Orphalan SA is laying the ground for a 2023 U.S. launch of Cuvrior for the treatment of Wilson’s disease, following FDA approval of the copper chelating drug. Cuvrior (trientine tetrahydrochloride) is a new salt of trientine that was designed to have superior properties to Syprine (trientine hydrochloride) from Bausch Health Companies Inc. and Cufence from Univar Solutions BV, which are approved as second-line treatments for the rare inherited copper transport disorder, in the U.S. and EU respectively. Read More
Could investments in biopharmaceutical companies in 2022 be as aggressive as 2021, which saw a record 1,968 biopharma deals worth about $213.5 billion? So far, 2022 may be the lowest financing year since 2017 overall. But, drilling down to venture capital, private companies raised $5.7 billion in Q1 through 129 transactions, making it the second-best first quarter in history with 2021 at the top. BioWorld Senior Analyst Karen Carey explores the data with staff writer Lee Landenberger, explaining what happened in Q1 and where Q2 is headed. Read More
Dragonfly Therapeutics Inc. added Gilead Sciences Inc. to its roster of partnerships in a deal that gives the Waltham, Mass.-based company $300 million up front, with opt-in payments, milestones and up to 20% royalties down the road. In exchange Foster City, Calif.-based Gilead gets exclusive, worldwide rights to DF-7001, a preclinical-stage immunotherapy, as well as rights to additional NK cell engager programs generated by Dragonfly’s TriNKET (Trispecific NK Engager) platform. Read More
A quartet of companies on May 2 announced three complete response letters (CRLs) that left them scrambling to get back on the path to approval. Hutchmed Ltd.'s surufatinib met with word from the U.S. FDA that two positive phase III studies in China and a bridging study in the U.S. would not support approval of the drug for pancreatic and extra-pancreatic neuroendocrine tumors. A multi-regional clinical trial in the U.S. is needed, the regulator said, brushing aside China-only studies when seeking a U.S. approval. Read More
For Kevin Friedman, the secret to making newly emergent Kelonia Therapeutics Inc. a success is reducing complexity and keeping everything as simple as possible. The Boston-based company just raised $50 million in series A funding to further its development of genetic medicines encompassing a range of diseases. Read More
After raising $17 million in seed funding, immunotherapy-focused biotech company, LTZ Therapeutics Inc., is announcing plans for the fledgling company whose acronym stands for “Lift to Zenith.” CEO and co-founder Robert Li told BioWorld that the company’s three-tiered immunotherapy platform will focus on reducing immunosuppression, reprogramming innate immunity and modulating adaptive immunity. Read More
Researchers at the University of Pennsylvania have gained new insight into how different inflammatory conditions reinforce each other via trained innate immunity. Read More
The latest in a spate of draft and final guidances released recently by the U.S. FDA could help sponsors developing drugs to treat early stage solid tumor malignancies. Read More
New hires and promotions in the biopharma industry, including: Arrowhead, Codiak, Dtx, Hookipa, Index, Insitro, JSR, KBI, Obseva, Phio, Roivant, Selexis, Servatus, Vistagen. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Astrazeneca, Denali, First Wave, Galera, Innate, Lyra, Novo Nordisk, Rezolute, Roche, Stealth, Timber. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bristol Myers Squibb, Finch, Gilead, Merck, Moderna, Pfizer. Read More
