Roche and partner Klinrisk have picked up a CE-mark in the EU for an AI-based tool that can be used to predict renal function decline in patients with chronic kidney disease (CKD). The algorithm will be added to Roche’s navify library of clinical decision-making algorithms and other digital health technologies (DHTs), designed to assist healthcare…
Stealth BioTherapeutics has claimed FDA approval for Forzinity, the first treatment for ultra-rare disease Barth syndrome, just a few months after it was turned down by the regulator. Forzinity (elamipretide) can be used to treat patients weighing at least 30 kg with Barth syndrome, an X-linked, inherited mitochondrial disorder that causes an enlarged and weakened…
MSD’s cancer immunotherapy Keytruda will soon be available as a subcutaneous injection that does away with the need to visit an infusion clinic. Keytruda Qlex (pembrolizumab and berahyaluronidase alfa) still needs to be administered by a healthcare professional, but requires just a couple of minutes to deliver, rather than a 30-minute intravenous infusion. It is…
Sanofi’s BTK inhibitor Wayrilz has become the first drug in the class to be approved by the FDA for immune thrombocytopenia (ITP), a rare autoimmune blood disorder. Wayrilz (rilzabrutinib) has been cleared by the US regulator for adults with persistent or chronic ITP who have had an insufficient response to a previous treatment. In ITP,…
Eisai and Biogen have won FDA approval for a subcutaneous injection version of Leqembi that could help accelerate uptake of the Alzheimer’s disease therapy. The green light for Leqembi Iqlik (lecanemab) means it can be used as an alternative to infusions during the maintenance phase of treatment with the anti-amyloid therapy, and patients will still…