News round-up for 5-9 June by DDW Multimedia Editor Megan Thomas.
Regulatory approvals and industry guidelines are key to the continued development and discovery of drugs, which is a common theme throughout this week’s news highlights, including an FDA approval for Pfizer, a NICE recommendation for AstraZeneca UK, and an update to the HER2 Breast Cancer Testing Guidelines.
The top stories:
FDA approves Phase III cerebral Adrenoleukodystrophy trial
THE FDA has approved Minoryx Therapeutics’ Phase III clinical trial (CALYX) of leriglitazone, to treat adult male X-linked Adrenoleukodystrophy (X-ALD) patients with cerebral Adrenoleukodystrophy (cALD).
Positive NICE recommendation for BRCAm ovarian cancer
AstraZeneca UK announced that Lynparza (olaparib) is recommended by the National Institute for Health and Care Excellence (NICE) for maintenance treatment of BRCA-mutated relapsed, platinum-sensitive, high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer in adults who have had two or more courses of platinum-based chemotherapy.
Updates to HER2 testing guidelines reduces confusion
The College of American Pathologists (CAP) and American Society of Clinical Oncology (ASCO) have reaffirmed the Human Epidermal Growth Factor Receptor 2 (HER2) Breast Cancer Testing Guidelines, reducing confusion over terminology for reporting HER2 results.
GSK faces RSV vaccine threat from rival Pfizer
An FDA approval for Pfizer’s Abrysvo respiratory syncytial virus (RSV) vaccine is likely to threaten GSK’s current hold on the market.
Patient dies in cell therapy clinical trial
A Phase I clinical trial testing a CAR-T cell therapy treatment in children with acute myeloid leukaemia (AML) has been paused due to a patient’s death.
