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Breaking News on Contract Research, Manufacturing & Clinical Trials

Hot Topics > Patient safety

Catalent unveils ulta-sensitive melamine test for drugs

05-Nov-2009 - US contract services firm Catalent has launched a new test service capable of detecting trace amounts of the toxic chemical melamine in pharmaceuticals.

News in brief

Covance’s Chandler site OKed by AAALAC

27-Oct-2009 - Covance’s animal testing facility in Chandler, Arizona has been fully accredited by the AAALAC with no recommendations for improvement.

“Tremendous scrutiny” of trials affects insurance; MD

26-Oct-2009 - Globalisation and “heightened awareness and scrutiny of clinical trials” in the wake of the Northwick Park, UK incident, where some patients suffered multiple organ failure, have had a significant impact...

CER is a “historical market opportunity”; Quintiles VP

22-Oct-2009 - Comparative effectiveness research (CER) represents a “historical market opportunity”, according to a VP at Quintiles who explained that pharmas that do the work will be “properly rewarded for their innovations”.

Prof Kummerer wins Recipharm environmental award

20-Oct-2009 - Swedish CDMO Recipharm’s International Environmental Award helps emphasize the drug industry’s wider role in society, according to company chairman Lars Backsell.

Animal testing could be eliminated; Kirkstall

20-Oct-2009 - A spectrum of systems could eventually replace animal testing and provide a more ethical and economical route through preclinical, according to Kate Darley, business development manager at Kirkstall.

ACRO wants trials for most biosimilars

15-Oct-2009 - ACRO says while a 12-year exclusivity period for innovative drugs is important for R&D, US legislation should include rules on trials for biosimilars

Postmarketing outsourcing worth over $1bn; Quintiles SVP

12-Oct-2009 - Quintiles and Cerner are combining their “unique sets of experience and expertise” to improve the efficiency of late phase research, the market for which exceeds $1bn (€677m), according to a...

Sigma-Aldrich gets MJFF grant to develop rat PD models

06-Oct-2009 - US life science firm Sigma-Aldrich has received a Michael J Fox Foundation (MJFF) grant to create knockout-rat models of Parkinson’s disease (PD) to improve preclinical drug development.

AAHRPP revises standards

01-Oct-2009 - The AAHRPP has issued a major revision of its standards, the first time it has done so, adding sections on transnational research and the separation of business interests from ethics...

FDA issues cancer vaccine trial guidance

30-Sep-2009 - Clinical trials of cancer vaccines should enrol patients with no evidence of residual disease, according to FDA guidance, but this will increase development times compared to cytotoxic agents.

WHO endorses African clinical trial registry

28-Sep-2009 - The Pan-African Clinical Trials Registry (PACTR) has become the first such database to be endorsed by the WHO, providing the world with access to studies on the continent and improving...

FDA EOP2A guidance aims to boost trial success

23-Sep-2009 - The FDA is hoping to increase the likelihood of a clinical trial being successful by making best use of science and alternative study designs and has issued end-of-Phase IIa (EOP2A)...

CROs alter IRB selection policies after GAO sting; VP

23-Sep-2009 - The GAO sting operation and subsequent increased scrutiny will “definitely change how pharma and CROs choose IRBs”, according to the VP of NEIRB who spoke to Outsourcing-Pharma after successfully completing...

Sentinel Initiative will help with postmarketing objectives; PRA

22-Sep-2009 - The Sentinel Initiative will help pharma and CROs pinpoint study objectives, according to a director at PRA who told Outsourcing-Pharma about the company’s postmarketing safety surveillance.

Quintiles: Africa is the next drug development frontier

21-Sep-2009 - Quintiles has targeted Africa as the next non-traditional area to develop new medicines and the opening of its office in Ghana, which is now fully operational, is a major step...

Bill aims to boost recruitment for rare disease clinical trials

18-Sep-2009 - Recruiting patients with rare diseases for clinical trials could become easier if the US Congress passes a bill to allow patients on supplemental security income (SSI) benefits to receive compensation.

Orasi service aims to cuts costs in Alzheimer’s trials

16-Sep-2009 - Orasi Medical claims CROs and pharmas can cut the cost and length of Alzheimer’s trials, and improve accuracy, by using its brain function measuring service, which is now being promoted...

CRO reputation vital when selecting outsourcing partner; CEO

16-Sep-2009 - Outsourcing to a well known CRO with a good reputation is vital to ensuring that data is well received by regulatory authorities, according to a CEO that just inked a...

Xybion and Locus team up on animal and preclinical data management

15-Sep-2009 - US firms Xybion Medical Systems and Locus Technology say their new animal management and data analysis partnership will help streamline preclinical development and reduce research costs.

Ghostwriting widespread in 6 of top 10 med journals; study

14-Sep-2009 - A significant number of articles in six of the top 10 medical journals in 2008 were ghostwritten, according to study by editors of JAMA that found responding authors reported a...

Warning letters increase as DSI rejigs operations

09-Sep-2009 - FDA warning letters to clinical trial investigators have increased by 50 per cent in 2009 as a consequence of improved processes at DSI, a spokesperson told Outsourcing-Pharma.

Lab Research lands new preclinical R&D contracts

09-Sep-2009 - New multi-million dollar R&D contracts with top three pharma and biotech players go someway to “alleviating” the negative impact of downturn, according to Lab Research CEO Luc Mainville.

Report recommends FDA revises postmarketing processes

04-Sep-2009 - Following a review of the backlog of postmarketing studies the FDA has initiated changes to improve its processes, including developing Manuals of Policies and Procedures (MAPP) to track the status...

Indian registered clinical trials soar

03-Sep-2009 - Clinical trials registered in India have soared in the past 12 months, as the nation has shifted its policy on recording full study details from voluntary to advisory and in...