Janssen aims to expand the label of delivery in the US and EU for its product, Darzalex, to include subcutaneous delivery through the use of Halozyme’s technology.
Astellas agrees a deal for the ex-US rights of Frequency’s lead drug candidate, FX-322, after the latter company posted positive results in a Phase I/II trial.
Despite positive movement on the number of women serving on executive committees since 2018, the industry has seen a significant drop in positions governing profit and loss.
In a warning letter, the US FDA details how its inspectors discovered cGMP document awaiting shredding and records discarded in a 55-gallon drum at Strides’ facility.
Indoco confirms receipt of a warning letter from the US FDA and the agency posts details of a Form 483 for two different facilities in the space of one week.
The two regulatory agencies have confirmed the addition of the last country to their mutual recognition agreement, with GMP inspections by Slovakia given a positive assessment.
The US FDA published another warning letter sent to Akorn, which details cases of improper investigation into faulty batches, failure to exercise controls over data, and ‘poor aseptic behaviour’.
