Hospira adds antibiotic API capacity in India

30-Aug-2012 - Hospira has bought Orchid Chemicals and Pharmaceutical’s active pharmaceutical ingredient (API) facility in Aurangabad, India, to support its expanding antibiotic business.

Emerging market regulatory staff should take test to level playing field, RAPS

30-Aug-2012 - Regulatory professionals working for contract research organisations (CROs) in emerging markets could benefit from taking a test to bring them up to par with those in developed countries, according to...

QPS buys JSW Life Sciences, boosts CNS

30-Aug-2012 - QPS has boosted its late phase offering after acquiring Austrian-based JSW Life Sciences.

People on the move: outsourcing jobs

30-Aug-2012 - Outsourcing-Pharma.com presents its weekly round-up of the latest chops and changes in the world of pharmaceuticals, including news from INC Research, Y-Prime and Ariana.

PRACS Institute sells Miami facility to CRI Phase I

29-Aug-2012 - The PRACS Institute has sold its Miami, US facility to a new early-phase focused CRO, CRI Phase I Corporation.

PRA talks about expansion in China

29-Aug-2012 - The lack of competing studies, proximity to the SFDA HQ and were the key drivers for the new Beijing, China office according to PRA International. 

EXCLUSIVE

GSK and AstraZeneca attracted by NHS' efforts to work with sponsors and CROs outside UK

29-Aug-2012 - GlaxoSmithKline (GSK) and AstraZeneca have been attracted by NHS efforts to work with sponsors and CROs outside the UK according to Government investment group, UK Trade and Investment.

Charles River buys Accugenix to boost microbial testing

29-Aug-2012 - Charles River Laboratories has acquired Accugenix in a bid to expand its endotoxin and microbial detection portfolio.

News in brief

United Drug buys DSA and Synpoia

28-Aug-2012 - United Drug (UD) has bought firms in the pharmacovigilance and market access sectors, following up on its acquisition in the contract packaging industry last week.

UPDATE

NHS announces plans to become international healthcare provider

28-Aug-2012 - The UK’s National Health Service (NHS) has launched plans to provide services to the pharmaceutical industry internationally.

Market access teams should have more influence in clinical trial design, say Cutting Edge Information

28-Aug-2012 - Health economics and outcomes research teams must have a greater influence over clinical trial design if pharma firms are to achieve reimbursement goals, according to Cutting Edge Information.

BE/BA sites must be logged with US FDA under GDUFA

28-Aug-2012 - CROs conducting bioequivalence and bioavailability (BE/BA) studies for generics firms will have to log details of their sites with the US FDA under new ‘self-identification’ rules.

India's IT providers must become experts to handle biostatistics boom, says Alticure

27-Aug-2012 - India’s IT sector must expand its knowledge base to fully meet the surge in demand for biostatistics says Alticure Research.

News in brief

Hospira to invest in $85m Rocky Mount, creating 200 jobs

27-Aug-2012 - US Injectable drugmaker Hospira will invest $85m and create 200 new jobs at its plant in Rocky Mount, North Carolina according to the State Governor.

Precos to expand cancer model portfolio thanks to new HTA license

27-Aug-2012 - Precos will expand its portfolio of preclinical cancer models after being licensed to store and handle human tissue by the UK’s HTA.

Cobra says timesaving cell line development tech will help it win customers

24-Aug-2012 - Cobra Biologics claims a new micro bioreactor technology it has adopted can cut three months off cell line development timelines and facilitate faster production scale-up.

Is cloud computing hot air? Comprehend Systems shoots the breeze with OSP

23-Aug-2012 - Comprehend Systems recently made its data analytics, visualisations and reports software available from the cloud. CEO Rick Morrison spoke with Outsourcing-Pharma.com about the firm’s reasoning, and why no rockets were...

Bend Research adds HP spray drying facility

23-Aug-2012 - Bend Research can now work with high-potency (HP) ingredients thanks to a new spray-drying facility.

United Drug asks US Courts to throw out Catalent case

23-Aug-2012 - United Drug wants the US courts to throw out accusations it disclosed confidential data about Catalent’s packaging business after secret acquisition talks collapsed last year.

West heads east with new Indian packaging plant

22-Aug-2012 - West Pharmaceutical Services has started construction of a facility in Sri City, India, citing growing importance of the Asia-Pacific market.

ShangPharma sees $10m lift in revenues thanks top 10 clients

22-Aug-2012 - ShangPharma saw a $10m lift in its Q2 revenues bolstered by increased business from its top ten clients.

News in brief

Verum.de targeting North American sponsors interested in trials in CEE

22-Aug-2012 - German CRO Verum.de wants to win business from US and North American sponsors keen to conduct trials in central and Eastern Europe (CEE).

