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Headlines > Clinical Development

US FDA accepts IND for TxCell's Crohn's cell therapy; Firm eyes European CRO for US trial

30-Jun-2015 - TxCell is set to expand a trial of its candidate Crohn’s disease cell therapy to the US after the FDA accepted its IND application.

News in brief

Aeterna Zentaris adds a Phase III trial to CRO Ergomed’s plate

30-Jun-2015 - Aeterna Zentaris has selected UK-based Ergomed again for a clinical trial, this time for a confirmatory Phase III study to demonstrate the efficacy of Macrilen (macimorelin), a novel orally-active ghrelin...

eCRO Bracket Global acquires trial tech provider Clintara

29-Jun-2015 - Bracket Global has acquired Boston-based Clintara, which will allow Bracket to integrate the Clintara platform of trial surveillance tools into its electronic platform for Clinical Outcome Assessments (eCOA). 

News in brief

Pharm-Olam sets up in Paris citing French R&D tax credit as driver

26-Jun-2015 - US CRO Pharm-Olam has opened a Paris office citing changes to the rules governing drug R&D and French tax credits as the driver.

Trial data: charity hits back at CRO’s anti-transparency bid

25-Jun-2015 - Charity Sense About Science is attempting to intervene in a UK CRO’s legal action against trial transparency.

CTTI offers range of QbD recommendations for clinical trials

25-Jun-2015 - The Clinical Trials Transformation Initiative, a public-private partnership between Duke University and the FDA, has created a list of four recommendations related to quality by design (QbD) for clinical trials.

Google unveils new wristband to collect trial participant data

25-Jun-2015 - Google’s life sciences group is developing a wristband dedicated exclusively to tracking clinical trial participants’ vital signs and other data.

Parexel to lay off 850 amid restructuring

25-Jun-2015 - Massachusetts-based CRO Parexel is eliminating 850 positions, which it expects will cost the company $30m to $40m in employee separation benefits.

Dispatches from DIA

An evolution: B-MS, Celgene offer early insights into RBM

24-Jun-2015 - Two early adopters of RBM (risk-based monitoring) – Bristol-Myers Squibb and Celgene – have provided details into the way they’re reducing clinical trial site visits to increase efficiencies around identifying...

Roundup of new CRO tech, research collaborations and more

19-Jun-2015 - The 51st annual DIA conference in Washington, DC has been abuzz all week with new offerings from the top CROs (contract research organizations), in addition to new collaborations between top...

Dispatches from DIA 2015

SynteractHCR driving growth via smaller clients, CEO says

18-Jun-2015 - With more than 90% of revenue coming from pharma and biotech companies outside the top 25, CRO SynteractHCR is seeing more growth stemming from an influx of funding to smaller...

BIO 2015

Ex-Homeland Security cyber chief warns of threats to pharma

17-Jun-2015 - The pharma industry must fight “vendor indifference” so suppliers and services companies are not prey to cyber attacks that can lose drug companies hundreds of thousands of dollars in minutes,...

Dispatches from DIA 2015

21st Century Cures: What it could mean for CROs

17-Jun-2015 - Last month, a US House committee unanimously passed a bill that would set up a host of new provisions tied to clinical trials, many of which will have an impact...

update

EU trade secret proposals could help pharma avoid publishing trial results says NGO

16-Jun-2015 - Trade secrets proposals supported by the European Parliament’s legal affairs committee could allow drugmakers to withhold trial results and drug safety data says Health Action International.

ESC: Simpler trials would encourage cardiovascular disease drug developers

16-Jun-2015 - A new trial model is needed to encourage cardiovascular disease drug development say researchers who claim the large, lengthly studies used to prove safety and efficacy of such drugs are...

Dispatches from DIA 2015

PPD partners with Anthem subsidiary to focus on post-approval research

16-Jun-2015 - CRO Pharmaceutical Product Development (PPD) has established a five-year partnership with Anthem subsidiary HealthCore to help sponsors more quickly and effectively demonstrate how their products will perform in the real...

Dispatches from DIA 2015

Parexel CEO: Consolidation has created ‘ferocious’ competition among CROs

16-Jun-2015 - Competition among the top CROs, many of which are conglomerations of smaller peers, is “ferocious” right now on nearly every level, Parexel CEO Josef von Rickenbach told Outsourcing-Pharma.com at the...

US FDA teams with PatientsLikeMe to access post-market patient data

15-Jun-2015 - PatientsLikeMe says a deal allowing the US FDA to use its patient-generated data is an “unprecedented step toward enhancing post-market surveillance.”

News in brief

Akebia signs up Quintiles for Phase III study

15-Jun-2015 - Akebia Therapeutics has signed a master services agreement with CRO Quintiles in connection with its planned Phase III studies for Akebia’s lead product candidate for the treatment of anemia secondary...

Canadian CRO leverages site relationships to target early-phase US biotech trials

15-Jun-2015 - Canada’s only oncology-focused CRO Scimega has created a program that allows it to align more closely with investigative sites across nine provinces.  

INC launches first SAG to drive earlier insights to protocol development of CNS studies

12-Jun-2015 - CRO INC Research has launched the industry’s first Site Advocacy Group (SAG), which will initially focus on central nervous system (CNS) protocols.

FDA offers guidance for running early-phase trials for gene, cell therapies

12-Jun-2015 - As the hype continues to hover around the promise of gene and cell therapies, the latest guidance from the FDA will help sponsors, CROs and investigators design early-phase clinical trials...

CRO market poised for 6% annual growth, Icon CFO says

10-Jun-2015 - As biotech cash continues to flood the coffers of CROs (contract research organizations), large pharma R&D is still relatively flat, which means CROs will see about 6% growth annually, Brendan...

Harvard professors question aspects of 21st Century Cures Act

09-Jun-2015 - The 21st Century Cures Act may actually offer the FDA too much discretion to approve drugs without conventional clinical trials, and in some cases “on the basis of less rigorous data,”...

EMA calls for 'stakeholder' input on design of new clinical trials database

09-Jun-2015 - The EMA has called for input on the design of the public clinical trial database it is developing via a survey sent to "stakeholders."

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