News & Analysis on Clinical Trial Services & Contract Research And Development
The European Commission (EC) can order the withdrawal of medicines that are not produced in accordance with GMP without having to prove they pose a specific health risk after a ruling in the EU Court of Justice.
Vials of two Roche biologics have been stolen and distributed illegally from Italy, say authorities.
The US Food and Drug Administration (FDA) has launched openFDA, a programme allowing web developers and researchers to access “massive” datasets on adverse effects and to use them to build their own applications.
The advocacy campaign to raise awareness about falsified and fake drugs has added 11 new partners to its cause, including US-based GPhA (Generic Pharmaceutical Association).
Supply chain security consortium Rx-360 has shifted its focus to China where it is forming a working group to further ensure compliance in a country that has had some difficulties with spurious drugs in the past.
When it comes to pharma acquisitions size does matter, according to analyst Ross Muken who says the momentary lapse in megamergers means business as usual for CROs.
Lonza has invested in single-use technology at its Swiss clinical manufacturing facility citing a rise in demand as customer’s grow their antibody-drug conjugate (ADC) pipelines.