Why are drugs so much more expensive to develop today? 📈 Clinical Trials and Manufacturing Costs: The bulk of pharmaceutical R&D spending goes towards clinical trials and associated manufacturing costs. Costs per patient ranging from $100,000 to as much as $500,000 for trials involving expensive standard-of-care medicines or hard-to-find patients, such as those with rare diseases. Fragmentation of R&D Activity: The trend towards greater fragmentation of R&D activity and investment, with large pharmaceutical companies relying more on acquiring drugs and technologies from smaller biotechs, has led to potential underinvestment in speculative, capital-intensive applied research. Analytical Assays for Gene or Cell Therapies: For complex cell and gene therapies, developers are required to run numerous analytical assays to assess quality and release a batch, even during early clinical trials. Check out Alex Telford's blog! Alex is the founder of Convoke, a software company helping to increase capital efficiency for drug developers from development to commercialization. #assaydevelopment #drugdiscovery #clinicaltrials
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Our most popular stories of the year involve CRISPR therapies, generative AI, obesity drugs entering prime time, and changes in the Covid-19 landscape, signaling the biggest trends in the pharmaceutical and biotech industry. Read the full article below on Pharmaceutical-Technology: #globaldata #pharmaceuticaltechnology #CRISPR #AI #drugdiscovery #pharmaindustry https://lnkd.in/eaPgwarh
Pharmaceutical Technology’s most-read stories of 2023 - Pharmaceutical Technology
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Feature - Pharmaceutical Technology’s most-read stories of 2023 Our most popular stories of the year involve CRISPR therapies, generative AI, obesity drugs entering prime time, and changes in the Covid-19 landscape, signaling the biggest trends in the pharmaceutical and biotech industry. - https://lnkd.in/dJw-if2G #pharma #crispr #generativeai #obesitydrugs #covid19 #biotech #ai #aiinhealthcare #rna #drugdiscovery
Pharmaceutical Technology’s most-read stories of 2023 - Pharmaceutical Technology
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𝐁𝐢𝐨𝐩𝐡𝐚𝐫𝐦𝐚𝐜𝐞𝐮𝐭𝐢𝐜𝐚𝐥𝐬: 𝐅𝐮𝐭𝐮𝐫𝐞 𝐒𝐜𝐨𝐩𝐞 𝐃𝐨𝐰𝐧𝐥𝐨𝐚𝐝 𝐅𝐫𝐞𝐞 𝐏𝐃𝐅 𝐒𝐚𝐦𝐩𝐥𝐞 𝐂𝐨𝐩𝐲: https://lnkd.in/dQd-_niU A biopharmaceutical, also known as a biological medical product, or biologic, is any pharmaceutical drug product manufactured in, extracted from, or semi synthesized from biological sources. Different from totally synthesized pharmaceuticals, they include vaccines, whole blood, blood components, allergenics, somatic cells, gene therapies, tissues, recombinant therapeutic protein, and living medicines used in cell therapy. Biologics can be composed of sugars, proteins, nucleic acids, or complex combinations of these substances, or may be living cells or tissues. They (or their precursors or components) are isolated from living sources—human, animal, plant, fungal, or microbial. They can be used in both human and animal medicine. The large majority of biopharmaceutical products are pharmaceuticals that are derived from life forms. Small molecule drugs are not typically regarded as biopharmaceutical in nature by the industry. However members of the press and the business and financial community often extend the definition to include pharmaceuticals not created through biotechnology. That is, the term has become an oft-used buzzword for a variety of different companies producing new, apparently high-tech pharmaceutical products. When a biopharmaceutical is developed, the company will typically apply for a patent, which is a grant for exclusive manufacturing rights. This is the primary means by which the developer of the drug can recover the investment cost for development of the biopharmaceutical. The patent laws in the United States and Europe differ somewhat on the requirements for a patent, with the European requirements are perceived as more difficult to satisfy. Application: · Tumor · Diabetes · Cardiovascular · Hemophilia · Others Types: · Monoclonal Antibodies · Interferon · Colony-Stimulating Factor · Erythropoietin · Insulin · Vaccines · Growth Hormones · Others #biopharma #biopharmaceuticals #biopharmaceutical #pharmaceutical #pharmaceuticals #biotech #biotechnology
