Preclinical

DIA 2018

The nexus of innovation, policy improvements changing at never-before-seen pace: DIA

10-Jul-2018 By Melissa Fassbender

Cross-industry discussion is expanding from early discovery to post-licensing challenges – as the nexus of innovation and policy improvements is rapidly changing, says DIA executive.

BioIVT 'better positioned' to support ADME-Tox clients with Optivia purchase

09-Jul-2018 By Melissa Fassbender

BioIVT adds transporter assay products and services to its ADME-Toxicology portfolio with the acquisition of Optivia Biotechnology – a deal which aligns with the company’s efforts to support drug safety and efficacy, says VP.

Catalent eyes early-phase work with $133m Juniper acquisition

03-Jul-2018 By Melissa Fassbender

Catalent is set to acquire Juniper Pharmaceuticals in a $133m deal, which will provide the CDMO with a new European hub and the ability to win a larger share of early-phase development programs says exec.

KCR adds trial execution consulting to CRO offerings

02-Jul-2018 By Melissa Fassbender

KCR has added clinical trial execution consulting to its portfolio in response to a demand which has increased over the last two years, says CEO.

Drug development innovations not widely adopted, despite benefits: Report

28-Jun-2018 By Melissa Fassbender

Innovations in drug development positively affect clinical trial timelines, market launch likelihood, and patient access – though adoption remains low, says report.

Emulate raises $36m to scale Organs-on-Chips technology

28-Jun-2018 By Melissa Fassbender

Emulate is further developing its Human Emulation System and building a team of experts to help drive broad adoption of its Human Emulation System in the pharmaceutical industry.

News in Brief

BioAgilytix expands bioanalytical offerings

20-Jun-2018 By Staff reporter

The contract bioanalytical testing services company BioAgilytix is expanding its technology suite with the addition of Sword Bio’s detection platform for immunoassays.

GE looks to speed drug discovery with new high capacity system

19-Jun-2018 By Melissa Fassbender

GE has introduced a new high capacity system designed to improve productivity in the increasingly complex drug discovery process.

Life science advances and gender equity on the program for DIA 2018

19-Jun-2018 By Melissa Fassbender

This year’s DIA Global Annual Meeting will focus on the latest global trends and showcase the "diverse group of key individuals driving the life science ecosystem forward," says DIA Americas managing director.

Changing the finish line: Syneos talks bringing payer, patient voice into drug development

19-Jun-2018 By Melissa Fassbender

The drug development “finish line” is not regulatory approval, says Syenos Health chief scientific officer Judith Ng-Cashin, MD, who discusses bringing the payer and patient voice into the process.

Evotec takes on Sanofi’s infectious disease unit as it aims to develop new anti-infectives

18-Jun-2018 By Melissa Fassbender

Evotec is integrating Sanofi’s infectious disease unit into its organization and will collaborate to launch new "open innovation" initiatives aimed at accelerating infectious disease research.

Medidata looks to deliver ‘digital transformation’ with Shyft Analytics deal

14-Jun-2018 By Melissa Fassbender

Medidata is acquiring Shyft Analytics for $195m, creating a new platform that will combine clinical development with commercial and real-world data analytics in a first for the industry, says a company executive.

AI-informed virtual assistant to help solve ‘stubborn problems,’ says Saama

13-Jun-2018 By Melissa Fassbender

Saama has launched a set of artificial intelligence (AI) capabilities designed to understand "typical life science domain questions" to better support clinical trial planning, feasibility, and conduct.

Wasdell invests £500k in new UK-based lab, offerings to be replicated in Ireland

11-Jun-2018 By Melissa Fassbender

Wasdell Group is investing £500k ($669k) in a new laboratory as the first phase of an expansion strategy, which includes a similar investment in Ireland "to cater for all situations after Brexit," says managing director.

State of the Industry

State of the Industry: Taking the pulse of the contract services market

11-Jun-2018 By Melissa Fassbender

Following on from the success of last year's survey, Outsourcing-Pharma is running another 'state of the industry' survey to gauge views about the current state of the pharmaceutical contract services industry.

Smallpox treatment nears FDA approval after years of development, collaboration

11-Jun-2018 By Melissa Fassbender

SIGA is slated to receive FDA approval for the world’s first antiviral drug to treat smallpox – a milestone not reached in isolation, but in collaboration with several CROs, government agencies, and others.

