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Current Trends in Regulatory Outsourcing Models

BIOLOGICS AND BIOSIMILARS MARKET

COMBINING SAFETY AND EFFICIENCY IN RECONSTITUTED DRUGS IN THE FAR EAST MARKETS

PRACTICE MAKES PERFECT

Novo Nordisk Pharmatech A/S

A New Strategy to Predict Neurovirulence Risk Associated with Covid-19 Vaccines

Predicting Quality Risks in Pharmaceutical Production

Applying PAT to the Continuous Digital Biomanufacturing of Monoclonal Antibodies

Chiral Chromatography in Pharmaceutical Analysis

CYBER-PHYSICAL SECURITY TOOL FOR CONTINUOUS PHARMACEUTICAL MANUFACTURING PROCESS

Get instant access to latest e-book

LATEST NEWSRead more...

20

Oct 2021

FSD Pharma Signs Agreement with Covar Pharmaceuticals to Support the Development of Lucid-PSYCH

FSD Pharma Inc a life sciences holding company dedicated to building a portfolio of assets and biotech solutions announced today it has entered into an agreement with Covar Pharmaceuticals Inc Covar a contract development and manufacturing services organization CDMO to commence work on providing res...

20

Oct 2021

CDISC and OpenClinica Collaborate to Drive Academic Clinical Research Forward

CDISC announced that it is collaborating with OpenClinica to improve data collection in clinical studies conducted by academic institutions and researchers with the goal of driving research forward The collaboration came about as a result of CDISCs efforts to better understand the barriers among the...

19

Oct 2021

Sumitomo Dainippon Pharma and BehaVR announce landmark deal for multiple virtual reality digital therapeutics

Sumitomo Dainippon Pharma Co Ltd and BehaVR Inc announce today that the companies have signed definitive agreements to develop and commercialize both prescription digital therapeutics and general wellness products for treatment of Social Anxiety Disorder SAD Generalized Anxiety Disorder GAD and Majo...

19

Oct 2021

PerkinElmer and Honeycomb Biotechnologies Launch the HIVE scRNAseq Solution for Single-Cell Analysis

PerkinElmer Inc and Honeycomb Biotechnologies Inc announced today the commercial launch of the first of its kind HIVETM scRNAseq Solution for singlecell isolation and analysis The HIVE solution leverages a portable handheld device for the capture storage and RNASeq library preparation of a diverse r...

18

Oct 2021

WuXi ATU Opens New Manufacturing Facility to Further Enhance Its CTDMO Services for Global Customers

WuXi Advanced Therapies Inc a wholly owned subsidiary of WuXi AppTec today announced the opening of its new process development and commercial manufacturing facility in Lingang Shanghai WuXi ATU is a leading Contract Testing Development and Manufacturing Organization CTDMO headquartered in Philade...

14

Oct 2021

Immusoft and Takeda Collaborate to Discover and Develop Cell Therapies for Rare Neurometabolic Disorders

Immusoft a cell therapy company dedicated to improving the lives of patients with rare diseases announced today that it has signed a research collaboration and license option agreement with Takeda Pharmaceutical Company Limited Takeda to discover develop and commercialize transformative cell therapi...

press releasesRead more...

20

Oct 2021

Turkish Cargo Has Been Carrying Cancer Medicine for 25 Years

Possessing the worlds strongest cargo flight network Turkish Cargo contributes its strength to Turkeys medical exports Flag carrier air cargo brand has been carrying Turkeys medicine and medical products to over countries in five continents for over years In the nuclear medicine sector Turkish Car...

19

Oct 2021

Boehringer Ingelheim and Partners to Accelerate Development of First-In-Class Gene Therapy for Patients with Cystic Fibrosis

Boehringer Ingelheim IP Group the UK Cystic Fibrosis Gene Therapy Consortium GTC consisting of researchers from Imperial College London and the Universities of Oxford and Edinburgh and Oxford Biomedica OXB announced today that Boehringer Ingelheim has exercised its options on intellectual property a...

19

Oct 2021

Antios Therapeutics and Assembly Biosciences Announce Clinical Collaboration Agreement to Evaluate the Combination of ATI-2173 and Vebicorvir in Patients

Antios Therapeutics Inc and Assembly Biosciences Inc today announced that the companies have entered into a clinical collaboration agreement to evaluate a triple combination treatment in patients with chronic hepatitis B virus HBV infection A single cohort in the ongoing Antios Phase a ANTT clinical...

