Pfizer has attributed a 12% operational decline from its sterile injectable products on “capacity constraints and technical issues” stemming from former Hospira facilities.
The US FDA says the recognition of facility inspections from eight European regulatory authorities is an “unprecedented and significant step forward” in the transatlantic Mutual Recognition Agreement.
A proposed regulation in New Jersey demonstrates a lack of understanding regarding the clinical trial process and has clear collateral damage to research conduct in the state, ACRO testifies.
Horizon Discovery and The Michael J. Fox Foundation have introduced two new preclinical models for Parkinson’s Disease research – including a first-of-its-kind model that will help researchers understand the biology behind a mutation linked to the disease.
Charles River is extending its preclinical services through a partnership with InSphero AG – “further affirmation” of its commitment to the in vitro oncology space, says executive director.