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Volunteer drug users: the highs and lows of addiction trials

A positive cannabis test could be OK for trial participation (Picture credit: Ashton/Flickr)

CROs must design their abuse liability studies to cope with volunteers who arrive under the influence or give misleading patient histories, says a specialist consultancy.

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People on the Move

People on the Move

Regulatory experts dominate this week's column on who's who in pharmaceutical outsourcing.

Patheon has acquired Gallus BioPharmaceuticals adding two US biologics plants and says with an industry shift towards medium sized bioreactors it now holds the market advantage.

Patheon has received approval from the DEA to bulk manufacture the schedule I product Gamma Hydroxybutyric Acid (GHB) from its facility in Cincinnati, Ohio.

Parallel deals to invest in Isofol Medical and manufacture the alternative chemotherapy agent Modufolin on its behalf are evidence of Recipharm’s ambitious growth strategy, the CDMO says.

Global Industry News

Argentina to allow Indian drug imports after inspecting five plants from

Argentina decided to allow Indian drug imports after inspecting just five of the country's 793 manufacturing facilities according to documents released this week.

EFPIA, EGA take issue with EMA’s guidance on stability data for APIs from

EFPIA (European Federation of Pharmaceutical Industries and Associations) and EGA (European Generics Association) have released comments suggesting specific changes to the EMA’s draft guidance on stability data for manufacturing changes.

Ampio shares tumble as albumin-derived trial drug suffers case of the chills from

Ampio Biopharmaceuticals will delay the release of Ampion trial data after discovering the drug was damaged by temperature fluctuations during shipment.


GE Healthcare: plans to move New Jersey ops to new Massachusetts HQ from

GE Healthcare has said it plans to relocate operations in New Jersey to its new Massachusetts life sciences headquarters.

Vast majority of ADC manufacturing outsourced, report finds from

Between 70-80% of ADC (antibody drug conjugate) manufacturing is performed by CMOs, according to a new report .

GSK welcomes US OK for Arnuity in light of declining Advair sales from

US FDA approval of the inhaled corticosteroid (ICS) asthma drug Arnuity will help offset declining sales of the off-patent bestseller Advair, says GlaxoSmithKline.

Ben Venue site has no place in injectables network, says new owner Hikma from

Ben Venue Laboratories will remain inactive says new owner Hikma as it looks to optimise its injectables manufacturing network.


Evotec confirms orphan drug development status with Shire contract

Evotec teams with Shire on Fabry's disease as pharma interest in orphans grows

Evotec has partnered with Shire to develop inhibitors against Fabry’s disease and says such collaborations will grow...

CRL nears 85% capacity use, but says sector pricing won't improve yet

CRL nears 85% capacity use, but says sector pricing won't improve yet

Charles River Laboratories is approaching its optimal capacity utilisation but says pricing will not improve until the...

CMO issues persist as Cubist announces third recall for antibiotic

CMO issues persist as Cubist announces third recall for potential glass in antibiotic

For the third time since last August, Cubist Pharmaceuticals has recalled lots of its antibiotic Cubicin injection...

AMRI: Big Pharma still reliant on CMOs for sterile injectables

Injectables outsourcing growing despite pharma M&A, says AMRI

Big Pharma is still reliant on CMOs despite talk of returning in-house, says AMRI, which has launched...

Quintiles sees strong demand from large pharma

Quintiles sees strong demand from large pharma

Quintiles CEO Tom Pike told investors last week that the company is seeing “very strong demand from...

Almac announces Government backed recruitment drive

Almac announces Government backed recruitment drive

Northern Ireland-based contractor Almac will create 348 jobs over the next five years in its pharma and...