#biologics — Public Fediverse posts

We published an article on Monday about India's biosimilar regulatory framework.

We are reposting the article again, in case you missed that:

#Biosimilars #ClinicalResearch #CRO #Pharma #Biologics #DrugDevelopment #CDSCO #RegulatoryAffairs #Pharmacovigilance #RWE

https://genelifecr.blogspot.com/2026/05/biosimilar-regulation-in-india-evolving.html

Our latest article explores the changing regulatory framework for biosimilars in India.

As the industry moves toward a more science-driven and risk-based approach, understanding the evolving biosimilar ecosystem becomes increasingly important for sponsors, researchers, and healthcare stakeholders.

#Biosimilars #ClinicalResearch #CRO #Pharma #Biologics #DrugDevelopment #CDSCO #RegulatoryAffairs #Pharmacovigilance #RWE

https://genelifecr.blogspot.com/2026/05/biosimilar-regulation-in-india-evolving.html

https://www.europesays.com/africa/168640/ Subcutaneous Drug Delivery Devices Market in Nigeria | Report – IndexBox #Biologics&LargeMoleculeDelivery #BiopharmaMarketReport #ChronicConditionSelfManagement #DrugContainerCompatibility&StabilityTesting #forecast #Gamma #HumanFactorsEngineering(HFE)&UsabilityDesign #MarketAnalysis #Nigeria #PrecisionMolding&AssemblyAutomation #RareDiseaseTherapies #SterilizationTechnologies(ethyleneOxide #SubcutaneousDrugDeliveryDevices #VaccineDelivery

#KNCVMCCB2026 comes to an end with an interesting talk by Danielle Vugts. She talked about the importance of #imaging during #DrugDevelopment on the example of PET imaging of #biologics.

https://link.springer.com/article/10.1186/s41181-024-00258-y
#DrugDiscovery #PETImaging #Radiolabeling #Antibodies #Nanoparticles #Chemistry

Bristol Myers Squibb’s global collaboration with Harbour BioMed — including $90M upfront and potential milestones exceeding $1B — highlights sustained momentum around next-generation antibody platforms.

Rather than single assets, pharma companies are increasingly investing in platform technologies designed to address the biological complexity of cancer.

🔗 https://www.movetheneedle.news/start-ups/bristol-myers-squibb-partners-with-harbour-biomed-as-multi-specific-antibodies-reshape-oncology-drug-development/

#business #pharma #oncology #investment #biologics #futureofmedicine #innovation

#FDA considering whether 2 place #blackbox warning, high #danger label, only used 2 flag risk of death severe harm or incapacitation, on #Covid vaccines. Initiative 2 include warning part of range of efforts by #Trump admin health officials to limit access public support for #Covid shots & other #vaccinations led by FDA chief #medical, scientific officer Vinay Prasad, who is also director of the agency’s Center for #Biologics Evaluation, & Research #publichealth #vaccines https://www.motherjones.com/politics/2025/12/fda-prasad-covid-vaccine-black-box-warning/

🧪 Could digital modeling redefine how we grow CHO cells for biologics?

🔗 Wheels turning: CHO cell modeling moves into a digital biomanufacturing era. Computational and Structural Biotechnology Journal, DOI: https://doi.org/10.1016/j.csbj.2025.06.035

📚 CSBJ: https://www.csbj.org/

#Biomanufacturing #CHOCells #DigitalTwins #BiotechInnovation #DigitalBiomanufacturing #Bioprocessing #Biologics #CellCulture #GenomeScaleModels #SmartManufacturing #BiopharmaInnovation #SystemsBiology #Biotechnology #Bioinformatics

🚀 Royed's Biopharma Global Business Course!
🌍 Designed for #Biologics & #Biosimilars pros to master regulatory, market access, CMC, digital & more.
📚 100% online | Self-paced | Certificate
🔗 https://zurl.co/Dzdcx
#BioPharma #PharmaBusiness #RoyedTraining #biopharmaBD

CVB #Notice 24-13: Field #Studies with Nonviable, Non-replicating #Veterinary #Vaccines Targeting #HPAI in #Livestock, #USDA: https://www.aphis.usda.gov/news/program-update/cvb-notice-24-13-field-studies-nonviable-non-replicating-veterinary-vaccines

Purpose of this notice is to provide an #update to interested parties regarding veterinary #biologics product license applications for veterinary biological products used to vaccinate livestock for Highly Pathogenic Avian Influenza (HPAI) #H5N1, clade 2.3.4.4b. This Notice includes an update on field studies to support licensure.

Imminent—Memoir of Pentagon UFO investigator Luis Elizondo

Per my previous question “…did you find anything?” Perhaps most serious claims to date, including “non-human cadavers.” (The “biologics” cited by others.) Immediate conclusion: many books will sell.

