DRUG PRICING FOR PERSONALISED MEDICINE

REGULATORY ASPECTS OF GENOTOXIC IMPURITIES

Is Blockchain the Right Technology for the Pharma Supply Chain?

NOVO NORDISK PHAMATECH - ENSURING QUALITY ASSURANCE

Compelling Pre-clinical Models

HEALTHCARE EVOLUTION

FOUND IN TRANSLATION

COMPUTER AIDED DRUG DESIGN IN PHARMA R&D

MESSY MARKETING

A QUALITY BY DESIGN APPROACH

Get instant access to latest e-book

LATEST NEWSRead more...

18

Oct 2019

Teijin and NeuroSigma Enter into Exclusive License Agreement

Teijin Limited Teijin and NeuroSigma Inc NeuroSigma a Los Angelesbased bioelectronics company focused on developing Trigeminal Nerve Stimulation TNS technology for the treatment of neuropsychiatric and neurological indications today announced entering into a partnership based on an exclusive license...

18

Oct 2019

Simulations Plus Partners with Large Pharmaceutical Company to Develop the Virtual Bioequivalence Trial Simulator™ Module

Simulations Plus Inc the leading provider of modeling and simulation solutions for the pharmaceutical biotechnology chemicals and consumer goods industries today announced that it has entered into a new funded collaboration with a large pharmaceutical company to develop the Virtual Bioequivalence BE...

17

Oct 2019

Mycovia Pharmaceuticals Announces Partnership with Gedeon Richter to Commercialize and Manufacture VT-1161 for Recurrent Vulvovaginal Candidiasis

Mycovia Pharmaceuticals Inc today announced it has entered into an exclusive license and development and technology transfer agreement with Gedeon Richter Plc based in Budapest Hungary to commercialize and manufacture VT in Europe Latin America Australia Russia and other CIS countries VT an oral ant...

17

Oct 2019

HitGen Enters into DNA-Encoded Library Based Drug Discovery Research Collaboration with Galapagos NV

HitGen Inc today announced that it has entered into a drug discovery research collaboration with Galapagos NV to identify potential small molecule leads against targets of interest to Galapagos NV In this collaboration HitGen will apply its technology platform based on DNAencoded library design synt...

16

Oct 2019

WindMIL Therapeutics and University of California, Irvine Announce Collaboration to Collect Bone Marrow from Patients with Gliomas

WindMIL Therapeutics and the University of California Irvine UCI today announced that the first patients have been identified in an investigatorsponsored study for the collection of bone marrow from patients with gliomas The study will evaluate generating marrow infiltrating lymphocytes MILs for the...

press releasesRead more...

18

Oct 2019

Genentech Announces FDA Approval of Xofluza (Baloxavir Marboxil) for People at High Risk of Developing Influenza-Related Complications

Genentech a member of the Roche Group today announced that the US Food and Drug Administration FDA has approved a supplemental New Drug Application sNDA for Xofluza baloxavir marboxil for the treatment of acute uncomplicated influenza or flu in people years of age and older who have been symptomati...

18

Oct 2019

FDA Grants Orphan Drug Designation for Neuren's NNZ-2591 to Treat Angelman, Phelan-McDermid and Pitt Hopkins Syndromes

Neuren Pharmaceuticals today announced that the US Food and Drug Administration FDA has granted Orphan Drug Designation to Neurens NNZ for the treatment of Angelman syndrome PhelanMcDermid syndrome and Pitt Hopkins syndrome

17

Oct 2019

Credence MedSystems Awarded Grant to Develop Its Dual Chamber Drug Delivery Device for the Global Health Setting

Credence MedSystems an innovator in injectable drug delivery technology for the biopharmaceutical industry announced today that it has been awarded a grant from the Bill Melinda Gates Foundation to support the development of Credences Dual Chamber Reconstitution Syringe tailored for use in developi...

17

Oct 2019

Adaptate Biotherapeutics formed to develop antibody-based therapies that modulate gamma delta T-cells

GammaDelta Therapeutics a company focussed on harnessing the unique properties of gamma delta Tcells to develop transformational immunotherapies today announced the formation of a spinout company Adaptate Biotherapeutics While GammaDelta Therapeutics primary goal is to develop Tcell based cell the...

