Breaking News on Contract Research, Manufacturing & Clinical Trials

Aptuit Laurus to feed off preclinical growth in India

Aptuit Laurus, the newly formed joint venture between Aptuit and Laurus Labs in India, will focus on an expected rise in the demand for preclinical and Phase I research and development services as part of its growth plan in India.

Indian CRO eyes US or EU buyout

India's Reliance Life Sciences (RLS) is planning an acquisition in Europe or in the US joining the slow infiltration of Indian firms cementing themselves in Western markets.

Pharmaceutical outsourcing: people on the move

Cook Pharmica, Cytovance, BioStorage Technologies, PRA International, Draxis Pharma, and MDS Pharma Services have all had people on the move in the world of pharmaceutical outsourcing.

Pharma investment in Ireland 'unbelievably significant'

Ireland has successfully established itself as a hub for the pharma and biotech industries, and the trend to invest in high value-added activities on the green isle shows no sign of slowing, according to Ireland's Industrial Development Agency (IDA).

Bespak to cut jobs as Exubera prospect falls short

Bespak, one of the two contract manufacturers of Pfizer's inhaled insulin Exubera, has announced it will cut a "significant" number of jobs as sales of the once-touted blockbuster are falling short of expectations.

Procter & Gamble looking to outsource API work

Procter & Gamble (P&G) has announced its intention to outsource the active pharmaceutical ingredient (API) R&D and manufacturing work undertaken at one of its US factories, with resultant closure of the site and job losses.

Indian clinical research industry shaping up

India's clinical research industry took on more shape this week with the launch of the Indian version of the Association of Clinical Research Professionals (ACRP) and the government's proposed new regulations on clinical trials conducted in the country.

Asterand job cuts 'not connected' with Russian ban

Asterand said it is to slash 10 per cent of its total workforce in a cost-cutting strategy although it is not a knock-on effect of the recent ban on export of human samples from Russia.

Pfizer's first day in Nigerian court in child death dispute

Pfizer has had its first day in a Nigerian court in a legal dispute over its alleged involvement in the death of Nigerian children during a clinical trial 11 years ago.

Contract manufacturing news in brief

Granules India, Dalton Pharma Services, Polymun, and CMC Biopharmaceuticals have all announced new contract manufacturing deals this week.

ICON eyeing Europe for observational research

ICON Clinical Research is stepping up its efforts to bring observational clinical research to European customers.

Preclinical services news in brief

In this week's review of recent activity within the preclinical research services arena, news has emerged involving Gendata, Achaogen, NiKem Research and Verona Pharma.

Updated FDA follow-on biologics bill released amidst anticipation and trepidation

A long-awaited and in some cases, long-feared, regulatory pathway for the US Food and Drug Administration (FDA) approval of follow-on biologics is now closer to fruition.

Microtest, Texcel combine for 'combo drugs'

Microtest Laboratories and Texcel Medical have teamed up to offer biopharma firms services to help them overcome the hurdles of developing "combination products" - a fast-growing market.

Roche signs $370m deal for Phase I arthritis drug

Roche has committed hundreds of millions of dollars to an early-phase rheumatoid arthritis drug, a move that is indicative of big pharma's increasing tendency to license earlier phase compounds.

Parexel talks Tegenero and Phase I future

Parexel talks to Outsourcing-Pharma about Phase I trials, touching on trends and growth opportunities, future plans for India and lessons learned from Tegenero.

INC Research says new process hastens trial start dates

INC Research said it is now able to bring the start date for its clinical trials forward by two weeks following the implementation of a company-wide process improvement strategy.

Beware of outsourcing myths, warns survey

A number of outsourcing misconceptions are luring companies into viewing offshoring as an easy process, new research reveals.

Third Chinese drug official charged in corruption scandal

China's resolve to clean up corruption in its pharma industry has intensified as the former assistant to the already-condemned-to-death former drug chief has now been charged.

Finnish CRO dives into metabolomics sea

Finnish CRO Technical Research Center (VTT) has spun-off Zora Biosciences, which becomes the only company in the Nordic region to provide metabolomics services to pharma companies - a market with high potential.