United Drug to buy Bilcare's UK and US trial supply businesses

21-Aug-2012 - United Drug will buy the UK and US trial supply businesses of Indian contractor Bilcare to further expand its packaging services division.

Almac and Quintiles latest to invest in genomics for personalised meds

21-Aug-2012 - Genomic analysis seems to be an area of interest for the contract services sector at the moment with Northern Ireland-based Almac and US CRO Quintiles only the latest firms to...

News in brief

MedPharm and Molecular profiles team on topical drug manufacturing for trials

21-Aug-2012 - MedPharm and Molecular Profiles have formed a dedicated topical medicine manufacturing service for clinical trials.

Changes to EU clinical trial laws will mean fairer playing field, says Clinipace

21-Aug-2012 - The proposed changes to European clinical trial regulations accepted by the European Commission (EC) in July  will put Europe on an equal playing field, according to Clinipace’s Andrea Schiefer....

People on the move: outsourcing jobs

21-Aug-2012 - Outsourcing-Pharma.com presents its weekly round-up of the latest movers and shakers in the world of pharmaceuticals, including news from INC Research, Elsevier and Invetech.

DaVita opens PI facility for kidney research

20-Aug-2012 - DaVita Clinical Research has opened a Phase I facility focussed on kidney research in a bid to meet a “growing demand” for renal trials.

US FDA updates guidance on treatment-emergent suicide risk in trials

20-Aug-2012 - The US FDA has revised its draft guidance on suicide risk in trials with updated terminology and expanded assessment criteria and has called for drug industry feedback.

BASi sees revs and gross profits fall in Q3 but upbeat about prospects

20-Aug-2012 - Preclinical CRO Bioanalytical Systems (BASi) saw revenue, margins and gross profits fall during its fiscal third quarter but the firm is positive about the impact of recent restructuring efforts.

update

Pfizer favours green contractors

16-Aug-2012 - Pfizer wants the CROs, CMOs and other suppliers it works with to be green and says such firms have an advantage when it comes to winning contracts.

Theorem and Gallus team up to help drugsmakers in emerging markets go State side

16-Aug-2012 - Theorem and Gallus say their new biologics manufacturing partnership is aimed at giving a “leg up” to drugsmakers in emerging markets looking to market products in the US.

People on the move: outsourcing jobs

16-Aug-2012 - Outsourcing-Pharma.com presents its weekly round-up of the latest new and changing faces in the pharmaceutical industry, including news from Parexel, Deloitte and Cerafor.

Wuxi grows revs thanks to lab biz, but margins suffer on costs

14-Aug-2012 - Chinese CRO Wuxi Pharmatech posted impressive revenue growth for Q2 driven by demand for lab services, but the firm still faced margin pressure due partly to rising labour costs.

Icon readies itself for translational medicine boom with Manchester expansion

14-Aug-2012 - Icon has boosted its Phase I translational medicine services in Manchester, UK, in preparation for what it believes will be a boom in the drug development area.

Difficult new biz acquisitions drag PDI's Q2 profits

14-Aug-2012 - Longer-than-expected ramp up in new business gains for PDI has dragged on Q2 earnings results for the firm.

News in brief

US FDA wants CRO and sponsor feeback on data exchange standards

14-Aug-2012 - The US FDA wants CROs, sponsors and the wider industry to debate the pros and cons of current and evolving approaches to sharing study data.

EMA calls for sponsor and CRO input on trial data publication plan

13-Aug-2012 - The EMA wants CROs and sponsors to share their thoughts on plans to make data from clinical trials publicly available.

Exclusive Research

India's inexpensive biostatistics outsourcing market set to boom: Beroe

13-Aug-2012 - India’s biostatistics outsourcing market is set to grow 15 per cent in two years thanks to a 50 per cent cost saving compared with the West, according to a new survey.

Exclusive interview

Cherry picking best functionalities is key, Bioclinca CEO tells OSP

13-Aug-2012 - BioClinica says the next eClinical revolution will be in programmes combining functionalities tailored to a client's specific needs.

People on the move: outsourcing jobs

09-Aug-2012 - Outsourcing-Pharma.com presents its weekly round-up of the latest pharma career changes, including news from Aesica, PharmaNet/i3 and Qforma.

EXCLUSIVE

Big Pharma looking to home care to bolster clinical activities: ResearchNurses.co

09-Aug-2012 - ResearchNurses.co will conduct home visits in clinical trials for three Big Pharma firms after forging an agreement with Nottingham University Hospitals Research and Innovation Department.

Parexel sees revenue and income growth in fiscal Q4 but margins slide

09-Aug-2012 - US CRO Parexel saw revenue and income growth in fiscal Q4 but margins shrank in the firm’s clinical research and eClinical business.

