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Headlines > Clinical Development

US FDA halts CTI BioPharma's Ph III cancer drug trial after patient deaths

11-Feb-2016 - The US FDA has ordered CTI BioPharma to halt a Phase III trial of a cancer drug candidate after patients died from “intracranial hemorrhage, cardiac failure and cardiac arrest.”

President's US FDA budget a 'barren request'

11-Feb-2016 - Under the President’s FY 17 proposed budget request, the FDA would receive $2.743bn in budget authority appropriations – and many are frustrated with the lack of funding.

CRO market to reach $45.2bn by 2022

10-Feb-2016 - The global healthcare CRO market is expected to reach $45.2bn by 2022, according to a report by Grand View Research.

‘Bleed to read’ tech will alter drug research and disease treatment, says CEO

05-Feb-2016 - Quanterix claims the updated version of its Simoa immunoassay platform allows biopharma researchers to study diseases in more detail than ever before.

Pharma, US Gov’t pushing for Zika vaccine

03-Feb-2016 - Sanofi Pasteur has launched a Zika vaccine project, levering its experience in developing vaccines for similar viruses, as the US government pushes for “intensified research.”

Microbioreactor could replace animal testing

02-Feb-2016 - Researchers have developed a microbioreactor that enables cultured liver cells to be used as test samples, instead of animals.

Clintec: new execs part of directed growth strategy

02-Feb-2016 - Mid-sized CRO ClinTec says it plans to grow considerably over the next 18 months with the addition of a new COO and CMO being the first step.

Education to boost retention? PRA hires UK Ad agency

01-Feb-2016 - PRA Health Sciences will launch a recruitment and education drive for trials in the UK this spring in collaboration with advertising agency DJM Pan Unlimited.

DAY 2

CRO world braves chilly Philly to attend CROWN Congress

27-Jan-2016 - The clinical trial industry has braved almost two feet of snow to attend this year's Clinical Research & Operations Worldwide Network (CROWN) Congress in Philadelphia. And Outsourcing-Pharma braved the cold...

RBM: 'Risks are not issues,' Boehringer Ingelheim

27-Jan-2016 - CROs have been experiencing increased pressure to implement risk-based monitoring (RBM), and while adoption has been slow, it is gaining speed, say speakers at CROWN Congress.

Should clinical trial data sharing be mandated?

25-Jan-2016 - Clinical trial participants willingly put themselves at risk, so a committee is proposing that data sharing be mandated before manuscript publication is considered.

Pharma fallout: Biotrial details emerge

25-Jan-2016 - New information, including Bial’s clinical protocol document have emerged over the past week, providing new insight into the Biotrial tragedy.

Trust needed to bring back clinical trials to India, says ISCR president

21-Jan-2016 - India has 16% of the world’s population, 20% of the disease burden, and has contributed to less than 1.4% of global clinical trials, but the country is looking to fix this imbalance.

Parexel acquires life sciences consulting firm Health Advances

20-Jan-2016 - Parexel has acquired a life sciences strategy consulting firm as it continues to build on its existing portfolio.

SAEs the only similarity between the BIA 10-2474 trial and 'elephant man' study, says MHRA

18-Jan-2016 - A study halted  in France after one volunteer died and others were injured differs markedly from the disastrous “elephant man” trial that hospitalized six in the UK in 2006 according to the MHRA....

Update

What we know: Biotrial clinical trial tragedy

18-Jan-2016 - On Friday, the French Minister of Health addressed the public pledging to provide answers after one man was declared clinically dead as the result of a clinical trial gone wrong.

Biotrial run PhI study halted after patient declared brain dead

15-Jan-2016 - A clinical trial being run by Biotrial has been suspended after six serious adverse events.

Pfizer, Calibr enter into strategic collaboration

14-Jan-2016 - Calibr and Pfizer have entered into a global strategic collaboration to develop novel antibody-based therapeutic agents to treat heart failure. 

Exclusive interview

India has 'natural potential to grow' in CRO space, says Syngene CEO

14-Jan-2016 - India’s CRO industry is playing catch-up to the generic and manufacturing sectors, according to the departing CEO of one of the largest players, Syngene.

update

Better data can encourage industry to trial generics for new indications

13-Jan-2016 - Higher quality data could convince pharma firms to pay to trial generic drugs for new indications say researchers calling for diclofenac to be studied as a cancer treatment.

Parexel: 2016 prescribing decisions to be driven by clinical and real-world data

07-Jan-2016 - In 2016 clinical trial and real-world data will become increasingly important in the decision to prescribe medicine, Parexel President and COO Mark Goldberg told Outsourcing-Pharma.com.

Will CROs adopt remote patient monitoring in 2016?

07-Jan-2016 - Experts agree that CROs will be more connected in 2016, however limitations – and hesitations – still surround remote based monitoring.

Bad data: new methods needed to catch errors in clinical trials

06-Jan-2016 - About 2% of researchers admit to data manipulation, but this figure may be much higher and a new method is being sought to detect flawed data.

CTMS market set to hit $2bn by 2019 yet CROs may not be the driver

06-Jan-2016 - The global clinical trial management system (CTMS) market is expected to grow 14% over a five-year period hitting an almost $2bn valuation by 2019, according to a new market report.

'Merger mania' could leave strategic CROs vulnerable in 2016, says PwC

05-Jan-2016 - Mergers among Big Pharma companies will continue into 2016 leaving strategic CRO partnerships at risk, according to a report from PwC.

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