The U.S. FDA has rejected Verrica Pharmaceuticals Inc.’s drug-device combination to treat the viral skin disease molluscum for a third time, losing more ground to a potential rival from Novan Inc., because of continued manufacturing issues. There are no FDA-approved treatments for molluscum contagiosum, which leads to skin-colored or pink lesions and affects around 6 million people in the U.S. annually. Read More
Solid phase III top-line results from a study in India for treating stroke with PMZ-1620 (sovateltide) have prodded Pharmazz Inc. to rethink its path to the clinic in the U.S. While the privately held company plans to apply for marketing authorization from the Indian Central Drugs Standard Control Organization, it also had planned to talk to the FDA about launching a phase II study. But since the new data are so solid, it may ask for an IND for a phase III study in the U.S., with the expectation that the number of participants would jump from 158 in the Indian study to as many as 400 to 500 participants in the U.S. and Europe, Anil Gulati, Pharmazz’s CEO and founder, told BioWorld. Read More
Paragon Biosciences-backed Castle Creek Biosciences Inc. pulled off an oversubscribed and upsized preferred stock financing of $112.8 million. The money should let the firm tie the bow on a phase III study and roll out top-line results of its lead ex vivo product candidate for recessive dystrophic epidermolysis bullosa (RDEB) called D-Fi (dabocemagene autoficel, also known as FCX-007). Read More
About $1.7 trillion in securities of China-based issuers listed on U.S. exchanges could face trading prohibitions in as little as two years, Y.J. Fischer, director of the U.S. SEC’s Office of International Affairs, warned during remarks at the May 24 annual meeting of the International Council of Securities Associations. Read More
Elasmogen Ltd. has secured a “transformational” £8 million (US$10 million) in new funding with which to move its shark-based, antibody-like constructs toward the clinic. Read More
New hires and promotions in the biopharma industry, including: Anebulo, Antibe, Capricor, Erasca, Genexine, Nanoscope, Remedybio, Senti, Shasqi, Tryp. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aerie, Alnylam, Alvotech, Caladrius, Cingulate, Cytokinetics, Edesa, Eli Lilly, Ensysce, Luxa, Pfizer, Recardio, Springworks, Windtree. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Antios, Assembly, Astrazeneca, Bavarian Nordic, Citius, Teva. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alpine, Antios, Assembly, Blue Lake, Ceruvia, CSL, Dermavant, ENB, Immune, Merck & Co., Neuronascent, Noveome, Ocugen, Roche, Synlogic, United, Xcovery. Read More
