Just over a month after scoring U.S. FDA clearance for dry eye disease therapy Miebo (perfluorohexyloctane), Bausch + Lomb Corp. is adding Xiidra (lifitegrast) to its arsenal in the same indication as part of the potential $2.5 billion deal with Novartis AG, which is divesting its “front-of-eye” ophthalmology assets. Read More
Cyteir Therapeutics Inc. is leading a pack of companies that have taken a hard look at their future and don’t care for what they see. According to BioWorld data, at least 100 biopharma companies have announced restructurings and layoffs this year, resulting in more than 8,400 jobs lost. Other companies either packing it in, restructuring from within or considering new paths include Aurinia Pharmaceuticals Inc., Bellerophon Therapeutics Inc., Calithera Biosciences Inc. and Spexis AG. Read More
Three years after stopping development in nonalcoholic steatohepatitis, Genfit SA and partner Ipsen Pharma SA have announced positive phase III data for elafibranor in the treatment of primary biliary cholangitis (PBC) and are preparing to file for U.S. FDA and EMA approval. Read More
SK Bioscience Ltd. and Sanofi Pasteur SA announced June 30 positive results from a phase II study for its 21-valent pneumococcal conjugate vaccine (PCV) candidate called GBP-410, or SP-0202 under Sanofi. Read More
Two separate insider trading tips involving a biopharma acquisition and trial results for Pfizer Inc.’s COVID-19 antiviral, Paxlovid, allegedly netted millions of dollars in “ill-gotten” trading profits, according to U.S. SEC complaints announced June 29. Read More
Having raised HK$791 million (US$101 million) through an IPO in Hong Kong, Laekna Inc., which develops therapies for cancer and liver fibrosis, now plans to focus on further developing its two lead products in-licensed from Novartis and push its pipeline of 14 products forward. Read More
Xuanzhu Biopharmaceutical Co. Ltd., a subsidiary of Sihuan Pharmaceutical Holdings Group Ltd., received marketing approval in mainland China for its anaprozole sodium enteric-coated tablet as a treatment of duodenal ulcer. Read More
Biopharmas raising money in public or private financings, including: Aeon, Biosenic, Black Diamond, Cytomx, Eleison, Intensity, Kiromics, Mira, Vitro. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ausper, Bristol Myers Squibb, Can-Fite, Celltrans, Endo, Genenta, Geron, Harbour Biomed, Ipsen, Italfarmaco, Paladin Labs, Recce. Read More