19

Oct 2021

Akero Therapeutics Receives FDA Fast Track Designation for Efruxifermin (EFX) for the Treatment of NASH

Akero Therapeutics Inc a cardiometabolic biotechnology company developing transformational treatments for nonalcoholic steatohepatitis NASH today announced that the US Food and Drug Administration FDA has granted Fast Track designation to its lead program investigating efruxifermin EFX for the treat...

19

Oct 2021

Plus Therapeutics Announces FDA Clearance of Investigational New Drug Application for 186RNL for the Treatment of Leptomeningeal Metastases

Plus Therapeutics Inc a US clinicalstage pharmaceutical company developing innovative targeted radiotherapeutics for rare and difficulttotreat cancers today announced clearance of its Investigational New Drug IND application from the US Food and Drug Administration FDA for Rhenium NanoLiposome RNL f...

18

Oct 2021

SOM Biotech granted Orphan Drug Designation by the FDA for SOM3355

SOM Biotech a clinicalstage drug discovery and development company focused on orphan diseases of the Central Nervous System today announces that the US Food and Drug Administration FDA has granted Orphan Drug Designation ODD for SOM currently in clinical development for the treatment of chorea movem...

EventsRead more...

11 - 22

Oct 2021

Pharma Europe 2021

Barcelona

19 - 21

Oct 2021

INTERPHEX 2021

Javits Center

25 - 27

Oct 2021

World Obesity and Weight Management Congress 2021

Holiday Inn Orlando

25 - 27

Oct 2021

International Vaccines Congress 2021

Orlando

28 - 29

Oct 2021

Pharmacovigilance Drug Safety

Dubai

29 - 01

Oct 2021

Human Health Summit 2021

Online

01 - 02

Nov 2021

Pharmacology and Drug Discovery 2021

New York

03 - 07

Nov 2021

Napa Primary Care Conference 2021

Napa Valley Marriot Resort and Spa

Saving Money, Saving Time In Pharma Operations

Thermo Fisher Scientific || Revolutionize your mAb manufacturing

Kerry || Webinar || Coatings Change Control Webinar || Recording-Webinar

Emirates Surgical Pathology Conference 2021

KNOWLEDGE BANK

Interviews

Bioquell Asia Pacific,

Managing Director
Bioquell Asia Pacific based in Singapore in April to be the regional office for our activities in Asia and Australasia I am responsible for the development of our business throughout the region and for the success and profitability of our activities We provide equipment and services for environmental biodecontamination across the pharmaceutical therapeutic development

Articles

Why You Might Need a Remediation Program

NSF remediation experts work to assist companies around the world in their remediation efforts Some projects arise from a client identifying a risk themselves while others are a company responding to a communication from a regulatory agency This article will look at why remediation projects are needed the traits of successful programs and what you need to do to ensure success in your remediation e...

Research Insights

Analytical Methods For Determination Of Terbinafine Hydrochloride In Pharmaceuticals And Biological Materials

Abstract Terbinafine is a new powerful antifungal agent indicated for both oral and topical treatment of mycosessince It is highly effective in the treatment of determatomycoses The chemical and pharmaceutical analysis of the drug requires effective analytical methods for quality control and pharmacodynamic and pharmacokinetic studies Ever since it was intro

Case Studies

Effect Of Cold Spells And Theirmodifiers On Cardiovascular Disease Events: Evidence From A Double Prospective Study

Abstract Cardiovascular disease CVD is the most common cause of death globally remaining a considerable burden both in terms of health and costs As in many countries CVD mortality in the UK exhibits a marked seasonal variation more people die during the winter months DecemberMarch than in other periods of the year and the majority of deaths occur

Techno Trends

TECARTUS™ Discovered for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma (MCL)

Kite discovered Tecartus brexucabtageneautoleucel formerly KTEX a novel Chimeric Antigen Receptor CAR T for the treatment of adult patients with relapsed or refractory Mantle Cell Lymphoma MCL

White Papers

Launching Global Clinical Trials—best Practices For Efficient And Cost-effective Translations: A Lionsbridge White Paper

Summary The target market for conducting global clinical trials has changed significantly moving beyond pharmaceutical early adopters to the mainstream marketplace This shift has placed a heightened focus on the language challenges and complexity of running a global clinical trial More and more companies are moving toward

Advisory Board

Stella

Sanjoy Ray

Rustom

Phil

Neil J

Laurence

Kenneth I

Georg C

Frank A

Douglas

Christopher-

Alan S Louie

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...

