Mike Hyungkyu Park’s Post

Global pharma majors pitch for faster approval of innovative drugs in India but CDSCO remains cautious 📌Global pharmaceutical giants, including Pfizer, Roche, Bayer, Merck, Novo Nordisk, and Novartis, are urging the Central Drugs Standard Control Organisation (CDSCO) to streamline approvals 📌They advocate for parallel market authorization, allowing drugs to launch simultaneously in India, the US, and Europe 📌The Organisation of Pharmaceutical Producers of India (OPPI) supports this initiative to reduce the delay in introducing international drugs to India. 📌While India permits clinical trial waivers for drugs licensed in their country of origin, the CDSCO rarely allows launches without local trials, resulting in significant delays. 📌Emergency use authorizations during the COVID-19 peak provided exceptions for drugs like favipiravir and paxlovid #India as the preferred destination for Phase 3 studies #cdsco

SPIMACO, a leading Saudi pharmaceutical manufacturer with a strong presence in 16 countries, has joined forces with #AltosBiologics, a South Korean #Biotechnology company that was founded as a subsidiary of ALTEOGEN Inc., in 2020. #Altos specializes in the development of #Biosimilars and #Biobetters. This strategic #Partnership will bring #ALTL9, a groundbreaking biosimilar treatment for #VisionDisorders, to patients across the region. The agreement will enable SPIMACO significantly expand its #Injectable and biosimilar portfolio, reinforcing its leading position in the region’s pharmaceutical market with #Innovative products and support a quick access to this essential treatment to patients who are suffering from #AgeRelatedMacularDegeneration (AMD), #DiabeticMacularEdema, and #RetinalVeinOcclusion, while therapeutic options remain limited. SPIMACO’s state-of-the-art manufacturing facilities and deep understanding of the local market, combined with Altos Biologics’ expertise in #Developing and #Commercializing biosimilars, create a powerful alliance. #SPIMACO #AltosBiologics #ALT_L9 #SaudiVision2030 #SaudiArabia #GCC #MENA #RASLifeScienceSolutions #MarketIntelligence #MarketResearch #CompetitiveIntelligence #StrategySupport #PortfolioOptimization #MarketExpansion #PartnerIdentification Detailed News: https://lnkd.in/d9EP2aFh Follow our page for more industry updates: https://lnkd.in/de5zNWmK

Susana Almeida's insights at the Global Quality Summit highlight a crucial focus: global regulatory harmonisation for biosimilars. This ET Pharma interview underscores the need for international collaboration to ensure widespread access to affordable, reliable healthcare solutions. A must-read for those driving innovation through strategic global partnerships in pharmaceuticals. #HealthcareInnovation #GlobalRegulation #Biosimilars

We are excited to share the latest updates from our📄weekly reports spanning from March 23rd to March 29th, 2024: 1️⃣Global Innovative Drugs R&D Progress Report 2️⃣China Generic Drugs Development Progress Report These reports provide invaluable insights into the ever-evolving pharmaceutical landscape. Here are some key highlights from the Global Innovative Drugs Report for the week: 1. Global Drug Approvals: - FDA approved Vadadustat for anemia in dialysis-dependent CKD adult patients. 2. BLA Approval - FDA approved Sotatercept for Pulmonary arterial hypertension (PAH) targeting Activins; Hemoglobins; and Bone resorption factor; TGF-β. 3. Oncology R&D: - Positive data presented for Plinabulin in ES-SCLC and DM5167 in TNBC. Several Phase I/II trials initiated in solid tumors. 4. Hematology R&D: - Phase I trials initiated for coagulation factor therapies TU-7710. Positive data from Phase II trials of SL-S009 in AML. The report provided updates on major regulatory milestones and progress in clinical research for innovative drug candidates globally and in China over the period. 📚 For a comprehensive analysis and in-depth insights, we encourage you to access the full reports on our website. To Download Full Reports, click the link below: https://lnkd.in/gpj5REyS 🚀 Stay informed and empowered in the dynamic field of drug development. Download the reports now to enhance your industry knowledge. 🔗 Remember to follow us on LinkedIn for regular updates and industry insights. #PharmaceuticalIndustry #DrugDevelopment #InnovativeDrugs #GenericDrugs #IndustryInsights #StayInformed" #SaSPinjara #PharmacodiaGlobal

The small molecule injectable drugs market is poised for substantial growth, with an estimated value of $355.14 billion by 2028 and a projected CAGR of 12.8%. Key drivers include advancements in drug delivery systems, personalized treatments, and the use of real-world evidence. Enhanced compliance, targeted treatment, and combination therapy options are significant benefits of these drugs, particularly for chronic diseases. Innovations such as new microparticle technology are expected to improve the solubility of active pharmaceutical ingredients, enhancing the efficacy of oral drug products. The market is also set to benefit from fast-track approvals of new drug formulations and a surge in R&D activities. Europe is anticipated to be the fastest-growing region from 2024 to 2033, while North America currently leads the market. These advancements reflect a broader trend towards improving patient outcomes and addressing the rising prevalence of chronic conditions through innovative therapeutic approaches. #SmallMoleculeInjectables #PharmaceuticalInnovation #DrugDeliverySystems #ChronicDiseaseTreatment #PharmaGrowth #Biotechnology #PersonalizedMedicine #R&D #HealthcareInnovation #CAGR https://lnkd.in/g86sq9kj

