, are helping reduce costs, improving access to biologics therapy and advancing the quality of care in LMICs. In line with our commitment of expanding access to biosimilars, we have commissioned a report that provides key insights into creating a more supportive environment for these lifesaving medicines in LMICs. Download the Report: https://bit.ly/47WvTBg Seema Shah Ahuja Gopal Rao Saurabh Narain Susheel Umesh Pritha Paul Rahul Kapur Dr. Shivani M. Nimish Shah Matt Erick Sandeep Athalye #CancerCare #AffordableHealthcare #Biosimilars #HealthcareForAll #BioconBiologics #ClarivateReport
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Pathways of drug development in Oncology specifically looking into time and nature of initial FDA approval, summarised by Tanja Obradovic https://lnkd.in/dE5DCHbg National Pharmaceutical Council Julie Patterson James Motyka Rayan Salih, PharmD Jon Campbell John O'Brien #Cancer #FDA #CancerDrug #CancerTreatment #Medicine #Health #Oncology #OncoDaily
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𝐀𝐮𝐠𝐮𝐬𝐭 19 - 20, 2024 𝐁𝐢𝐨𝐭𝐞𝐜𝐡 𝐚𝐧𝐝 𝐏𝐡𝐚𝐫𝐦𝐚 𝐔𝐩𝐝𝐚𝐭𝐞𝐬 • Eli Lilly's GIP/GLP-1 golden-goose reduces type 2 diabetes occurrence • J&J nabs FDA approval for first-line mAb+small molecule combo in lung cancer • Pathalys Pharma $105M Series B • Organon buys migraine med Emgality rights from Eli Lilly for multiple countries • Emergent to donate 50k smallpox vaccines • Ozempic/Wegovy use may be linked to suicidal thoughts • Teva & Biogen (separately) sued for alleged pharmacy/PBM kickbacks related to MS meds More in today's TLDR Biotech newsletter: https://lnkd.in/gzXHDX4i #biotech #pharma #pharmanews #biotechnews #tldrbiotech
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Thoughts on this? >> Bristol Myers nabs approval for Opdivo combo as first-line bladder cancer treatment >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #productmarketing #pharma #pharmaceutical #healthcare #biotech
Bristol Myers nabs approval for Opdivo combo as first-line bladder cancer treatment
https://endpts.com
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It is hard not to be cynical in the benefit space! 😒 This week Merck announced that Keytruda has shown success with subcutaneous injection. For the world's bestselling drug, approved for 41 cancer indications (and counting), a form that doesn't involve an infusion in an infusion center would be a great step forward for patients. What else is exciting for Keytruda? 🎉 Keytruda is coming off patent in 2028! 🎉 Price should lower as competition is coming! 🛑 Unless everyone switches to subcutaneous, it says on patent, and continues to drive cost Back to cynical about something that should be exciting! 😒 It is hard not to think that this is coming out to protect profits versus coming out as a great needed improvement! 💡 Tip- Monitor your medical claims for Keytruda (you won't see this on pharmacy!). It is one of the most inflate infusions that we see and jump into work on! Reach out to me about what you are paying for a dose of Keytruda, and I will let you know where you stand with it! 💡 #Pharmacist #Pharmacybenefits #PBM #Medical #Oncology https://lnkd.in/g2vrQYVU
Taking its best shot at Roche, Merck scores in phase 3 trial of subcutaneous Keytruda
fiercepharma.com
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Thoughts on this? >> FDA rejects liver cancer drug combo, shares of Korean biotech tank >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #pharma #healthcare #pharmaceutical #productmarketing #biotech
FDA rejects liver cancer drug combo, shares of Korean biotech tank
https://endpts.com
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(Benefit-Risk Management / Bladder Cancer Treatments / (Revised) US FDA Draft Guidance) If you're in the clinical cancer space (and possibly not in bladder CA area), I would still recommend reviewing this guidance as the latest pulse on FDA's onc considerations during drug development and net-benefit assessments for bringing a product to market. Start w/table of contents. Drug or biologic, both inclusive. #fda #cder #cber #drugs #biologics #bladdercancer #cancerdrugs #clinicalstudies #clinicalresearch #clinicaltrials
BCG-Unresponsive Nonmuscle Invasive Bladder Cance
fda.gov
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AstraZeneca India to Launch Tremelimumab (Imjudo) in October 2024 #AstraZenecaIndia is preparing to launch #Tremelimumab (#Imjudo) in combination with #Durvalumab (#Imfinzi) for the treatment of patients with #UnresectableHepatocellularCarcinoma (uHCC) in October 2024. This launch represents a major step forward in providing cutting-edge treatment options for #LiverCancer patients in #India. The company received #Import and #Market #Permission from the #DrugsControllerGeneralofIndia (#DCGI) on June 1, 2023, for Tremelimumab (Imjudo) Concentrate for infusion (20 mg/ml) in 25 mg and 300 mg single-dose vials for intravenous administration. This milestone underscores AstraZeneca's commitment to advancing #Oncology care and improving #PatientOutcomes in India. #AstraZeneca #Pharma #Oncology #uHCC #Tremelimumab #Imjudo #Imfinzi #CancerCare #Innovation #DCGI #LiverCancer #Healthcare #Pharmaceuticals #India #RASLifeScienceSolutions #MarketIntelligence #MarketResearch #CompetitiveIntelligence #StrategySupport #ConferenceCoverage #PortfolioOptimization Detailed News: https://lnkd.in/dMPYCZMQ Follow our page for more industry updates: https://lnkd.in/de5zNWmK
AstraZeneca Pharma India to launch Tremelimumab
indianpharmapost.com
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Innovate Pasadena #FridayCoffeeMeetup with Clincy Cheung - Scaling overl… Powered by Restream https://restream.io/ Recently, radiopharmaceutical development has re-accelerated with the notable approvals of Lutathera and Pluvicto; both have been effective for neuroendocrine and prostate cancers, respectively, while limiting radiation to healthy tissue within the body. However, one major issue surrounding all types of radiopharmaceuticals is the difficulty of navigating the supply chain and supporting expensive development for each drug. DropletPharma aims to support pharmaceutical companies of all sizes in scaling development for their radiopharmaceutical pipelines, establishing quick and robust supply for clinical trials, and enabling vast distribution around the world through its development of a new unified platform. As new cancer diagnoses each year are projected to increase to 2.2M patients by 2050 in the United States alone, radiopharmaceuticals and DropletPharma aim to play a major role as a scal…
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