Catalent plans single use overhaul of bioreactors

31-Jul-2012 - Catalent has replaced all stainless steel bioreactors at its biologics facility in Middleton, Wisconsin with single-use techs citing cost and flexibility advantages.

Ricerca launches two new in vitro assays including cytokine storm test

31-Jul-2012 - US Preclinical CRO Ricerca has launched two new assay services one of which is designed to help assess the risk a biologic drug will induce a cytokine storm. 

BioFocus and Activiomics team up to boost drug candidate selection

31-Jul-2012 - BioFocus and Activiomics have teamed up to offer a drug discovery and biomarker service which it says will improve the identification of novel targets.

GVK gets facility OK; ClinTec expands in Africa

30-Jul-2012 - Developments in the CRO sector continue despite the summer vacation season with news from GVK Biosciences and ClinTec International.

News in brief

Quintiles to promote Almirall's COPD drug in UK

30-Jul-2012 - Spanish pharmaceutical firm Almirall has called on Quintiles to help promote its respiratory drug portfolio in the UK.

Payment based on CRO results is the wave of the future: iGate

30-Jul-2012 - Outcome-based payment for CRO services is the “wave of the future” for pharmaceutical outsourcing, according to iGate.

UPDATE

Covance's flagging early phase biz puts downer on net profits in Q2

26-Jul-2012 - Covance has reported a net loss of $12.7m in this year’s Q2 as what it says is the result of facility closures and restructuring costs, particularly for its early phase...

PCORI says Pharmas may bias trials

26-Jul-2012 - The US Patient-Centered Outcomes Research Institute (PCORI) has suggested the pharmaceutical industry is introducing bias into clinical trials through selective use of inclusion/exclusion criteria and comparators.

News in brief

Beta Pharma lands cancer drug manufacturing and development contract

25-Jul-2012 - Beta Pharma Canada will produce a batch of adva-27a, a developmental cancer drug being developed by Sunshine Biopharma.

CMO pharma biz set to boom thanks to uptick in Asian activities

25-Jul-2012 - The global CMO market will grow from $26bn in 2010 to $59.9bn by 2018 thanks to a boom in the amount of work outsourced to the Asia market, says GBI Research.

Parexel backs EU trial laws changes but wants faster implementation

24-Jul-2012 - Parexel says EU trials directive never achieved harmonization aims and welcomes plans to simplify regulations, even if the implementation date is further away than expected.

Novasep latest firm to invest in ADC capacity

24-Jul-2012 - Novasep has joined the growing number of manufacturers betting on the antibody drug conjugate (ADC) market with a €3m investment at its plant in Le Mans, France.

Icon takes Q2 operating hit thanks to $5.6m restructuring charges

24-Jul-2012 - Icon’s operating profits have dropped by almost half since last year as a result of a $5.6m payout related to restructuring costs.

UPDATE

All Indian pharmaceutical CMOs must pay the excise duty, says SPIC

23-Jul-2012 - SPIC has pressed the Indian PM to issue a standardised excise duty to all contract manufacturers operating in the country so drugsmakers can have a level playing field.

Parexel teams with KDDF

23-Jul-2012 - The billion dollar Korea Drug Development Fund (KDDF) has called on US CRO Parexel to help local developers commercialise pharmaceuticals on the global market.

News in brief

Reports suggest Covance has sold its shares in Caprion

23-Jul-2012 - Reports suggest Covance has sold its minority stake in biomarker service firm Caprion Proteomics which has been acquired by Chicago Growth Partners.

People on the move: outsouricng jobs

23-Jul-2012 - Outsourcing-Pharma.com presents its weekly low down of the movers and shakers in the world of pharmaceuticals, including news from Parexel, Ricerca, and CSC.

Poll closes 31/07/12

CRO Poll: What do you think of proposed changes to EU trial laws?

19-Jul-2012 - The EC says proposals to replace the Clinical Trials Directive with simplified rules will make Europe more attractive for trials, but what do CROs think? Share your opinions in this...

ScinoPharm wins API contract for new US obesity drug Qsymia

19-Jul-2012 - Approval of Qsymia - Vivus’ anti-obesity drug – may be good news for the 35 per cent of US citizens classed as obese , but it is definitely good news for...

EC adopts plan to change trial rules, yet to decide on non-EU inspections

18-Jul-2012 - European lawmakers still need to decide how to inspect clinical trials in non-EU countries under proposed regulatory reforms adopted by the EC.

People on the move: outsourcing jobs

18-Jul-2012 - Outsourcing-Pharma.com presents the latest in the busy world of pharmaceutical careers, including news from PPD, Parallon, ShangPharma and C3i.

Indian API production takes hit as APPCB shuts 12 plants

18-Jul-2012 - API production in India will take a hit this week with plant closures for Aurobindo, Hetero Drugs, Divis Pharmaceuticals, and Sri Krishna Pharmaceuticals following allegations of environmental wrongdoing.

BioFocus gives itself room to update compound library

17-Jul-2012 - BioFocus has taken on Titian’s sample management software in a bid to pump more resources into “refreshing” its 900,000 strong high-throughput screening (HTS) compound portfolio.

DSM's CMO biz wins second contract in two months

17-Jul-2012 - DSM Pharmaceutical Products (DPP) has won its second biologics manufacturing contract in two months signing up Brazil’s Recepta Biopharma as a new customer.

Medpace doubles early-phase capacity with a new clinical pharmacology unit

17-Jul-2012 - Ohio, US-based CRO Medpace says it has finished work on a new pharmacology unit in Cincinnati and plans to close its old facility in Norwood.

Big eClinical mergers can work, Medidata CEO says

17-Jul-2012 - The CEO of Medidata has said big eClinical mergers can succeed if there is an alignment of the businesses and technologies.