𝗦𝗵𝗮𝗽𝗶𝗻𝗴 𝗮 𝗳𝘂𝘁𝘂𝗿𝗲-𝗿𝗲𝗮𝗱𝘆 𝗽𝗵𝗮𝗿𝗺𝗮𝗰𝗲𝘂𝘁𝗶𝗰𝗮𝗹 𝗲𝗰𝗼𝘀𝘆𝘀𝘁𝗲𝗺 𝘁𝗼 𝗲𝗺𝗽𝗼𝘄𝗲𝗿 𝗶𝗻𝗻𝗼𝘃𝗮𝘁𝗶𝗼𝗻 & 𝗮𝗱𝘃𝗮𝗻𝗰𝗶𝗻𝗴 𝗽𝗮𝘁𝗶𝗲𝗻𝘁 𝗰𝗮𝗿𝗲 𝗶𝗻 𝘁𝗵𝗲 𝗘𝗨 We are proud to join forward-thinking pharmaceutical companies in signing EUCOPE - European Confederation of Pharmaceutical Entrepreneurs’ open letter to EU Institutions and Member States, advocating for a future-proofed ecosystem that fosters progress, research, and access to cutting-edge therapies. Together, we call on the leaders of the EU Institutions to take decisive actions, ensuring the EU leads the way in pharmaceutical innovation. A stronger, more supportive framework will enable groundbreaking advancements that improve patients’ lives across Europe and beyond. #AngeliniPharma #EveryStepCloser #EUPharma

#BioBDHighlights According to industry statistics, Hengrui Pharmaceutical company has made significant strides in innovative drug development this year, with over 40 Category 1 new drugs approved for clinical trials. Notably, 2 Category 1 new drugs received their first market approvals, 2 gained approval for new indications, and 3 have submitted their NDAs for the first time. 📢 In recent news, Hengrui Pharmaceutical company announced that its subsidiary, Beijing Shendi Pharmaceutical Co., Ltd., has received clinical trial approval from the National Medical Products Administration (NMPA) for SHR-6934 injection. This breakthrough drug targets heart failure, a condition for which there are currently no similar products approved globally. The clinical trials will soon begin, and the future looks bright for patients! #InnovativeMedicine #HengruiPharma #ClinicalTrials #HeartFailure #Biotech #Pharmaceuticals #DrugDevelopment #Healthcare

🚀Novel Drug Approvals: August 2024 Highlights 🚀 The pharmaceutical industry continues to make significant strides in advancing healthcare, and August 2024 has been a month of remarkable progress with as many as ten new drug approvals in different indications! Recent approvals underscore the dynamic nature of our industry and the relentless drive towards innovation and patient care. 💊 Highlighting this month’s progress, the USFDA approved six new medicines, and the EMA approved four. The number of drugs approved significantly increased compared to July 2024. 🌟Key companies securing approvals - #Takeda #JohnsonandJohnson #Incyte #Gilead #Galderma #Ascendis #Servier #Roche #ARSPharma For further information, feel free to connect with Nishu Sharma, Amit Arya, PhD, and Simrat Kaur Stay tuned for more updates on the latest in pharmaceutical innovations! 📈 AdametNext

Very informative Report by PharmaShots Team Thanks for sharing this Report

🌍 Building a Competitive & Innovative Pharmaceutical Ecosystem for the EU   As the EU looks ahead to the next decades, it's crucial to prepare the European pharmaceutical sector to tackle emerging challenges and seize new opportunities.    ✒️ By signing EUCOPE - European Confederation of Pharmaceutical Entrepreneurs’s open letter to the Presidents of the European Commission, European Parliament, and Council of the European Union, 24 EUCOPE members urge the EU Institutions and Member States to collaborate in creating a competitive and attractive pharmaceutical landscape. 🏥✨    🔬 To remain globally competitive, pharmaceutical companies need a robust, predictable and strong investment and industrial ecosystem.    💊  Special emphasis should be placed on small and mid-sized innovative companies, which are pivotal in driving technology and medical advancements across Europe.    #PharmaInnovation #EUPharma #InnovationEcosystem #RareDiseases    👓 Read the open letter here: 👉 https://lnkd.in/eCeJk8U5   Alexion Pharmaceuticals, Inc. Amgen Angelini Pharma AOP Health Biogen BioMarin Pharmaceutical Inc. Blueprint Medicines Chiesi Group Circius Pharma CSL Emergent BioSolutions Incyte Insmed Incorporated MENARINI Group Miltenyi Biomedicine MSD Norgine Orion Corporation Sanofi Santen Shionogi Europe Sobi - Swedish Orphan Biovitrum AB (publ) Takeda