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EDITORIAL SECTION

  • STRATEGY

    Smarter Pharma

    Quality management systems QMS are the backbone of pharmaceutical manufacturing ensuring safe products

  • EXPERT Talk

    Compliance to Competitive Advantage in Pharma Supply

    Compliance gets you through an audit Resilience gets medicines to patients on the day something unexpected happens The DSCSAs enhanced requirements took effect November but real interoperability required three more rounds of accommodation phased implementation with the smalldispenser

KNOWLEDGE BANK

  • Articles

    Digital Biomarkers and Wearables: Transforming Clinical Trial Data Collection

    A participant enrolled in a week pharmaceutical trial may spend fewer than six hours inside a clinical site The remaining odd hours of that year the stairs the fatigue the broken nights the good days and the collapsed ones pass unrecorded Clinical development has quietly accepted this trade for decades building enormous capital decisions on a handful of supervised snapshots taken under artificia...

    Assessing the Impact of Tariffs on the Pharmaceutical Industry

    The pharmaceutical industry function as a vital foundation for worldwide healthcare infrastructure because they push medical advancement while supporting medication availability to patients The pharmaceutical industry deals with major operational obstacles when public authorities establish tariffs for both pharmaceutical imports and exports The implementation of tariffs affects how prices shift wh...

    AI-Native Pharmaceutical Manufacturing: Transforming the Smart Factory

    Most European manufacturing leaders have already paid for a smart factory Sensors were installed historians consolidated execution systems layered over the batch record and dashboards commissioned and mounted on shopfloor screens The plant became visible What it rarely became was decisive Information now moves faster than it did a decade ago yet the decisions that carry real cost and risk

    The 2025 Agenda: Navigating New European Compliance Challenges in Pharma

    EU pharma industry expectate new regulations changes in the year European Medicines Agency EMA and other regulatory authorities in the continent gradually increase regulatory requirements that exercise greater pressure on business entities to implement patientoriented sustainable and innovative production standards

    The Competitive Generic Therapy (CGT)

    Generic medications are critical in the healthcare sector due to their affordability and accessibility to the public while maintaining comparable quality efficacy and safety to that of branded products Generic medications research and development followed by commercialisation also fosters competition and innovation within the pharmaceutical

    AI-Native R&D: Transforming Drug Discovery Through Intelligent Automation

    For four decades pharmaceutical research productivity has moved stubbornly in the wrong direction A new medicine still takes ten to fifteen years to reach patients at a capitalised cost approaching US billion

TOP ARTICLES

  • 4

    The Competitive Generic Therapy (CGT)

    Raghunandhan Painoori

    Dr. Naveen Chella

    The Competitive Generic Therapy (CGT) Act, introduced by the US FDA in 2017 under the Generic Drug User Fee Act (GDUFA), aims to lower drug costs by promoting generics where competition is limited. It...

press releases Read more...

MacroGenics Announces First Patient Dosed in Phase 1 Study of MGC030 in Patients with Advanced Solid Tumors

MacroGenics Inc a clinicalstage biopharmaceutical company focused on developing innovative antibodybased therapeutics for the treatment of cancer today announced that the first patient has been dosed in the Phase study of MGC a firstinclass antibodydrug conjugate

Legend Biotech Announces U.S. FDA Clearance of IND Application for LB2501, an Investigational CD19/CD20 In Vivo CAR-T Therapy

Legend Biotech Corporation a global leader in cell therapy today announced that the US Food and Drug Administration FDA has cleared the investigational new drug IND application for LB an investigational in vivo CART therapy designed to generate CDCD dualtargeting chimeric antigen receptor T

Eikon Therapeutics Submits IND for Novel Androgen Receptor Antagonist EIK1006 in Prostate Cancer

Eikon Therapeutics Inc a latestage clinical biopharmaceutical company dedicated to developing innovative medicines to address serious unmet medical needs today announced the submission of an Investigational New Drug IND application to the US Food and Drug Administration FDA to evaluate EIK for the t...

Orvida Pharma Announces FDA Acceptance of KM-023 (ontivatrep) into Rare Disease Evidence Principles Process for Olmsted Syndrome

Orvida Pharma a clinicalstage biotechnology company developing first and bestinclass treatments for rare and severe genetic skin diseases today announced that the US Food and Drug Administration FDA has accepted KM ontivatrep the Companys lead oral investigational therapy for Olmsted syndrome

21 - 23

Oct 2026

21 - 22

Oct 2026

22 - 23

Oct 2026

PDA Aseptic Symposium 2026

Congress Square Nakanoshima, O...

26 - 28

Oct 2026

ACHEMA Middle East 2026

RICEC, Riyadh, KSA, Saudi Arab...

26 - 28

Oct 2026

World Orphan Drug Congress

RAI, Amsterdam, Netherlands

27 - 28

Oct 2026

Pharma Manufacturing & Automation Convention 2026

Novotel Hyderabad Airport, Ind...

28 - 30

Oct 2026

02 - 04

Nov 2026

Pharma Forum EMEA 2026

Dom Pedro Lisboa Hotel, Lisbon...

LATEST NEWS Read more...

AtomVie Global Radiopharma Announces Strategic Partnership with Jubilant Radiopharma to Strengthen Logistics and Distribution in Clinical Trials

AtomVie Global Radiopharma a global contract developer and manufacturer CDMO for radiopharmaceuticals today announced a strategic partnership with Jubilant DraxImage Inc operating as Jubilant Radiopharma Jubilant Radiopharma to provide logistics approval and lastmile distribution services to support

Transcripta Bio Announces Research Collaboration to Advance Discovery of New ALS Treatments

Transcripta Bio an AIpowered drug discovery company focused on neurological and neuromuscular diseases today announced a research collaboration and licensing agreement with Mayo Clinic centered on amyotrophic lateral sclerosis ALS a fatal neurodegenerative disease with few effective treatments

Insitro Announces a Strategic Collaboration with AstraZeneca for AI-enabled Discovery of Novel Therapeutics for MASH and Cardiomyopathies

Insitro an AI company unlocking causal human biology to systematically generate highvalue therapeutics to treat grievous illness today announced a worldwide exclusive research collaboration agreement with AstraZeneca to discover novel targets and therapeutics in metabolic dysfunctionassociated steat...

Vir Biotechnology Enters Multi-Program Collaboration and License Agreement with Gilead Sciences to Discover and Develop Novel PRO-XTEN® Dual-masked T-cell Engagers for Solid Tumors

Vir Biotechnology Inc announced a collaboration and license agreement with Gilead to discover and engineer three novel PROXTEN dualmasked Tcell engager TCE development candidates targeting selected solid tumorassociated antigens Gilead will have an exclusive license to develop and commercialize

Genezen and Galibra Neuroscience Partner to Advance Gene Therapy for SSADH Deficiency Toward First-in-Human Trial

Genezen a gene therapy contract development and manufacturing organization CDMO and Galibra Neuroscience a biotechnology company developing transformative therapies for rare neurological disorders today announced a manufacturing partnership to advance Galibras GAL program an AAVbased gene therapy fo...

Zealand Pharma and Generate Biomedicines Enter Collaboration and License Agreement to Develop Protein Therapeutics Engineered with AI for Metabolic Diseases

Zealand Pharma AS a biotechnology company transforming the future of metabolic health today announced a multitarget strategic collaboration with Generate Biomedicines Inc Under the collaboration the companies intend to design and develop multispecific protein therapeutics