THE GLOCALISATION CHALLENGE

NEW WORKING MODELS WITH PHARMA

DISTRIBUTED LEADERSHIP AND DECISION-MAKING

SGS HEALTH SCIENCE

Safety De-risking Approaches for Advanced Modalities

THE SCIENCE OF ALIGNMENT

START WITH Y

AUTOMATION ACCELERATORS IN DRUG DISCOVERY AND DEVELOPMENT

TARGETED MEDICINES USING NANOTECHNOLOGY

GeneTherapy

FUTURE OF OPEX IN PHARMA

Enabling Digital and Decentralised Solutions in Clinical Research

Get instant access to latest e-book

LATEST NEWSRead more...

27

Jan 2023

Roche Launches COVID-19 PCR Test for Omicron Sub-Variant

Roche and its subsidiary TIB Molbiol developed a COVID PCR test for researchers to detect and differentiate the latest variant of concern XBB The XBB variant is prevalent in the United States and is quickly spreading to other countries Being able to differentiate emerging variants and understand the...

27

Jan 2023

Evotec Enters into Agreement with Janssen

Evotec SE announced a strategic collaboration and licence agreement with Janssen Biotech Inc Janssen one of the Janssen Pharmaceutical Companies of Johnson Johnson The collaboration mainly focuses on the development of firstinclass targeted immunebased therapies

27

Jan 2023

CytomX Therapeutics Announces Probody® T-Cell Engaging Bispecific (TCB) Achievement in Collaboration with Astellas

CytomX Therapeutics Inc today announced that it has achieved a clinical candidate milestone under its TCB agreement with Astellas The clinical candidate is the first Probody TCB molecule to progress in the collaboration and will trigger a million dollar milestone payment to CytomX CytomX and Astell...

25

Jan 2023

Thermo Fisher Scientific Partners with AstraZeneca to Develop Test for Tagrisso

Thermo Fisher Scientific announced to partner with AstraZeneca to develop a solid tissue and bloodbased companion diagnostic CDx test for Tagrisso osimertinib The CDx helps in identify patients with nonsmall cell lung cancer NSCLC eligible for treatment with Tagrisso by identifying tumours that exhi...

25

Jan 2023

US FDA Accepts Supplemental New Drug Application for Jardiance®

Boehringer Ingelheim and Eli Lilly and Company announced that the US Food and Drug Administration FDA has accepted a supplemental New Drug Application sNDA for Jardiance empagliflozin tablets which is being investigated as a potential treatment to reduce the risk of kidney disease progression and ca...

25

Jan 2023

Lupin Digital Health Launches LYFE, Digital Therapeutic Solution

Lupin Digital Health a whollyowned subsidiary of global pharma major Lupin announced the launch of its digital therapeutics solution LYFE LYFE helps patients in improving their heart health through doctorconnected online and offline modules LYFEs simple and intuitive interface offers medication remi...

press releasesRead more...

26

Jan 2023

BioAegis Therapeutics Announces FDA Clearance of IND for its ‘Inflammation Regulator Protein,’ Gelsolin, for the Treatment of ARDS

BioAegis Therapeutics Inc a clinicalstage company developing therapies for inflammatory diseases through a portfolio built around plasma gelsolin a highly conserved and abundant endogenous human immune regulatory protein announces that the US Food and Drug Administration FDA has approved its Investi...

26

Jan 2023

Enhertu approved in the EU as the first HER2-directed therapy for patients with HER2-low metastatic breast cancer

AstraZeneca and Daiichi Sankyos Enhertu trastuzumab deruxtecan has been approved in the European Union EU as monotherapy for the treatment of adult patients with unresectable or metastatic HERlow IHC or IHC ISH breast cancer who have received prior chemotherapy in the metastatic setting or develope...

26

Jan 2023

Lilly Supports Direct Relief's Efforts to Expand Access to Medicines by Improving Cold Chain Capacity

Eli Lilly and Company and Direct Relief today announced a new initiative to expand access to medicines in low and middleincome countries by boosting cold chain capacity in countries Supported by M in funding from Lilly Direct Relief will purchase and install an estimated medicalgrade refrigeration...

26

Jan 2023

Sona Nanotech to Acquire Cancer Therapy Developer Siva Therapeutics

Sona Nanotech Inc is pleased to announce that it has entered into a binding agreement the Definitive Agreement on January to acquire Siva Therapeutics Inc Siva the developer of Targeted Hyperthermia Therapy THT photo thermal therapy for cancer tumors using Sonas uniquely biocompatible gold nanorod...

