Breaking News on Contract Research, Manufacturing & Clinical Trials

Artwork system may help cut generic launch times

A new packaging artwork management system will help cost-sensitive generics producers cut launch times and make increased use of outsourcing, according to US developer Precise Data (PD).

Covance chief predicts healthy sector growth in Q2 statement

US contract research giant Covance saw a strong performance across its divisions in the second quarter that lifted its revenues by 15 per cent to $462m.

Brown steps up pharma outsourcing probe

US Senator Sherrod Brown has fired off another broadside in his probe into pharmaceutical outsourcing, this time sending a request to Merck & Co “for further information on its heavy reliance on global outsourcing for the manufacture of pharmaceutical ingredients and finished products.”

Nectar to set up RS 6bn bulk drug plant

Contract manufacturer Nectar Lifesciences is to invest around RS 6bn ($141m) in a new bulk drug and pharmaceutical intermediate manufacturing facility in India's northern Punjab state.

EDC helps Phase Forward march ahead in 2Q

Like many of its peers in the contract clinical research sector, data management specialist Phase Forward put in another bumper financial performance in the second quarter headed by a 30 per cent hike in revenues to $41m.

eClinical news in brief

Outsourcing-Pharma.com provides its periodic round-up of developments in the eClinical space, including a tough decision for Datatrak, news of a new contract for Medidata , a recruitment package from HMS and cardiac data certification for specialty CRO Clinilabs.

Weekly comment

Roche faces obstacles in acquiring Genentech

Roche’s proposed $44bn acquisition of Genentech is facing some opposition with Wall Street saying the offer undervalues the company, disquiet among the biotech’s employees and shareholders suing the Swiss giant.

ClinPhone shareholders give Parexel a green light

ClinPhone's shareholders have now approved the acquisition of the company by Parexel after rival Quintiles withdrew from the race to buy the eClinical technology company.

Biotechs generate 30% annual CRO revenue

The estimated 15 year period, $800m (€509) investment and one in 5,000 chance of successfully developing a new drug is likely to see more and more pharmaceutical firms partner with CROs in a bid to offset risk, according to a report Turner Investment Partners (TIP).

PPD shares dip despite robust results

Pharmaceutical Product Development (PPD) reported a bumper set of second quarter figures, well ahead of analysts expectations, but saw its share price take a dip anyway.

GSK continues shift in strategic direction

The pace of change at GlaxoSmithKline (GSK) is showing no sign of slowing, with new CEO Andrew Witty unveiling the company’s new strategic direction with the release of second quarter results.

Contract research news in brief

Outsourcing-Pharma.com rounds up recent developments among contract research organisations, including WuXi PharmaTech, AMRI, Physiomics, Biofocus and Metabolon.

Small molecules drive Lonza contract unit in 1H

Lonza of Switzerland is reaping the benefit of a shift away from bulk chemicals and towards custom manufacturing of high-value pharmaceuticals with a 13 per cent hike in sales in the first half of the year.

Medtox sees dip in clinical lab services, but profits rise

Laboratory services and diagnostics company Medtox Scientific has posted a healthy hike in operating profits for the second quarter, despite a challenging operating environment that pegged back sales growth.

Internet one answer to the trial recruitment problem

The pharmaceutical industry’s poor reputation among the public, a lack of understanding of clinical research and the increasing complexity of trials are all problems affecting patient recruitment, but greater use of the Internet could be a solution, according to Datamonitor.

Pharmaceutical outsourcing: people on the move

Outsourcing-Pharma.com presents its periodic round-up of personnel changes in the pharmaceutical outsourcing arena, with senior appointments at Bristol-Myers Squibb, Parexel and GVK Bio, amongst others.

Overseas customers boost China Bottles contracts

Plastic packaging specialist China Bottles (CB) says that nearly two thirds of the $3.3m worth of contracts it signed in June were with pharmaceutical companies based outside its home territory.

