China’s National Medical Products Administration (NMPA) granted new approvals to several Chinese biopharmaceuticals this week, including expanding indications of four different cancer drugs and clearing one sublingual tablet for stroke.
China’s National Medical Products Administration (NMPA) granted new approvals to several Chinese biopharmaceuticals this week, including expanding indications of four different cancer drugs and clearing one sublingual tablet for stroke.
The phase III study of Zepzelca (lurbinectedin) as combination therapy from Jazz Pharmaceuticals plc and Pharmamar SA was a stumble, but the companies said they found plenty of encouraging data prompting them to continue development.
The latest global regulatory news, changes and updates affecting biopharma, including: Lawmakers spill Purdue documents on heels of settlement; Western states join forces to review vaccines; FDA finalizes nicotine drug guidance; CBER tackling guidance agenda; Innovation Alliance voices support for PTAB changes.
The large-scale failure of a handful of drugs repurposed for COVID-19 hasn’t slowed efforts to find existing – and new – therapies as well as vaccines that can fight the pandemic, with research updates continuing to roll out.
The large-scale failure of a handful of drugs repurposed for COVID-19 hasn’t slowed efforts to find existing – and new – therapies as well as vaccines that can fight the pandemic, with research updates continuing to roll out.
Two months earlier than expected, Pharmamar SA and partner Jazz Pharmaceuticals plc received an accelerated FDA approval of Zepzelca to treat relapsed metastatic small-cell lung cancer patients.