Ex Cardinal Health contract biz reborn as Catalent

The contract manufacturing business that Cardinal Health sold earlier this year has just been launched as an independent operating company rebranded as Catalent Pharma Solutions.

Thermo Fisher Scientific launches RNAi services laboratory

Thermo Fisher Scientific has opened a new RNAi Discovery and Therapeutics Services Laboratory to help pharmaceutical companies in their quest for new drugs.

Disposables crucial in future of patient-specific meds

At a time when single-use manufacturing equipment is riding on a surge of popularity, in-PharmaTechnologist.com talks to Vijay Singh of GE Healthcare's newly acquired Wave Biotech unit about the impact disposables will have on the future of personalised medicines.

EU and US agencies bolster bonds

European and US regulatory bodies have revamped their relationship to ease administrative burdens and improve communication, as well as implementing new measures directed specifically at paediatric drug products.

Parexel opens first Indian operation

US contract research organisation (CRO) Parexel has just announced the establishment of its first operation in India.

Russians left in the dark despite lifted export ban

Despite a lift of the ban on biological sample transportation out of Russia, the country's clinical research industry is still in the dark on the new rules to control export of such materials.

Patheon and Senopsys in tasty deal

Patheon is teaming up with formulation development services firm Senopsys to offer pharma companies combined services to test and improve drug flavour.

Asia beckons DSM anti-infectives

Dutch ingredients firm DSM has announced plans to carve out its anti-infectives business and boost its presence in Asian markets following a review of the active ingredient unit.

Patient registries on the up

Patient registries are becoming increasingly popular as their value is now being recognised, according to an industry expert.

Aptuit splurges $100m in India

US firm Aptuit has announced it will invest $100m (€75m) in India-based Laurus Labs to form a new joint venture - just a few months after splurging a similar amount to expand its capabilities.

Synexus 'confident' despite profit drop

UK-based Synexus was optimistic last week when it announced its preliminary financial results for the year, despite a plummeting operating profit.

Diamyd tries to salvage something from clinical wreck

Diamyd Medical will continue with a clinical trial of its gene therapy designed to protect insulin-producing cells in diabetes patients, despite major errors invalidating the study.

Pharmaceutical contract services round-up

In a round-up of motley pharmaceutical services contracts, Outsourcing-Pharma takes a look at recent news involving Movianto, PDI, inVentiv Health and Exel.

West wields the axe in UK

The loss of a significant contract has left West Pharmaceutical Services wielding the axe at one of its UK facilities.

Viracept: lessons to be learnt?

Just over a week after Roche was forced to initiate a Europe-wide recall of HIV drug Viracept (nelfinavir), in-PharmaTechnologist.com considers the contamination case and the pharmaceutical processes blamed for the incident.

Nicholas Piramal opens second research site

Nicholas Piramal India (NPIL) has opened its second clinical research facility and is eyeing the growing area of biopharmaceutical testing.

Weekly comment

Corrupt Chinese drug official appeals death penalty

The former director of the country's State Food and Drug Administration (SFDA) has lodged an appeal against the death penalty slapped on him after a corruption conviction.

Indian investors buy Radiant Research

Indian private equity firm ICICI Venture has taken over the ownership of US site management organisation (SMO) Radiant Research as it seeks to evolve.

Pfizer invests $300m in Korean R&D

Pfizer is to plough $300m (€226m) into South Korean research and development over the next five years, while it's CEO is planning to visit North Korea tomorrow.

Lonza leans towards highly potent APIs

Lonza is building a new plant in its home country to become the only contract manufacturer with large-scale capacity for making highly potent active pharmaceutical ingredients (APIs).

Asterand outlines action for profitability

Asterand has announced a restructure and changes to its operational model in a bid to grasp hold of profitability.

Pharma industry 'better off' under new REACH rules

Pharmaceutical companies are actually set to benefit from reduced testing requirements now that the new European chemicals regulation is in place, however, some bulk manufacturers and ingredients suppliers could face increased burdens.

Patheon steps up 'damage control' over Puerto Rico

After dismal second quarter results Patheon is stepping up its resolve for 'damage control' and indicated that further cutbacks at its problematic Puerto Rico plant are imminent.

Hunting for drug candidates on Kinase SARfari

BioFocus DPI has released a new informatics system that can combine chemical and biological data from various sources to optimise protein kinase inhibitor candidate selection.

