505(b)(2): It’s A Different Animal
Camargo
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30-Sep-2008
Capsugel gets commercial deal from NicOx
30-Sep-2008 - Capsule specialist Capsugel has won the contract to make a highly-touted new anti-inflammatory developed by French biotechnology company NicOx as the product approaches registration.
Publication bias emerges again in clinical research
30-Sep-2008 - Clinical trials that support the effectiveness of drugs filed for approval in the US are more likely to be published than those that are less supportive, according to researchers at...
Encorium backs away from Prologue deal
30-Sep-2008 - US contract research organisation Encorium Group has postponed its planned acquisition of Prologue Research International and cut staff in the latest twist in a rollercoaster ride for the firm in...
28-Sep-2008
Astech REACTS to pharma’s automation needs
28-Sep-2008 - UK-based automation expert, Astech Projects, has been signed up to assist a ‘top 5 pharmaceutical company’ just months after launching its new automation maintenance service.
27-Sep-2008
Pharma outsourcing: people on the move
27-Sep-2008 - Outsourcing-Pharma.com presents its periodic round-up of executive appointments in the contract services sector.
India’s biotech industry a “sunrise sector”
27-Sep-2008 - Indian pharmaceutical companies are making their first forays in the biotechnology arena, helping the market expand from a standing start at the beginning of the decade to reach a value...
25-Sep-2008
Melbourn offers integrated drug delivery service
25-Sep-2008 - UK-based Melbourn Scientific is now offering an integrated package of formulation, method development, analysis and short-run clinical manufacture services to industrial clients.
Moody's down on pharma prospects
25-Sep-2008 - Pharmaceutical companies on both sides of the Atlantic are facing a particularly difficult time over the next 12 to 18 months, according to a report by financial research and analysis...
India’s Lupin buys into southern Africa
25-Sep-2008 - Indian pharmaceutical company Lupin Ltd has expanded into Africa by acquiring a 60 per cent stake Pharma Dynamics, a generics company and contract manufacturer based in Cape Town, South Africa.
23-Sep-2008
Encorium wins $6.2m EU vaccine trial deal
23-Sep-2008 - US CRO group Encorium has signed new contracts worth around $6.2m (€4.1m) under which it will conduct trials of a developmental vaccine on behalf of a global biopharmaceutical company.
China No1 for outsourcing, says PwC
23-Sep-2008 - China is the ideal destination for outsourcing, according to a report by PricewaterhouseCoopers (PwC) that has calculated rankings based on a range of parameters.
Phylogeny launches first in situ miRNA detection service
23-Sep-2008 - Phylogeny has launched the first microRNA (miRNA) in situ hybridisation detection service to help scientists delve deeper into the mechanisms controlling key biological processes.
ChanTest to increase range of ion channel services
23-Sep-2008 - Ion channel expert ChanTest is expanding its range of ion channel services and cell lines that help identify promising target compounds and those that could cause harmful side effects.
22-Sep-2008
Acquisition looming in Calyx Pharma’s future, says CEO
22-Sep-2008 - Active pharmaceutical ingredient specialist Calyx Chemicals and Pharmaceuticals is planning an acquisition within the next two years, probably in the US or Europe, according to chief executive Smitesh Shah.
Joint API inspection service to cut costs
22-Sep-2008 - Germany-based Diapharm has launched a service allowing pharmaceutical manufacturers to perform joint third-party audits of active pharmaceutical ingredients (APIs).
Merck signs sales outsourcing deal
22-Sep-2008 - Merck & Co has added additional sales staff by signing an outsourcing agreement with inVentiv Health.
18-Sep-2008
Aseptic outsources “revolutionary” vial filler
18-Sep-2008 - CMO NextPharma has signed a deal to make Aseptic Technologies “revolutionary” ‘closed-vial’ filling system available as part of its offering to clients.
Pharmaceutical Profiles the effects of diabetes drug
18-Sep-2008 - UK-based Pharmaceutical Profiles has used an imaging technique known as scintigraphy to quantify the effects of Amylin / Eli Lilly’s latest diabetes drug on the stomach.
