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The Lead

Bridging the Gap Between Value and Affordability

June 2, 2015 8:52 am | by Jane Horvath, Market Access Lead, 3D Communications | Articles | Comments

Today’s biopharma industry faces more in-market risks than ever before. Read more...

Quintiles, Quest to Join to Provide Global Clinical Trials Lab Services

March 31, 2015 11:38 am | News | Comments

Quintiles and Quest Diagnostics announced a definitive agreement to form a global clinical...

Adopting Adaptive Designs: Update

January 12, 2015 8:59 am | by Phil Birch, DPhil, VP Innovation Strategy, Alliance Partnerships at ICON plc. | Articles | Comments

In early 2013, adaptive clinical trials represented 20% of all clinical trials, according to the...

Rho Awarded New Federal Contract

October 21, 2014 2:46 pm | News | Comments

Rho, a contract research organization (CRO)...

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Majority of CROs Exchange TMFs Via Outdated Methods

October 8, 2014 11:05 am | News | Comments

The vast majority of contract research organizations (CROs) surveyed lag clinical trial sponsors in how they exchange trial master file (TMF) documents, according to the Veeva 2014 Paperless TMF Survey: The State of CRO TMFs. Read more...

inVentiv to Conduct Clinical Trials of Advaxis Immunotherapies

May 30, 2014 2:24 pm | News | Comments

inVentiv Health Clinical, a leading global CRO, and Advaxis Inc., a biotechnology company developing cancer immunotherapies, announced that they have entered into a global master services agreement for the clinical development of certain immunotherapy product candidates in Advaxis's proprietary pipeline. Read more...

Array, Biogen Collaborate on Kinase Inhibitors

May 29, 2014 2:48 pm | News | Comments

Array BioPharma announced a collaboration agreement with Biogen Idec for the discovery and development of inhibitors targeting a novel kinase for the treatment of autoimmune disorders that were discovered through Array's proprietary Kinase-Directed Phenotypic Screening Platform. Read more...


Oncothyreon, Celldex Partner on Cancer Immunotherapy

May 29, 2014 2:34 pm | News | Comments

Oncothyreon Inc. and Celldex Therapeutics Inc. announced that they have agreed to collaborate on a combined clinical trial of ONT-10 (a therapeutic vaccine targeting the tumor-associated antigen MUC1) and varlilumab (a fully human monoclonal antibody that targets CD27). Read more...

Huntingdon Life Sciences Acquires Harlan Laboratories

May 2, 2014 10:28 am | News | Comments

Huntingdon Life Sciences announced that it has acquired Harlan Laboratories. The new company will have two operating divisions: Research Models and Services and Contract Research Services. Read more...              

AMRI to Acquire Cedarburg Pharmaceuticals for $38.2M

March 24, 2014 2:24 pm | News | Comments

Albany Molecular Research Inc. (AMRI) announced that it has signed a definitive agreement to acquire all the outstanding shares of Cedarburg Pharmaceuticals Inc. for $38.2 million in cash. Read more...              

Charles River to Acquire CRO Services from Galapagos

March 14, 2014 10:22 am | News | Comments

Charles River Laboratories International Inc. announced that it has entered into a definitive agreement to acquire the CRO services division of Galapagos NV, which includes both Argenta and BioFocus. Read more...           

HHS Establishes New Clinical Study Network

March 12, 2014 3:09 pm | News | Comments

The U.S. Department of Health and Human Services (HHS) established a network of five clinical research organizations that will design and conduct clinical studies needed to develop medical countermeasures. Read more...          


Worldwide Clinical Trials to Use BioClinica’s CTMS for Global Trial Management

March 7, 2014 10:52 am | News | Comments

BioClinica Inc. announced that Worldwide Clinical Trials Inc. has selected BioClinica’s OnPoint CTMS (clinical trial management system) to support international studies spanning all phases of drug development in diverse therapeutic areas. Read more...

ProBioGen and Merus Sign Deal on GlymaxX ADCC Enhancement Technology

March 4, 2014 8:36 am | News | Comments

ProBioGen AG and Merus B.V. signed a non-exclusive commercial option and license agreement on ProBioGen’s GlymaxX fucose-engineering technology. Under the terms of the agreement, ProBioGen is granting Merus the non-exclusive right to use the GlymaxX technology to enhance the ADCC (Antibody-Dependent Cell-Mediated Cytotoxicity) activity of one of its lead products, a bispecific anti-cancer antibody.

KCR Strengthens its Footprint in Western Europe

March 4, 2014 8:24 am | News | Comments

European Contract Research Organization (CRO), KCR, which is already operating across 18 countries in Europe as well as the U.S., has recently registered new entities in the UK and Germany. This move is part of the company’s strategy to bring the business closer to Western European customers and further deepen client relationships.