26

Jan 2023

Centessa Pharmaceuticals Announces FDA Clearance of IND Application for Phase 1/2a Clinical Trial of LB101, First LockBody® Candidate, for Solid Tumors

Centessa Pharmaceuticals plc a clinicalstage pharmaceutical company that aims to discover and develop medicines that are transformational for patients today announced that it has received clearance of its Investigational New Drug IND application from the US Food and Drug Administration FDA to initia...

26

Jan 2023

TG Therapeutics Announces Commercial Launch of BRIUMVI™ (ublituximab-xiiy) for the Treatment of Adult Patients with Relapsing Forms of Multiple Sclerosis

TG Therapeutics Inc announced the commercial launch of BRIUMVI ublituximabxiiy for the treatment of relapsing forms of multiple sclerosis RMS to include clinically isolated syndrome relapsingremitting disease and active secondary progressive disease in adults BRIUMVI is the first and only antiCD mon...

EventsRead more...

30 - 01

Jan 2023

Precision Medicine in Inflammatory

Hanson Wade
Embassy Suites by Hilton Boston

31 - 02

Jan 2023

Viral Vector Process Development

Hanson Wade
Omni Parker House

08 - 09

Feb 2023

RNA Therapeutics Conference

SAE Media group
Copthorne Tara Hotel London Kensington

14 - 16

Feb 2023

CRISPR AgBio Congress 2023

Hanson Wade
The Westin San Diego Bayview

14 - 16

Feb 2023

mRNA Analytical Development

Hanson Wade
Hyatt Regency Boston

21 - 23

Feb 2023

5th Bacteriophage Therapy Summit

Hanson Wade
Virtual Event

21 - 23

Feb 2023

Retinal Vascular Disease Drug Development

Hanson Wade
Hilton Boston Logan Airport

13 - 14

Mar 2023

OPT Congress 2023

Boston

Development and Validation of a Platform Assay Method Using Variable Pathlength Technology for Oligonucleotide Drug Products

Thermo Fisher Scientific - Gibco solutions

KNOWLEDGE BANK

Interviews

ExpreS<sup>2</sup>ion Biotechnologies

Vice President - Business Development
ExpreSion Biotechnologies protein expression system ExpreS is an important protein expression tool in the scientists tool box for protein expression The ExpreS platform has demonstrated in many instances its usefulness in RD with several ExpreSmade proteins having now been crystallized

Articles

Envisioning the Biomanufacturing Facility of the Future

Development and delivery of lifesaving therapeutics to patients in the most efficient and costeffective manner possible is the goal of biomanufacturers While templated processes in biologic manufacturing have served to decrease timelines over the past years legacy approaches remain highly manual As we consider methods to expedite manufacturing

Research Insights

A spectrum of verticality across genes

Lateral gene transfer LGT has impacted prokaryotic genome evolution yet the extent to which LGT compromises vertical evolution across individual genes and individual phyla is unknown as are the factors that govern LGT frequency across genes Estimating LGT frequency from tree comparisons is problematic when thousands of genomes

Case Studies

Diagnostics - Stable Aqueous Horseradish Peroxidase

Challenge The main use of Horseradish peroxidise HRP is in diagnostic applications to produce a detectable signal indicating presence of a molecular target Typically HRP is used in conjugates with antibodies the antibody to recognise the molecular target an

Techno Trends

British scientists discover major treatment for bladder cancer

A significant breakthrough in years for treating the advanced bladder cancer Scientists from Queen Mary University of London discovered that an antibody allows immune system to gather and eliminate cancer cells before they could spread A cancer immunotherapy medicine named MPDLA being developed by Roche has been admin

White Papers

Pharmacopeia Requirements For Pure Steam And Final Rinse Verification Of Cip: A METTLER TOLEDO White Paper

Summary Validation of Pure Steam and the verification of the final aqueous rinse in a CIP process are defined by regulatory standards which change periodically and challenge system designers and owners to know the latest requirements This white paper contains an overview of current pharmacopeia requirements which will assist in the design and monitoring of comp

Advisory Board

Brian D Smith

Nigel Cryer FRSC

Quang Bui

Gervasius Samosir

Tamara Miller

Imelda Leslie Vargas

Andri Kusandri

Nicoleta Grecu

Alessio Piccoli

Pramod Kashid

Neil J

EDITORIAL SECTION

STRATEGY

Crucial Decision-making in Drug Development for COVID-19

Modelling and simulation has been growing rapidly in impact and is now actively used by biopharmaceutical companies worldwide for drug development and...

