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MHRA stalls cannabis-based MS drug
23-Jul-2007 - A UK firm developing cannabis-derived multiple sclerosis (MS) treatments has decided to pull an EU application for its lead candidate Sativex, following demands by UK regulators for additional data in support of the treatment.
FDA draft guideline on ICH Q10
19-Jul-2007 - The US Food and Drug Administration (FDA) has released a draft guideline document outlining a model for implementing the International Conference on Harmonization's (ICH) Q10.
New test machines have the X factor
17-Jul-2007 - Productivity bottlenecks will be a thing of the past thanks to the new 'X' range of automated drug delivery testing machinery from UK-based firm Astech Projects.
Sustainability study provides risk assessment
12-Jul-2007 - A new study by Deloitte Consulting has been developed to help manufacturers assess the impact that the drive towards sustainability could have on their business and operations.
AeonClad the way to better drug, particle and device coatings
12-Jul-2007 - University of Texas at Arlington (UTA) spin-out has exclusively licensed plasma coating technology that could improve the controlled release of drugs and the biocompatibility of medical implants.
New scales outweighs the competitors
10-Jul-2007 - The end to botch-ups in batches is being heralded with the launch of a new set of scales.
China gets tough on manufacturers
09-Jul-2007 - China is cracking down on its pharmaceutical manufacturers with the State Food and Drug Administration (SFDA) revoking the production licenses of five drug makers since July, according to reports in the local media.
Oxoid's new portable air monitoring device
05-Jul-2007 - Microbiology expert Oxoid has released a new active air quality monitoring device to help pharmaceutical companies prove that their clean areas are microbe free.
Gel cap strength put to the test
05-Jul-2007 - A UK firm has introduced a new piece of kit for pharma firms to test how the contents of their hard gel capsules can affect the strength and stability of the outer shell.
Initiative launched to tackle ICH
04-Jul-2007 - The International Society for Pharmaceutical Engineering (ISPE) has launched a new initiative to help implement the International Conference on Harmonization (ICH) guidelines.
Anti-obesity drug slim on safety aspects
02-Jul-2007 - Sanofi-Aventis' hotly touted anti-obesity blockbuster drug has become weighted down in safety concerns as the French company withdraws its New Drug Application (NDA) in the US and awaits a safety review in the EU.
Plant-based insulin to jump to Phase II next year
27-Jun-2007 - Canadian biotech firm SemBioSys Genetics has presented an update on its project to promote plant-derived recombinant human insulin on a commercial scale, expecting to hop directly to Phase II trials early next year.
Integrating the monitoring of bioprocesses
26-Jun-2007 - Dutch researchers have developed a sensor array for monitoring fermentation in microwell plates to aid bioprocess design and scale-up.
Viracept saga continues
25-Jun-2007 - In the latest episode of the Viracept contamination case, the drug is now at risk of losing its marketing authorisation across Europe while the dangers posed by the chemical contaminant are established and manufacturer Roche rectifies its manufacturing mistakes.
To test or not to test? The glycerin debate
14-Jun-2007 - Following last year's contaminated glycerin poisonings in Panama and last month's FDA guidance, US-PharmaTechnologist.com takes a look at the implications of testing for the excipient glycerin in the pharmaceutical supply chain.
Manufacturers to get insider tips from big guns
14-Jun-2007 - Several top pharmaceutical companies have had their business practices scrutinized by a benchmarking company to help provide executives with ways to stay out of trouble with regulatory authorities.
Viracept: lessons to be learnt?
14-Jun-2007 - Just over a week after Roche was forced to initiate a Europe-wide recall of HIV drug Viracept (nelfinavir), in-PharmaTechnologist.com considers the contamination case and the pharmaceutical processes blamed for the incident.
Applikon releases 'generic' bioreactor controller
12-Jun-2007 - Applikon Biotechnology has launched a new bioreactor controller, the i-ControlXL, that has been designed to work with reactors of any size, from any supplier.
Patheon steps up 'damage control' over Puerto Rico
12-Jun-2007 - After dismal second quarter results Patheon is stepping up its resolve for 'damage control' and indicated that further cutbacks at its problematic Puerto Rico plant are imminent.
Contamination leads to EU-wide Viracept recall
07-Jun-2007 - Roche has initiated a recall of its HIV drug Viracept (nelfinavir) right down to the patient level after finding evidence of dangerous contaminants in the tablets.
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