Biopharma Services Launches Full Research Services Platform

February 14, 2014 2:33 pm | News | Comments

Biopharma Services Inc. is pleased to announce that in collaboration with its sister company, ADA Medical Ltd., it can now offer a complete range of contract research services, from early pre-clinical drug development through clinical trials. Read more...

BioClinica Grows eClinical Results in Europe

February 5, 2014 10:42 am | News | Comments

BioClinica Inc. announced that Europe was the fastest growing geographic region in 2013 for its eClinical technology products. Read more...                                 


Ergomed, Ferrer to Co-Develop Insomnia Drug

February 4, 2014 9:45 am | News | Comments

Ergomed Clinical Research Ltd. announces that it has entered into an agreement with Spanish pharmaceutical company Ferrer to support further clinical studies of Lorediplon in patients with insomnia. Read more...          

Datatrak, Clinverse Launch Strategic Partnership

January 21, 2014 12:00 pm | News | Comments

Clinverse Inc., provider of end-to-end technology solutions to automate the financial lifecycle of global clinical trials, announced that it has formed a strategic partnership with Datatrak, which specializes in developing cloud-based, unified eClinical technologies. Read more...

Former Merck Exec Moves to Covance

January 21, 2014 11:53 am | News | Comments

Covance announced that Barry Goldstein has joined its Clinical Development Services business as Vice President and Global Therapeutic Area Head of the expanded Cardiovascular, Metabolic, Endocrine and Renal unit. Read more...       

Par to Acquire JHP Pharmaceuticals

January 21, 2014 11:34 am | News | Comments

Par Pharmaceutical Companies Inc. announced that it has entered into a definitive agreement to acquire JHP Group Holdings, the parent company of JHP Pharmaceuticals, a specialty pharmaceutical company. Read more...           

Reaction Biology, Cisbio Bioassays Sign Distribution Agreement

January 20, 2014 2:35 pm | News | Comments

Reaction Biology Corp. (RBC) announced that it has signed an agreement for Cisbio Bioassays to distribute its epigenetic proteins. This new agreement will give Cisbio worldwide rights to co-market and sell RBC's proteins, used worldwide by researchers in drug discovery. Read more...

Harlan Labs to Open Research Model Facility in India

January 16, 2014 10:35 am | News | Comments

Harlan Laboratories announced the site of its first research model breeding facility in India, located in the Genome Valley Alexandria Technology Park in Hyderabad. Read more...                      

Royal DSM, JLL Create Pharma Services Company

November 19, 2013 10:19 am | News | Comments

JLL Partners (JLL) and Royal DSM  announced the creation of a new company, which will be a global contract development and manufacturing organization (CDMO) for the pharmaceutical industry. So what will this new company offer? Find out...

PRA Acquires CRI Lifetree

November 14, 2013 9:25 am | News | Comments

PRA, a leading clinical research organization (CRO), announced its intent to acquire privately held CRI Lifetree, a specialized research organization. So what will the acquisition of CRI Lifetree enable PRA to provide its clients? Find out...

Alzheimer's Drug Discovery Foundation Expands ACCESS Program

November 6, 2013 2:33 pm | News | Comments

The Alzheimer's Drug Discovery Foundation (ADDF) launched its newly expanded ADDF ACCESS program to provide scientists in academia and small biotechnology companies with access to a virtual network of drug discovery experts and contract research organizations (CROs). How could this accelerate research and bring novel therapies to patients faster? Find out...

Covance, Pathoquest to Provide NGS Biosafety Assessments

November 5, 2013 10:34 am | News | Comments

Covance Inc. and Pathoquest have announced a collaboration that will provide next-generation sequencing (NGS) based biosafety assessments.  How will this solve the problem of viral contamination of biologics during development? Find out...

Cel-Sci Seeks $50M in Damages From Former CRO

October 31, 2013 12:19 pm | News | Comments

Cel-Sci Corporation has initiated an arbitration claim against inVentiv Clinical LLC, the clinical research organization that was initially retained to conduct the phase 3 clinical trial of the company's lead investigational drug. What are the reasons for this claim? Find out... 

Molecular Imaging Launches New Imaging Center

October 23, 2013 2:41 pm | News | Comments

Molecular Imaging Inc. (MII) has finalized an agreement to run a new state-of-the-art preclinical imaging center at the Sanford Consortium for Regenerative Medicine (Sanford Consortium) in La Jolla, California. So will the center serve Sanford Consortium investigators, non-affiliated stem cell researchers, other academic scientists and the pharmaceutical discovery industry? Find out...

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