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Groups Question Overlap, Redundancy in FDA Draft Guidance on IRBs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.

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.

EC Updates Guidance to Ensure Supplier Compliance

22-Jan-2013 - The European Commission has updated its GMP guidance to notify manufacturing authorization holders (MAHs) of their legal obligation to ensure that active substances are produced in accordance with GMP.

Updated

Lonza to Evaluate BaroFold’s Protein Refolding Technology

21-Jan-2013 - Lonza has agreed to evaluate BaroFold’s high-pressure refolding technology for difficult to express microbial products expressed as inclusion bodies.

CDSCO Sets 18 Month Deadline for Efficacy, Safety Testing

21-Jan-2013 - Indian drug manufacturers have 18 months to test drugs not approved by India’s Central Drugs Standard Control Organization (CDSCO) for efficacy and safety or they will be pulled from the...

ADC Bio open to antibody drug conjugate collaborations and CMO takovers

21-Jan-2013 - ADC Biotechnology has secured funding to take its cost-cutting antibody drug conjugate (ADC) tech to market and says pharma demand will drive partnerships and maybe even attract CMO takeover bids.

update

Mitsui confirms increased Arch Pharmalabs investment; wants to build API biz

17-Jan-2013 - Mitsui & Co has upped its stake in Indian API maker Arch Pharmalabs in an effort to expand its CMO business.

Acquisation expands Argenta’s arsenal

17-Jan-2013 - Argenta says the acquisition of company Cangenix Ltd was an opportunist addition to its structure-based drug discovery service.

UK Health Committee Calls for All Clinical Trial Data to be Public

17-Jan-2013 - The UK government’s health committee is calling for all clinical trial information to be in the public domain but industry push back is expected, experts say.

EMA: Shared Manufacturing Facilities Must Calculate Contamination Risk

16-Jan-2013 - EU pharmaceutical and active substance manufacturers should determine the threshold for cross-contamination when multiple drugs are produced in shared facilities.

Almac opens new non-GMP plant and says 'send us your CV!'

16-Jan-2013 - Almac Group says high demand for potent tabs and liquids was driving forces in creation of its new $10.5 million facilities.

Variations in site recruitment performance a risk, says Tufts

16-Jan-2013 - Variation in site recruitment performance is a major risk factor for CROs and their sponsors according to new research.

News in brief

Aesica teams with more academics to optimise Cramlington plant

16-Jan-2013 - UK CMP Aesica has continued its strategy of partnering with academics with a new collaboration designed to make operations at its Cramlington plant more efficient.

update

Greece is the word: BASF tells Pronova shareholders revised bid is fair value

15-Jan-2013 - BASF says revised offer for omega-3 API maker Pronova Biopharma is fair value given recent Greek Government decision to stop reimbursing two key drugs. 

Aptuit’s global connection whizz API to market

15-Jan-2013 - Aptuit says that collaboration amongst its global facilities was a key factor in bringing Lomitapide to market.

New Guideline Lays Out Minimum Content of a Clinical Trial Protocol

15-Jan-2013 - Experts have created a new minimum content guideline addressing quality gaps seen in many trial protocols.

Wuxi JV is about building in China's late-stage sector says PRA

15-Jan-2013 - PRA wants to build its late-phase offering in China and has committed to provide staff and knowhow to Wuxi Pharmatech joint venture. 

American Capital to expand Cambridge Major Labs' API biz

15-Jan-2013 - Cambridge Major Labs’ (CML) new private-equity investor plans to expand the CMO’s chemistry and API business and assess cross selling synergies with other firms in its portfolio.

IDIFarma OKed to make commercial batches of high-potency drugs

14-Jan-2013 - IDIFarma has been cleared to make commercial batches of high potency tablets and hopes the new capability will attract developers of niche drugs and large CMOs. 

UPS’ TNT takeover bid fizzles out

14-Jan-2013 - United Parcel Service (UPS) has abandoned its bid to buy Holland-based logistics firm TNT Express after the European Commission said it would block the deal.

MHRA asks drugmakers for more data on API suppliers

14-Jan-2013 - The UK MHRA says regulators Europe-wide are asking drugmakers for additional data to identify plants that need to be inspected under new EU API import rules.

US approval for omega-3 suppliers BASF and Chemport key for Amarin in 2013

10-Jan-2013 - Winning US FDA approval for omega-3 API suppliers like BASF and Chemport is a key milestone for Amarin in 2013 according to CEO Joe Zakrzewski.

News in brief

Icon teams with EHR speclalist Cerner

10-Jan-2013 - Icon claims its collaboration with electronic Health record (EHR) specialist Cerner will help drug and device makers streamline data collection.

Public Citizen concerned about impact of 'lax' OHRP oversight on kids in trials

10-Jan-2013 - A US advocacy group says poor HHS oversight of an ongoing type-1 diabetes study could undermine rules designed to protect children in trials.

News in brief

Exela expands North Carolina facility

09-Jan-2013 - Exela Pharma Sciences will invest $8.5million in its research and manufacturing plant in North Carolina. The venture, to be spread over the next three years, will provide 38 new jobs...

Almac and TTP combine Flurescence Lifetime Technology

09-Jan-2013 - Almac says that a cost-cutting plate reader technology developed by TTP Labtech is an ideal addition to its drug discovery offering.

Lonza to boost complex manufacturing at underperforming Visp plant

09-Jan-2013 - Swiss supplier Lonza has underlined its belief that ramping up complex manufacturing is key to improving the profitability of its Visp plant.

LGC buys into bioanalytical services sector

08-Jan-2013 - LGC says entry into bioanalytical services space through the acquisition of Quotient testing division is part of a wider expansion plan.

Oncotest offer Reinnervate’s 3D cell technology to clients

08-Jan-2013 - Oncology CRO, Oncotest GmbH, will incorporate a new 3D cell culture technology into its range of preclinical assay services. 

Warburg Pincus bags CMO biz with JHP buy; eyes B+L sale

07-Jan-2013 - Private equity group Warburg Pincus has acquired sterile injectables specialist JHP Pharmaceuticals for $195m and says it has a “sizable amount” to invest in the CMO.

Questcor buys API maker Biovectra

07-Jan-2013 - API maker BioVectra has been acquired by autoimmune disease focused drugmaker Questcor Pharmaceuticals for C$50m.

Australian CRO buys in New Zealand to establish ‘regional solution’

07-Jan-2013 - Australian CRO Clinical Network Services (CNS) has positioned itself as a “truly regional solution” with the acquisition of New Zealand-based Beltas.

Synteract cites global expansion as driver for HCR takeover

07-Jan-2013 - Synteract will add trial capacity in Europe, Israel and South America through the acquisition of Munich-based Harrison Clinical Research. (HCR).

Parexel buys Liquent for $72m

03-Jan-2013 - Parexel has acquired niche regulatory information management software firm Liquent and raised its guidance for 2013.

News in brief

Illegal trials creating Havoc in India says Judge

03-Jan-2013 - Indian Judge says uncontrolled clinical trials are causing ‘havoc’ and that the Government is not doing enough to address ethical concerns.

Wuxi and PRA team in China

03-Jan-2013 - Local knowledge and global experience should be enough to see PRA and Wuxi PharmaTech buck the trend of failed China JVs, says analyst.

Mitsubishi to buy dominant HPMC capsule maker Qualicaps as gelatin shortages continue

03-Jan-2013 - Mitsubishi Chemical Holdings (MCHC) has announced plans to buy the ‘dominant’ pharma-grade HPMC capsule maker Qualicaps as the global gelatin shortage continues.