CDSCO can inspect trial sites and seize docs unannounced under new guidelines

09-Aug-2012 - Inspectors will be able to visit clinical trial sites unannounced and seize records under new draft guidelines issued by the Indian Central Drugs Standard Control Organisation (CDSCO).

Almac doubles refrigerator capacity for trial suppliers seeking biologics business

08-Aug-2012 - Almac has doubled refrigerator capacity at its site in Craigavon, Northern Ireland citing demand from its roster of biologics producing clients.

Access to patient population more important than price for Phase I outsourcing, says ISR

08-Aug-2012 - Access to patient populations is a bigger deciding factor than low cost when selecting a Phase I service provider, according to ISR’s new quality benchmarking report.

Trends reverse at Charles River Laboratories in Q2

08-Aug-2012 - Trends reversed at Charles River Laboratories in Q2 with preclinical services revenue (PCS) growing for the first time in 14 quarters while research models and services (RMS) sales fell for...

Aurobindo sets eyes on API CRAMS biz

08-Aug-2012 - Aurobindo has announced long term plans to steer away from its generics making business in a bid to focus on long term API manufacturing partnerships.

Halo seeks renewal as controlled substance producer; buys Teva plant

08-Aug-2012 - US CMO Halo Pharma has asked the Drug Enforcement Administration (DEA) to renew its registration as a manufacturer of controlled substances.

DSM to continue Phama cuts beyond recent Percivia reorganisation

07-Aug-2012 - DSM will conduct further cost cutting at its Pharma business as part of a wider ‘profit improvement initiative’ that will see it cut 1,000 jobs over the next 18 months.

Parexel acknowledges new BioPharm unit's matchmaking potential

07-Aug-2012 - Parexel may be willing to act as a matchmaker for the small and midsized developers that work with its new BioPharm unit according to COO Mark Goldberg.

News in brief

GE provides e-health management tech for US athletes at 2012 Olympics

07-Aug-2012 - The luggage Team USA took to the London 2012 Olympics was lighter than that carried to previous tournaments thanks to a technology provided by GE Healthcare.

New pharma services from M&A and partnerships: round-up

07-Aug-2012 - Outsourcing-Pharma.com presents the low down on new services forged by partnerships and M&A (mergers and acquisitions), including a molecular biology offering for Quotient, Onyx’s added purification and separation capabilities, and...

NPS' CMO runs into fill/finish problems as BLA filing nears

06-Aug-2012 - The CMO producing Natpara for NPS Pharmaceuticals has hit problems just as the company was preparing to submit its BLA.

Bills to cut duplicate trials and force Pharmas to publish data put before US lawmakers

06-Aug-2012 - Proposed law changes put before the US Senate and the House of Representatives last week seek to eliminate duplicate trials and force sponsors to display all results on Clinical trials.gov website....

West Pharmaceutical continues balancing act despite CMO uptick

06-Aug-2012 - West Pharmaceutical Services is sticking with plans to lessen CMO (contract manufacturing organisation) activities and boost proprietary products despite a hefty uptick in contract production in Q2.

News in brief

ShangPharma considers private equity takeover bid

06-Aug-2012 - Chinese contract research organisation (CRO) ShangPharma has called in JP Morgan to help independent board consider a takeover bid.

AMRI's Burlington facility sees unexpected uptick in Q2

02-Aug-2012 - AMRI’s once troubled Burlington facility has seen an uptick in new contracts and is showing strong potential for more, according to CEO Thomas D'Ambra.

People on the move: jobs in pharma

02-Aug-2012 - Outsourcing-Pharma.com presents its latest round up of career moves in the pharmaceutical industry, including news from Theorem, FMC Technologies and EMD Serono.

Indian CRO spending down as effect of weak rupee continues

02-Aug-2012 - Indian CROs continued to limit their spending in the second quarter as the weak rupee, fallout from Dateline and regulatory inertia hit business.

Breaking news

LabCorp says it has no knowledge of private-equity takeover bid

01-Aug-2012 - LabCorp says it is not in talks after rumours that it is a private-equity takeover target.

Medidata beats Q2 expectations following landmark $100m contract

01-Aug-2012 - Medidata beat analyst expectations in this year’s Q2 results after inking a five-year $100m clinical cloud deal – the largest in the firm’s history.

AstraZeneca and Assay Depot's VRM allows full drug discovery from a laptop

01-Aug-2012 - AstraZeneca and Assay Depot have launched a new “virtual research lab” which they say will allow a small group of scientists to run full drug discovery from a laptop....

Lonza calls in former SGS man to oversee ‘Visp challenge’

01-Aug-2012 - Lonza has brought in a new exec to oversee cost reduction and efficiency efforts at its largest custom API manufacturing plant in what CEO Richard Ridinger calls the Visp challenge.  ...