16

Oct 2019

Replimune Provides Update on RP1 Clinical Development Program in Cutaneous Squamous Cell Carcinoma

Replimune Group Inc a biotechnology company developing oncolytic immunogene therapies derived from its Immulytic platform today announced that the first patient has been enrolled in its registrationdirected randomized controlled Phase clinical trial of RP in combination with Regeneron and Sanofis L...

EventsRead more...

20 - 24

Oct 2019

Emergency Medicine (WACEM)

Index Conferences & Exhibitions
Roda Al Bustan

21 - 22

Oct 2019

Highly Potent Active Pharmaceutical Ingredients

SMi Group Ltd
Sheraton Boston Hotel

21 - 22

Oct 2019

Down Syndrome, Autism & Cerebral Palsy

Tokyo, Japan

22 - 25

Oct 2019

3rd Combination Products Forum 2019

Mercure Hotel MOA Berlin

22 - 23

Oct 2019

BIO Investor Forum

Biotechnology Innovation Organization (BIO)
Westin St. Francis Hotel

22 - 24

Oct 2019

Macrophage Directed Therapies Summit 2019

Hanson Wade Limited
Aloft Boston Seaport District

PDA - 2019 The Universe of Pre-filled Syringes and Injection Devices

Eppendorf AG || rAAV Production in Single-Use Vessels

AirBridgeCargo - Air frieght solutions for your Pharma

KNOWLEDGE BANK

Interviews

Merck

Staff Engineer, Manufacturing Science and Technology, South East Asia
Karen Chan is a process engineer at Merck Pte Ltd Chan has six years of experience in the biopharmaceutical industry and two years of experience in research development She provides technical support in areas such as process development troubleshoot...

Articles

Pharmaceutical Component Kinetics Inventory dynamic control is crucial

Packaging Material PM components either primary secondary or tertiary are important for the medicinal product identity safety and stability despite they are not part of the dosage forms PM importance is evident from many recalls of drug products recorded in FDA database for various reasons such as mislabeling and contaminated materials

Research Insights

Clonal Evolutionary Analysis during HER2 Blockade in HER2-Positive Inflammatory Breast Cancer: A Phase II Open-Label Clinical Trial of Afatinib +/- Vinorelbine

Abstract Background Inflammatory breast cancer IBC is a rare aggressive form of breast cancer associated with HER amplification with high risk of metastasis and an estimated median survival of y We performed an openlabel singlearm phase II clinical trial ClinicalTrialsgov NCT to in

Case Studies

Rapid, Comprehensive, And Aff Ordable Mycobacterial Diagnosis With Whole-genome Sequencing: A Prospective Case Study

Abstract Background Slow and cumbersome laboratory diagnostics for Mycobacterium tuberculosis complex MTBC risk delayed treatment and poor patient outcomes Wholegenome sequencing WGS could potentially provide a rapid and comprehensive diagnostic solution In this prospective study we compare realtime

Techno Trends

UNC Lineberger Researchers Discover Experimental Compound to Block Lymphoma

The University of North Carolina UNC Lineberger Comprehensive Cancer Center researchers have discovered a hyperactive cell that contributes to tumor growth in primary effusion lymphoma and a potential treatment strategy to block down its downstream effects

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

REDUCTION OF HEALTH COSTS

Since autumn the first package of costcutting measures in Switzerlands healthcare system is being reviewed One of the measures is the socalled refere...

RESEARCH DEVELOPMENT

Academic Ventures and Professional Service Companies

Over the past few decades life science and pharma have been characterised by a series of radical changes that have been at the origin of an impressive...

CLINICAL TRIALS

The Virtual World of Digital Clinical Trials

Emerging technologies have the potential to fundamentally alter how patients engage with and participate in clinical trials Creating a digital strateg...

MANUFACTURING

ADVANCES IN SPRAY DRYING FOR THE IMPROVED DELIVERY OF POORLY SOLUBLE DRUGS

Spray drying is an important unit operation first patented in Essentially the technique involves the pumping of a solution through a nozzle into a dr...

