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The world’s largest contract research organisation, Covance, has maintained its earnings guidance for 2009 despite a slowdown in revenue growth and lower profits in the fourth quarter of 2008.
Contract research organization (CRO) Quintiles has announced a deal with India’s Apollo Hospitals Group that will see the two firms collaborate in opening a Phase I clinical trials unit.
American Peptide Company (APC) is expanding its manufacturing facility in Vista, California to meet growing demand for high quality peptides.
Sepracor is reducing its contract sales force by 410 and its in-house team by 350 as part of restructuring efforts that will eliminate 20 per cent of its workforce.
Contract research company Parexel saw its share rocket more than 30 per cent yesterday after it reported a hike in its second quarter revenues and despite a fallback in net profits.
eClinical specialist Medidata Solutions has filed to list on the US Nasdaq exchange via an initial public offering that it hopes will raise $86m.
Icon has brought its operations in line with new FDA guidelines by implementing an electronic system to accelerate the adjudication of cardiovascular events in diabetes trials.
NextPharma Technologies has doubled the Alu Alu blister packaging capacity at its facility for Cephalosporins in Göttingen, Germany.
Active pharmaceutical ingredient (API) manufacturer Ash Stevens Inc has been accredited under an industry-backed scheme that certifies companies whose processes are environmentally sound and safe.
OutsourcingPharna.com presents a round-up of recent contracts awarded to contract development and manufacturing services companies – and finds a lot of activity in the biomanufacturing sector.
The US Food and Drug Administration (FDA) gave the go-ahead to the first clinical trials of a stem cell-based therapy late last week, in a major boost to the development of the technology.
The US National Institutes of Health has awarded a series of new contracts to try to stimulate greater use of sophisticated data management software in small to medium-sized clinical trials.
We spoke with Martijn Eijkenboom, president of NAF & VSM, to discuss his companies’ entry into the market for pre-washed vials, ampoules and test tubes.
Two US companies specialising in sleep disorders - Rem Medical and PsyPharma Global, have pooled their resources to offer research services to the pharmaceutical industry.
Indian company Neuland Laboratories has launched a push into the peptide manufacturing sector to expand the range of active pharmaceutical ingredients (APIs) it can offer to customers.
The GAO has criticised the FDA’s efforts in overseeing clinical trials, with the agency accused of failing to implement recommendations that were made as far back as 2001.
A new report suggests the large numbers of fake drugs produced in China could drive CMO customers away and see Central and Eastern Europe (CEE) emerge as a contract manufacturing hotbed.
A social networking tool specifically designed for patients involved in clinical trials has been set up by Acurian, a company specialising in patient recruitment services.
UK-headquartered Premier Research Group has signed a deal to buy the assets of fellow contract research organisation (CRO) Pivotal Research Centers, a specialist in Phase I to IIa trials, for $4.75m.
The US Food and Drug Administration (FDA) has issued a draft guidance on the measures pharmaceutical and other manufacturers should take to make sure imported FDA-regulated products are in line with federal statutes and regulations.
Cogenics has entered into a partnership with SinoGenoMax to bring its clinical genotyping services to the expanding Chinese market.
An Indian doctor has slammed the nation’s clinical trials, claiming they use the vulnerable, the system is corrupt and that the country lacks high quality scientists.
Lonza is spending $26m to expand capacity at its facility in Walkersville, Maryland, US as regulatory progress made with Osiris’ Prochymal looks set to kick start the era of cell therapies.
Contract research firm Covance has been given the green light for its $100m (€77m) animal testing and drug candidate development facility in Chandler, Arizona, US.
Pharmaceutical Product Development of the US is expecting to post a 12 per cent hike in revenues in 2009, helped by the recent opening of offices in Ireland and Singapore and new deals with Merck & Co.
Indian contract research firm Jubilant Biosys has teamed up with US company BioLeap to offer drug early-stage discovery services which incorporate computational drug design.
Kendle is continuing its efforts to increase its presence outside the US with the establishment of a second office in Ahmedabad in Western India.
Outsourcing-Pharma.com presents its periodic round-up of executive appointments in the contract services sector.
Senator Richard Moore has criticised transparency laws in Massachusetts, US, which he claims allow pharmaceutical companies to hide payments made to physicians conducting clinical trials.
Non-profit R&D organisation Battelle is investing $200m in its facilities in Ohio, which will see the company’s contract research capabilities upgraded.
The rise in international, multi-centre clinical trials has complicated reporting pathways and led to institutional review boards (IRBs) being overloaded with adverse events, according to FDA guidance.
US biotechnology company Cel-Sci is hoping to offer contract manufacturing to pharmaceutical partners from its new facility in Baltimore, as it tries to raise money to support the clinical development of its cancer immunotherapy Multikine.
In the latest part of its “beyond our borders” scheme, the US FDA is asking drugmakers to volunteer supply chain information for drugs and APIs sourced outside the USA.