@books @bookstodon @religion #bookstodon #ChristianSciFi #ProfessorK #luiselizondo #UFO #biologics

https://apple.news/AGTkAI2MvQQe0HzJ8Exxtvg

#TheMetalDogArticleList
#BLABBERMOUTH
ALEX LIFESON On Possibility Of RUSH Carrying On With New Drummer: 'It Would Just Be A Money Ploy'

https://blabbermouth.net/news/alex-lifeson-on-possibility-of-rush-carrying-on-with-new-drummer-it-would-just-be-a-money-ploy

#alexlifeson #rush #tour #rumors #legacy #neilpeart #geddylee #paulstewart #biologics #psoriaticarthritis #taylorhawkinsbenefit #southpark #christmasshows #andykim

A developer of an auto-injection technology says its device can deliver a biologic drug under the skin in a fraction of the time of conventional syringes.

https://sciencebusiness.technewslit.com/?p=45342

#News #Press #Science #Business #DrugDelivery #Chemistry #ClinicalTrial #Hyaluronan #Enzyme #MedicalDevice #Subcutaneous #AutoInjector #Biologics #Immunoglobulin

A group of managed care organizations is examining the value of real world data from Europe and the U.S. to help FDA review alternative biologic drugs.

https://sciencebusiness.technewslit.com/?p=45310

#News #Press #Science #Business #Biologics #Biosimilars #Pharmaceuticals #FDA #Regulations #Grant #RealWorldData #HealthRecords #InsuranceClaims #ManagedCare #DataScience

A company developing a drug delivery process with treatments activated by ultrasound received an option to license a key technology from its founders' university labs.

https://sciencebusiness.technewslit.com/?p=45126

#News #Press #Science #Business #Biotechnology #IntellectualProperty #Option #Licensing #MaterialsScience #Ultrasound #Chemistry #Physics #University #Capsules #NucleicAcids #Biologics

Regeneron Pharmaceuticals, a maker of synthetic biologic treatments, is acquiring Decibel Therapeutics, developer of gene therapies to treat hearing loss and balance disorders.

https://sciencebusiness.technewslit.com/?p=45086

#News #Press #Science #Business #Finance #Acquisition #Shareholders #Biotechnology #Neuroscience #Genetics #GeneTherapy #Biologics #HearingLoss #Balance #Cochlea #ClinicalTrial

The developer of a biologic drug-making process with engineered plant crops is collaborating with a vertical farming company to create a network of biologics production facilities.

https://sciencebusiness.technewslit.com/?p=45058

#News #Press #Science #Business #Agriculture #Biotechnology #Collaboration #Biologics #MonoclonalAntibodies #Engineering #VerticalFarming #Tobacco #Automation #Algorithms #Italy #UK

Happy #PharmPhriday! A question I get a lot is “what’s a #biosimilar?” Well, it’s like a #generic but for #biologics

Because a biologic is made from something living, you can’t exactly copy the drug recipe like you can with generics. There are also some differences in testing.

A biosimilar has no clinically meaningful differences from an existing FDA-approved biologic.

A generic drug demonstrates bioequivalence to an existing FDA-approved drug.

Infographic from https://www.fda.gov/media/166334/download

Complex Learned Social Behavior Discovered in Bee’s Waggle Dance
👇🧐🐝🍯

https://neurosciencenews.com/social-learning-waggle-dance-22749/

#bees #biology #honeybee #biologics

It’s frustrating that, with the human body and #health we know a lot, yet there is still so much we don’t know or that we can’t do anything about.

All kinds of chronic illnesses, debilitating conditions, etc., it’s like a raging river and best we can do is give people a small bucket.

The future looks so close, with #stemcell , #genetherapy, #biologics, #BCI, and so forth but also, it’s so far away…

Higher affinity is always better, right?

Wrong! Especially when we're trying to fine-tune biology rather than fully inhibit a pathway, ultra-high affinity is a liability. Great read out today:

https://www.nature.com/articles/s41586-022-05673-2

#biotech #biologics #biophysics #drugdiscovery

New review on AlphaFold2 applications, excited to see everyone's findings and how it matches with our own usage of AF2 #drugdiscovery #biologics #biotech https://www.nature.com/articles/s41594-022-00849-w

Oh hey… adding some hashtags to my timeline. My interests as a dull list: #chemistry #bioinformatics #ai #ml #Proteindesign #biologics #epidemiology #immunology #aviation #stem #proteinstructure #biomanufacturing #software #chemometrics #stemjobs #drugdiscovery #drugmanufacturing

🇮🇳 Les opérateurs Quantum revendiquent une attaque informatique à l'encontre de Freyr Solutions (freyrsolutions.com) #india #biotechnology #ransomware #innovative #future #databreach #solutions #industrial #quantum #experts #compliance #business #regulatory #usa #japan #canada #australia #swiss #uk #europe #france #germany #poland #uae #slovenia #malaysia #china #mexico #africa #india #services #clients #fda #sciences #strategic #shareholders #businesses #markets #industries #threats #excellence #smart #covid19 #pharma #global #spain #devices #medical #surveillance #deliveries #firms #technologies #biologics #food #drugs #intelligence #partnership #cosmetics #chemicals #vaccines #equipment #financial #tracking #support #toxicological #customers #healthcare #bacterial #framework #audits #corporate #clinical #medicine #reporting #italy #mexico #ireland #turkey #brazil #products #patients #affairs #brands #software #management #guidance #careers #manufacturers #safety #informatique

Despite unproven efficacy, #Alzheimer's drug set to cost $56,000/year per patient Flushed face Current trends in medicine lean to #biologics: it's profits & patents as tantalizing as it is frighteningly expensive.
#Aduhelm #Medicine #BigPharma #Pharma #news

https://arstechnica.com/science/2021/06/controversial-alzheimers-drug-could-cost-us-334b-nearly-half-of-dod-budget/