Preclinical CRO Admescope acquires MetaSafe to up drug metabolism services

07-Jun-2018 By Melissa Fassbender

The preclinical contract research organization (CRO) Admescope has acquired MetaSafe in a deal which will bolster its drug metabolism services for clinical phase projects.

PPD: Meeting biopharma demand is a ‘substantial undertaking’ for CRO industry

07-Jun-2018 By Melissa Fassbender

PPD Laboratories SVP says its been a substantial undertaking – for every company in the CRO industry – to meet the demand for biopharmaceuticals as the industry's pipeline continues to expand.

BIO 2018

Celltrion gets into outsourcing with Bio CDMO launch

06-Jun-2018 By Melissa Fassbender

Celltrion has launched Bio CDMO, its new contract development and manufacturing business and part of the company's "open innovation strategy" to expand its drug pipeline portfolio.

Syngene teams with immuno-oncology firm to provide ‘greater value-added services’

04-Jun-2018 By Melissa Fassbender

Syngene International has inked a non-exclusive partnering agreement with the emerging immuno-oncology company Zumutor Biologics after collaborating for more than a year.

Personalized medicine driving biobanking demand, says sample management provider

29-May-2018 By Melissa Fassbender

The growing emphasis on personalized medicine is driving the need for biobanking services – demand for which is expected to continue increasing.

Lonza grows hepatocytes portfolio

24-May-2018 By Melissa Fassbender

Lonza has added to its hepatocytes portfolio to provide researchers with the foundation to create “more physiologically relevant” in vitro models for liver disease research.

How big data can design safer clinical trials and reduce animal testing

24-May-2018 By Melissa Fassbender

Bayer AG and Elsevier studied more than 1.6m adverse events to show how big data can be used to reduce animal testing and design trials "altered to potential risks," says researcher.

PPD, Evidera join MIT ‘think and do’ tank as a strategic partner

23-May-2018 By Melissa Fassbender

PPD and Evidera have joined MIT’s NEWDIGS initiative through which the CRO aims to scale sustainable, commercially viable tools to “drive more value faster.”

Eurofins to offer biopharma testing in Japan with Astellas lab deal

22-May-2018 By Flora Southey

Astellas will contract out an internal testing laboratory to Eurofins Scientific, marking the CRO’s entry into biopharmaceutical product testing in Japan.

Celgene targets solid tumours in $65m Evotec drug discovery deal

22-May-2018 By Flora Southey

Celgene has selected Evotec’s phenotypic screening capabilities and compound libraries to identify potential cancer therapeutics for development.

TriNetX launches new offering as it continues ‘re-imagining’ clinical research: CEO

21-May-2018 By Melissa Fassbender

The global health research network today has announced the availability of TriNetX Research, a suite of analytics solutions designed to leverage real-world data during observational and outcomes research.

WuXi AppTec IPO tops $353m

09-May-2018 By Melissa Fassbender

The Chinese contract research and development company WuXi AppTec has raised more than $353m in its initial public offering of common stock on the Shanghai Stock Exchange.

Evotec, Carna Biosciences collaborate on INDiGO to treat blood cancer

09-May-2018 By Brittany Farb Gruber

Evotec has entered into a strategic collaboration to accelerate Carna Biosciences’s program CB-1763, which is being developed for the treatment of blood cancer.

UK commits to post-Brexit clinical trial rule harmonization but uncertainties remain

07-May-2018 By Nick Taylor

The UK government has provided the “strongest possible reassurance” that it will implement the incoming European Union Clinical Trial Regulation, whatever happens in the Brexit negotiations.

CRO market to reach $44.4bn by 2021

03-May-2018 By Melissa Fassbender

The global contract research organization (CRO) market is forecasted to grow 12% year-on-year through 2021 – led by IQVIA with 12.4% of the market share.

Charles River expands early discovery services

01-May-2018 By Melissa Fassbender

Charles River has upped to its early discovery capabilities with the addition of high-throughput technologies and expanded pharmacokinetic services.

Catalent investing $5m to bolster early development offering

25-Apr-2018 By Melissa Fassbender

Catalent plans to invest $5m to create a new drug development center of excellence focusing on preclinical to clinical phase IIb formulation, analytical, and manufacturing solutions.

Letter to the editor

Sizing up: Does CRO consolidation leave space for smaller firms?

