West has begun production at its second manufacturing facility in China, driven by the growing market for pharma injectable components in the Asia pacific region.
Quintiles is looking into a new way of using biomarkers to speed the process of selecting patients for trials and new treatments, Quintiles Chief Medical and Scientific Officer Dr. Jeff Spaeder told us.
The use of "flaking" and non-sterile gloves in aseptic processing, as well as cGMP violations, has led to the the US FDA issuing a warning letter to Agila for its Bangalore, India plant.
Pharma Technology Inc. (PTI) says its new deduster offers tablet manufacturers more flexibility with greater residual powder being removed due to its polymer spiral.
Molecular Profiles has been chosen to develop topical and solid dose formulations of a preclinical psoriasis treatment as part of a multicompany conglomerate led by Telormedix.
A federal judge in the Southern District of Ohio has approved a US FDA consent decree against Shamrock Medical Solutions for drug manufacturing and labeling violations.
The panic behind the patent cliff for big pharma is now hitting generic companies, which are increasingly turning to service providers and consultants to help find solutions for holes in their pipelines.
Pfizer, GlaxoSmithKline, Sanofi, and at least ten other big pharma companies, CMOs and industry groups are criticizing aspects of the recent FDA draft guidance governing quality agreements.
Catalent Pharma Solutions has been named as the supplier of delayed-release technology for an epilepsy treatment launched by Supernus Pharmaceuticals in the US this month.
US authorities are holding more excipient imports at ports according to industry group IPEC Americas, which said that the increase has already halted the production of at least one drug.
US scientists have claimed that ‘bacterial autopsies’ could accelerate the discovery of new antibiotics in an announcement made just days after the US CDC warned of a potential “post-antibiotic era” and called for renewed development efforts.
The California Board of Pharmacy is proposing to amend the state pharmaceutical track-and-trace legislation to exempt wholesalers from e-pedigree requirements in cases where manufacturers directly ship drugs to pharmacies.
The US FDA has finalized guidance on electronic case report forms (eCRFs), which offers advice for sponsors and CROs on how and in what cases to capture electronic source data.
CRO sales representatives do a good job of explaining the basics of their service offerings but they need to be more innovative in tackling sponsors’ individual challenges, according to a new survey.
CRO Harlan Laboratories, has expanded its specialty research production facility in southern Europe to provide its complete portfolio of contract breeding and health monitoring services to clients in Europe.
German CRO Evotec and the Harvard Stem Cell Institute have partnered to discover compounds that might prevent or slow ALS (amyotrophic lateral sclerosis) and other motor-neuron diseases.
After more than a year delay, IPEC India is expected to be created by the end of the year after IPEC-Americas’ vice chair confirmed that the registration process is moving forward.
CRO inVentiv on Monday announced a joint venture with the partners of the US lobbying firm Mehlman Vogel Castagnetti to help pharma companies further understand the health policy and regulatory landscape.
The EMA has announced plans to change how it reviews drugs and inspects production facilities by 2014 as part of a wide ranging restructuring programme.
After finding cGMP violations at another Ranbaxy plant in India, the US FDA on Monday issued an import alert that effectively stops all of the plant’s drug shipments from entering the US.
Soon sponsors and CROs seeking ethical approval for clinical trials in the UK will have to register them in a public database under the HRA's transparency plan.
Aurobindo Pharma has given more details of a planned expansion of its API and antibiotics businesses and has confirmed its intention to rejig its injectables operations.
Johnson & Johnson is battling another onset of quality concerns as its subsidiary Janssen is pulling one lot of its Risperdal Consta injection in the US due to a mold contamination.
Cargill says interest from the pharma industry for its seaweed-derived excipient is growing as it invests $15m (€11.3m) into its French alginate production plant.
Regulators in Southeast Asia say draft process validation guidelines issued for consultation last week are a work in progress and likely to change as discussions continue.
In a first for CROs, INC Research has implemented an international accreditation program for its clinical research associates to further understand trial monitoring and ensure consistency for biopharma sponsors.
India’s top drug regulator on Wednesday unveiled a list of all the pending clinical trials before its apex committee, which includes information on what the top CROs are working on in the subcontinent.
