22-Sep-2014 - The US FDA was flooded with comments on its draft guidance seeking to amend the informed consent process – with some saying the guidance will further confuse patients while others took issue with what...
17-Sep-2014 - Shifting EMA oversight to DG Enterprise and Industry will put patients at greater risk of adverse events according to NGO Health Action International, which suspects EFPIA “had a hand” in...
15-Sep-2014 - Drugmakers sponsoring trials in India will need to weigh the potential risks and benefits for the people who take part under new guidelines issued by the CDSCO.
11-Sep-2014 - Industry groups BIO (Biotechnology Industry Association) and GPhA (Generic Pharmaceutical Association) are calling for outsourcing facilities to be held to the same standards as other, larger manufacturers.
09-Sep-2014 - US authorities have arrested Glenn Chin, a supervising pharmacist they say was involved in compounding the contaminated injections behind an outbreak of fungal meningitis that struck 751 patients and killed 64 in 2012....
24-Jul-2014 - WIRB-Copernicus Group (WCG), a provider of regulatory and ethical review services for clinical research, has acquired biosafety consultancy Alliance Biosciences. Financial terms of the deal were not disclosed.
07-Jul-2014 - Sponsors and CROs must ensure that clinical studies are properly designed and that investigators work on a maximum of three trials simultaneously under new guidelines issued by Indian regulators.
14-Apr-2014 - Patient recruitment is “the major bottleneck” in clinical development, an Industry Standard Research report says, but though it predicts a drive to ‘push’ patients into trials, industry disagrees.
09-Apr-2014 - Genentech says its collaboration with PatientsLikeMe will enable more effective clinical trial recruitment but will not affect its partnerships with CROs.
26-Mar-2014 - BioReliance has updated its big blue assay for the second time in six months by creating a version of the drug genotoxicity test that can be used in rats.
11-Mar-2014 - Nearly a quarter of drugs made in Jammu & Kashmir and 10% of those produced in Himachal Pradesh are substandard according to new testing data published by CDSCO.
30-Jan-2014 - The Institute of Medicine is conducting a consensus study to recommend guiding principles and a framework for the responsible sharing of clinical trial data before a final report is released...
23-Jan-2014 - The need to improve efficiency and comply with regulatory and geographical demands is driving the third-party clinical payment industry, say Greenphire, CFS and Clinverse.
22-Jan-2014 - Novo Nordisk has selected patient recruitment firm Trialbee to boost participant numbers in diabetes studies using its web-based platform.
16-Jan-2014 - As part of its shift to cut costs, Covance has demolished an unfinished $175m (€128m) toxicology laboratory it was building in Manassas, Virginia.
09-Jan-2014 - Davita Clinical Research (DCR) has said increasing client demand for adaptive trial designs in early Phase research prompted its partnership with Pacific Pharma Group study expert, Jon Ruckle.
07-Jan-2014 - Theorem has partnered with BioTelemetry in order to offer its clients cardiovascular testing services.
20-Dec-2013 - Drugmakers and academics will have to upload the results of trials run in Europe to a public database under a provisional deal agreed in the European Parliament earlier today.
17-Dec-2013 - German electronics firm Siemens has been contracted to develop and commercialize companion diagnostics by US drug giant Pfizer.
16-Dec-2013 - Fewer animals were used to test the safety of life saving drugs in Europe in 2011 than in previous years according to the sixth edition of a research report by...
11-Dec-2013 - Italian CRO Centro Ricerche Cliniche di Verona (CRC) has become the first firm to be awarded a new early phase accreditation from the European CROs Federation (EUCROF).
05-Dec-2013 - CMO Ben Venue Laboratories has asked Bank of America Merrill Lynch to try and find a buyer for its generic injectables business, Bedford Labs.
02-Dec-2013 - The US FDA has defined compounding pharmacies as ‘outsourcing facilities’ in new guidance issued days after the Drug Quality and Security Act (DQSA) became law .
25-Nov-2013 - Smartphones are changing the role of the patient in clinical trials and can be used for industry success, Pfizer and technology provider firm Exco InTouch said at PCT 2013.
20-Nov-2013 - CRA Assessments says its standardised simulation approach to clinical trial monitors is a novel way for CROs and pharma firms to save costs and ensure quality.