Fred Hutchinson Cancer Research Center will use Origin Sciences’ novel mucosal sampling device, OriCol, for sample collection as part of a Phase I HIV study.
The US Justice Department has announced Charles River Laboratories International Inc. will pay the US government $1.8m to settle claims that it violated the False Claims Act.
The US FDA has criticised Badrivishal Chemicals & Pharmaceuticals for failing to document production and monitor the efficacy of water purification systems at its API plant in Maharashtra.
Heptares Therapeutics has entered into a drug discovery and licensing agreement with Daiichi Sankyo – providing further validation of the company’s structure-based drug design approach, says CEO.
Celerion has implemented Verified Clinical Trials’ (VCT) biometric fingerprint technology to address “significant amount” of participants dual enrolling at Ph I units.
DSM Sinochem Pharmaceuticals has licensed enzyme-based antibiotic production IP to Sandoz and accused Sinopharm Weiqida Pharmaceutical of patent infringement.
Cytel Inc. has established a dedicated quantitative pharmacology and pharmacometrics team to meet an increasing demand for model-informed drug development from biopharma clients.
Last week, President Donald Trump announced Scott Gottlieb as his nomination for the new US FDA commissioner – a candidate that ACRO says, “understands the complexities of drug development.”
Siegfried saw higher sales in 2016 thanks to the API business it bought from BASF and opening of new plant in China, but profits fell on integration costs and higher taxes.
Charles River Laboratories has extended its integrated respiratory program with Chiesi Farmaceutici, through which it identifies and tests candidates for preclinical development.
The Danish Medicines Agency (DKMA) has cleared Europharma DK ApS to resume drug sales and distribution after the firm appointed a new managing director.
SRI International will advance compounds with the potential to treat persons exposed to biological, radiation, nuclear, and chemical agents – in a deal worth up to $90m.
PCI Pharma Services has tripled its serialization capacity ahead of US DSCSA and EU FMD deadlines with follow-on investments planned to finalize its serialization infrastructure.
The US FDA has told Scynexis not to start trials of an injectable formulation of its candidate antifungal Scy-078 after several volunteers developed blood clots during a Phase I study.
Certara has developed a new licensing approach, which provides smaller organizations access to its physiologically-based pharmacokinetic (PBPK) modeling and simulation platform.
SGS has signed a partnership agreement under which it will operate a dedicated clinical pharmacology unit for conducting Ph I inpatient clinical trials in Budapest, Hungary.
NovAliX has signed an insourcing agreement with UCB Biopharma, a model that the CRO says “energizes scientific organization” and offers "significant" cost advantages.
Nicox S.A. has resubmitted AC-170, its conjunctivitis associated itching drug candidate, for US FDA review after its API supplier resolved the problems that saw the agency reject the New Drug Application (NDA) last year.
A second Megafine Pharma plant has landed a US FDA warning letter for cGMP violations, including sourcing API intermediate materials from a facility on import alert.
In the absence of a CRO, the 200 patient NeoART study is relying on the UK NHS, crowdfunding and charity to trial an antimalarial generic for late stage bowel cancer.
The Health Products Regulatory Authority of Ireland (HPRA) has said it did not recommend renewal of the GMP certificate for Wockhardt’s site in Shendra, Aurangabad.
Cerveau has signed a research agreement through which it will supply its early-stage imaging agent to assess the stages of Alzheimer’s disease and other neurodegenerative diseases.
High turnover rates among clinical research associates (CRA) continue to plague the industry – and competence and staff engagement are the "crux" of the issue, says IAOCR.
The US FDA has told Wockhardt its quality issues are company-wide, citing problems at subsidiary Morton Grove as an example in a warning letter published today.
Richmond Pharmacology has opened up a third Phase I research centre in London Bridge, taking over the former Drug Research Unit at Guy’s teaching Hospital.
Former J&J controlled substance API unit Noramco is to rejig its business to cater for branded and generic drug firms and companies looking for formulation tech solutions.
The US FDA has cleared Seattle Genetics to restart trials of its blood cancer candidate vadastuximab talirine that were halted last year after patient deaths.
The CRO market in Asia has “massive implications” as it continues to emerge as a preferred destination for clinical trials – a global market expected to reach $57bn by 2020.