New study reveals concerns over cancer drugs' added benefit and pricing, urging greater transparency and accountability in the pharmaceutical industry. https://lnkd.in/d97-seph . . . . #CancerDrugs #DrugPricing #HealthcareCosts #Pharmaceuticals #EvidenceBasedMedicine #PatientOutcomes #HealthPolicy #MedicalResearch #HealthEquity #DrugAffordability #HealthcareAccess #DrugApproval #Transparency #QualityOfLife #BMJStudy
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The global pharmaceutical market is 1475 billion USD in 2022 growing at a CAGR of 5% during the next six years. In comparison the chemical drug market is estimated to increase from 1005 billion in 2018 to 1094 billion U. S. dollars in 2022. #GlobalPrecisionCancerDiagnostics #CancerCare #EarlyDetection #PersonalizedMedicine #AdvancedDiagnostics #HealthcareInnovation #OncologyResearch #PatientOutcomes #MedicalTechnology #CancerTreatment
Global Precision Cancer Diagnostic Solutions Market Research Report 2024
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The global pharmaceutical market is 1475 billion USD in 2022 growing at a CAGR of 5% during the next six years. In comparison the chemical drug market is estimated to increase from 1005 billion in 2018 to 1094 billion U. S. dollars in 2022. #GynecologicalCancer #CancerDiagnostics #GeneticCounseling #CancerRisk #DiagnosticKits #EarlyDetection #CancerScreening #PharmaceuticalMarket #ChemicalDrugs #Healthcare
Global Gynecological Cancer Diagnostics Market Research Report 2024
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Johnson & Johnson's recent success in the phase 3 trial of their autoimmune drug, nipocalimab, is a significant milestone for the company. The $6.5 billion acquisition of Momenta Pharmaceuticals has proven to be a strategic move, positioning J&J to potentially compete in the treatment of generalized myasthenia gravis (gMG). However, the competitiveness of the late-to-market asset still remains unknown, despite the promising results from the trial. 🌐💉💼 The acquisition of Momenta Pharmaceuticals has opened up a world of opportunities for J&J, providing them with a viable competitor to currently approved drugs from argenx and UCB. With the potential to pursue various indications that could respond well to FcRn blockade, the company stands to gain a significant share of the market. While argenx's setbacks have tempered initial excitement surrounding FcRn, there is still the potential for billions of dollars to be up for grabs in this space. 💰📈💊 In their most recent announcement, J&J shared positive results from the phase 3 clinical trial of nipocalimab in gMG, with the drug meeting its primary endpoint. The successful comparison of nipocalimab and placebo on MG-ADL indicates a positive impact on the daily lives of patients. This exciting development paves the way for discussions with regulators about approving the anti-FcRn antibody for the treatment of gMG. 🎉🔬👩⚕️ #Pharmaceuticals #AutoimmuneTreatment #MedicalInnovation
J&J's $6.5B autoimmune drug hits phase 3 goal, teeing up approval talks and keeping heat on argenx, UCB
fiercebiotech.com
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Recruitment Consultant - Quality & GMP Manufacturing within the Pharmaceutical and Biotechnology sector
Great article detailing the top 20 drugs worldwide by sale in 2023: The predominance of monoclonal antibodies (mAbs) among the top 20 drugs by sales in 2023 is extremely clear and can be attributed to several key factors: 1. **Targeted Therapy**: Monoclonal antibodies are highly specific to their targets, which allows them to effectively target and neutralize disease-causing agents, particularly in cancer and autoimmune diseases. This specificity results in better efficacy and fewer off-target effects compared to traditional small-molecule drugs. 2. **Advancements in Biotechnology**: Over the past few decades, significant advancements in biotechnology have enabled the efficient production and development of monoclonal antibodies. Techniques like recombinant DNA technology and hybridoma technology have streamlined the creation of these complex biologics. 