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Headlines > January 2012

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31-Jan-2012

TNT offering temperature-controlled logistics services

TNT Express is now offering temperature-controlled logistics services to support global distribution of biologics.

Avoca invites CROs to join Pharma sponsors in Quality management debate

Sponsors want CROs to join the debate on quality management in clinical research says the Avoca Group, which has invited contractors to sign up to its recently established industry consortium.

Dishman considers future of Chinese API plant

Ingredient maker Dishman Pharmaceuticals has confirmed that it may offload its Chinese API (active pharmaceutical ingredients) factory.

Parexel posts soaring sales and backlog but costs cut profits

Parexel posted double-digit revenue growth and record backlog in its second quarter, but rising costs drove down profits.

30-Jan-2012

Russian trial approvals up in 2011, but reviews still slow says ACTO

Russia’s trial sector has largely recovered from the ‘crisis’ created by revision of approval system in 2010, but regulators are still taking too long to OK studies says industry group ACTO.

News in brief

Lpath suspends dosing after FDA warns of CMO failings

Lpath has suspending dosing in its iSONEP clinical trials after learning the CMO handling fill and finish has cGMP failings.

HUYA Bioscience wants stronger bonds with international drugmakers

HUYA Bioscience says it will strengthen bonds between Chinese drug innovators and worldwide developers and through its new partnership with the Tianjin Institute of Pharmaceutical Research (TIPR).

Covance plans cuts to early dev unit if sales are flat in 2012

Covance could cut early development capacity if the unit posts flat sales in the coming fiscal year, its CEO said.

26-Jan-2012

People on the move: outsourcing jobs

Outsourcing-Pharma presents its weekly round-up of the latest changes on the pharmaceutical career ladder, including news from Patheon, Wolfe Laboratories, and Premier Research.

Covance shocks analysts with two year IT investment plan

Covance is accelerating IT investment faster and for longer than expected, resulting in 2012 guidance that met analysts’ “worst-case fears”.

Contract manufacturing round-up

Outsourcing-Pharma presents a round-up of the latest headlines within the world of contract manufacturing. Catalent and Patheon have each launched oral dosage partnership news, whilst Frontage and AMPAC have received regulatory go-aheads.

Jubilant buys Lilly out of early-phase JV

Jubilant Life Sciences has bought US drugmaker Eli Lilly’s stake in the early-stage development focused JV the firms set up in 2008.

News in brief

DHL gains license for packing & labelling medical devices

DHL has obtained a license for packaging, labelling and storing medical devices at its logistics site in Tokyo, Japan.

25-Jan-2012

An experienced CMO is key to successful biologics development says Cobra Biologics

Detailed market knowledge and an experienced CMO are still critical to successfully developing a biopharmaceutical or biosimilar according to Cobra Biologics.

CFS plans to tackle financial management diversity in different countries through expansion

Clinical Financial Services (CFS) has made its first foray into the global market after opening a new office in Edinburgh, Scotland.

EU CMO market to top $20bn as big pharma ups outsourcing

A patent loss-fuelled surge in big pharma outsourcing will push the European CMO market through the $20bn barrier by 2018, analysis claims.

Plummeting profits prompt Lonza to fire CEO

Lonza has fired its CEO after a halving of net income prompted the board to find another leader for “the challenging years ahead”.

24-Jan-2012

News in brief

PrioTrials Research moves its clinical trial services into the global arena

UK-based ProTrials Research will expand a new subsidiary in a bid to meet its clients increasing demands for a wider range of multi-national clinical trials.

Takeovers & tox top agendas as preclinical CROs’ results near

Preclinical CROs begin reporting full year results this week, with talk of takeovers and toxicology high on agendas.

Round up of eClinical news

Outsourcing-Pharma presents a roundup of eClinical technology news, including “omnics” at Oracle and DDi at DIA.

Outsourcing still a gamble that needs strategic vision to succeed, says study

Outsourcing is a gamble for the industry that needs a closer collaborative approach if pharma firms want a successful performance, according to new research.

23-Jan-2012

Language skills and local knowledge a must for BPO success in Asia says Quintiles

Multilingual ‘magic’ and cultural knowledge are the keys to business process outsourcing (BPO) success in North Asia according to Quintiles.

Polytherics buys Warwick Effect Polymers for biodrug modification tech

UK-based Polytherics has acquired Warwick Effect Polymers (WEP) to expand biologic drug modification offering.

News in brief

Almac isotope and lab sites pass UK inspections

Almac says its isotope chemistry facility and its lab division both passed UK regulators’ inspections.

Acurian’s opt-in database hits 70m potential subjects

Acurian says rapid expansion of its opt-in trial subject database is testament to the efficacy of direct-to-patient communication.

