Pharma service provider inVentiv Health has acquired Catalina Health and is merging it with its subsidiary Adheris to create the largest direct-to-patient adherence program in the US.
Sponsor network developer DrugDev on Monday announced it would acquire CFS Clinical, which specializes in managing the financing of clinical trials. Financial terms were not disclosed.
In calling an unregistered product ‘fake,’ the Ghanaian FDA has sparked a media war with industry, but are critics using this as an excuse to knock the regulators whilst importers gain undeserved sympathy? in-Pharmatechnologist’s Dan Stanton believes...
Lab service provider LabCorp said Friday its third quarter net income was nearly the same as the identical quarter in 2012 because one-time restructuring and other costs offset a slight increase in revenue.
The US Food and Drug Administration (FDA) will soon run out of funding for the limited amount of medical product regulatory work it has carried out during the Government shutdown according to an agency spokesman.
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has withdrawn its good manufacturing practice certificate for Wockhardt’s Chikalthana, India-based plant due to cGMP violations.
The Ghanaian FDA has defended its decision to ban all imports from India' Bliss GVS amid growing industry concerns about the speed of the agency's decision making.
Furloughed US FDA staff will face a huge backlog of manufacturing plant inspections when the Government shutdown eventually ends, according to an influential healthcare advocacy group.
The US FDA has updated its list of activities during the Government shutdown and says it is unable to accept new fee-based regulatory submissions until the shutdown is over.
In a move that could be a sign of a changing tide in India, the Ministry of Health and Family Welfare said the government will invest almost $3bn (€2.2bn) to add hundreds of new inspectors for drug manufacturers and other oversight initiatives that could...
Bliss GVS says allegations of supplying fake medicines and a blanket ban imposed on its products by the Food and Drugs Authority Ghana (FDA) are both “harsh” and “baffling.”
Merck, Novartis, GlaxoSmithKline, Celgene and industry groups are taking issue with recent FDA draft guidance on how manufacturers can reject or limit agency inspectors.
A new range of culture media dishes cut contamination risk during analysis of facility microbiological QC samples says developer Sartorius Stedim Biotech (SSB).
United Drug has rebranded its contract pharmaceutical packaging business and unveiled plans to build in Asia in a move it says provides “global opportunities” for employees.
Marken on Wednesday announced its pharma depot network is expanding to Russia to meet the growing needs of clients looking to store materials for clinical trials there and in Eastern Europe.
India’s Supreme Court has called for all of the data supporting the approval of 162 clinical trials between July and August of this year by the Drug Controller General of India.
Sartorius Stedim Biotech (SSB) has launched a new range of culture media dishes designed cut the risk of contamination during lab analysis of facility microbiological QC samples.
Interest in the US biosimilars market is still growing despite Big Pharma delaying tactics and continuing regulatory uncertainty according testing services CRO, BioOutsource.
Continued manufacturing problems at CMO Ben Venue Laboratories will cause an interruption of supplies of the cancer treatment Doxil in mid-to-late October, Janssen said.
The US House on Saturday passed legislation that calls for the tracking and tracing of pharmaceuticals through the nation's supply chain after agreeing on the bill with the Senate last week.
In the wake of recent bribery scandals, Boehringer Ingelheim (B-I) has called for stricter regulations in China, as it plans to triple production at its Shanghai manufacturing site.
After nearly 50 years in use, UK’s MHRA is now looking into whether it should update and replace its system for reporting drug side effects to increase incident reporting and decrease confusion.
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.
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.
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.
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.
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.
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.
