Merus NV added Gilead Sciences Inc. to its collaboration roster, entering a deal potentially worth more than $1.5 billion. While its previous agreements have focused primarily on bispecific antibodies, the Gilead alliance takes aim at trispecifics, antibodies capable of binding three targets at once. In other news, shares of Biomx Inc. (NYSE:PHGE) jumped 194% March 6, ending the day at 68 cents, up 45 cents, on news that it was merging with fellow phage-focused company Adaptive Phage Therapeutics Inc. and raised $50 million in a concurrent private placement. Read More
Sionna Therapeutics Inc.’s approach with small molecules in cystic fibrosis (CF) yielded the Boston-based firm an upsized and oversubscribed $182 million series C financing. The company is working on drugs that could fully restore the function of the CF transmembrane conductance regulator protein by stabilizing the first nucleotide-binding domain (NBD1). Four compounds are expected to enter the clinic this year – three NBD1 stabilizers and one ICL4 modulator. Read More
Shionogi & Co. Ltd., of Osaka, Japan, gained standard approval from Japan’s Ministry of Health, Labour and Welfare for Xocova (ensitrelvir fumaric acid) on March 5, making it the first COVID-19 antiviral to win full approval in the country. Read More
Though down nearly 6% in January, the BioWorld Drug Developers Index (BDDI) rebounded in February, finishing the month with a 4.41% increase and outperforming both the Nasdaq Biotechnology Index (NBI; up 1.33%) and the Dow Jones Industrial Average (DJIA; up 3.47%). In 2023, BDDI concluded the year down 11.35%, trailing behind the NBI and DJIA. Read More
The biosimilars revolution continues with the U.S. FDA’s approval of the first denosumab biosimilars: Wyost (denosumab-bbdz) and Jubbonti (denosumab-bbdz) from Sandoz Inc. for treating osteoporosis and to prevent bone problems in cancer. The approval puts up a strong challenge to Amgen Inc.’s Prolia, the first biologic for osteoporosis, and Xgeva, for bone cancer. Read More
Foreign investment in China’s biopharma sector is beginning to pick up after the hit of severe pandemic restrictions, and as Western governments look to revive trading relationships following a spate of diplomatic rows. While the geopolitical tensions remain, the mantra from Europe is not to de-couple, but to de-risk. Following a policy review in 2023, the U.K. government position is that a positive two-way trade and investment relationship with China is “mutually beneficial.” Read More
The World Trade Organization wrapped up its 13th ministerial conference and, as the saying goes, no news is good news. Life science trade associations in the U.S. lauded the end of the conference without an extension of intellectual property rights waivers for therapies and diagnostics for the COVID-19 pandemic, although this outcome was not entirely surprising. Read More
A heads up for the biopharma and med-tech industries: The U.S. government is going beyond warning letters to slap companies for violating the FDA’s good manufacturing practice (GMP) regulations. KVK Research Inc., a U.S.-based generic drug manufacturer, pleaded guilty March 6 to two misdemeanor counts of violating the Federal Food, Drug and Cosmetics Act by introducing adulterated drugs into interstate commerce. As part of the plea, the company agreed to pay a proposed fine and forfeiture amount of $1.5 million. Read More
Discover a wealth of industry insights with BioWorld’s extensive collection of infographics, covering the latest trends and developments in both biopharma and med-tech. Our weekly infographics are curated to provide concise summaries of key topics: financings (IPOs, private financings, public/other and follow-on offerings), deals and M&As (top deals, and monthly value and volume), regulatory (including U.S. FDA and worldwide approvals), clinical trials and more. In addition, you’ll find access to BioWorld’s year-in-review reports, as well as special infographics about obesity, pain and addiction, biosimilars and the aging space. Read More
New hires and promotions in the biopharma industry, including: Aerovate, Asceneuron, Aslan, Fibrobiologics, Hepion, Iteos, Mbrace, Neovac, Vaxart, Zenas. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbvie, Aptorum, Bostongene, Candel, Crossbow, Cyclacel, Dragonfly, Elicera, Formosa, Gensight, Gilead, Imidomics, Nec, Sonata, Sonrai, Sosei, Transgene, UCB, Yoov. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aimmax, Allyx, Anheart, Formosa, Innovent, Lipella, Madrigal, Noxxon, Oncolytics, Photon, TME. Read More