Current Trends in Regulatory Outsourcing Models

BIOLOGICS AND BIOSIMILARS MARKET

COMBINING SAFETY AND EFFICIENCY IN RECONSTITUTED DRUGS IN THE FAR EAST MARKETS

PRACTICE MAKES PERFECT

Novo Nordisk Pharmatech A/S

A New Strategy to Predict Neurovirulence Risk Associated with Covid-19 Vaccines

Predicting Quality Risks in Pharmaceutical Production

Applying PAT to the Continuous Digital Biomanufacturing of Monoclonal Antibodies

Chiral Chromatography in Pharmaceutical Analysis

CYBER-PHYSICAL SECURITY TOOL FOR CONTINUOUS PHARMACEUTICAL MANUFACTURING PROCESS

Get instant access to latest e-book

LATEST NEWSRead more...

20

FSD Pharma Signs Agreement with Covar Pharmaceuticals to Support the Development of Lucid-PSYCH

20

CDISC and OpenClinica Collaborate to Drive Academic Clinical Research Forward

19

Sumitomo Dainippon Pharma and BehaVR announce landmark deal for multiple virtual reality digital therapeutics

19

PerkinElmer and Honeycomb Biotechnologies Launch the HIVE scRNAseq Solution for Single-Cell Analysis

18

WuXi ATU Opens New Manufacturing Facility to Further Enhance Its CTDMO Services for Global Customers

14

Immusoft and Takeda Collaborate to Discover and Develop Cell Therapies for Rare Neurometabolic Disorders

press releasesRead more...

20

Turkish Cargo Has Been Carrying Cancer Medicine for 25 Years

19

Boehringer Ingelheim and Partners to Accelerate Development of First-In-Class Gene Therapy for Patients with Cystic Fibrosis

19

Antios Therapeutics and Assembly Biosciences Announce Clinical Collaboration Agreement to Evaluate the Combination of ATI-2173 and Vebicorvir in Patients

19

Akero Therapeutics Receives FDA Fast Track Designation for Efruxifermin (EFX) for the Treatment of NASH

19

Plus Therapeutics Announces FDA Clearance of Investigational New Drug Application for 186RNL for the Treatment of Leptomeningeal Metastases

18

SOM Biotech granted Orphan Drug Designation by the FDA for SOM3355

EventsRead more...

11 - 22

Pharma Europe 2021

19 - 21

INTERPHEX 2021

25 - 27

World Obesity and Weight Management Congress 2021

25 - 27

International Vaccines Congress 2021

28 - 29

Pharmacovigilance Drug Safety

29 - 01

Human Health Summit 2021

01 - 02

Pharmacology and Drug Discovery 2021

03 - 07

Napa Primary Care Conference 2021

TOP ARTICLES

1

Metabolic Stability

2

Kinase Inhibitors as Antiviral Agents

3

A Structured Review on BCRP-Mediated Multidrug Resistance

4

Approach for Producing Pharmaceuticals in Layer By Layer Fashion: Additive Manufacturing

5

Artificial Intelligence

KNOWLEDGE BANK

Bioquell Asia Pacific,

Why You Might Need a Remediation Program

Analytical Methods For Determination Of Terbinafine Hydrochloride In Pharmaceuticals And Biological Materials

Effect Of Cold Spells And Theirmodifiers On Cardiovascular Disease Events: Evidence From A Double Prospective Study

TECARTUS™ Discovered for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma (MCL)

Launching Global Clinical Trials—best Practices For Efficient And Cost-effective Translations: A Lionsbridge White Paper

Advisory Board

EDITORIAL SECTION

Crucial Decision-making in Drug Development for COVID-19

DIGITAL SOLUTIONS IN DRUG DEVELOPMENT

Double-blinding Capsules for Clinical Trials

INTEGRATED CONTINUOUS BIOMANUFACTURING

ARTIFICIAL INTELLIGENCE IN PHARMACY PRACTICE

PHARMA LOGISTICS TRENDS