Contract manufacturing news in brief

CMC ICOS, PharmEng, HollisterStier and RxElite are among the contract manufacturing organisations (CMOs) with news updates over the last few days.

MeadWestvaco and Bilcare jointly buy packaging firm

Contract packaging company International Labs has been taken over in a joint acquisition between India's Bilcare and MeadWestvaco of the US.

Amgen taps Jubilant for drug discovery services

India's Jubilant Biosys, a subsidiary of Jubilant Organosys, has scored a major deal with US biotech giant Amgen for the provision of early-stage drug discovery services.

MDS trims down Pharma Services to cut costs

Life science tools and services company MDS Inc has said it will cut about 210 jobs at two of its divisions - its MDS Pharma Services and MDS Analytical Technologies - in a bid to reduce costs by around $20m a year.

Four years in prison for counterfeiter

A man has been sentenced in the US to four years imprisonment for trafficking 38,000 counterfeit Viagra (sildenafil citrate) tablets with a wholesale value of $400,000.

MDS trims down Pharma Services to cut costs

Life science tools and services company MDS Inc has said it will cut about 210 jobs at two of its divisions - its MDS Pharma Services and MDS Analytical Technologies – in a bid to reduce costs by around $20m a year.

Roche shares dip on $43.7bn offer for Genentech

Roche offered this morning to take complete control of US biotechnology giant Genentech for the princely sum of $43.7bn in a move that it says would “enhance innovation” and cut costs for both companies.

Hikal's sales up two thirds on long-term contracts

Supply and manufacturing contracts signed during fiscal 2008 helped India's Hikal achieve first quarter sales of Rs 920m ($21.5m), up 63 per cent on the year-earlier comparable period.

US federal agencies mull IRB training, register

The US government is considering setting up a register of institutional review boards (IRBs) and asking for enhanced training of individuals involved in carrying out research in human subjects.

Weekly comment

Globalisation of advanced R&D services 'on the rise'

Pharmaceutical companies in the developed world have already shifted substantial manufacturing and clinical trial work to emerging economies such as China and India, but a new study suggest they are increasingly counting on these countries for advanced research and development services as well.

Veeda snaps up another cancer CRO

Acquisitive Indian contract research organisation Veeda has added another company to its portfolio, buying International Oncology Network (ION) of the US.

United makes Sharp deal to boost stateside presence

United Drug of Ireland said yesterday that it had signed a deal to acquire Sharp Corp, a contract pharmaceutical packager based in the US, for $99m.

Ranbaxy claims big pharma company behind falsification accusations

Ranbaxy has claimed that a pharmaceutical company is making a concerted effort to depress the company's share price by initiating the accusations that the generics manufacturer falsified data to achieve compliance.

MDS updates clinical trial management software

Contract research organisation MDS Pharma Services has launched a new version of its ClinQuick electronic data capture (EDC) system designed to help in the design and management of Phase I clinical studies.

FDA launches QbD pilot programme

The US Food and Drug Administration (FDA) is launching a quality-by-design (QbD) pilot programme for biotechnology submissions.

Lonza to co-develop Novartis' biologics

Lonza is to co-develop and manufacture Novartis' biological pipeline as part of a long term strategic partnership that has been struck between the companies.

Ranbaxy probe on data forging reaches US court

The US Food and Drug Administration has resorted to a legal challenge against India's Ranbaxy Laboratories in an ongoing investigation into the sale of substandard drugs.

AAIPharma's plant gets EMEA GMP accreditation

AAIPharma's contract manufacturing facility in Wilmington, North Carolina has received European Medicines Agency (EMEA) good manufacturing practice (GMP) status.

High five for WCT's latest acqusition

The splurge of acquisitions by Worldwide Clinical Trials (WCT) is continuing unabated with the company wrapping up the take over of MediQuest.

Contract manufacturing news in brief

in-PharmaTechnologist.com's periodic round-up of developments in the world of contact manufacturing includes a plant approval for PharmEng and new contracts for Akorn.

