Less than two years on from its formation, central nervous system diseases specialist Accure Therapeutics SL has landed a $1 billion-plus agreement to out-license the lead program ACT-01, a first-in-class molecule with neuroprotective properties that is in a phase IIa study in acute optic neuritis. Taking on ACT-01 is ophthalmology specialist Oculis SA, which once it has positive data from the phase IIa, intends to expand to broader indications, including glaucoma and geographic atrophy. Read More
Pathalys Pharma Inc., a privately held startup focused on developing new medicines chronic kidney disease, has emerged with an exclusive license from Tokyo-based EA Pharma Co. Ltd. to develop the small molecule calcimimetic upacicalcet for markets outside of Japan and Asia. Read More
A total of seven new molecular entities (NME) have been approved by the U.S. FDA this year, while another seven therapies received dreaded complete response letters from the agency. Out of 9 FDA approvals in February, including two BLAs, three NDAs, three supplemental applications, and one abbreviated NDA, were three NME clearances. Read More
Researchers from Massachusetts General Hospital have identified peripheral neuropathy in more than half of a group of long COVID patients, suggesting that it may be a mechanism that contributes to multiple, seemingly disparate, long COVID symptoms. Read More
Shanghai Junshi Biosciences Co. Ltd. and Mabwell Bioscience Co. Ltd. have won marketing approval for the adalimumab biosimilar Junmaikang from China’s NMPA for the treatment of patients with rheumatoid arthritis, ankylosing spondylitis, and psoriasis. It’s Mabwell Bio’s first commercial product. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biolinerx, Biomind, Currax, Genome, Merck, Novo, Pfizer, Vivus. Read More