High-potency unit opens at Phamatek
18-Sep-2008 - Pharmatek Laboratories has opened its highly-potent and cytotoxic facility located in San Diego, US, just over a year after announcing its move into this growth area of contract manufacturing.
17-Sep-2008
Charles River expands Discovery Services
17-Sep-2008 - Charles River Laboratories has agreed to buy US-based drug discovery imaging expert Molecular Imaging Research, Inc. (MIR) for approximately $12.5m (€8.8m) in cash.
Pharma outsourcing: people on the move
17-Sep-2008 - Outsourcing-Pharma.com presents its latest round-up of new appointments, employment moves and personnel news in the pharmaceutical contract services sector.
16-Sep-2008
Outsourcing drives growth in trial sector, Bilcare GCS
16-Sep-2008 - Bilcare GCS, the clinical supplies arm of Indian packaging giant Bilcare, has considerably expanded its Phase III trial offering in an effort to provide drugmakers with a complete package.
Competition intensifying for diabetes subjects; Acurian
16-Sep-2008 - Patient recruitment specialist Acurian has hit a major milestone in its business, with more than half of the entire US population of type 2 diabetics now opted into its database.
India tipped for 15% share of clinical sector by 2011
16-Sep-2008 - Shifting clinical trial operations from Western markets to India can reap substantial benefits for sponsors in saved costs and time, according to KPMG’s just-published report India Pharma Inc.
Assay Depot: ‘Ebay’ for drug discovery services debuts
16-Sep-2008 - Assay Depot, a new online marketplace which allows bench researchers around the world to choose and buy a broad range of drug discovery services, went live yesterday.
15-Sep-2008
Takeda pursues CMO in court for $26.7m
15-Sep-2008 - Takeda Pharmaceutical has filed a lawsuit in an attempt to recoup $26.7m in damages, after it had to recall a product made by a contract manufacturing organisation (CMO).
Boom times continue for Indian CMOs
15-Sep-2008 - India’s contract manufacturing market is expected to rocket forward over the next couple of years to reach a value of $2.46bn in 2010, according to a just-released report from KPMG....
BMS gets closer to Accenture with $550m IT deal
15-Sep-2008 - Pharmaceutical major Bristol-Myers Squibb has signed another deal with outsourcing specialist Accenture, this time tapping the firm for IT and financial support services via a 10-year contract worth $550m.
Quintiles gets bigger in Singapore to continue Asian push
15-Sep-2008 - Quintiles Transnational Corp has announced an expansion of its operations in Singapore in order to meet what it described as “surging demand” in the Asia-Pacific region.
PharmaNet slumps on another ‘08 earnings cut
15-Sep-2008 - Drug development services company PharmaNet saw its share price slashed in half on Friday after downsizing its 2008 revenues and earnings forecasts for the second time this year.
11-Sep-2008
Parexel feels effects of adding ClinPhone
11-Sep-2008 - Parexel has trimmed back its earnings guidance for the first quarter of fiscal 2009 as it starts the process of integrating ClinPhone, which the company bought for £91m (€114m) last...
Phase I outsourcing to India by 2010?
11-Sep-2008 - The outsourcing of Phase I trials to India may be allowed by 2009-10 after the Central Drugs Standard Control Organisation (CDSCO) said it is considering changing its stance.
BioReliance expands to keep pace with GeneTox demand
11-Sep-2008 - BioReliance has had to significantly expand its Rockville, US, facility and hire new staff in order to accommodate the growing demand for its genetic toxicology (GeneTox) testing services.
Tripos looks to the future with Pharsight acquisition
11-Sep-2008 - Drug discovery informatics and services provider, Tripos International, has agreed to buy Pharsight Corporation, a provider of software and strategic services for clinical drug development.
10-Sep-2008
Merger beefs up German CMO Haupt Pharma
10-Sep-2008 - Haupt Pharma has completed its merger with fellow German companies Amareg and Wülfing Pharma to create a major new force in the European contract development and manufacturing sector, with around...
