Takeda Pharmaceutical Co. Ltd. has grabbed a slice of the non-small-cell lung cancer (NSCLC) market, becoming the first company to gain FDA approval for an oral drug targeted against a rare form of the disease.
A new law in China will grant physicians the right to use off-label drugs, giving clearer definition to a gray area and lending hope that it could benefit pharma companies.
Samsung Bioepis Co. Ltd. has emerged as the first company to obtain marketing authorization from the EMA for a biosimilar of Lucentis (ranibizumab), a significant development for the Korean biosimilar specialist. The approval comes less than two months after the company received a positive opinion from the EMA’s CHMP for Byooviz (ranibizumab), formerly called SB-11.
PERTH, Australia – As the Delta variant of SARS-CoV-2 sweeps across the globe, drugs like Roche Holding AG’s interleukin-6 receptor inhibitor Actemra (tocilizumab) are being used, often off-label, to treat serious cases of COVID-19. That usage, however, is resulting in serious drug shortages that may leave some without treatment options.
An update from China’s NMPA clarifying registration requirements and classification methods for drug-device combination products has been welcomed by industry as the regulator seeks to keep pace with fast-moving developments in the sector.
PERTH, Australia – The Australian government is investing AU$79 million (US$56.75 million) in medical research and innovation projects to develop new drugs, devices and digital health technologies through its AU$20 billion Medical Research Future Fund (MRFF).
A new rule published by India’s Central Drug Standards Control Organization that would require additional tests, trials or even approvals for drugs after changes in their active substances is likely to have only limited impact on companies and the market, despite evoking memories of a bruising patent dispute eight years ago.
PERTH, Australia – The Treasury Department is seeking feedback from industry stakeholders on its discussion paper on a patent box policy, which was first announced in the May 2021 federal budget.
The increasing use of artificial intelligence (AI) technologies across all stages of drug development is presenting challenges for regulators across the world.
Burning Rock Biotech Ltd. has formed a global strategic partnership with Impact Therapeutics Inc. to develop companion diagnostics for a pipeline of drugs in the field of synthetic lethality.