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Headlines > January 2013

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People on the move: Outsourcing jobs

31-Jan-2013 - Outsourcing-Pharma.com presents its latest round-up of the movers and shakers in the pharma service industry, including news from Novella, Pantheon and Synteract.

Cytovance ups biologics capacity as small pharma demand rises

31-Jan-2013 - Cytovance Biologics says an increase in demand from small pharma was the driving force in expanding its biologics capacity.

Lonza hints at manufacturing cuts

31-Jan-2013 - Lonza says it will “move from a product-oriented to a market-oriented organisation” suggesting a restructuring of its manufacturing division is on the cards.

Parexel Exceeds Expectations in Q2, Analysts Skeptical About Future

31-Jan-2013 - Parexel may have raised its forecast for fiscal 2013 after reporting a 26% hike in second quarter revenues this week, but analysts still have concerns about its spending.

JLL bids $123m for Bioclinica and plans imaging bolt-on

31-Jan-2013 - Bioclinica has agreed to a takeover by JLL Partners in a deal that would see the eClinical provider merge with medical imaging firm CoreLab Partners.

Scinopharm starts developing own drugs with eye on API customers

30-Jan-2013 - Taiwanese API maker Scinopharm has taken a first step towards developing its own drug portfolio in partnership with delivery tech firm Foresee Pharmaceuticals.

Lonza to take viral immunotherapy to market

30-Jan-2013 - Lonza has ramped up US viral immunotherapy production capacity citing expanding regenerative medicine market as the key driver.

Groups Question Overlap, Redundancy in FDA Draft Guidance on IRBs

30-Jan-2013 - The Association of Clinical Research Organizations (ACRO) and others are cautioning the FDA against issuing guidance that could muddle or duplicate the responsibilities of institutional review boards (IRBs) and trial...

FDA Adopts 'Practical' ICH Q&A to Clarify Clinical Study Reports

30-Jan-2013 - The US Food and Drug Administration (FDA) has adopted a practical Q&A  from the International Conference on Harmonisation (ICH) to help sponsors and CROs craft clinical study reports (CSRs), an expert...

GenScript plays piper bringing transgenic rats to Asia

29-Jan-2013 - GenScript says the chance to expand into Asia is the drive for taking its drug delivery platform out on the road.

GSK Forms Joint Venture in India to Develop New Pediatric Vaccine

29-Jan-2013 - As vaccine production in India has hit manufacturing roadblocks over the past few years, GlaxoSmithKline (GSK) has signed a joint venture to begin development of a six-in-one pediatric vaccine.

Quintiles and TPG tight-lipped on latest IPO rumours

29-Jan-2013 - Quintiles and investor TPG Capital declined to comment on rumours the CRO is sizing up banks and preparing for an IPO.

update

US asks for exemption from EU API import laws

28-Jan-2013 - The US wants exemption from new European Union import rules for active pharmaceutical ingredients (APIs) and says such status would cut manufacturers' admin and help prevent drug shortages.

AmerisourceBergen eyes foreign lands after Q1 results

28-Jan-2013 - AmerisourceBergen has announced upbeat Q1 results as contributions from Consulting Services and World Courier offsets ongoing cost issues in Drug Distribution.

Covance Remains Upbeat on Future as Q4 Exceeds Expectations

28-Jan-2013 - Covance management sounded relatively upbeat about its expectations for 2013 as late-stage clinical trials continue to grow and IT spending begins to taper off, company officials said on Friday.

India's Top Court Takes Control as Trial Regulations in Flux

24-Jan-2013 - Despite conflicting media reports and confusion over where India stands in its regulation of clinical trials, Indian drug officials have until the end of January to respond to a Supreme...

People on the move: Outsourcing jobs

24-Jan-2013 - Outsourcing-Pharma.com presents its latest round-up of the movers and shakers in the world of pharmaceuticals, including news from Parexel, AmerisourceBergen and Norwich Pharmaceuticals.

Software Offers Sponsors, CROs Improvements to On-Site Monitoring

24-Jan-2013 - Following the release of FDA and EMA guidance in 2011 calling for CROs and trial sponsors to take a more risk-based approach to monitoring trials, companies have begun offering products...

Janssen says 'alternative manufacturing' will restore doxil supplies; Ben Venue gets consent decree

24-Jan-2013 - Janssen says an alternative manufacturing approach will restore Doxil supplies, days after Ben Venue Laboratories’ (BVL) entered into consent decree with FDA.

Synthon Unveils ADC Facility as Data Show Promise for First Candidate

24-Jan-2013 - Following a wave of recent investment in ADC production, Synthon has opened an ADC manufacturing facility in Nijmegen, Netherlands, to help bring its first preclinical ADC program to clinical trials...

GSK Shifts Supplier Invoice Payment Timing, Business Forum Cries Foul

23-Jan-2013 - GlaxoSmithKline has decided to only make once-monthly payments to suppliers, which could increase the amount of time it takes a CRO, CMO or other supplier to be paid for its...

Covance collaboration with NHS on phase I trials

23-Jan-2013 - Covance says its agreement with the Royal Liverpool and Broadgreen University Hospitals NHS Trust will improve drug development and bring drugs to market sooner.

UK Cell Therapy Trial Database to Help Advance Trials to Later Stages

23-Jan-2013 - The UK's cell therapy industry now has a database of all ongoing clinical trials in the country with the aim of expanding research partnerships and pushing more early-stage trials to...

update

SFDA yet to publish excipient list as implementation date for GMP nears

22-Jan-2013 - Chinese regulators have just 11 days left to define which excipients must be licensed or require DMFs under new quality regulations due to be introduced next month.

KTP adds string to Almac’s biocatalysis bow

22-Jan-2013 - Almac says the completion of a Knowledge Transfer Partnership (KTP) has aided biocatalysis development offering clients an array of streamlined processes.

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