Clinical data quality not impacted by location, study

16-Jul-2012 - The location of a clinical trial has no-impact on data quality according to new research.

News from LabCorp, Quintiles, Synexus and CRI

16-Jul-2012 - LabCorp moves closer to expanding central labs biz, Quintiles builds in Brazil, Synexus grows in South Africa and CRI opens new research facility -  Welcome to Outsourcing-pharma.com’s round up of...

Acquisitions and contracts in Outsourcing-pharma.com's CMO news roundup

12-Jul-2012 - Ampac gets the OK from the DEA, Syngene lands PE-ED manufacturing contract and Great Southern is bought by Pernix Therapeutics – welcome to Outsourcing-pharma.com’s CMO round-up.

Dishman abandons pharma SEZ plan

12-Jul-2012 - Dishman Pharmaceuticals has abandoned plans to set up a special economic zone (SEZ) citing law changes that make the project less attractive and unfavourable economics as the reasons for the decision.  ...

News in brief

InVentiv further expands biz with patient counseling partnership

12-Jul-2012 - inVentiv Health’s medical management business – iMM – has partnered with patient behavioural counselling firm Vital Decisions to develop a care management and counselling programme for patients suffering from progressive disorders.

People on the move: outsourcing jobs

12-Jul-2012 - Outsourcing-Pharma.com presents its latest round-up of the latest newcomers and career climbers in the world of pharmaceuticals, including news from AMRI, Ark, and IMC.

FDA 483 makes example of Exemplar Pharma

11-Jul-2012 - Specialist aerosol CDMO Exemplar Pharma has been issued with a 483 by the US FDA for inadequate process control procedures.

Top eClinical firms to win market share over next decade; analyst

11-Jul-2012 - Leading eClinical firms will win market share over the next decade as biopharma firms stick with tools they know, an analyst predicts.

Pacific Biolabs predicts regulation-driven surge in medical device outsourcing

10-Jul-2012 - CROs can expect more business from medical device makers as regulations become more complex according to Pacific Biolabs.

Warnex agrees new ‘adaptable’ credit facility

10-Jul-2012 - Lab services firm Warnex has rejigged its finances yet again and reiterated its plans to focus on the contract bioanalytical testing market.

No cuts at DPT Labs says new owner Renaissance Pharma

09-Jul-2012 - No job losses, facility divestitures or strategic changes are planned at DPT Laboratories according to new owner Renaissance Pharma, which bought the CDMO in an out-of-the-blue deal last week. 

Newly private ERT to buy invivodata for ePRO boost

09-Jul-2012 - eResearch Technologies (ERT) says it will buy invivodata citing the electronic patient reported outcomes (ePRO) market as the key driver for the deal.

iGATE says new data management tech will change R&D

09-Jul-2012 - iGATE says its new information management platform will provide a 70 per cent decrease in content management costs for the drug development process.

New foreign body inspection squad for RSSL

05-Jul-2012 - RSSL says its new foreign body inspection team could help get offline factories up and running more quickly following incidents of contamination.

EMA wants debate on clinical data extrapolation; new concept paper

05-Jul-2012 - The EMA wants a debate on the extrapolation of clinical data to see if a framework is needed to govern this potential approach to reducing unnecessary research and letting industry...

EXCLUSIVE

CDMO and CRO must become one so clinical research can evolve: Quotient.

05-Jul-2012 - ‘Merge CDMO and CRO activities to fix the holes in the early phase clinical research industry’, said Quotient Clinical’s CEO Mark Egerton.

Argentina's CRO market set to boom, says report

04-Jul-2012 - Argentina’s clinical trial market will hit $76m (EUR60.4) by 2015 with growth driven by low costs, a good regulatory environment and large patient populations, according to a new study.

OLAW clarifies position on cost’s role in animal welfare after feedback

04-Jul-2012 - The US NIH has clarified its position on research animal welfare after its original statement raises concerns.

People on the move: outsourcing jobs

04-Jul-2012 - Outsourcing-Pharma.com presents its weekly round-up of the changing faces in the world of pharmaceuticals, including news from Icon, NIH and Theradiag.

UPDATE

Cut in-house R&D and increase outsourcing, says GBI

03-Jul-2012 - Cutting in-house R&D staff to outsource more activities cuts will drive the industry forward, according to a new report.

Investments in CMO activities: round up

03-Jul-2012 - Outsourcing-Pharma.com presents a round-up of the latest contract manufacturing investments, including new screening services for Imaxio, Encap’s renewed push for its CMO biz, and Pernix’s bid to take over Great...

EU defends trials directive but commits to make process faster and more efficient

03-Jul-2012 - European laws on clinical trials need to be faster and more efficient but they are not the only reason for the decline in the sector according to EU health and...

UPDATE

New draft guidance on clinical trial insurance in the UK to accelerate ethics committees, says Government

02-Jul-2012 - A new draft guidance stating the level of insurance cover required for trial participants in the UK will accelerate ethics committees’ approval process, according to experts.

ScinoPharm to invest in cancer drug capacity

02-Jul-2012 - API maker ScinoPharm is to invest in cancer drug and injectables capacity, citing current global shortages as a driver for its decision.

News in brief

EPS launches same-day microbial analysis service

02-Jul-2012 - Emeryville Pharmaceutical Services (EPS) has launched a new “same day” chemistry and microbiology analysis service.

Over 25% of clinical trial procedures are pointless, says Medidata

02-Jul-2012 - A quarter of procedures carried out during clinical trials may be pointless according to a new study, which suggests that this unnecessary work costs around $5bn (€3.96bn) a year. ...