24-Apr-2018 By Melissa Fassbender

A continued need for specialized services and expertise will keep smaller firms in business – though many have forecasted the “death of small- to mid-sized CROs” as the industry continues to consolidate, say experts.

WuXi AppTec opens second NJ-based site following ongoing expansion efforts

23-Apr-2018 By Melissa Fassbender

WuXi AppTec is converting its Plainsboro, NJ lab into a fully GLP-regulated bioanalytics facility after opening a new site in Cranbury which doubles the company’s total operation space to more than 115,000 square feet.

Why is pharma grounding costly trials on low-quality preclinical studies? Researchers ask

17-Apr-2018 By Melissa Fassbender

Poor animal study design and reporting raise concerns about whether current processes are the best way to conduct effective and efficient drug development.

Charles River investing in expanded biologics partnership with PathoQuest

16-Apr-2018 By Melissa Fassbender

Charles River Laboratories and PathoQuest have expanded their strategic partnership to help move vaccine, biologic, and gene-therapy candidates through the drug discovery and development pipeline.

Bridging Clinical 2018

Clinical research a ‘sickly link’ in health care enterprise: CDER director

11-Apr-2018 By Melissa Fassbender

To bridge the gap between clinical research and health care, the industry must connect with marginalized practitioners and patients – and create greater incentives for collaboration.

ImmunoPrecise adds next-gen antibody discovery tech with ModiQuest purchase

11-Apr-2018 By Melissa Fassbender

ImmunoPrecise Antibodies has acquired ModiQuest Research BV to create a “single source provider of services across the full antibody discovery value chain,” says CRO.

DCAT WEEK

Pharma 'endangered,' though 'huge opportunities' exist as the industry evolves

10-Apr-2018 By Melissa Fassbender

Pharma must look outward to innovate and find new areas of growth, as research and development productivity and returns on innovation continue to decline, says industry expert.

Frontage Laboratories acquires Concord Biosciences: ‘Committed to build a global CRO’

09-Apr-2018 By Melissa Fassbender

Frontage Laboratories has acquired Concord Biosciences, taking a “significant step” towards the company’s goal of building a global organization, says CEO.

Twist Bioscience secures $50m to advance DNA Synthesis Platform

03-Apr-2018 By Melissa Fassbender

The synthetic DNA provider Twist Bioscience Corporation has completed a private placement of $50m to advance its proprietary, silicon-based DNA Synthesis Platform.

A molecular match: Exactis using Thermo NGS tech to profile patient samples, speed trial matching

02-Apr-2018 By Melissa Fassbender

Exactis Innovation is standardizing its sequencing labs as it aims to quickly match at-risk cancer patients with clinical trials through its longitudinal, biopsy-led registry.

Top global CROs form industry standards group to support clinical trials

29-Mar-2018 By Melissa Fassbender

Align Clinical CRO is "committed to operating with speed" as it aims to solve common pre-competitive industry challenges to improve clinical trial execution and collaboration between sponsors and CROs, says exec.

DCAT WEEK

CMOs, CDMOs give company updates at DCAT Week: Acquisitions, expansions on all sides

29-Mar-2018 By Melissa Fassbender

At DCAT Week, contract manufacturing and development companies from across the globe shared updates and news – from multi-million dollar investments to new business structures and areas of focus.

Abzena: Manufacturing suite remodel supports ADC production for preclinical, early-phase studies

28-Mar-2018 By Melissa Fassbender

Abzena has completed a remodeling of its new antibody-drug conjugate (ADC) GMP manufacturing suite, which will support customers progressing drug development programs from research into clinical trials.

BioIVT expands drug safety testing and toxicology portfolio

27-Mar-2018 By Melissa Fassbender

BioIVT has acquired the multinational cell-based assay company Ascendance, adding proprietary bioengineered micro-liver platforms to its portfolio.

News in brief

GSK signs R&D agreement with India-based CRO Syngene

26-Mar-2018 By Melissa Fassbender

Syngene International has signed a multiyear agreement with GSK through which the companies will focus on accelerating the discovery of new drug candidates using the CRO’s discovery services platforms.

Envigo ups capacity ten-fold to create new Center of Excellence for surgery

22-Mar-2018 By Melissa Fassbender

Envigo is increasing its surgical footprint ten-fold to create a West Coast Center of Excellence for surgery and supply myocardial infarction research models regionally.