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💊𝗕𝗹𝗼𝗴𝗴𝗲𝗿 #ConnectingInforming #DrugDiscoverytoDrugDelivery 💻𝗩𝗶𝗱𝗲𝗼 𝗖𝗼𝗻𝘁𝗲𝗻𝘁 𝗖𝗿𝗲𝗮𝘁𝗼𝗿 YouTube: RSK Life Science Media 📈𝗖𝗼𝗻𝘀𝘂𝗹𝘁𝗮𝗻𝘁-LinkedIn/Marketing/Media/Events, Brand Champion
#News: The FDA approved nearly 50% more #noveldrugs in 2023 than in 2022, putting it back on pace with historical levels, an improvement analysts and investors said could lead to increased investment in #biotech firms. #FDA nods for innovative #therapies containing an #activeingredient or #molecule not previously approved, rose to 55 in 2023, up from 37 in 2022 and 51 in 2021. Historical data shows the FDA typically green lights about 45-50 new drugs a year and hit a peak of 59 in 2018. The agency approved several high-profile therapies such as Eli Lilly and Company 's (LLY.N) #obesity drug #Zepbound and Eisai US (4523.T) and Biogen 's (BIIB.O) #Alzheimer's treatment #Leqembi. It also approved five #genetherapies in addition to the 55 #noveldrugs, including a #sicklecell disease treatment from Vertex Pharmaceuticals (VRTX.O) and CRISPR Therapeutics (CRSP.BN) using the latter's innovative #geneeditingtechnology. Read more from Reuters link in comments 👇🏽
US FDA approvals bounce back in 2023, sparking hopes of a biotech recovery
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Despite its humble beginnings, the U.S. pharmaceutical industry has come a long way. From merely producing alkaloids as agents to treat diseases, in recent times, the industry has emerged as a front-runner in creating monoclonal antibodies, gene therapies, and biosimilars to treat diseases that were once fathomed untreatable by mankind. Despite the tough competition it is facing from emerging economies like China, the U.S. continues to make great strides in the global pharmaceutical industry. The U.S. occupies a lion's share of around 42.6% of the global pharmaceutical market. Here are some interesting insights about the global pharmaceutical leader, the U.S. pharmaceutical industry. Its market value, market segmentation, growth drivers, factors changing the industry's course, and more to make the right data-backed decisions that propel your venture's revenue growth. Explore more: https://lnkd.in/ddV3qNZf #healthcare #pharmaceutical #marketinsights #USpharmaceuticalindustry #pharmaceuticalindustry #pharmaceuticalmarket #insights #infocleanse
U.S. Pharmaceutical Market Size, Share & Growth | Forecast
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🌟 This week is Canadian Innovation Week #CIW2024. What a great opportunity to showcase the innovative work of our colleagues in #Vancouver! At Evonik Health Care’s Vancouver Laboratories (VAN), our colleagues are creating the next generation of #pharmaceuticals. They bring together expertise in pharmaceutical technology, formulation and manufacturing process design, scale-up and much more to work on cutting edge technology as a center of excellence for lipid nanoparticles (LNPs), nucleic acid-based formulations and vaccines.👨🔬👩🔬 LNP-based formulations are used to create innovative and future drug products for a whole range of therapies including protein replacement therapy, preventative and curative vaccines, and for gene editing. Potential applications are huge! As one of the world’s leading CDMOs for LNP-based drug products, our roots in Canada go back over two decades, when we acquired and integrated Transferra Nanosciences. 💜 A big thanks to all our colleagues in Canada, who work tirelessly to support the pharma industry worldwide with comprehensive services for early clinical-phase GMP-compliant manufacturing, and with our LIPEX® branded products. 💡 Read more about why LNPs represent a significant opportunity for LNP-based formulations in our recent article: https://lnkd.in/enzUFrKA 🌐 Or visit our website to learn more about our drug delivery solutions for nucleic acid delivery: https://lnkd.in/dBng3VSF #lipids #LNPs #lipidnanoparticles #vaccines #mRNA #rna #genedelivery #nanoscience #drugdevelopment
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IIT Guwahati | Registered Pharmacist @WBPC | M Tech in Biomedical Science and Engineering | Medical Device and Diagnostics
