Newest Issue is Out. Get your exclusive copy today.

Subscribe for Free

Fishawack Health expands its global market access and HEOR capabilities with the acquisition of PRMA Consulting

Innovation in pharmacovigilance

Understanding Bio-summary Tables for ANDA Submissions

PATENTS AND EXCLUSIVITY

Biomedical Market Leaders

Brexit and Pharmacovigilance

EMPLOYING REAL-WORLD EVIDENCE TO IMPROVE CLINICAL TRIAL STRATEGIES

PERSONALISING PRESCRIPTION

Future of Pharmaceutical Manufacturing

DATA INTEGRITY - In pharma’s rush to end the pandemic

Get instant access to latest e-book

LATEST NEWSRead more...

12

Jun 2021

Moderna and Tabuk Pharmaceuticals Partner to Commercialize Moderna’s COVID-19 Vaccine in Saudi Arabia

Moderna Inc a biotechnology company pioneering messenger RNA mRNA therapeutics and vaccines and Tabuk Pharmaceutical Manufacturing Company a fully owned subsidiary of Astra Industrial Group a leading Saudi pharmaceuticals company today announced an agreement to commercialize the Moderna COVID Vaccin...

11

Jun 2021

Vicore announces FDA acceptance for pivotal phase 3 trial of C21 in COVID-19

Vicore Pharma Holding AB a rare disease pharmaceutical company developing innovative medicines for fibrotic lung disorders such as idiopathic pulmonary fibrosis IPF today announces that the US Food and Drug Administration FDA has accepted the Investigational New Drug IND application for the companys...

11

Jun 2021

Avantor® Completes Acquisition of Ritter GmbH and its Affiliates

Avantor Inc a leading global provider of missioncritical products and services to customers in the life sciences advanced technologies and applied materials industries announced today it has completed its previously announced acquisition of Ritter GmbH and its affiliates By combining Ritters liquid...

10

Jun 2021

Arena Pharmaceuticals Announces Orphan Drug Designation for Etrasimod for the Treatment of Eosinophilic Esophagitis (EoE)

Arena Pharmaceuticals Inc today announced that the US Food and Drug Administration FDA has granted Orphan Drug Designation status to etrasimod a highly selective oncedaily oral sphingosine phosphate SP receptor modulator for the treatment of eosinophilic esophagitis EoE

press releasesRead more...

11

Jun 2021

Sanofi provides update on Aubagio® (teriflunomide) submission for children and adolescents with relapsing-remitting multiple sclerosis in the U.S.

The US Food and Drug Administration FDA issued a Complete Response Letter regarding the supplemental New Drug Application for Aubagio teriflunomide for children and adolescents to years of age with relapsing forms of multiple sclerosis The FDA deemed the data submitted were not sufficient to obtai...

10

Jun 2021

Novartis Entresto® indicated for treatment of hypertension in China

Novartis today announced that Entresto sacubitrilvalsartan has received a new indication in China for the treatment of patients with essential hypertension a disease affecting approximately million adults in the country This National Medical Products Administration NMPA decision follows the approv...

10

Jun 2021

U.S. Food and Drug Administration Approves New Formulation of Epclusa®, Expanding Pediatric Indication to Treat Children Ages 3 and Older With Chronic Hepatitis C

Gilead Sciences Inc announced today that the US Food and Drug Administration FDA has approved an expansion of the pediatric indication of Epclusa sofosbuvirvelpatasvir for the treatment of chronic hepatitis C virus HCV to now include children as young as years of age regardless of HCV genotype or l...

10

Jun 2021

Veru Enrolls First Patient in Phase 2 Clinical Trial of VERU-100, Novel Long-acting GnRH Antagonist Decapeptide Injection Formulation, for the Treatment of Hormone

Veru Inc an oncology biopharmaceutical company with a focus on developing novel medicines for the management of prostate and breast cancer today announced that it has enrolled the first patient in its Phase clinical trial of VERU a novel proprietary gonadotropinreleasing hormone GnRH antagonist dec...

EventsRead more...