09-Sep-2008
MDS struggles as Pharma Services' revenue drops
09-Sep-2008 - Beleaguered life science tools and services company MDS Inc, has recorded disappointing third quarter results, with revenues from its Analytical Technologies and MDS Pharma Services divisions missing forecasts.
FDA lists drugs with potential safety issues
09-Sep-2008 - A list of drugs currently being evaluated for potential safety issues by the US Food and Drug Administration (FDA) has been posted on its website.
Contract manufacturing: News in brief
09-Sep-2008 - in-PharmaTechnologist.com’s latest round up of developments in contract manufacturing includes Therapure’s launch and facility expansions by Hollister-Stier, West and Dow.
Phase Forward buys Clarix for $40m
09-Sep-2008 - eClinical specialist Phase Forward has added to its portfolio by purchasing interactive-response technology company Clarix for $40m in cash in a move aimed at toppling ClinPhone from its leading position...
08-Sep-2008
Bids imminent for Elan's contract division
08-Sep-2008 - The second round of bids for Elan Drug Technologies (EDT) is expected to be received by mid-September, with a sale price of up to $1.4bn mooted in press reports.
New investment to help Quotient grow even faster
08-Sep-2008 - UK analytical services expert, Quotient Bioscience has received a significant equity investment from TA Associates to help further the firm’s acquisition-led and organic growth strategy.
Pharma outsourcing: people on the move
08-Sep-2008 - Outsourcing-Pharma.com presents its periodic round-up of executive appointments in the contract services sector.
Patheon slashes losses in Q3
08-Sep-2008 - Canada’s Patheon put in another quarter of robust revenues growth in its third quarter, which coupled with cost-reduction measures helped the firm trim its net loss to $14.7m, down 75...
04-Sep-2008
Caliper measures up kinase profiling
04-Sep-2008 - Caliper Life Sciences has launched two new kinase profiling services as well as new assay kits that aim to provide researchers with a better understanding of their kinase inhibitor drug...
Clinical development news in brief
04-Sep-2008 - Recent developments in the clinical research sector include an acquisition by Canada’s Algorithme, a Dutch CRO looking to push into the North American market, and a £20m boost for UK...
SAFC Pharma to get even bigger in high-potency APIs
04-Sep-2008 - US fine chemical company Sigma-Aldrich said this morning that subsidiary SAFC Pharma has kicked off a $30m expansion plan for its active high-potency pharmaceutical ingredient (API) manufacturing facility in Madison,...
02-Sep-2008
Merck’s ADVANTAGE trial misled patients, claim researchers
02-Sep-2008 - Merck & Co has been accused of carrying out clinical trials of its Vioxx (rofecoxib) painkiller that were designed primarily for marketing purposes rather than to answer a clinical hypothesis....
Major expansion at Coating Place completed
02-Sep-2008 - Microencapsulation specialist Coating Place Inc has just completed a major expansion of its contract manufacturing capacity in Wisconsin, US.
EU’s Clinical Trial Directive ‘put no brake on trials’
02-Sep-2008 - Contrary to fears, the European Union’s Clinical Trials Directive has not had an inhibitory effect on the number of studies carried out by publicly-funded researchers, at least in Denmark....
01-Sep-2008
AMRI raises guidance after BMS project moves forward
01-Sep-2008 - A milestone payment from Bristol-Myers Squibb for the successful advancement of a project into clinical development, along with strong sales by its contract research and manufacturing services unit, prompted Albany...
ACRI bolts on CRO services with Clinesian deal
01-Sep-2008 - US trial firm ACRI and contract research organisation (CRO) Clinesian have teamed up to target the pharmaceutical sector’s ever growing demand for integrated clinical development capacity.
PharmEng cuts costs despite tripled turnover
01-Sep-2008 - Canada’s PharmEng International almost tripled its turnover in the second quarter, as its acquisition of a Pfizer manufacturing facility at the end of 2007 transformed sales at contract manufacturing facility...
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