3. **High Unmet Medical Needs**: Many mAbs address conditions with high unmet medical needs, such as various forms of cancer, rheumatoid arthritis, and other autoimmune diseases. Diseases in these categories often have fewer effective treatment options, and mAbs can offer significant therapeutic benefits. 4. **Market Exclusivity and Patent Protection**: Monoclonal antibodies often benefit from extended market exclusivity and strong patent protection, allowing pharmaceutical companies to maintain higher prices for longer periods. This exclusivity can make mAbs highly profitable. 5. **Clinical Efficacy and Safety**: Monoclonal antibodies have shown impressive clinical efficacy and safety profiles in treating a range of serious conditions. Their ability to specifically target disease mechanisms often results in better outcomes and fewer side effects, enhancing their adoption in clinical practice. 6. **Chronic Diseases and Long-Term Use**: Many mAbs are used to treat chronic conditions that require long-term management. This leads to sustained demand and consistent sales over time, contributing to their high sales volumes. 7. **Regulatory Approvals and Expanding Indications**: Regulatory bodies have approved numerous monoclonal antibodies for a wide range of indications. Furthermore, many mAbs receive additional approvals for new indications beyond their original use, expanding their market and sales potential. 8. **Strong Commercialization and Marketing**: Pharmaceutical companies have heavily invested in the commercialization and marketing of monoclonal antibodies. This includes educational campaigns for healthcare providers and patients, which increase awareness and adoption of these therapies. In summary, the top sales rankings of monoclonal antibodies in 2023 are driven by their targeted action, clinical effectiveness, ability to meet significant medical needs, strong patent protection, and successful commercialization efforts. full article: https://lnkd.in/eQx636x4 #biotechnology #pharmasales #qualityassurance
The top 20 drugs by worldwide sales in 2023
fiercepharma.com
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Executive Board Advisor & Consultant. International scaleup. Go-to-market options. Optimising international scaleup through distributors. Improving business development success in complex sales for B2B service providers.
"The science is not enough to succeed" as this (yet another) example proves. I have been reciting my mantra to small-time life science companies who I describe as "science rich, commercially naive" for some time now. This example shows several features about drug development: 1. The huge risks involved in bringing a drug to market. 2. The fact that some therapy areas are more challenging than others for drug development. 3. The fatal flaw of focusing on science when instead they must "begin with the end in mind" (Covey: 7 Habits book) by defining the unmet need versus current standard care, how difficult, costly and risky it will be to prove the drug works with outcomes a payor will fund. 4. Not considering a payor's perspective which is never on the science, but on the impact the drug has on the burden of illness and if it can be proven to be cost-effective. Anything in neurodegenerative disease (such as Alzheimer's and dementia for example) is challenging to show efficacy. After that, the pricing becomes sensitive as recent developments in the amyloid story have proven. It seems to me that being science-rich in SMEs is akin to a Lemming philosophy where they all blindly follow each other for funding only to leap off a cliff to their death drowned in debt through commercial failure. If only.... If only they opened themselves to strong challenges about their asset from me before they drowned, they may have followed a better path towards success because with me, they would tightly define unmet need and the size of the opportunity to assess how costly and risky it would be to turn that base-metal into gold. Perhaps they should have studied alchemy instead of biochemistry?
Amylyx Pharmaceuticals is keeping a promise by pulling the amyotrophic lateral sclerosis (ALS) therapy Relyvrio off the market after the drug failed in a confirmatory trial.
