Five-year follow-up data from the SEQUOIA study demonstrates zanubrutinib's sustained efficacy in treatment-naive chronic lymphocytic leukemia and small lymphocytic lymphoma patients with del(17p).
Alvotech's Swedish Depository Receipts (SDRs) offering was multiple times oversubscribed, attracting over 3,000 new shareholders and raising approximately SEK 39 million.
The FDA has accepted Teva Pharmaceuticals' supplemental Biologics License Application for AJOVY (fremanezumab) to expand its indication to include prevention of episodic migraine in children and adolescents aged 6-17 years weighing at least 45 kg.
GLP-1 receptor agonists like semaglutide, originally approved for diabetes (Ozempic), have expanded to weight management (Wegovy) and show potential in treating neurocognitive disorders and reducing alcohol cravings.
The FDA has approved ten adalimumab biosimilars, with Simlandi (adalimumab-ryvk) becoming the latest addition in February 2024, expanding treatment options for various autoimmune conditions.
The U.S. District Court ordered Teva Pharmaceuticals to remove its ProAir HFA inhaler device patents from the FDA's Orange Book, ruling they don't meet statutory listing requirements.
Phase 2 study results demonstrate GA Depot's safety profile in progressive MS patients, with stable EDSS scores maintained over three years and minimal disability progression.
Latin America has emerged as a key investment destination for Big Pharma, with Brazil leading pharmaceutical market growth despite challenges in generics market share.
Teva and Medincell announce FDA acceptance of supplemental New Drug Application for UZEDY as a maintenance treatment for bipolar I disorder in adults, expanding from its current schizophrenia indication.
Johnson & Johnson has initiated legal action against Samsung Bioepis, alleging breach of contract regarding an unauthorized sublicense deal for Stelara biosimilar Pyzchiva.