News & Analysis on Clinical Trial Services & Contract Research And Development
Cempra has asked Uquifa for API manufacturing data to support its US solithromycin efforts after raising concerns that information from Wockhardt in the current dossier will delay review.
Data integrity issues and the unexplained disappearance of drums of pharmaceutical ingredients have landed a Chinese API maker with a US FDA warning letter.
The $34m expansion at its Madison, Wisconsin site will support Phase III and commercial biologics production, says Catalent.
Smaller drugmakers are shifting away from generics and towards niche new molecules says Recipharm, which has expanded a small-scale API facility to feed demand.
The NORLUX Neuro-Oncology Laboratory has installed MR Solutions’ preclinical scanner to advance cancer research and translation to clinical applications.
Litmus Health imagines a future where all the world is “one big clinical trial,” and as the first step, it has launched its clinical data science platform into public beta.
Knudra Transgenics has licensed CRISPR-Cas9 genome editing patents from ERS Genomics to turn model organisms into ‘powerful platforms for discovery,’ says CSO.
Lonza has opened a drug quality testing and formulation laboratory in Basel, Switzerland.