News & Analysis on Clinical Trial Services & Contract Research And Development
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Regulations governing the production of vaccines in China have been praised by WHO director general Margaret Chan following an assessment of the CFDA's oversight of the sector conducted last October.
The complex nature of biopharmaceuticals dictates the choice of contract manufacturer when compared with selecting a partner for small molecule drugs, according to a life sciences consultant.
Janssen Pharmaceuticals is prepared for Tramadol's reclassification by the US Drug Enforcement Administration (DEA) and says the supply of its versions of the opioid analgesic will not be interrupted.
Cited with data quality issues, Italian API manufacturer Trifarma has until July 24 to respond to a litany of requests from the US FDA.
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CRO Theorem Clinical Research and Excel Life Sciences have formed a strategic relationship to bolster Theorem’s clinical development offerings in India just as regulations begin to shift on the subcontinent.
UK-based CRO Chiltern has agreed to acquire Ockham, a North Carolina-based full-service CRO, and the combined company will now compete with mid-sized CROs. Financial terms of the acquisition were not announced.
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Hovione has teamed up with delivery tech developer Merrion Pharmaceuticals to provide developers of BCS class III and IV drugs with more solubility enhancement options.