US contract manufacturer Ash Stevens Inc has upgraded its active pharmaceutical ingredient (API) facility in Riverview, Michigan, with new equipment for parallel synthesis and calorimetry.
Drug contract services specialist inVentive Health has selected a new office in Somerset, New Jersey, US which will house its patient outcomes, clinical, health and commercial division.
A FDA warning letter has been sent to a clinical investigator who administered incorrect doses of investigational drugs having taken the patient’s weight and height from their driving license.
Switzerland-based CRO PFC Pharma Focus is entering the South American market through a partnership with Argentinean company Blanchard y Asociados.
Despite criticism in certain quarters, joint GMP inspections represent the best use of resources in an increasingly globalised market, according to the EMEA.
Sanofi-Aventis Canada has licensed I-many’s suite of software for managing pharmaceutical contracts, with the IT company also performing installation, maintenance and support.
A US HHS report on FDA oversight during trials has found that, with current procedures, the agency cannot tell whether drugmakers are disclosing complete financial information from all investigators who worked on a particular study.
There is still no formal offer on the table for Canadian contract manufacturer Patheon from JLL Patheon Holdings, an investment group which currently owns around 29 per cent of the firm.
Cincinatti, US-based clinical research organization Kendle has cut back its revenue expectations for 2008, primarily as a result of the strengthening of the US dollar, in common with some of its peers in the CRO sector.
Since its inauguration last year, IPEC China has been working to improve the quality of excipient manufacturing in the country. in-PharmaTechnologist spoke with organisation president Nevin Cheng about the steps the body has taken so far and what it will be doing in 2009, including its plans for a new SFDA approved Drug Master File (DMF) scheme.
A $1bn fraud scandal has rocked Indian IT outsourcing company Satyam, which provides services to leading pharmaceutical companies, and resulted in three of its executives spending the weekend in jail.
Ireland’s Icon plc has scaled back its revenue forecasts for 2008 but says it expects 2009 profits to come in higher than previous guidance.
Akrimax Pharmaceuticals, which entered the contract manufacturing sector via the purchase of a Wyeth facility in New York, US, a year ago - has signed its first third-party agreement.
Clinical research firm Quintiles may be thinking about shifting its UK-base according to conflicting reports in the UK’s press last week.
The FDA has established its first permanent presence in Latin America by opening an office in Costa Rica as part of “Beyond Our Borders Initiative”, which has also seen the agency set up three sites in China.
The proportion of global clinical trials conducted In India is expected to more than double between 2007 and 2012, according to market research firm RNCOS.
Contract research organisation Bio-Imaging Technologies has decided to sell off its CapMed subsidiary in order to focus its efforts on its core business, providing imaging series to clinical investigators.
Drug raw materials maker Akron Biotechnology has selected Austin Chemical Company to help expand its client-base in the global biotech, pharmaceutical, and diagnostic industries.
We present our exclusive interactive timeline of the heparin scandal that allows you to get a unique overview of the chronology of events, discover incidents you missed and read in-depth articles on each twist and turn.
Merck & Co’s thirst for outsourcing continues, with United Parcel Services (UPS) taking over two of its distribution centres and providing services from for the pharma company from the sites.
Clinical laboratory services company LabCorp saw its shares slide yesterday after cutting back its sales and earnings targets for 2009 in light of the economic downturn.
US-based BioReliance has won the contract to supply bulk adenovirus for several live oral vaccines being produced by Barr Pharmaceutical’s Duramed subsidiary.
US contract research organisation Integrated Clinical Trial Services has set up a team that will help pharmaceutical companies communicate information on their products to the medical community.
DHL Global Forwarding has opened a Life Science Competency Center in Carolina, Puerto Rico, which will offer shipping services tailored to the needs of the island’s biotech and pharmaceutical companies.
WuXi AppTec is to use ThalesNano’s H-Cube for laboratory-based hydrogenation, which the CRO believes offers advantages in drug discovery over traditional batch processes.
Contract research organization Pharmaceutical Product Development Inc (PPD) has moved further into providing central laboratory services with the purchase of a 130,000 sq. ft. laboratory from Merck & Co.
Outsourcing-Pharma.com presents its periodic round-up of executive appointments in the contract services sector.
Recipharm hopes that its new tablet and capsule manufacturing facility in Fontaine-Les-Dijon, France, which significantly expands its dry powder production capacity, will help it broaden its European client base.
Perceptive Informatics has gained the right to use EQ-5D, which will allow the company to offer clinical study sponsors the option to collect health-related quality of life outcomes using a telephone.
Blue Reference has formed a Quality by Design Product Development Consortium (QbD PDC) to provide a forum for the improvement of its process analytics software.
Two contract manufacturing organisations PrimaPharm have been cited by the US Food and Drug Administration for not adhering to Good Manufacturing Practice standards.
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