PDUFA V: What you need to know about the upcoming Prescription Drug User Fee Act
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21-May-2012 - The US FDA has updated its preclinical testing requirements for biotech drugs citing advances since the publication of ICH S6 and the need to harmonize with international standards.
16-May-2012 - SNBL USA has invested in ‘social housing’ at its lab in Everett, Washington citing ‘recent reductions’ in US non-human primate lab capacity as the driver.
15-May-2012 - Preclinical services firm SNBL has fixed most of the deficiencies observed during a US FDA inspection in 2010 and says it is working to ‘quickly’ resolve the remaining issues.
15-May-2012 - BASi is planning further cost cutting actions after continued weakness in toxicology led to a double-digit drop in revenue.
10-May-2012 - MPI Research must reconfigure its enclosures after they led to the death of a non-human primate, a USDA report obtained by animal rights activists shows.
07-May-2012 - The CEO of Charles River said asset transfer strategic deals make little “rational sense” to clients or CROs.
03-May-2012 - Covance is to close its toxicology facility in Arizona after early development demand dipped at the start of 2012.
30-Apr-2012 - Outsourcing-Pharma looks at the wages of the remaining big four public CROs and how they compare to operating income.
26-Apr-2012 - Pressures on Indian CROs hit first quarter instrument and research materials sales at Waters and Sigma-Aldrich.
24-Apr-2012 - Acquisition of rival RDDT gave vivoPharm a larger share of Australia’s toxicity services market and will reduce outsourcing costs, says CEO.
23-Apr-2012 - Analysts expect Covance to cut toxicology capacity in response to continued weak demand for GLP services.
19-Apr-2012 - Half of large pharma firms plan to offshore more discovery and early-stage work in the next two to five years, a survey found.
18-Apr-2012 - Australian preclinical CRO vivoPharm has bought toxicology testing firm RMIT Drug Discovery Technologies (RDDT) and will relocated to a new Melbourne HQ.
17-Apr-2012 - Positive survey results have added to evidence that outsourcing of drug discovery can partly offset weakness in GLP toxicology.
05-Apr-2012 - Outsourcing-Pharma presents a roundup of recent CRO deals, including agreements at Quintiles, MPI, and AMRI.
04-Apr-2012 - Niche CRO Proteome Sciences is poised for triple-digit sales growth as its biomarker business takes off, an investment research firm said.
03-Apr-2012 - Sigma-Aldrich plans to grow its new biologics toxicology services unit by creating targeted cell lines and animal models.
02-Apr-2012 - Affymetrix will distribute a mircoarray developed by Almac for personalised medicine development applications under an exclusive global distribution deal.
22-Mar-2012 - AMRI is to end operations at its discovery and chemistry services facility in Hungary by the end of next week.
15-Mar-2012 - Two major ferry companies have decided to stop shipping animals used in preclinical drug development to the UK, prompting concerns about the future of the country’s research sector.
15-Mar-2012 - Growth in demand for toxicology services will be weak for the foreseeable future as the sector has “structurally changed”, analysts said after SOT.
14-Mar-2012 - UK drug major AstraZeneca has contracted BioFocus and Argenta to provide it with discovery services just weeks cutting its internal R&D capacity.
13-Mar-2012 - Preclinical CRO CiToxLAB has added inhalation testing capacity, citing growing demand from Pharmas and chemicals firms as key driver for the investment.
13-Mar-2012 - WuXi expects its GLP toxicology unit to turn profitable this year and it, like ShangPharma, is pinning its growth hopes on new services.
06-Mar-2012 - Horizon Discovery has launched a new website to provide technical support to researchers using its rAAV-mediated genome editing tech.