INC trims down but says growth plans are on track

US contract research organisation (CRO) INC Research has cut some of its workforce at its headquarters in Raleigh, North Carolina, but insists it is still following a growth strategy announced last October.

Start-ups shot down as credit crunches

The credit crunch is putting the squeeze on start-ups and established companies alike, with numerous firms struggling to obtain the financing that is their lifeblood.

CRAMS sector key to Anu's future

Indian contract drugmaker Anu's Laboratories will focus its efforts on expanding its presence in the country's booming contract research and manufacturing (CRAMS) market, according to managing director Hari Babu.

Contract manufacturing market changing shape

The contract manufacturing sector is likely to enjoy "continued and accelerating growth" in the coming years as big pharma companies continue to increase the level of outsourcing, with firms now viewing outsourcing as the default approach for making new products.

Althea and Protein'eXpert pool resources

US firm Althea Technologies and Protein'eXpert have teamed up to provide a broad array of biomanufacturing services, from protein engineering right through to commercial-scale production.

Polish bureaucracy holding back clinical growth

Poland urgently needs to take some of the red tape out of clinical trial applications if it is to fulfil its potential as a hub for clinical research, according to new market research.

Pfizer's plan to sell Little Island API plant falters

A deal to sell Pfizer's active pharmaceutical ingredient manufacturing (API) plant in County Cork, Ireland, has fallen through according to a statement by the US drug giant, placing over 180 production jobs under threat.

Tougher tests for diabetes drugs?

The US Food and Drug Administration (FDA) could raise the bar for clinical trials of diabetes drugs if it follows the advice of one of its advisory committees.

Weekly comment

GSK opens pipeline up for comment

New GlaxoSmithKline chief executive Andrew Witty has said the company will allow regulators and other healthcare officials to have a say on the products it advances through development.

Senesco inks deals for Factor 5A

Senesco Technologies has signed a contract manufacturing deal for plasmids and a licensing agreement for a drug delivery technology as it seeks to get its Factor 5A treatment into clinical trials.

MDS Analytical buys Blueshift Biotechnologies

MDS Analytical Technologies has followed its acquisition of Molecular Devices last year by snapping up high content screening (HCS) experts Blueshift for $15m (€9.45m).

Symbio enters, BASi exits Phase I scene

This week one North American contract research organisation (CRO) has entered the Phase I clinical trials market, while another has exited the scene.

Preclinical services news in brief

In this week's review of activity within the preclinical research services arena, news has emerged involving Charles River Laboratories, Galapagos and AstraZeneca.

ClinPhone forms adaptive trials partnership

ClinPhone has formed a partnership that is aimed at giving it the edge in the evolving adaptive trials technology sector.

Binto eliminating the detective work from clinical trials

A service provider called Binto is filling a much needed vacuum in the clinical trial industry in terms of patient tracking, eliminating the need for big pharmaceutical firms to resort to methods such as hiring private investigators to track down "lost" patients.

Patheon to offer cytotoxic services through BSP deal

Contract research and production specialist Patheon is to promote BSP Pharmaceuticals' cytotoxic development and manufacturing services as part of a marketing agreement that the two firms have signed.

Investors not charmed by Cobra's results

Cobra Biomanufacturing has had a disappointing first six months of 2008, reporting an operating loss of $4.8m.

Lonza scores stem cell deal; builds facility

Lonza has scored a contract manufacturing agreement from Osiris Therapeutics for its investigational adult stem cell therapy is building a new facility to support future business activities in this area.

Pfizer outsources oncology drug sales in China

Pfizer has enlisted outsourcing services firm NovaMed Pharmaceuticals to conduct the distribution, sales and marketing of some of its products in the country.

Clinical contract news in brief

Outsourcing-Pharma.com compiles the news that has featured in the clinical contract community of late, involving Parexel, Chiltern, Accelovance and Icon.

Immtech joins the China club

Immtech Pharmaceuticals has become the latest in a string of western research and development services firms to announce a partnership with a peer in China in a bid to get a foothold in this market of vast potential.