Alentis Therapeutics SA has closed a $105 million series C round which will fund simultaneous phase II and phase Ib trials of anti-Claudin-1 antibodies in the treatment of organ fibrosis and phase I development in fibrosis-associated cancers. At the same time, the company will extend the reach of its Claudin-1 biology into antibody-drug conjugates and bispecific constructs, to further exploit the role of the transmembrane protein in maintaining cellular integrity and controlling cell-to-cell signaling. Read More
With no treatments available to effectively clear mucus, Aer Therapeutics Inc. secured $36 million in a series A financing to advance its novel inhaled small-molecule mucolytic treatment, AER-01, bringing optimism to about 5 million Americans with chronic obstructive pulmonary disease (COPD) who have a high burden of mucus plugs. Read More
With the backing of €2 million (US$2.17 million) in seed funding from venture capital company Adbio partners, French biotech Calida Therapeutics hopes that drawing on some U.S. academic research into thrombo-inflammatory disorders will enable it to develop a series of monoclonal antibodies. Read More
With a May 29 PDUFA date nearing, the U.S. FDA’s Antimicrobial Drugs Advisory Committee meets April 17 to discuss the merits of Entasis Therapeutics Inc.’s hospital-acquired infection therapy. Read More
Junshi Biosciences Co. Ltd.’s PARP inhibitor, senaparib (JS-109/IMP4297), met the primary endpoint of progression-free survival in a phase III ovarian cancer study, according to a prespecified interim analysis. Read More
Specialised Therapeutics Asia Pte Ltd. has inked a $73 million deal with CTTQ-Akeso Biomed Tech. Co. Ltd. to buy the rights to commercialize the latter’s anti-PD-1 antibody in Australia and Southeast Asia. Read More
Danco Laboratories LLC’s abortion pill, Mifeprex (mifepristone), and a generic will remain on the U.S. market with tighter restrictions while a challenge to the drug’s 2000 accelerated approval and the FDA’s subsequent loosening of prescribing requirements plays out on appeal. That is unless the Supreme Court says otherwise. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Covis, Junshi, Kala, Oncolyze. Read More
