AstraZeneca (AZ) has been granted a priority review by the US Food and Drug Administration (FDA) for a new four-week, fixed-dose regimen of its PD-1 inhibitor Imfinzi. AZ have stated that if the new regimen is approved, Imfinzi could be administered intravenously every four weeks at a fixed dose of 1500mg in approved indications. This includes unresectable,
Approval was made after an FDA inspection of the Harmans state-of-the-art, commercial-scale gene therapy manufacturing center in June 2020. Since Catalent’s partnership with AveXis, a Novartis company, was announced in July 2019, dedicated suite space has been prepared at the Harmans facility for the commercial manufacture of this adeno-associated virus (AAV) gene therapy. “This is
Janssen receives approval from the FDA for its Spravato CIII nasal spray, in combination with an oral antidepressant, to treat depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behaviour. The approval is based on two phase 3 clinical trials in which Spravato, plus comprehensive standard-of-care, demonstrated a significant and rapid
The European Commission (EC) has authorised the world’s first subcutaneous formulation of infliximab, Remsima SC, for an additional five indications including for use in inflammatory bowel disease and ankylosing spondylitis. The authorisation for the subcutaneous (SC) formulation now applies to all previously approved indications for the intravenous (IV) formulation in adults including: ankylosing spondylitis (AS),
Critical Path Institute (C-Path) announced that the Biomarker Qualification Program (BQP) at the Center for Drug Evaluation and Research (CDER) in the FDA issued a positive response to the Letter of Intent (LOI) developed by C-Path’s Predictive Safety Testing Consortium (PSTC) and Duchenne Regulatory Science Consortium (D-RSC), for a panel of four safety biomarkers of
The MHRA has granted Alnylam’s lumasiran a positive scientific opinion through the Early Access to Medicines Scheme (EAMS). The decision will allow patients with the ultra-rare disease primary hyperoxaluria type 1 (PH1) access to the drug before its official approval by the European Commission. PH1 is an ultra-rare orphan disease affecting around 90 patients in
The European Commission has approved AstraZeneca (AZ) and Merck/MSD’s PARP-inhibitor Lynparza for the treatment of patients with BRCA-mutated metastatic pancreatic cancer. The approval was based on results from the phase 3 POLO trial of Lynparza in advanced pancreatic cancer patients whose tumours carry BRCA mutations. About 5-7% of metastatic pancreatic cancers are caused by mutations in one
The European Medicines Committee’s human medicines committee (CHMP) has backed approval of eight new medicines across a range of indications. Gilead’s remdesivir has been previously recommended for conditional approval for treatment of COVID-19 in adults and adolescents from 12 years of age with pneumonia who require supplemental oxygen. The drug is the first medicine against
FDA has launched Project Patient Voice, an initiative of the FDA’s Oncology Center of Excellence (OCE). Through a new website, Project Patient Voice creates a consistent source of publicly available information describing patient-reported symptoms from cancer trials for marketed treatments. While this patient-reported data has historically been analysed by the FDA during the drug approval
FDA has approved the first video game-based treatment for ADHD created by Akili. The video game, called EndeavorRx, has been years in development and is approved for children between the ages of eight and 12 with certain types of ADHD. The game is used in conjunction with other treatments such as clinician-directed therapy, medication and education to treat
