All articles by Vidya Sagar Maddela
GSK secures expanded EC approval for Jemperli plus chemotherapy
The expanded approval is based on results from the Phase 3 RUBY Part 1 trial, which showed a clinically meaningful and statistically significant overall survival (OS) benefit in primary advanced or recurrent EC
AstraZeneca secures FDA approval for Calquence plus chemo
FDA approved Calquence plus chemoimmunotherapy based on results from the Phase 3 ECHO trial, which showed the combination reduced the risk of disease progression or death compared to standard-of-care
Zai Lab Announces Acceptance of New Drug Application for KarXT for the Treatment of Schizophrenia
KarXT (xanomeline and trospium chloride) is a combination of an oral M1/M4-preferring muscarinic acetylcholine receptor agonist and a muscarinic acetylcholine receptor antagonist
Innovent, ASK Pharm’s lung cancer drug limertinib approved in China
China’s NMPA approved Innovent and ASK Pharm’s New Drug Application (NDA) for limertinib to treat adults with locally advanced or metastatic EGFR T790M-mutated non-small cell lung cancer (NSCLC)
MalarVx licenses HDT Bio’s repRNA/LION Technology for Novel Malaria Vaccine
MalarVx is a Seattle-based clinical-stage biopharmaceutical company developing vaccines to prevent malaria
Lilly secures FDA approval for Omvoh to treat Crohn’s disease
The FDA approval is based on positive results from the Phase 3 VIVID-1 study of Omvoh, which met both primary endpoints, including clinical remission by Crohn’s Disease Activity Index (CDAI) and endoscopic response
Be Bio Announces Closing of $92M Series C Financing and Completes Transition
Financing includes participation from new investor Nextech1 along with existing investors Arch Venture Partners, Atlas Venture, RA Capital, Alta Partners, Longwood Fund, Bristol Myers Squibb, Takeda Ventures and Others
Regenxbio, Nippon partner to develop therapies for rare diseases
Regenxbio will be responsible for manufacturing, and Nippon Shinyaku for commercialising the first potential gene therapies for Mucopolysaccharidosis II (MPS II) and Mucopolysaccharidosis I (MPS I) in the US and Asia
Teva, Samsung Bioepis partner to commercialise Epysqli in US
Samsung Bioepis will be responsible for the development, regulatory registration, manufacture, and supply of Epysqli, while Teva will be responsible for the marketing of Epysqli in the US
Light Horse established with $62m financing, partners with Novartis
Light Horse Therapeutics has been established with a $62m Series A financing led by founding investor Versant Ventures and partnered with Novartis to identify and develop potentially advanced therapeutics