China drug safety crackdown continues

China has announced a crackdown on its drug safety regulations in an attempt to remedy its international reputation as a producer of unsafe and counterfeit drugs.

FDA probe continues to hit MDS Pharma's pocket

The fallout from a US Food and Drug Administration (FDA) probe continues to haunt MDS Pharma, dragging it into the red again during the second quarter.

Intertek in US analytical lab buyout

UK's Intertek Pharmaceutical Services is expanding the range of its offerings with the acquisition of QTI, a US contract analytical laboratory.

The 'biogeneric' analysis problem

The apparent inability of current analytical techniques to fully characterise complex biological drugs still stands in the way of easy approval pathways for 'biogenerics' or copies of off-patent brand name biologics.

eClinical news in brief

Outsourcing-Pharma tracks the latest eClinical movements, featuring ClinPhone, Phase Forward, etrials and DecisionView.

Biologicals ban could halt the rush on Russia for clinical trials

Just as the clinical trials sector in Russia is starting to take off, the industry has been dealt a severe blow with the sudden and indefinite banning of biological sample exports.

Clinical trials funding affects results, says new research

Further evidence has emerged claiming that clinical trials are more likely to report positive results when funded by drug companies.

Contract manufacturing news in brief

Morphotek, CMC Biopharmaceuticals, Cobra Biomanufacturing, and Fraunhofer have all announced new contract manufacturing deals this week, while Jubilant Organosys completed its US buyout.

Journal-compliant clinical trial requirements updated

The number of clinical trial registries that drug companies and researchers can use if they want to have their results later published in prominent medical journals has been increased. Meanwhile, as of July next year, Phase I trials will also have to comply with the registration requirements.

First Chinese CRO merger announced

Two Chinese contract research organisations (CROs) have announced they will merge - a first in China's CRO industry.

Managing risk in clinical outsourcing

Sponsors need to ensure they are managing the risk involved in clinical outsourcing, particularly when dealing with multiple contractors.

Abbott to use Dowpharma technology

Abbott is the latest pharmaceutical company to scoop up Dowpharma's exclusive protein-producing technology.

UK to pioneer carbon footprint labelling innovation

In a bid to push manufacturers to reduce their greenhouse gas emissions, the UK government last week unveiled a proposal that could pave the way for "carbon footprint" labels on products.

More Phase 0 studies needed to sway 'conservative pharma'

Phase 0 studies have a great potential in selecting drug candidates early in the drug development but the pharma industry will stay sceptical until more research has been done, said Prof. Colin Garner, CEO of microdosing service firm Xceleron.

Revolutionary Phase I trial design speeds up development

A new approach to Phase I clinical trials could revolutionise drug development, enabling innovative drugs to get to market faster and cheaper.

Lucrative prospects for India-UK pharma trade

The pharmaceutical and healthcare industries will help to push trade between India and the United Kingdom up by 60 per cent within three years, claims a soon-to-be released report.

Kendle named 'top CRO to work with'

Kendle received good news after being rated top contract research organisation (CRO) in the US by a survey of more 500 clinical investigative sites.

'Free drugs', but only if they don't work, proposes drug firm

In a groundbreaking decision, Janssen-Cilag has offered to give the UK government their money back if its expensive new bone cancer treatment does not work on patients.

Improved image analysis in proteomics research

Analysing the images from protein separation experiments, such as 2D gel electrophoresis (2DGE), is not only time consuming but can often miss 'hits' and give false positives. But it doesn't have to be that way, according to Swedish company Ludesi.

UK logistics supplier bags £6m deal with AZ

British drug maker AstraZeneca has awarded UK-based NYK Logistics a two and a half year contract for the distribution of its drugs throughout Europe, worth £6m (€8.9m).

Anglo-Indian CRO eyes US market

Veeda Clinical Research, an Anglo-Indian contract research organisation (CRO) formed two years ago, said it will soon enter the US market with a new acquisition - the fourth since the company's creation.

Five-fold increase in drug fakes over 2006

The European Commission has released figures showing that there has been a dramatic and concerning increase in pharmaceutical counterfeiting, with seizures in Europe hitting an all time high of over 2.5m items.