The Drugs Controller General of India (DCGI) has issued a new order under Rule 101 of the New Drugs and Clinical Trial Rules, 2019, specifying certain countries for waiver of local clinical trials for new drug approvals. This update is crucial for pharmaceutical companies and stakeholders in the healthcare sector. 🔍 Key Points from the Order: 1. Countries Included: - USA 🇺🇸 - UK 🇬🇧 - Japan 🇯🇵 - Australia 🇦🇺 - Canada 🇨🇦 - EU 🇪🇺 2. Categories of New Drugs: - Orphan Drugs for rare diseases - Gene and cellular therapy products - New drugs used in pandemic situations - New drugs used for special defense purposes - New drugs having significant therapeutic advance over the current standard of care This decision aims to streamline the approval process for innovative therapies and ensure timely access to advanced treatments. It is a significant step towards enhancing healthcare outcomes in India. 📢 Spread the word and stay updated on the latest regulatory changes in the pharmaceutical industry! Follow Raksha Ray #Pharmaceuticals #DrugApproval #ClinicalTrials #Healthcare #DCGI #India #NewDrugs
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Chief Editor at Follow Your Buyer, Host of The Trailblazers, Moderator & Host for Outsourced Pharma Capacity Update, Clinical Leader Solutions Expo & Virtual Pharma Expo.
NOT YOUR YOUR GRANDFATHER'S DRUG DEVELOPMENT PROCESS! Specialized, patient-centered drug development calls for a more specialized way for you to find the right CDMO to advance your drug therapy. We’ve expanded the Outsourced Pharma Capacity Update, May 20th-23rd, with a series of specialized sessions. Each day delivers presentations from innovative CDMOs and they are grouped by specific capabilities, so that you can attend the sessions that most meet your needs. Register now https://lnkd.in/gjrh6vJQ for fill-finish, large molecule drug substance & development, small molecule API & HPAPI development, small molecule finished dosage form, and cell & gene therapy. The presenters include: AbbVie Ajinomoto Bio-Pharma Services Alcami Corporation INCOG BioPharma Services Pfizer CentreOne Resilience SMC Ltd. AGC Biologics EirGenix, Inc. JOINN Biologics US Inc. KBI Biopharma Mabion S.A. Samsung Biologics Scorpius BioManufacturing, Inc. SGS Singota Solutions Adare Pharma Solutions Lonza Pharma Expanse Societal™ CDMO Aldevron Andelyn Biosciences Cellistic Comprehensive Cell Solutions (CCS) ElevateBio MilliporeSigma Recipharm Theragent Inc Vernal Biosciences WuXi Advanced Therapies #pharmainnovation #pharmaceutical #pharmaceuticalmanufacturing Life Science Connect Cory Coleman Nathan Miller Tim Bretz Michael Stadtlander Andreas Migias Owen Takac Jon Howland Kevin Morey Courtney Sargent
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Over the past few decades, biologic drugs have broadened their therapeutic applications. Our recent blog explores the key differences between biologic and small molecule drugs, focusing on their source, size, structure, stability, and immunogenicity. Biologic drugs, derived from living sources, are larger and more complex than chemically synthesized small molecule drugs. This complexity leads to unique challenges and benefits in drug development and patient care. Read the full article: https://bit.ly/3YkyodX #Biologics #PharmaInnovation
Why are Biologics Drugs Different
synergbiopharma.com
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Director, Regulatory Affairs CMC at Syner-G BioPharma Group | Supporting clients with strategic and effective presentation of CMC data to global regulatory authorities
Great quick read providing an introduction to the attributes which make biological drugs unique
Over the past few decades, biologic drugs have broadened their therapeutic applications. Our recent blog explores the key differences between biologic and small molecule drugs, focusing on their source, size, structure, stability, and immunogenicity. Biologic drugs, derived from living sources, are larger and more complex than chemically synthesized small molecule drugs. This complexity leads to unique challenges and benefits in drug development and patient care. Read the full article: https://bit.ly/3YkyodX #Biologics #PharmaInnovation
Why are Biologics Drugs Different
synergbiopharma.com
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