Nabriva Therapeutics plc has gained FDA approval of NDAs for both I.V. and oral formulations of lefamulin, a semisynthetic antibiotic for the treatment of community-acquired bacterial pneumonia (CABP) it will market as Xenleta. It's the first pleuromutilin for systemic use in humans to win FDA approval, leading the first new class of antibiotics for CABP in almost 20 years. Read More
In a second opinion of sorts, a government report suggests that some of the drug pricing remedies U.S. lawmakers and the Trump administration have proposed could be the right prescription for the wrong setting, especially when it comes to pharmacy benefit managers (PBMs). Read More
BEIJING – Look out, Hong Kong Stock Exchange (HKEX). Chinese pre-profit biotech startups are now starting to apply for listing on Shanghai's sci-tech innovation board known as the STAR, with the latest application filed by HIV drugmaker Frontier Biotechnologies Inc., of Nanjing. Read More
Interim results from Kalytera Therapeutics Inc.'s phase II open-label study of multiple doses of cannabidiol (CBD) in preventing acute graft-vs.-host disease (GVHD) were positive enough to persuade the company to skip enrolling the high-dose cohort and move directly to a phase III registration study. Read More
Chief Commercial and Strategy Officer Elizabeth Jeffords told BioWorld that the endpoints in Alkahest Inc.'s just-begun phase II trial with human plasma fraction GRF-6021 will not only test how well patients bounce back from hip or knee arthroplasty but "could absolutely support the work in cognitive and neurodegenerative indications as well," where data rolled out earlier this month. Read More
Biomedical researchers at Vanderbilt University have created "cellular soldiers" that use the body's innate defenses to eliminate cancer cells dispersed during surgery. When used perioperatively, the attack cells kill stray cancer cells and keep them from forming metastases. Read More
Generex Biotechnology Corp., of Miramar, Fla., said it acquired an additional 38% of Olaregen Therapeutix Inc., of New York, for total ownership of approximately 99% through a cashless exchange of Generex stock (OTCQB:GNBT) at $2.50 per share. Read More
The FDA's Center for Drug Evaluation and Research (CDER) is looking for five drug companies to participate in a Fit for Use pilot program to test the processing and analysis of nonclinical study data provided electronically for the Clinical Data Interchange Standards Consortium (CDISC) using the SEND 3.1 format. Read More
LONDON – Juvenescence Ltd. has closed a $100 million series B round, providing ample scope for the anti-aging specialist to make further investments in the band of companies it is supporting to develop products that aim to increase the healthy lifespan of humans. Read More
