CRO consolidation has left market opportunities for providers who serve mid-size pharma, UK-based private equity firm Cinven says as it acquires Medpace.
Fraudsters who try to extort money by impersonating regulators are an ongoing problem, the US FDA says, after the Gujarat FDCA warns drugmakers about a new scam.
A longer than expected upgrade to one of its injectable plants has caused Pfizer to announce that there is a shortage of methylprednisolone sodium succinate injections.
Ben Venue Laboratories, a Boehringer Ingelheim subsidiary that was recently closed after a spate of quality problems, issued a US-wide voluntary recall for its Acetylcysteine Solution 10% at the patient level.
The European Commission (EC) has increased the pressure on Ireland, Italy, Poland and Slovenia to fall into line with other EU member States and introduce anti-drug counterfeiting legislation.
As Commisioner Margaret Hamburg flies back from an eight day tour of India, the US Food and Drug Administration (FDA) says it is recruiting seven new drug investigators in the country.
Mid-tier pharma mergers and a shift to more complex trials will benefit broad-based CROs, whilst smaller outsourcing partners will be forced to consolidate, an industry report by Citi Research predicts.
CMO Cytovance Biologics has entered into a manufacturing agreement with Pamlico Biopharma to develop a group of three human IgG monoclonal antibodies intended for the treatment of Streptococcus pneumoniae infections.
Debate rages over the significance of safety data from a trial of Oramed’s oral insulin pill, but the firm is still confident in its delivery technology.
WCCT Global has launched a patient recruitment platform it says speeds up recruitment time and can cut sponsor costs with a more targeted advertising campaign.
DaVita Clinical Research has formed a pact with Pyxant Labs where Pyxant will provide bioanalytical laboratory services for DCR's early-phase clinical trials.
AMRI says it intends to expand its API business to target both generics and more complex molecules after reporting record full year revenue from contract services.
A new study published in the Institute of Physics Science reveals that Chinese researchers have developed gold nanoparticles that may help deliver cancer treatments to specifically targeted cells.
A US attorney who worked with Pfizer, Lilly and Merck to jail drug counterfeiters says cutting off criminal access to active pharmaceutical ingredients (APIs) is key.
The US FDA has upgraded Hospira’s troubled Rocky Mount, North Carolina plant to VAI (voluntary action indicated) status though its 2010 Warning Letter still stands.
MPI Research, inviCRO and 3D Imaging have partnered to build a Translational Imaging Center, providing molecular imaging, autoradiography, and animal modelling for pharmaceutical clients to investigate drug candidates.
It is too early to predict what impact proposed changes to US rules on chemical plant security and anti-terrorism measures would have on the drug industry according to PhRMA.
Charles River Laboratories says it will shutter a Research Models and Services (RMS) facility in Michigan as softened demand for the sector offset a strong year for its preclinical service business.
Cobra says it will no longer need to rely on third-parties for its biologics quality control tests after receiving an extension to its GMP certification at a Swedish facility.
Theorem Clinical Research has announced the formation of a strategic alliance with Decision Driver Analytics (DDA) to integrate health economics and outcomes research, predictive modeling and definitive analysis to maximize return on investment for pharmaceutical...
In an exclusive Q&A, new ACRO Chairman Ciaran Murray says conducting trials in countries such as China and India is critically important for speeding up drug development.
NSF International has acquired the auditing subsidiary of the International Pharmaceutical Excipients Council of the Americas (IPEC) as part of a way to ensure a more streamlined supplier qualification process.
European drug manufacturers will have to control the critical aspects of their operations through qualification and validation over the lifecycle of the product and process, according to a new draft GMP guideline from the European Commission.
The team behind the scheme that helped BASF, Seppic and Merck KGaA reduce their audit burdens expect more excipient suppliers to seek certification as an independent association.
The National Institutes of Health and 10 pharmaceutical companies have launched a partnership to transform the current model for identifying and validating promising biological targets for Type 2 diabetes, Alzheimer’s disease, lupus and rheumatoid arthritis.
Perrigo Company has reported a 40% drop in contract manufacturing revenue year-on-year due to a key client, assumed by analysts to be J&J, returning to OTC in-house production.
In an exclusive interview, Parexel’s president told Outsourcing-Pharma.com small pharma is increasing demand for CROs, commercialisation services are growing, and strategic partnerships are changing.
Indian health minister Sh Ghulam Nabi Azad has defended the quality of the country’s drug exports, telling visiting US FDA Commissioner Margaret Hamburg that “affordable” does not mean cheap and spurious.
Pfizer says its ‘off the shelf’ aseptic processing capacity is shifting the paradigm of pharma manufacturing, with emerging markets and personalised medicine driving the change.