19-Jan-2012

SGS to open 2nd Indian lab on schedule; 2011 revs grow despite ‘tough’ European market

SGS’ new analytical lab in Mumbai, India will open later this week just six months after the analytical services firm began its construction .

inVentiv agrees to buy SDI from IMS in bid to boost analytics offering

InVentiv will boost its market research and analytics offering with the acquisition of SDI’s medical audit activities.

News in brief

Pii to double sterile capacity in Maryland site expansion

Pharmaceutics International, Inc (Pii) is to double its sterile GMP production capacity by building a 24,000 sq ft facility.

People on the move: outsourcing jobs

Outsourcing-Pharma presents its weekly round-up of the latest career changes in the pharmaceutical industry, including news from Premier Research, Almac, and AAI Pharma.

Use of subcontractors a strain on GCP compliance, EMA says

The EMA has warned sponsors must take “great care” when outsourcing to niche subcontractors to avoid violating GCP.

18-Jan-2012

CRAs spend less than half their time in on-site monitoring tasks, says Tufts

Clinical research associates (CRAs) spend less than half of their time conducting ‘on site’ monitoring with training, travel and admin taking up the majority of their time according to new research

Quintiles invests £3m in biomarker R&D firm; establishes BPO centre in China

Quintiles has invested £3m ($4.6m) in a new UK-based biomarker R&D company in a continuation of its efforts to build in the field of personalised medicines.

News in brief

NSF moves into medical device trial training

Training and consultancy firm NSF Health Sciences (NSF-DBA) has acquired Pink Associates in a bid to broaden its service offering.

US DoD awards CMO Paragon Bioservices $15m vaccine deal

CMO Paragon Bioservices has won a $15m DoD contract to develop a large-scale mammalian process for a trivalent filovirus vaccine.

Patient derived tumours can take candidate selection to a 'new level', says VivoPharm

VivoPharm says its new agreement with primary patient-derived tumour creators EPO-GmbH will bring drug candidate selection to a “new level” for US drug researchers.

17-Jan-2012

Carbogen Amcis buys French CMO Creapharm Parenterals

Swiss API maker Carbogen Amcis has bought French contract manufacturer Creapharm Parenterals to boost capabilities in early-phase high potency drug development.

News in brief

inVentiv combines pharma training units for fuller offering

inVentiv Health says it will now offer a one-stop-shop for pharma and biotech training services after merging its subsidiaries Pharmaceutical Institute and Preceptiv Learning Solutions.

Greenphire teams with Merge on automated payment for trials

Study payment tech firm Greenphire says partnership with Merge Healthcare’s trial arm will offer greater efficiencies for pharmaceutical industry sponsors.

Doxil supplies going further but J&J CMO uncertainty remains

J&J has enough Doxil to meet the needs of patients on its waiting list but warned CMO Ben Venue is unlikely to resume supply until late 2012.

16-Jan-2012

Warnex will be forced to leave Toronto exchange next month

Contract services firm Warnex will leave the Toronto Stock Exchange (TSX) after failing to meet the requirements for continued listing.

Contract manufacturing news round-up

Outsourcing-Pharma presents a round-up of the latest contract manufacturing headlines in the industry, including news from Nanohale, Fleming and Trophogen.

Covance unveils further, ‘substantial' IT investment at JP Morgan conf

Covance plans a ‘substantial investment’ to consolidate its international data centres and develop clinical tools to arrest expanding IT costs.

News in brief

Almac opens new trial supplies centre

Almac has opened a new clinical services building at its HQ in Craigavon, Northern Ireland to bring together staff involved in trial supplies.

Popsi Cube using iPhones for blood pressure data tracking

CRO Popsi Cube is using iPhones to track blood pressure data and send questionnaires to patients.

12-Jan-2012

Big preclinical CROs stuck in tox time warp says upbeat Cyprotex CEO

Cyprotex says bigger preclinical CROs are stuck in toxicity testing ‘time warp’, citing drug industry demand for innovative cellular methods as key to its second half performance.

News in brief

UK Ab maker extends dye label license with Lab Technologies

Custom antibody manufacturer Cambridge Research Biochemicals (CRB) has expanded its range of labelling dyes through a new agreement with supplier Life Technologies.

Indian CRAMS sector to fuel export growth, CARE says

Outsourcing to Indian CRAMS and bulk drug businesses will drive the country’s export growth, a credit rating agency said.

Charles River talks up unity, ‘no comments’ takeover reports

Charles River’s CEO has reiterated the importance of integrating its research models and preclinical units but refused to discuss takeover reports.

11-Jan-2012

Amarin wants fourth omega-3 API supplier for AM101

Amarin plans to add a fourth API maker to its supply chain as it prepares for a potential launch of its triglyceride lowering therapy, AMR101, in the US in 2012.

CRO consolidation to slow in 2012, Icon CEO says

Major CRO consolidation will slow down in 2012 after the big wave of deals last year, the CEO of Icon said.

ShangPharma opens new plant to meet Lilly's R&D needs

ShangPharma has revealed its newly opened 100,000 sq foot facility will serve the growing capacity needs of pharma giant Eli Lilly.