Amylyx to pull failed ALS drug Relyvrio from market, cut 70% of staffers
fiercepharma.com
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Regulatory Affairs Professional || Regulatory Compliance || Regulatory Strategy || CAPA || Change control || Pre-clinical and Clinical Research || Actively seeking full time opportunities in Regulatory and Quality domain
📢Exciting News 📍 Today, Accord Biopharma, Inc. a subsidiary of Intas Pharmaceutical Ltd has gotten the acceptance of its #Biosimilar DMB-3115 which is proposed biosimilar to STELARA ® (ustekinumab) from #USFDA 📌Accord Biopharma, Inc. conducted multi-regional Phase-III clinical trail in patients with plaque psoriasis. The main focus of the study was the rate of change in the Psoriasis Area and Severity Index (PASI) to assess skin symptom improvement. 💊 STELARA®, a Janssen Biotech blockbuster, approved for psoriasis, psoriatic arthritis, Crohn's, and colitis. It raked in $13.9B in U.S. sales in 2022, ranking among top biologics. #Biosimilar #USFDA #ustekinumab #accordbiopharma #Intas https://lnkd.in/eQiVMPst
Accord BioPharma, Inc. Announces U.S. FDA Acceptance of Biologics License Application for Proposed STELARA® Biosimilar DMB-3115
prnewswire.com
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KORU today announced a collaboration with a global pharmaceutical company to initiate a feasibility study with the Freedom System for an FDA and EMA approved subcutaneous oncology biologic drug currently being delivered via manual syringe administration by healthcare professionals. The Freedom System is a purely mechanical ambulatory drug delivery device with 11 drugs approved on the label and over 40,000 patients globally. It’s designed to deliver large volumes of biologic medications subcutaneously and is capable of allowing patients to self-administer at home or by healthcare professionals in a clinic setting. Conversion of intravenous biologics to subcutaneous administration formulations is a growing trend in the oncology market. Evidence suggests subcutaneous administration of oncology therapy simplifies treatment, reduces pressure on hospitals, and improves quality of life. With the development of new subcutaneous drug therapies, there is an opportunity to develop drug delivery administration solutions which will optimize drug administration. “This collaboration presents an exciting, new opportunity to enter the growing oncology subcutaneous biologic market to solve significant unmet needs in the delivery of this life-saving therapy with our patient-centric solutions,” said Linda Tharby, KORU Medical’s President and CEO. “There are multiple subcutaneous oncology biologics currently approved using manual administration with an estimate of over one million global infusions. We anticipate progressing to commercialization of the Freedom System for this drug within 12 months.” Read full announcement here: https://hubs.la/Q02zL76s0 #KORU #FreedomInfusionSystem #FreedomInfusion #Milestone
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The global pharmaceutical market is 1475 billion USD in 2022 growing at a CAGR of 5% during the next six years. In comparison the chemical drug market is estimated to increase from 1005 billion in 2018 to 1094 billion U. S. dollars in 2022. #GlobalOvarianCancerDrugsMarket #OvarianCancerTreatment #CancerResearch #PharmaceuticalIndustry #CancerTherapeutics #PersonalizedMedicine #Healthcare #CancerCare #MedicalAdvancements #MarketOutlook
Global Ovarian Cancer Drugs Market Research Report 2024
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Exciting strides in the pharmaceutical world! Sally Turner’s recent article for Pharmaceutical-Technology explored the most groundbreaking pharmaceutical breakthroughs of 2023 with the valuable insights from Surbhi Gupta, Senior Industry Analyst, Growth Opportunity Analytics – HLS, at Frost & Sullivan. 🌐 From cancer treatments to rare diseases, the pharmaceutical industry is revolutionizing healthcare. Explore the top 10 novel drugs that made headlines. #MedicalAdvancements #PharmaBreakthroughs
Pharma breakthroughs: 10 novel drug approvals that made headlines in 2023 - Pharmaceutical Technology
pharmaceutical-technology.com
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FDA/CDER Approvals in 2023: A Comprehensive Overview of Novel Drugs The FDA approved 56 innovative drugs in 2023, a 51% increase from the previous year. Pfizer had the highest number of approvals with 6 drugs, while Biogen AstraZeneca , Chiesi Group and UCB also had multiple approvals. The drugs covered various conditions and belonged to different therapeutic classes. #Oncology had the highest number of approvals, followed by neurology and autoimmune disorders. The drugs had different regulatory designations, such as accelerated approval or orphan drug status. For more details please click the link! https://lnkd.in/dChzJjiP #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical #fda
FDA/CDER Approvals in 2023: A Comprehensive Overview of Novel Drugs
https://marketaccesstoday.com
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