Information Technology

IOT AND AI CREATE ‘SMART’ DIGITAL ASSISTANTS

was the year where pharma realised that Big Data could dramatically increase the value of data produced during drug development or coming from Electr...

EXPERT Talk

The Pharmaceutical Supply Chain from a CDMO’s Perspective

The primary change we see is that of market dynamics and rapid growth resulting in an increased complexity in the supply chain In an era of globalisat...

DRUG PRICING FOR PERSONALISED MEDICINE

REGULATORY ASPECTS OF GENOTOXIC IMPURITIES

Is Blockchain the Right Technology for the Pharma Supply Chain?

NOVO NORDISK PHAMATECH - ENSURING QUALITY ASSURANCE

Compelling Pre-clinical Models

HEALTHCARE EVOLUTION

FOUND IN TRANSLATION

COMPUTER AIDED DRUG DESIGN IN PHARMA R&D

MESSY MARKETING

A QUALITY BY DESIGN APPROACH

Get instant access to latest e-book

LATEST NEWSRead more...

18

Teijin and NeuroSigma Enter into Exclusive License Agreement

18

Simulations Plus Partners with Large Pharmaceutical Company to Develop the Virtual Bioequivalence Trial Simulator™ Module

17

Mycovia Pharmaceuticals Announces Partnership with Gedeon Richter to Commercialize and Manufacture VT-1161 for Recurrent Vulvovaginal Candidiasis

17

HitGen Enters into DNA-Encoded Library Based Drug Discovery Research Collaboration with Galapagos NV

16

WindMIL Therapeutics and University of California, Irvine Announce Collaboration to Collect Bone Marrow from Patients with Gliomas

press releasesRead more...

18

Genentech Announces FDA Approval of Xofluza (Baloxavir Marboxil) for People at High Risk of Developing Influenza-Related Complications

18

FDA Grants Orphan Drug Designation for Neuren's NNZ-2591 to Treat Angelman, Phelan-McDermid and Pitt Hopkins Syndromes

17

Credence MedSystems Awarded Grant to Develop Its Dual Chamber Drug Delivery Device for the Global Health Setting

17

Adaptate Biotherapeutics formed to develop antibody-based therapies that modulate gamma delta T-cells

16

Replimune Provides Update on RP1 Clinical Development Program in Cutaneous Squamous Cell Carcinoma

EventsRead more...

20 - 24

Emergency Medicine (WACEM)

21 - 22

Highly Potent Active Pharmaceutical Ingredients

21 - 22

Down Syndrome, Autism & Cerebral Palsy

22 - 25

3rd Combination Products Forum 2019

22 - 23

BIO Investor Forum

22 - 24

Macrophage Directed Therapies Summit 2019

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TOP ARTICLES

1

Metal Organic Framework-Mesoporous Silica Nanoparticle Composite for Controlled Drug Delivery

2

Facing the Autoimmune Epidemic Prevention and treatment by novel vaccines

3

Bio-Inspired Nanomedicine An Emerging Trend For Drug Targeting Into Cancer Cells

4

Sunlight Assisted Degradation of Waste Chemicals Green Technology for Pharmaceutical Waste Management

5

Ligand Decorated Theranostic Nanomedicines

KNOWLEDGE BANK

Merck

Pharmaceutical Component Kinetics Inventory dynamic control is crucial

Clonal Evolutionary Analysis during HER2 Blockade in HER2-Positive Inflammatory Breast Cancer: A Phase II Open-Label Clinical Trial of Afatinib +/- Vinorelbine

Rapid, Comprehensive, And Aff Ordable Mycobacterial Diagnosis With Whole-genome Sequencing: A Prospective Case Study

UNC Lineberger Researchers Discover Experimental Compound to Block Lymphoma

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

Advisory Board

EDITORIAL SECTION

REDUCTION OF HEALTH COSTS

Academic Ventures and Professional Service Companies

The Virtual World of Digital Clinical Trials

ADVANCES IN SPRAY DRYING FOR THE IMPROVED DELIVERY OF POORLY SOLUBLE DRUGS

IOT AND AI CREATE ‘SMART’ DIGITAL ASSISTANTS

The Pharmaceutical Supply Chain from a CDMO’s Perspective