Article - Issue 55

Artificial Strategy: How to think strategically about AI

Article - Issue 55

Addressing the yearly $53B problem for pharma companies using groundbreaking AI and ‘Patient- on-a-chip’ technology

Article - Issue 55

Advancing Machine Learning and Artificial Intelligence in Pharmaceutical Manufacturing

Article - Issue 55

Predictive AI model for drug development

Article - Issue 55

Unlocking New Frontiers in Drug Discovery with Hybrid AI

Article - Issue 55

AI in Pharma - Transforming Sample and Biomarker Data into.....

Article - Issue 55

Predictive AI and ML Models in Drug Development

Article - Issue 55

GenAI's Impact on Reshaping the Pharma Industry

Article - Issue 55

The AI Revolution in Pharma

Article - Issue 55

Artificial Intelligence: Insights and outlook in precision and personalised medicine

LATEST NEWSRead more...

26

Jul 2024

Ractigen Secures FDA Rare Pediatric Disease Designation for RAG-18 in Duchenne Muscular Dystrophy Treatment

Ractigen Therapeutics a leader in small activating RNA therapies has received Rare Pediatric Disease Designation from the US Food and Drug Administration for its saRNA candidate RAG

26

Jul 2024

IASO Bio Secures NMPA Approval to Begin Trials for IASO-782 in Systemic Lupus Erythematosus (SLE)

IASO Biotechnology a company specializing in advanced cell therapy and antibody products has received approval from the National Medical Products Administration for its investigational new drug

26

Jul 2024

A.forall Secures FDA Approval for Fifth Generic Drug Application on First Submission Cycle

Aforalls US subsidiary Milla Pharmaceuticals Inc has introduced its generic version of PrecedexDexmedetomidine Hydrochloride Injection in mcg per mL and mcg per mL formulated

25

Jul 2024

Eisai and EcoNaviSta Forge Business Partnership to Develop a Dementia Care Ecosystem and Initiate Collaboration

Eisai Co Ltd and EcoNaviSta Inc have formed a strategic alliance to tackle dementia a significant challenge in Japans aging population Eisai a leader in dementia research and awareness and EcoNaviSta

25

Jul 2024

Pfizer Reveals Successful Phase 3 Outcomes for Hemophilia A Gene Therapy Candidate

Pfizer Inc has released positive topline results from the Phase AFFINE study which tested giroctocogene fitelparvovec a gene therapy for adults with moderately severe to severe hemophilia A

24

Jul 2024

BeiGene Launches U.S. Biologics Manufacturing and R&D Facility, Advancing Global Expansion to Serve More Patients

BeiGene Ltd a global oncology company has launched its flagship US facility at the Princeton West Innovation Campus in Hopewell NJ This advanced site features cuttingedge biologics

press releasesRead more...

26

Jul 2024

Breakthrough in gene therapy brings new hope to Glaucoma patients

Macquarie University researchers have identified a gene therapy that could help treat the eye disease glaucoma with potential applications for other neurodegenerative conditions such as Alzheimers disease Glaucoma may result in irreversible blindness over to years if left untreated Like Alzheimers...

26

Jul 2024

Bio-Thera Solutions Initiates Integrated Phase I / Phase III Clinical Trial for BAT3306, a Proposed Biosimilar of Keytruda® (Pembrolizumab)

BioThera Solutions Inc a commercialstage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars today announced that dosing has recently begun in an integrated Phase I

26

Jul 2024

Innovent and WeComput Announce Strategic Partnership to Advance AI-Driven Drug Discovery and Development

Innovent Biologics Inc a worldclass biopharmaceutical company that develops manufactures and commercializes highquality medicines for the treatment of oncology cardiovascular and metabolic

26

Jul 2024

ObvioHealth announces strategic investment by Guardant Health to accelerate deployment of oncology clinical trials globally

ObvioHealth a global digital clinical trials company announces a new strategic investment by Guardant Health Inc a leading precision oncology company offering liquid

25

Jul 2024

Bio-Thera Solutions Announces Regulatory Filing Acceptance for BAT2206, a Proposed Biosimilar to Stelara® in the US and EU

BioThera Solutions Inc a commercialstage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars today announced that the FDA has accepted the BLA for BAT a proposed

25

Jul 2024

COVID is Here to Stay and NV-387 is a Much Needed Drug Against It, Reminds NanoViricides

NanoViricides Inc a clinical stage global leader in broadspectrum antiviral nanomedicines today reminds the strong safety and effectiveness against coronaviruses demonstrated by its lead clinical drug candidate

EventsRead more...

