Clavis Pharma ASA has announced a delay in the start of a Phase 3 study of its new treatment for acute myeloid leukaemia (AML). Separately, the Norwegian oncology company said it has raised NOK 163 in a private share placement with investors.
Just six months after approving Adcetris (brentuximab vedotin), the US Food and Drug Administration has announced that the developer, Seattle Genetics Inc, will be tightening the drug’s label to warn against the rare PML brain infection.
After regaining rights to the broad-spectrum antibiotic, ceftobiprole, Basilea Pharmaceutica Ltd has announced plans to file a European marketing authorisation application in the second half. Talks with the FDA are ongoing about a US filing.
The US Food and Drug Administration has issued an order prohibiting the off-label use of cephalosporin antibiotics in food-producing animals in response to concerns about the continuing effectiveness of these drugs in humans.
The US Food and Drug Administration has approved Prevnar 13, a pneumococcal 13-valent conjugate vaccine, for people 50 years and older to prevent pneumonia and invasive disease caused by the bacterium, Streptococcus pneumoniae.
The European Medicines Agency has announced the start of a safety review of aliskiren-containing medicines following a decision by Novartis, the developer, to stop a Phase 3 study of the drug in a new indication.
The Roche group’s new kinase inhibitor for metastatic melanoma, Zelboraf (vemurafenib), has been given a positive opinion by the European Medicines Agency, following its approval by the US Food and Drug Administration in August.
Since 2003, the European Medicines Agency and the US Food and Drug Administration have been working actively behind the scenes to coordinate decision-making. This doesn’t mean issuing the same opinions on new products. But it does mean sharing intelligence, and taking a common approach to problem-solving.
A decision by the US Food and Drug Administration to allow non-prescription use of an emergency contraceptive for all women of child-bearing age has been overruled by Secretary of Health and Human Services, a political appointee.
AstraZeneca Plc has announced plans to make 22 compounds available to medical researchers in the UK free of charge in a bid to promote more drug discovery. The compounds are not the focus of current research at the company.