Neratinib's value as extended adjuvant therapy for HER2-positive breast cancer may be diminished if Roche succeeds in altering the standard of care for initial adjuvant treatment, among other challenges.
Puma Biotechnology Inc.'s Nerlynx (neratinib) came through the US FDA's Oncologic Drugs Advisory Committee with a guarded recommendation for approval as extended adjuvant treatment of HER2-positive breast cancer, but even if it is cleared the company faces significant challenges ahead.
Much of the May 24 panel discussion focused on a potential narrowing of the indication, the possibility that the circumstances...
Glenmark’s managing director talks about IGI’s billion dollar-plus deal with AbbVie, ISB-2001’s striking data, the BEAT platform, other "exciting" pipeline assets and the "blood, sweat and tears" to get to this stage.
Four Chinese companies have won approvals in China, the first anywhere, for novel drugs for diffuse large B-cell lymphoma, certain types of non-small cell lung cancer and influenza A.
IGI CEO Cyril Konto said in an interview that his company picked AbbVie for its agility, drug development acumen and expertise in areas like intellectual property and legal affairs.
The Swiss company believes its platform can make radiopharmaceuticals easier to produce and more accessible to patients.
IGI CEO Cyril Konto said in an interview that his company picked AbbVie for its agility, drug development acumen and expertise in areas like intellectual property and legal affairs.
The osteogenesis imperfecta drug stumbled in a second interim analysis.
The Swiss company believes its platform can make radiopharmaceuticals easier to produce and more accessible to patients.
