505(b)(2): It’s A Different Animal
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Headlines > Clinical Development
US House Bill Aims to Expand Release of Clinical Trials Data
21-May-2013 - US House Democrats have re-introduced a bill that would expand trial data reported by companies to clinicaltrials.gov, but a recent EU court decision shows what kind of resistance should be expected....
Exclusive interview
Quintiles’ Lead Medical Expert: Real World Patient Data Hold Enormous Potential
21-May-2013 - Supplementing prospective randomized, double-blinded clinical trial data with real-world patient data holds “an enormous amount of potential” for CROs and trial sponsors, according to an expert.
News in brief
Harlan Doubles Number of Isolators at Two US Research Facilities
20-May-2013 - CRO Harlan Laboratories has more than doubled the number of isolators at its Indianapolis and Livermore, Calif., research facilities to meet client demand for immunocompromised animal models.
Covance Pushes Further into Biologics Development, Lead Optimization
20-May-2013 - Although preclinical work for CROs has fallen flat in recent quarters, Covance is looking to take advantage of the industry’s shift to early biologic developments and lead optimization.
PRA Prepares to Go Public with Confidential SEC Filing
17-May-2013 - US CRO PRA is proposing to go public again, more than six years since it was taken private, according to a confidential draft registration statement submitted to the US SEC.
PPD Subsidiary Expands Biopharma Services with New China Lab
16-May-2013 - BioDuro opened a new laboratory in Shanghai, China on Wednesday to offer a range of customized biopharma services for its Asia Pacific clients.
Quintiles Signs Exclusive Development Deal with Merck Days After $1B IPO
16-May-2013 - Just days after raising more than $1B in its IPO, Quintiles announced Wednesday it signed a five-year clinical development agreement with Merck Serono.
Clinical Cymru Can Compete on Costs says PRA
15-May-2013 - PRA International says technology and IT innovation will help it compete with rivals that have moved their service centres to cheaper locations in the East to cut costs.
Wuxi Manufacturing Services Help Increase Quarterly Earnings
15-May-2013 - Better than expected growth in Wuxi’s manufacturing services has driven the CRO to exceed its earlier guidance in the first quarter of 2013.
Lack of Milestones Affect Q1 but Evotec Optimistic for Future
14-May-2013 - Evotec says it is confident underlying growth, expansion of its clinical stage pipeline and upcoming milestone payments will counter Q1’s downcast results.
Former RPS CIO's Lawsuit Claims Wrongful Termination
14-May-2013 - Research Pharmaceutical Services' (RPS) former chief information officer (CIO) claims he was unfairly dismissed after discovering the CRO was unlawfully storing potential employees' personal data.
Executives Raise Questions on Clinical Trial Sponsors’ Oversight of CROs
13-May-2013 - Tension between clinical trial sponsors and CROs in terms of CRO oversight may not be relieved any time soon, but both sides seem intent on arriving at a middle ground...
Local Indian Committees to Conduct Annual Inspections of Trial Sites
13-May-2013 - Clinical trial sites in India will be inspected at least once a year under a new regulatory plan issued by the CDSCO.
Parexel Upbeat After Strong Quarter, Acquisition of Heron
07-May-2013 - With a more than 27 percent increase in revenue for Q3 of FY 2013 over the same quarter last year, CRO Parexel has raised its guidance for both the fiscal...
PE group invests in Australia's Novotech
07-May-2013 - US private-equity group Mercury Capital has bought a 30 per cent stake in Australian CRO Novotech.
News in brief
ClinTec Launces Clinical Trials Master's Degree
07-May-2013 - CRO ClinTec International says a new Master’s degree course will help research professionals make tremendous strides in the highly competitive global clinical research market.
Covance Sees Healthy Growth in First Quarter of 2013
06-May-2013 - Covance’s 10 percent growth in Q1 2013 compared to the same quarter last year was driven mostly by its central laboratories business and has caused a boost in its revenue...
Live From Interphex in New York City - Updated
AMRI Exec Discusses 'New Bar' in FDA Enforcement
02-May-2013 - Following the completion of remediation efforts to deal with an FDA warning letter, Chris Phillips, AMRI's senior director of its Burlington, Massachusetts site, discusses what he considers to be a "new...
Quintiles Seeks to Raise as Much as $790M in IPO Next Month
30-Apr-2013 - CRO Quintiles and its shareholders are offering more than 19 million shares of common stock that will be priced between $36 and $40 per share, according to an updated S-1...
Ohio District Court Ruling Against Medpace Could Set Bar for MSAs
30-Apr-2013 - With a ruling that could have implications for any CRO looking to understand its rights under a MSA (master services agreement) with a sponsor, a federal district court in Ohio...
Icon Beats Expectations in Q1, Sees Unexpected Uptick in Revenue Growth
29-Apr-2013 - Icon’s first quarter FY2013 revenue increased 26% year on year, besting analysts’ expectations and resulting in a nearly 7% increase in the company’s stock price.
News in brief
PRA Wins Kansas Grant to Create 80 New Jobs
22-Apr-2013 - The Kansas Bioscience Authority has awarded a $400,000 grant to the CRO PRA to create a new program to attract recent college graduates into the clinical research and CRO industries.
CROs Not Feeling Impact of Clinical Trial Downturn, Analyst Says
22-Apr-2013 - Despite a downturn in the number of clinical trials across all phases, CROs may still see a substantial increase in bookings as large pharma and biotech companies look to keep...
News in brief
Ex-Aptuit Employee Gets Jail Time for Manipulation of Trial Data
18-Apr-2013 - A man has been given a custodial sentence by a court in Edinburgh, UK after being found guilty of altering preclinical trial data.
World Medical Association Revises Ethical Principles in Clinical Trials Declaration
18-Apr-2013 - Draft revisions to the Declaration of Helsinki (DoH) clarify how placebos should be used and add a general principle for adequate compensation to injured trial participants according to the WMA.
