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RBM wins Roche schizophrenia bioassay contract

09-Dec-2009 - Swiss drug major Roche has called in biomarker testing lab Rules-Based Medicine (RBM) to help give its candidate schizophrenia drugs a commercial edge.

Medidata launches Rave automatic SAE reporting add-on

09-Dec-2009 - Medidata says the latest addition to its EDC platform, the Rave Safety Gateway, will cut the time it takes to report adverse events during trials and help CROs and their...

Absorption Systems rolls-out preclinical device testing service

08-Dec-2009 - Preclinical drug testing specialist Absorption Systems has branched out and opened a new surgical lab designed to help pharmaceutical firms assess the safety of biomaterials and medical devices.

India wants biometric data for trials; may enable Phase I studies

07-Dec-2009 - India’s Ministry of Health and Family Welfare (MHFW) want to make the collection biometric data from all clinical trial participants standard across the country’s research sector.

MEP questions figure used to justify not having mandatory inspections of API plants

02-Dec-2009 - A MEP has questioned the EC’s estimate that 20,000 API producers supply the EU, which was used to justify not having mandatory inspections, and the CEO of Hovione added that...

QSI installs ERP system

30-Nov-2009 - Infosys Technologies has helped CRO Quantum Solutions India (QSI) implement Microsoft Dynamics NAV 2009 which will allow data management, process harmonisation and reduce delays.

IQWiG calls for EU trial disclosure laws, says Pfizer delayed report

30-Nov-2009 - IQWiG says Pfizer’s refusal to make some data available “hindered” its report on antidepressants and called for EU mandated trial registration and publication rules.

Unilife files US patents for “world first” RTF vacc syringe; mulls Nasdaq listing

30-Nov-2009 - Unilife Medical Solutions has filed US patents for Unifill Select, which it claims is the first ready-to-fill (RTF) syringe specifically designed for vaccine delivery.

14 C "synth to clinic" simplifies development process, says Quotient CEO

24-Nov-2009 - UK contract services firm Quotient Bioresearch says its "Synthesis-to-clinic" service for 14 C labelled compounds can simplify early drug development.

Further boost for Covance’s biomarker offering in RBM deal

19-Nov-2009 - Covance will outsource biomarker activities to US laboratory group Rules-Based Medicine (RBM) in an exclusive deal announced yesterday.

Work needed to close gender knowledge gap

18-Nov-2009 - Regulators, industry and academia must do more to close the knowledge gap created by a historic shortage of women in clinical trials, according to speakers at AAPS 2009.

Icon plans for 35,000 sq ft site at hospital

17-Nov-2009 - Icon is currently planning to occupy over a third of the 100,000 sq ft redeveloped hospital in Manchester, UK, which is due to open in 2012 and will become a...

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)...

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