30 - 01

Jul 2024

3rd Heart Failure Drug Discovery & Development

Boston, MA, USA

30 - 01

Jul 2024

chemical indonesia

jakarta barat, Indonesia

30 - 01

Jul 2024

Inalab 2023

Jakarta Barat, Indonesia

13 - 14

Aug 2024

ADVANCING BUSINESS, TECHNOLOGY AND INNOVATION

Songdo Convensia, Incheon, South Korea

13 - 14

Aug 2024

12 YEARS OF EXCELLENCE: SOUTH KOREA’S BIOLOGICS

Songdo Convensia, Incheon, South Korea

19 - 21

Aug 2024

Biomedical Engineering and Biotechnology

Lisbon, Portugal

19 - 20

Aug 2024

Pharmaceutics, Formulations & Drug Delivery

London, UK

19 - 20

Aug 2024

International Conference on 3D Printing & Additive

Dubai, UAE

2nd Annual Pharma Impurity Conclave 2024

Thermo Fisher - Drug Discovery and the impact of mAbs

KNOWLEDGE BANK

Interviews
Takeda Pharmaceutical Company Limited
Chief Medical & Scientific Officer
Scientific progress depends upon collaboration iPS cell technology is at the forefront of pharmaceutical innovation and Takeda strives to bring innovative treatments to patients Both Takeda and CiRA have the common goal of providing patients and healthcare professionals with innovative new treatments

Articles
CAR-T Cell Therapy and NexCAR19
Radiation therapy chemotherapy and surgery have been the cornerstones of cancer treatment for many years While they remain essential therapy pillars recent advancements in the field have significantly changed the treatment landscape for cancer patients

Research Insights
Trends in clinical development timeframes for antiviral drugs launched in the UK, 1981–2014: a retrospective observational study
AbstractObjectivesRecent decades have witnessed the development of highly innovative new antiviral drug therapies However there are concerns that rising costs and lengthening development times could have implications for future patient access to innovative new drugs We sought to establish whether the tim

Case Studies
A Dose-Escalation Case Study Of A Second-Generationnon-Ansamycin HSP90 Inhibitor, Onalespib (AT13387), Incombination With Imatinib In Patients With Metastaticgastrointestinal Stromal Tumour
AbstractGastrointestinal stromal tumours GIST are commonly driven by activating mutations in the KIT or PDGFRA receptor tyrosine kinases Although the initial response rates for newly diagnosed GIST to the tyrosine kinase inhibitorTKI imatinib can be most tumours ultimately become resistant commonly through secondary mutations or through alternative pa

Techno Trends
Janssen Pharmaceutical Discovered First-of-its-Kind ERLEADA® (apalutamide)
The Janssen Pharmaceutical Companies of Johnson Johnson discovered firstofitskind ERLEADA apalutamide for the treatment of patients with nonmetastatic castrationresistant prostate cancer nmCRPC and for the treatment of patients with metastatic castrationsensitive prostate cancer mCSPC

White Papers
Effective Randomization Is Key To The Success Of A Trial: A Cenduit White Paper
SummaryRandomized doubleblind clinical trials are the gold standard for adequate and wellcontrolled studies in modern times However prior to the late s randomization and blinding were not used in medicine and as result bias was common For example treatment bias was often observed as physicians would treat sicker patients with known controls while

Advisory Board

Brian D Smith

Nigel Cryer FRSC

Quang Bui

Gervasius Samosir

Tamara Miller

Imedla Leslie Rillon

Andri Kusandri

Nicoleta Grecu

Alessio Piccoli

Pramod Kashid

Neil J

EDITORIAL SECTION

STRATEGY
Accelerating Cell and Gene Therapy Treatments to Patients with the Right CDMO Outsourcing Model
Approximately million people worldwide are living with a rare disease and about half of those affected by rare diseases are children

RESEARCH DEVELOPMENT
An introduction to FDA’s Human Factors Engineering Requirements for Drug-Device Combination Products
Although less well known than other drug development phases human factors engineering HFE is critical to meeting regulatory expectations for drugdevic...

