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HEADLINE NEWS
Phase Forward: growth depends on a full offering
Today
Clinical data management solution provider Phase Forward Inc achieved double-digit revenue growth in the final quarter of 2009, in what its chairman and CEO, Bob Weiler , called "a strong finish to a successful year", boosted by pharmaceutical industry demand for increasingly integrated clinical ...
A busy time for UBC...
Cancer Research UK selects Phase Forward software...
Quanticate launches pharmacovigilance service; hires head to lead development
04 February 2010
CRO Quanticate has launched a new pharmacovigilance service that offers clinical trial and post-marketing safety to provide comprehensive surveillance throughout the product lifecycle, and has hired an ex-PAREXEL International employee Dr Alison Bond , PhD to head up the team. Quanticate sought ...
FDA emphasises postmarketing safety in 2011 budget outline
04 February 2010
The FDA is asking for an extra $28 million in its 2011 budget request to enhance its postmarketing safety activities, with the Sentinel Initiative to benefit as well as the CDER's centre and field activities. The budget request, which comes under the Protecting Patients Initiative, "will support ...
CROs to benefit as AstraZeneca looks to R&D outsourcing
02 February 2010
AstraZeneca (AZ) is planning to outsource more R&D in the future as the company seeks to cut costs in anticipation of a difficult 2010. In a presentation to investors following publication of its 2009 results, the company announced massive job cuts,with more than 3,500 additional R&D redundancies ...
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NEWS
North Carolina consortium readies for clinical network launch
Today
The North Carolina Biomedical Innovation Network, founded by The Hamner Institutes for Health Sciences, SynecorLABS, and The University of North Carolina Good Laboratory Practice (GLP) Bioanalytical Facility, will be officially launhced on 26 February. Overall, the goal is to utilise the ...
Phase Forward: growth depends on a full offering
Today
Clinical data management solution provider Phase Forward Inc achieved double-digit revenue growth in the final quarter of 2009, in what its chairman and CEO, Bob Weiler , called "a strong finish to a successful year", boosted by pharmaceutical industry demand for increasingly integrated clinical ...
Centrephase Solutions launches clinical trial business model
Today
Centerphase has formed an alliance with its equity partner, the not-for-profit medical practice Mayo Clinic, to speed up the development time of treatments developed by the biopharmaceutical industry. The aim is to pinpoint the root causes which have historically plaguing the clinical trials ...
Fovea Pharmaceuticals collaborates to analyse Phase II clinical data
04 February 2010
Ariana(R) Pharma, a provider of data analysis solutions, has won a "significant" but undisclosed fee for a service collaboration deal with Fovea Pharmaceuticals to carry out systematic analysis of Fovea's Prednisporin Phase II clinical data. The company says the KEM(R) (Knowledge Extraction and ...
Optibrium launches enhanced drug optimisation tool
04 February 2010
Optibrium has launched StarDrop 4.3, a software which guides compound selection and design decisions in all stages of drug discovery. It is an interactive software platform that helps drug discovery scientists to guide their decisions while designing and prioritising molecules with the aim of ...
>> More News...
FEATURES
Strategies for periodic safety reporting: update on the new DSUR concept
04 February 2010
The submission of periodic reports to Regulatory Authorities (and ethics committees) is mandatory in many countries. In the USA for instance, an Investigational New Drug (IND) Annual Report detailing the safety profile of an investigational drug is submitted to the FDA on an annual basis. ...
Battling for patients...
The highly automated approach to QT assesment...
EndPoint: Jeff Thomis
03 February 2010
Dr Jeff Thomis, PhD, is president of global clinical development services at Quintiles. He has worked at the CRO since 1997 but has held his current position, which involves selling and delivering services for Phase II-V studies, since 2006. Before Quintiles he spent 21 years at Bristol Myers ...
Playing data capture catch-up in Japan
22 January 2010
Over the last decade Japan, despite being the second largest drug market in the world and possessing a notable R&D ability, has lagged behind the US and Europe in bringing drugs to market. Japan’s Pharmaceutical and Medical Device Agency (PMDA) calculated in its 2007 annual report that it took 2.5 ...
Reviving the Japanese clinical trial system
21 January 2010
Japan is one of a few countries that develop innovative medicine for patients globally and as in other countries, such as America and China, Japan has some unique regulatory requirements for conducting its clinical trials. In 1996 the ICH-GCP standards were agreed across Japan, the US and the EU, ...
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PEOPLE
New director as Immunocore approaches clinical testing
Immunocore Ltd has appointed Dr Jonathan Knowles to its board as a non-executive director. In addition to a number of academic positions, Dr Knowles was president of group research at F.Hoffman-LaRoche and a member of that company’s executive committee for 12 years, but left his executive ...
Questcor appoints chief medical officer
Questcor Pharmaceuticals has hired Dr Jason Zielonka as its new chief medical officer, replacing Steve Cartt who is now executive vice-president and chief business officer. Dr Zielonka will assume overall responsibility for collaborating with researchers on the numerous clinical and preclinical ...
ABPI appoints new government affairs head
A new head of government affairs has been appointed by the Association of the British Pharmaceutical Industry (ABPI) to spearhead its work with politicians and those in Government in both the UK and Europe. Amanda Stuart , who is currently associate director at Insight Public Affairs, will take up ...
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COMMENTARY
The fight against malaria - all still to play for
If you didn't know, how many cases of malaria would you guess occur every year around the globe? A million? Two million? In fact, around 250 million cases of malaria occur each year. Most of these occur in developing countries, although malaria is also an issue for travellers from developed ...
UK wants harmonisation, not centralisation, of European trial approvals
The UK drug regulator, the MHRA, says it does not want a centralised approvals system for clinical trials in Europe, preferring instead the voluntary harmonisation project for authorising multinational studies that is currently being piloted in the EU. The MHRA also feels that introducing a single ...
EU promises multinational CTA harmonisation at last
The problem stems mainly from the way that the EU clinical trials Directive (2001/20/EC) has been implemented by the various member states. National authorities have different format, language and content requirements for clinical trial approvals, as well as different timelines for reviewing ...
Search continues for improved BPH treatments
The recent announcement by Boehringer Ingelheim that it plans to make the alpha blocker tamsulosin available without a prescriptionin the UK is a reflection of the continued interest in the benign prostatic hyperplasia (BPH) market. The condition affects some 15 million men across the seven major ...
Abuse liability requirements during drug development
In recent years, while illicit drug use has stabilised or decreased, prescription drug abuse, particularly of scheduled drugs, has become a growing public health problem. In 2005, 49% of all emergency department visits reported to the US Drug Abuse Warning Network involved pharmaceuticals. With ...
Brain waves make billions
Estimates of the size of the market for anticonvulsant drugs vary, but a conservative estimate for 2009 would be around $12 billion worldwide. The market is concentrated on a handful of blockbuster products: the top five products had joint sales of more than $10 billion in 2008 (although some of ...
>> More Commentary...
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EVENTS
11th Annual Phase I Clinical Trials
23 February 2010
London, UK
Clinical Trial Supply
23 February 2010
London
Clinical Trials in Emerging Markets
01 March 2010
Prague, Czech Republic
