Three Chinese biopharmaceuticals have filed for IPOs on the Hong Kong exchange in July alone, highlighting a potential “newfound positivity” to strengthen the HKEX IPO market in the second half of 2024. Read More
The European Commission has approved Cstone Pharmaceuticals Ltd.’s PD-L1 monoclonal antibody, sugemalimab, in combination with platinum-based chemotherapy for first-line treatment of adults with metastatic non-small-cell lung cancer with no sensitizing EGFR mutations, or ALK, ROS1 or RET genomic tumor aberrations. Read More
Triastek Inc., of Nanjing, China, scored a potential $1.2 billion collaboration and platform technology license deal with Biontech SE to manufacture oral RNA therapeutics with 3D printing technology. Read More
Ensho Therapeutics Inc. launched in July after licensing a pipeline of four oral α4β7 inhibitors for inflammatory and gastrointestinal disorders, including inflammatory bowel disease (IBD), from EA Pharma Co. Ltd. “Millions of people worldwide are living with IBD,” Ensho founder, president and executive chair Neena Bitritto-Garg recently told BioWorld, “and while there are a number of approved medications to address the symptoms of IBD, it remains a difficult-to-treat disease with high relapse rates for a considerable proportion of patients.” Read More
The U.S. FDA accepted Telix Pharmaceuticals Ltd.’s new drug application for TLX-007-CDx, a new cold kit for preparing prostate-specific membrane antigen-PET imaging for prostate cancer. Read More
Astellas Pharma Inc.’s claudin (CLDN) 18.2-targeted monoclonal antibody, zolbetuximab, received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) and could be the first CLDN18.2 molecule to be approved in Europe if it receives final approval. Read More
The U.S. FDA has approved Sun Pharmaceutical Industries Ltd.’s Leqselvi (deuruxolitinib), a JAK1 and JAK2 inhibitor for adults with severe alopecia areata, a chronic autoimmune disease. The twice-daily, oral treatment will be targeting a company-estimated market of about 300,000 people in the U.S. This is the third FDA-approved treatment for severe alopecia areata in the past three years. Read More
Alkira Bio, a new spinout from Australia’s Florey Institute of Neuroscience and Mental Health has emerged from stealth mode thanks to seed funding from Curie.bio. Although the amount of funding is not disclosed, Curie.bio typically invests $5 million to $10 million in a founder company and then co-pilots the drug discovery program, deploying drug development experts to its portfolio companies to help navigate decision making as part of the deal, Florey researcher turned Alkira Bio CEO Daniel Scott told BioWorld. Read More
SK Bioscience Co. Ltd. signed a simple agreement for a future equity (SAFE) deal totaling $2 million with Hingham, Mass.-based Sunflower Therapeutics PBC on July 25 to secure both Sunflower’s equity and its yeast-based protein manufacturing technology. The conditional agreement will grant SK Bioscience future equity rights in Sunflower without the need for immediate valuation, allowing for minimal investment. Read More
The 2024 meeting of the International AIDS Society (IAS) is wrapping up as the 2024 Olympic Games are about to begin. That timing was probably what prompted the use of multiple sports analogies at Thursday’s plenary session on HIV prevention strategies. Read More
In June 2024, BioWorld covered 221 clinical trial updates, compared to 298 in May. BioWorld recorded 23 phase III trial successes in June, seven failures, and one with mixed results. Read More
Two costs of developing drug candidates have been upended by new research from the Tufts University School of Medicine’s Center for the Study of Drug Development. New data have produced some very different numbers than you might expect in the cost of a single day of a clinical trial and of missing a day to generate prescription drugs sales. The center’s director, Ken Getz, spoke to the BioWorld Insider podcast about updating the outdated numbers and what it means for companies and investors. Read More
From no hope to viable treatments, BioWorld is there to cover the breakthroughs in medicine. Listen to Randy Osborne explain why the BioWorld team is ‘always on the lookout for what's next.’ Read More
Biopharma happenings in Asia-Pacific including deals and partnerships, grants, preclinical data and other news in brief: Acino, Cue, Eyenovia, LG Chem, M8, Ono, Prelude, Qdx, Senju. Read More
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Biogen, Bio-Thera, Immutep, Mesoblast, Ractigen, Samsung Bioepis, Sun Pharmaceutical, Telix. Read More