CLINICAL TRIALS

MANUFACTURING
Just in Time Manufacturing Creating more sustainable supply chains
Drug development has transformed immeasurably over the past decade Even before the Covid pandemic and the conflict in Ukraine

Information Technology
Challenges and Advantages of Using Artificial Intelligence in Pharma
Many advanced largescale AI initiatives still need to be proved successful in Pharma

EXPERT Talk
Innovative Biotech Ecosystem in Singapore and Asia
Singapore has had a multidecade longterm vision for building a worldclass biomedical cluster

Artificial Strategy: How to think strategically about AI

Addressing the yearly $53B problem for pharma companies using groundbreaking AI and ‘Patient- on-a-chip’ technology

Advancing Machine Learning and Artificial Intelligence in Pharmaceutical Manufacturing

Predictive AI model for drug development

Unlocking New Frontiers in Drug Discovery with Hybrid AI

AI in Pharma - Transforming Sample and Biomarker Data into.....

Predictive AI and ML Models in Drug Development

GenAI's Impact on Reshaping the Pharma Industry

The AI Revolution in Pharma

Artificial Intelligence: Insights and outlook in precision and personalised medicine

LATEST NEWSRead more...

26

Ractigen Secures FDA Rare Pediatric Disease Designation for RAG-18 in Duchenne Muscular Dystrophy Treatment

26

IASO Bio Secures NMPA Approval to Begin Trials for IASO-782 in Systemic Lupus Erythematosus (SLE)

26

A.forall Secures FDA Approval for Fifth Generic Drug Application on First Submission Cycle

25

Eisai and EcoNaviSta Forge Business Partnership to Develop a Dementia Care Ecosystem and Initiate Collaboration

25

Pfizer Reveals Successful Phase 3 Outcomes for Hemophilia A Gene Therapy Candidate

24

BeiGene Launches U.S. Biologics Manufacturing and R&D Facility, Advancing Global Expansion to Serve More Patients

press releasesRead more...

26

Breakthrough in gene therapy brings new hope to Glaucoma patients

26

Bio-Thera Solutions Initiates Integrated Phase I / Phase III Clinical Trial for BAT3306, a Proposed Biosimilar of Keytruda® (Pembrolizumab)

26

Innovent and WeComput Announce Strategic Partnership to Advance AI-Driven Drug Discovery and Development

26

ObvioHealth announces strategic investment by Guardant Health to accelerate deployment of oncology clinical trials globally

25

Bio-Thera Solutions Announces Regulatory Filing Acceptance for BAT2206, a Proposed Biosimilar to Stelara® in the US and EU

25

COVID is Here to Stay and NV-387 is a Much Needed Drug Against It, Reminds NanoViricides

EventsRead more...

30 - 01

3rd Heart Failure Drug Discovery & Development

30 - 01

chemical indonesia

30 - 01

Inalab 2023

13 - 14

ADVANCING BUSINESS, TECHNOLOGY AND INNOVATION

13 - 14

12 YEARS OF EXCELLENCE: SOUTH KOREA’S BIOLOGICS

19 - 21

Biomedical Engineering and Biotechnology

19 - 20

Pharmaceutics, Formulations & Drug Delivery

19 - 20

International Conference on 3D Printing & Additive

TOP ARTICLES

1

Nanoemulsion - A Promising Nanocarrier for Dermal Drug Delivery in Psoriasis

Sindhoor S M

Assistant Professor, Department of Pharmaceutics, Sri Adichunchanagiri College of Pharmacy

Marina Koland

Professor and Head of Department of Pharmaceutics, NGSM Institute of Pharmaceutical Sciences, Nitte (Deemed to be University)

2

Data-Enriched Edible Pharmaceuticals (DEEP) as Patient-Tailored Drug Products

Natalja Genina

Associate Professor, University of Copenhagen (UCPH)

Jukka Rantanen

Professor, UCPH

Johan Bøtker

Associate Professor, UCPH

Sofia Kalvemark Sporrong

Professor, Uppsala University

3

The Past, Present, and Future of Sickle-cell Disease Registries: Findings from a Global Review

Samuel Llewellyn

Associate Director, Vitaccess

Fatemeh Amini

Medical Writer, Vitaccess

Oktawia Borecka

Research Associate, Vitaccess

Akosua Ofori

Associate Consultant, Vitaccess