Breaking News on Contract Research, Manufacturing & Clinical Trials

Exclusive interview with Bilcare CSO Dr Praful Naik

India’s Bilcare unveils anti-counterfeiting system

Executives in pharmaceutical companies tasked with implementing an anti-counterfeiting strategy already have a difficult job assessing a frankly bewildering array of technological solutions.

LGC adds digital PCR to its service offering

UK laboratory services firm LGC has brought the first BioMark system into the UK in order to accurately quantify rare gene sequences for its pharmaceutical customers.

Chiltern revamps early-phase clinical division

Contract research organisation Chiltern International has finalised the reorganisation of its early-stage clinical development activities, following its acquisition of Drug Development Solutions in February.

Galapagos adds Sareum services to BioFocus portfolio

Galapagos has bolstered the portfolio of its BioFocus DPI contract services unit by purchasing the structure-based drug discovery business of UK firm Sareum.

MD Logistics plans Indy facility to tap local pharma boom

Supply chain specialist MD Logistics is planning to set up a further distribution plant in Indiana, US, specifically targeted at pharmaceutical customers.

Dishman targets India’s booming oncology market

India’s Dishman Pharmaceuticals is eyeing up the lucrative oncology market to further its development as one of the region's major CRAM firms, according to company managing director Rajnikant Vyas.

Sancilio opens batch manufacturing plant

Sancilio & Co (SCI) says that its new contract manufacturing plant in Riviera Beach, Florida can provide pharmaceutical manufacturers with small batch production capacity for drug tablets and capsules.

Pharma outsourcing: people on the move

Outsourcing-Pharma.com presents its latest round-up of new appointments, employment moves and personnel news in the pharmaceutical contract services sector.

NME applications climb in 2007 says Parexel study

A new study by US contract services giant Parexel International reveals that the number of marketing applications for NMEs in the US grew 33 per cent in 2007.

Indian congressmen says clinical trials must stop

The revelation that 49 infants died during clinical trials in India has sparked anger among the nation’s congress, with some calling for all studies to be stopped while investigations take place despite the trials having an infant mortality rate (IMR) below the national average.

Recipharm adds lyophilisation to repertoire

Sweden’s Recipharm hopes that its newly acquired lyophilisation plant will complete its contract services offering and firmly establish it as a player on the CDMO stage.

AstraZeneca and NCCS set sights on HCC

AstraZeneca and Singapore’s National Cancer Centre (NCCS) have selected inoperable hepatocellular carcinoma (HCC) as the first target for their new drug collaboration.

G&W receives FDA warning letter

The US Food and Drug Administration (FDA) has issued a warning letter to contract manufacturer G&W Laboratories.

Mallinckrodt and Rubicon to develop PanExcea

CRO Rubicon Research and chemicals manufacturer Mallinckrodt Baker are teaming up to develop the PanExcea excipient range, which was launched by the latter firm’s parent company Covidien in July.

Further restructuring at Cardinal?

Cardinal Health’s announcement that it is considering spinning off some of its divisions has provoked fevered speculation among industry analysts and media observers alike.

AgenoLab first to install Roche’s new assay platform

German biotech and life science laboratory services firm AgenoLab has installed the first xCelligence real-time cell analysis system to bolster its assay offering to customers.

Contract research news in brief

in-PharmaTechnologist.com presents its round up of the latest developments in contract research, including CTI partnering to access Latin America, Encorium signing contracts worth $13.5m and Omnicare setting up in Sweden.

HGS enlists Eden for client indentification

UK-based Eden Biodesign has been selected as marketing services partner for US drug developer Human Genome Sciences (HGS).

CSL snaps up Talecris for $3.1bn

Australia’s CSL Ltd has signed a $3.1bn agreement to acquire Talecris Biotherapeutics of the US and throw down the gauntlet to rival Baxter International in the plasma-based pharmaceutical sector.

Sanofi and NovaMed expand distribution deal

Sanofi Aventis has extended its deal with China’s NovaMed, adding the anti-convulsant Depakine (valproic acid) to the latter firm’s distribution roster.

DPT secures Nasulin manufacturing deal

San Antonio-headquartered manufacturing firm DPT Laboratories has won a long-term contract to produce stocks of CPEX Pharmaceuticals’ candidate intranasal insulin product Nasulin for clinical trials.

High-potency buoys Cambrex in 2Q

Cambrex posted a 5 per cent hike in revenues in the second quarter, helped by its shift into contract controlled substance manufacture, although without favourable currency effects sales would have slipped back 2.6 per cent.

Enzon may sell Indy plant alongside specialty pharma

Pharmaceutical company Enzon may hive off its entire specialty drugs division, including a manufacturing facility in Indianapolis, US, in the face of pressure from shareholder Carl Icahn.

EU GMP award a boost for Venus’ expansion plans

Venus Remedies’ oncology facility has received EMEA GMP accreditation, making it one of very few Indian contract manufacturers licensed to make cancer treatments for the European market.

Pharma outsourcing: people on the move

Outsourcing-Pharma.com presents its periodic round-up of new appointments, employment moves and personnel news in the pharmaceutical contract services sector.

Research business lifts Charles River in 2Q

Charles River Laboratories saw its operating income advance 16 per cent to $77m in the second quarter on strong demand for its research services division, and also announced a $53m deal to buy a German contract service organisation.

Kendle benefits from early-stage research push

Kendle has posted a sprightly 30 per cent increase in service revenues in the second quarter, bringing in $127m, well ahead of forecasts and providing further evidence of the buoyancy of the contract research market.

West’s Q2 sales and profits climb

US packaging specialist West Pharmaceutical Services has carried the earnings momentum it generated in the first three months of the year through to the second quarter.

Lilly sells R&D campus to Covance in pioneering deal

Eli Lilly took a giant leap down the outsourcing road yesterday with the sale of a major R&D facility to contract research organisation Covance and the forging of additional agreement with Quintiles and i3.

Lonza opens Guangzhou engineering services unit

Lonza hopes that the new business it has set up in China will help cement its position as a leading provider of services to the country’s pharmaceutical manufacturing sector.

ICON module makes electronic patient diaries easy

ICON has introduced an electronic Patient Recorded Outcomes (ePRO) module that could slash weeks off the time it takes to implement the technology in clinical trials.

inVentive to expand offering with PMG buy

Pharmaceutical commercialization services specialist inVentive Health is to buy fellow New Jersey-based healthcare research firm Patient Marketing Group (PMG) for an all cash payment of $14.5m (€9.4m).

FDA builds higher walls between advisors, industry

Panellists serving on the FDA's advisory committees will have stricter limits on their financial ties to industry under a raft of reforms announced by the agency yesterday.

Healthcare slows down at Cognizant in Q2

IT infrastructure and business process services firm Cognizant has cut back its full-year financial forecasts on signs that the downturn in the economy is starting to bite at some of its major clients, particularly those in the healthcare sector.

Return to the black for PharmaNet

PharmaNet has reported a stellar set of second-quarter results, reversing its year-earlier loss with a $2.2m profit that was driven by a good performance by the firm’s early-stage development business.

Akorn's potential for growth despite contracting blip

Combined CMO and specialty pharmaceutical group Akorn hopes that deals signed this month with Bioniche Pharma and an as yet unidentified drugmaker will help its manufacturing division make up the ground lost in the last quarter.