14 - 15

Jun 2021

5th Annual Pre-Filled Syringes West Coast 2020

Hyatt Regency Mission Bay Spa and Marina

14 - 15

Jun 2021

2nd Advanced Chemistry World Congress

Peers Alley Media
Berlin

14 - 15

Jun 2021

Ophthalmology Conferences 2021

Peers Alley Media
Berlin

15 - 17

Jun 2021

2nd RNAi- Based Therapeutics Summit 2021

Online

Rousselot - X-Pure® || Modified Products

The Live-to-Virtual Pivot 4 Best Practices

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

Commissioning the 505(b)(2) Pathways in Hastening the Clinical Translation of Various Drugs via Nanotechnological Approaches

Centre for Drug Evaluation and Research CDER a fundamental component of Food and Drug Administration implements guidelines on various drug products vaccines and biologicals Pharmaceutical industries seeking approval to market various therapeutic products must be in accordance with these guidelines

Research Insights

Whole blood transcriptome biomarkers of unruptured intracranial aneurysm

The rupture of an intracranial aneurysm IA causes devastating subarachnoid hemorrhages yet most IAs remain undiscovered until they rupture Recently we found an IA RNA expression signature of circulating neutrophils

Case Studies

Applying Data Mining Techniques To Medical Time Series: An Empirical Case Study

Abstract One of the major challenges in the medical domain today is how to exploit the huge amount of data that this field generates To do this approaches are required that are capable of discovering knowledge that is useful for decision making in the medical field Time series are data types that are common in the medical domain and require specialized analy

Techno Trends

High speed production of new antibiotics that could treat MRSA and drug-resistant TB

Scientists at the University of Bristol have found a faster and cheaper way to produce new antibiotics to tackle drugresistant superbugs There was a per cent increase in production when the genes involved in the pleuromutilin production were expressed in a different type of fungus by the research team This is considered to b

White Papers

Increasing Tablet Production With Multi-tip Tooling: An I-holland Whitepaper

Summary Multitip punches increase the number of tablets produced per turret rotation which increases production rates of existing presses Steve Osborn product design manager at tablet tooling manufacturer I Holland spoke to Pharmaceutical Technology Europe about the key considerations for successful implementation of multitip tooling in tableting operatio

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...

Fishawack Health expands its global market access and HEOR capabilities with the acquisition of PRMA Consulting

Innovation in pharmacovigilance

Understanding Bio-summary Tables for ANDA Submissions

PATENTS AND EXCLUSIVITY

Biomedical Market Leaders

Brexit and Pharmacovigilance

EMPLOYING REAL-WORLD EVIDENCE TO IMPROVE CLINICAL TRIAL STRATEGIES

PERSONALISING PRESCRIPTION

Future of Pharmaceutical Manufacturing

DATA INTEGRITY - In pharma’s rush to end the pandemic

Get instant access to latest e-book

LATEST NEWSRead more...

12

Moderna and Tabuk Pharmaceuticals Partner to Commercialize Moderna’s COVID-19 Vaccine in Saudi Arabia

11

Vicore announces FDA acceptance for pivotal phase 3 trial of C21 in COVID-19

11

Avantor® Completes Acquisition of Ritter GmbH and its Affiliates

10

Arena Pharmaceuticals Announces Orphan Drug Designation for Etrasimod for the Treatment of Eosinophilic Esophagitis (EoE)

press releasesRead more...

11

Sanofi provides update on Aubagio® (teriflunomide) submission for children and adolescents with relapsing-remitting multiple sclerosis in the U.S.

10

Novartis Entresto® indicated for treatment of hypertension in China

10

U.S. Food and Drug Administration Approves New Formulation of Epclusa®, Expanding Pediatric Indication to Treat Children Ages 3 and Older With Chronic Hepatitis C

10

Veru Enrolls First Patient in Phase 2 Clinical Trial of VERU-100, Novel Long-acting GnRH Antagonist Decapeptide Injection Formulation, for the Treatment of Hormone

EventsRead more...

14 - 15

5th Annual Pre-Filled Syringes West Coast 2020

14 - 15

2nd Advanced Chemistry World Congress

14 - 15

Ophthalmology Conferences 2021

15 - 17

2nd RNAi- Based Therapeutics Summit 2021

TOP ARTICLES

1

Nanotechnology Strategies for Age –Related Macular Degeneration

2

Advancing Automation and Digitalization in the Industrial Microbiology Workflow

3

3D Printing Revolutionising Nanotechnology

4

Is Convex Dose Dependence A Side Effect That Multiple Drug Treatment Causes?

5

Envisioning the Biomanufacturing Facility of the Future

KNOWLEDGE BANK

ExpreS<sup>2</sup>ion Biotechnologies

Commissioning the 505(b)(2) Pathways in Hastening the Clinical Translation of Various Drugs via Nanotechnological Approaches

Whole blood transcriptome biomarkers of unruptured intracranial aneurysm

Applying Data Mining Techniques To Medical Time Series: An Empirical Case Study

High speed production of new antibiotics that could treat MRSA and drug-resistant TB

Increasing Tablet Production With Multi-tip Tooling: An I-holland Whitepaper

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