The US FDA has revoked approval for Sun Pharmaceutical Industries’ extended-release epilepsy drug Elepsia XR over concerns the firm's manufacturing plant in Halol, India does not meet quality standards.
GSK will create 300 new production jobs in France despite R&D pull out
Increasing QbD needs and a range of technical service centres have driven up the prices of Evonik’s drug delivery excipient portfolio, the company says.
Mayne Pharma has started adding contract manufacturing capacity at its site in North Carolina in an project that will also see it consolidate US distribution operations.
Lonza has published a guide to clinical-grade induced pluripotent stem cell (IPSC) manufacture, addressing concerns around the derivation of cellular materials.
Cobra Biologics, a Swedish contract development and manufacturing organisation, has launched a project to improve scale-up of biologics with the University of Manchester, UK.
Full spectrum CROs are well-positioned to service the growing demand for late-stage observational trials driven by regulatory and patient pressure, says Quintiles.
Hangzhou CMO Ausia BioTech has partnered with New Mexico-based PaizaBio to market its manufacturing services to Western drugmakers interested in the Chinese sterile injectables market.
Drugmakers need more certainty and reliabilty around their supply chain in light of increased regulatory vigilance says Mylan, itself carrying out remediation across several Indian facilities.
Standard & Poor has assigned a ‘stable’ rating to Greatbatch after the contract manufacturer secured $1.5bn to buy fellow medical devicemaker Lake Region Medical.
Novo Nordisk building its first manufacturing facility in Middle-East
Venn Life Sciences has bid €6.5m ($7.2m) for preclinical CRO Kinesis Pharma BV in a move prompted by increased Big Pharma focus of efficient early phase drug discovery.
South African Police shut down three counterfeit drug making plants last weekend in an INTERPOL-co-ordinated operation that seized 150 tonnes of fake medicines.
A Massachusetts-based police department has published contact and salary details of Big Pharma CEOs in an effort to force industry to help manage opiate addiction.
Aid agencies providing relief to refugees across Europe say drug firms should give financial support or make products more affordable rather than donate pharmaceuticals.
More evidence of sponsor demand for direct-to-patient (DTP) services with Marken announcing an expansion of its deal with GlobalCare Clinical Trials just a week after rival Almac launched its to-the-door study drug delivery offering in Europe.
A Japanese company has filed the first US FDA application for a drug with an embedded sensor which can tell doctors if patients have taken their pills.
Illegal internet pharmacies and a desire for cheaper meds mean fake drugs are a problem even in smaller pharmaceutical markets say Estonian regulators.
Danish biotech Bavarian Nordic has signed a $9m contract from Johnson & Johnson to improve stability of their joint Ebola vaccine. After options and milestone awards, payment could total $33m.