News in brief

Catalent to build biologics plant at former GE Healthcare facility

US contractor Catalent Pharma Solutions’ new biologics plant will be a facility formerly owned by GE Healthcare.

10-Jan-2012

Sigma-Aldrich to offer start to finish bio-testing thanks to BioReliance takeover

Sigma-Aldrich says it is a step closer to becoming a one-stop-shop for biopharmas in the drug discovery process after it inked a takeover agreement with biological testing firm BioReliance.

Charles River considering sale, media report claims

Charles River is reportedly considering selling the business, with private equity and rival companies believed to be possible buyers.

Long-term relationship key to Icon’s Shire deal

A prior relationship rather than price was the most significant factor in helping Icon win its strategic deal with Shire according to an analyst who says such a trend is good for the sector.

AMRI mulls Hungary chemistry site's future

AMRI has begun reviewing its chemistry services operation in Hungary and says it may cut jobs and shift work to other facilities.

News in brief

Bioligands bought by investors and UK's Bridge BioResearch

Preclinical molecular biology services firm BioLigands has changed ownership.

09-Jan-2012

Icon says it will be Shire's sole central labs provider and share clinical dev work with PRA

Ireland-based CRO Icon will do all of Shire’s central laboratory work under a new strategic alliance announced today.

People on the move

Outsourcing-Pharma presents its weekly round-up of the latest appointments within the pharmaceutical industry, including news from Mylan, Aegate, and Intralinks.

News in brief

EU preclinical CROs partner on profiling & discovery services

European CROs Dualsystems Biotech and NiKem Research have partnered to offer drug profiling and discovery services.

AMRI to streamline US workforce and mothball R&D lab

Albany Molecular Research (AMRI) says ‘streamlining’ plan will focus on its drug licensing unit not its contract API research, development and manufacturing services division.

Toray takes stake in Japanese CMO to boost life sciences biz

Toray Industries has acquired a stake in a Japanese CMO and ingredient supplier as part of its push into life sciences.

05-Jan-2012

ACRO concerned about ethics committees' SAE role under draft Indian rules

ACRO says latest draft rules on trials in India – which would see ethics committees take sole responsibility for determining SAE cause and compensation - are a backwards step that would make high quality research impossible.

ValiRx expands into services with biomarker business buy

UK-based biotech ValiRx has acquired a biomarkers business from Finnish preclinical CRO Pharmatest Services.

Biopharm ink New Year service deals in drive to enter clinic

Biopharm companies have inked a raft of contract service deals at the start of 2012 in efforts to push compounds into the clinic.

04-Jan-2012

UPDATE

New online patient recruitment unit will streamline process, says Quintiles

Quintiles says it will streamline its patient recruitment model with a new digital unit.

AAIPharma plans lab and manufacturing capacity expansion

AAIPharma Services says it will expand its contract analytics and manufacturing capacity to meet increasing customer demand.

News in brief

Marken cuts ribbon on Argentinian temperature-controlled distribution unit

Supply chain management company Marken has opened the doors to its new temperature-controlled clinical distribution depot in Argentina.

Journals aim at recruitment & data in trial transparency push

Publication of all clinical data and recruitment targets is needed to boost trial transparency, researchers claim.

FDA group calls for industry to submit draft guidance docs

The FDA should encourage industry to submit draft guidance to speed regulatory development, an agency working group found.

03-Jan-2012

ENCePP to let biopharm firms post Ph IV trial requests on private partner forum

The ENCePP (European network of centres for pharmacoepidemiology and pharmacovigilance) is seeking to facilitate better interaction with biopharm companies on post-authorisation studies.

Shasun’s Cuddalore plant operations still on hold after cyclone

Manufacturing operations at Shasun Pharma’s plant in Cuddalore, Tamil Nadu are still suspended days after Southern India was battered by a cyclonic storm.

Data standards group CDISC gains US charitable status

The clinical data interchange standards consortium (CDISC) has been designated as a charitable organisation by the US tax authorities, meaning it can now receive tax-deductible contributions from corporate donors.

02-Jan-2012

News in brief

PPS admits falsifying record for a 2007 trial of Boehringer’s ‘female viagra’

US CRO PPS Clinical Research has admitted that an employee falsified patient record during a trial of Boehringer Ingelheim’s failed ‘female Viagra,’ Flibanserin.

People on the move; outsourcing jobs

Outsourcing-Pharma presents its first round-up of the movers and shakers within the pharmaceutical industry of 2012, including news from Icon, Marken and ClinStar.

India posts draft guidance on stability data for clinical trials

India has released draft guidance on stability data needed to support approval of Phase I to III clinical trials.

Troubled CMO Ben Venue extends manufacturing shutdown

Ben Venue Laboratories will not restart manufacturing at its plant in Bedford, Ohio until later this quarter – at the earliest - after extending the voluntary suspension it implemented in November.

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