French authorities are investigating if a packaging mix-up at generics giant Teva Pharmaceutical Industries played a role in the death of a man in Marseilles last week.
Boehringer Ingelheim will build a biomanufacturing facility in Shanghai in a strategic alliance designed to cater for Pharmas nervous about setting up plants in China.
Japan has become the third country outside the EU to be exempt from providing written confirmation that APIs imported into Europe have met required standards when legislation commences on July 2nd.
Three private equity firms could be ready to bid for PRA International, following indications that the US CRO would take Quintiles' lead and go public.
Early clinical research organisation Celerion has added a containment room to its UK facility in response to client demand for live biologics and vaccine studies.
Impax Laboratories says it remains committed to resolving manufacturing issues at its troubled Californian plant though 110 jobs will go as production continues to be transferred to Taiwan.
Janssen has recalled 179 batches of an oral contraceptive after problems with the release of the active pharmaceutical ingredient (API) were discovered.
The state of Indiana has unveiled a new industry-led Biosciences Research Institute though it is unclear how companies will divide intellectual property and product patents.
As sponsors recognize the value of adaptive clinical trial designs and regulators come on board, CROs are beginning to shift their priorities to be more flexible.
Hepregen has agreed to provide US CRO QPS Holdings with long-term liver cell models to aid its offerings in drug metabolism and pharmacokinetic (DMPK) services.
The Commissioner of the FDA says laboratory-developed diagnostic tests needs to be regulated for clinical validity to stop erroneous results and ensure patient and clinician confidence.
As propofol comes off its shortages list, the FDA says manufacturing problems still cause the majority of supply issues though legislation has helped to alleviate this.
The ever-expanding market in China has plenty of room for 3rd party pharmaceutical distribution and logistics companies says UPS as it opens a new facility in Zhejiang Province.
The US House of Representatives has passed a bill by voice vote that would for the first time create a system to track and trace drugs through the supply chain.
The EU will become more competitive thanks to new clinical trial regulations that include data transparency, says rapporteur Glenis Willmott MEP, though industry is opposed.
Reducing cycle times and leveraging CRO expertise will drive sponsors’ decisions in choosing partners as they look to reduce costs and oversight obligations, according to a new report.
USP has decided to delay the implementation of two general chapters on elemental impurities until ICH has further established its own impurity testing requirements.
The US FDA is allowing Fresenius Kabi USA to import trace elements and phosphate injections from its Norway plant to help improve a critical shortage of components of total parenteral nutrition (TPN).
As Cobra wins a cell line development contract with Recopharma, the firm says its cost-effective gene expression technology has been its biggest growth area.
Although written quality agreements are not required under cGMP regulations, the US FDA is recommending that pharma companies and CMOs adopt the agreements to delineate responsibilities.
Scientists at the UK University have developed what they refer to as 'a simple lab-based skin test' which eliminates the risk of adverse reactions to new drugs, cosmetics, and household chemicals.
Clean air solutions firm Camfil has opened a new £2.4m ($3.6m) facility in the UK offering customers better support and faster delivery times in Europe.
Fresenius Kabi says drug shortages won’t be affected as it recalls a lot of magnesium sulphate, and there’s news from Glenmark and J&J – welcome to in-Pharmatechnologist.com's recall round-up.
Pharmaniaga Berhad has set up a joint venture to manufacture pharmaceuticals in Saudi Arabia citing opportunity growth in the region as a major catalyst.
As new API regulations are set in July for those outside the EU, the European Medicines Agency (EMA) has unveiled what its inspectors expect to see from API manufacturer or supplier audit reports from inside the region.
Ranbaxy Laboratories is putting all of its weight behind a quality push following its admission of manufacturing adulterated drugs, and just as its parent company Daiichi Sankyo is pursuing legal action.
Pharma and CRO executives have said that CROs could do more to be proactive in their partnerships, though some CRO executives believe that can be difficult because of the varying nature of their clients.
Pfizer and other EU industry and academic groups are calling on the European Commission to revise its plans for authorizing and regulating ATMPs (advanced therapy medical products).