RESEARCH DEVELOPMENT

DIGITAL SOLUTIONS IN DRUG DEVELOPMENT

From mobile medical apps and fitness trackers to software that supports the clinical decisions that doctors make every day digital technology has been...

CLINICAL TRIALS

Double-blinding Capsules for Clinical Trials

Capsules are tried tested and trusted but that is not to say that the method is simple or without innovation Formulation considerations and patientcen...

MANUFACTURING

INTEGRATED CONTINUOUS BIOMANUFACTURING

Batch manufacturing is the technology platform that is currently used for production of biopharmaceutical products It involves stepbystep processing w...

Information Technology

ARTIFICIAL INTELLIGENCE IN PHARMACY PRACTICE

Artificial Intelligence AI and machine learningbased technologies have the potential to transform healthcare because they offer new and important insi...

EXPERT Talk

PHARMA LOGISTICS TRENDS

Pharma logistics is undergoing profound change throughout Asia as the ageing population drives a growing need for new pharma solutions together with s...

THE GLOCALISATION CHALLENGE

NEW WORKING MODELS WITH PHARMA

DISTRIBUTED LEADERSHIP AND DECISION-MAKING

SGS HEALTH SCIENCE

Safety De-risking Approaches for Advanced Modalities

THE SCIENCE OF ALIGNMENT

START WITH Y

AUTOMATION ACCELERATORS IN DRUG DISCOVERY AND DEVELOPMENT

TARGETED MEDICINES USING NANOTECHNOLOGY

GeneTherapy

FUTURE OF OPEX IN PHARMA

Enabling Digital and Decentralised Solutions in Clinical Research

Get instant access to latest e-book

LATEST NEWSRead more...

27

Roche Launches COVID-19 PCR Test for Omicron Sub-Variant

27

Evotec Enters into Agreement with Janssen

27

CytomX Therapeutics Announces Probody® T-Cell Engaging Bispecific (TCB) Achievement in Collaboration with Astellas

25

Thermo Fisher Scientific Partners with AstraZeneca to Develop Test for Tagrisso

25

US FDA Accepts Supplemental New Drug Application for Jardiance®

25

Lupin Digital Health Launches LYFE, Digital Therapeutic Solution

press releasesRead more...

26

BioAegis Therapeutics Announces FDA Clearance of IND for its ‘Inflammation Regulator Protein,’ Gelsolin, for the Treatment of ARDS

26

Enhertu approved in the EU as the first HER2-directed therapy for patients with HER2-low metastatic breast cancer

26

Lilly Supports Direct Relief's Efforts to Expand Access to Medicines by Improving Cold Chain Capacity

26

Sona Nanotech to Acquire Cancer Therapy Developer Siva Therapeutics

26

Centessa Pharmaceuticals Announces FDA Clearance of IND Application for Phase 1/2a Clinical Trial of LB101, First LockBody® Candidate, for Solid Tumors

26

TG Therapeutics Announces Commercial Launch of BRIUMVI™ (ublituximab-xiiy) for the Treatment of Adult Patients with Relapsing Forms of Multiple Sclerosis

EventsRead more...

30 - 01

Precision Medicine in Inflammatory

31 - 02

Viral Vector Process Development

08 - 09

RNA Therapeutics Conference

14 - 16

CRISPR AgBio Congress 2023

14 - 16

mRNA Analytical Development

21 - 23

5th Bacteriophage Therapy Summit

21 - 23

Retinal Vascular Disease Drug Development

13 - 14

OPT Congress 2023

TOP ARTICLES

1

Use of Steroids in COVID-19 patients

Anoop Kumar

Assistant Professor, Department of Pharmacology, Delhi Pharmaceutical Sciences and Research University

2

Magnetic Nanoparticles and their Application Studies on Synthesis Characterisation

Prabhanjan S Giram

Department of Pharmaceutics, Dr. D.Y. Patil Institute of Pharmaceutical science and Research

Shubham R Musale

Department of Pharmaceutics, Dr. D.Y. Patil Institute of Pharmaceutical science and Research

Sushil Y Raut

Department of Pharmaceutics, Dr. D.Y. Patil Institute of Pharmaceutical science and Research

3

Untapped Opportunities in Southeast Asia

Sue Lee

Technical Portfolio Manager, World Courier

4

Kinase Inhibitors as Antiviral Agents

Thanigaimalai Pillaiyar

Junior Research Group Leader, Pharmaceutical/Medicinal Chemistry, Tuebingen University

Stefan Laufer

Professor, Pharmaceutical/Medicinal Chemistry, Tuebingen University

5