The good news is that the U.S. FDA’s complete response letter (CRL) for Venatorx Pharmaceuticals Inc.’s intravenous antibiotic combination, cefepime-taniborbactam, in complicated urinary tract infections (cUTIs) requested no additional clinical testing. The bad news is the inevitable delay for a drug Venatorx and partner Melinta Therapeutics Inc. are aiming to position as a much-needed option for the fight against drug-resistant gram-negative infections. Read More
The new director of the U.S. NIH, Monica Bertagnolli, has set out the prospectus for her tenure, saying she intends to apply the agency’s $47 billion per annum budget to reverse the decline in health and life expectancy in the U.S. Read More
In a surprise reveal that propelled stocks by 25%, Alteogen Inc., of Daejeon, South Korea, named MSD International Business GmbH as its counterpart in a near-$4 billion technology transfer agreement inked in 2020, while upping terms of the deal. Read More
Chief executives of U.K. medical research charities have issued a call for speedier uptake and more equitable access to new drugs that have received a cost-effectiveness seal of approval from the National Institute for Health and Care Excellence. In a joint report with the Association of the British Pharmaceutical Industry, the heads of eight charities examined a number of cases where access has been limited and set out recommendations to address the challenges of equity, uptake and health inequalities. Read More
Seven new therapies, including two influenza vaccines, were recommended for approval by the EMA’s Committee for Medicinal Products for Human Use during its February 2024 meeting. One of these was sparsentan by CSL Vifor Pharma Inc. and Travere Therapeutics Inc. for the treatment of IgA nephropathy (IgAN), for which the committee has awarded conditional marketing authorization. Read More
In the first month of 2024, BioWorld reported on 252 phase I-III clinical trial updates, marking a 10% decrease from the 281 updates in December 2023, as well as a decline from 354 updates in November and 416 in October. The number of trial updates is also a 10% drop compared to January 2023, which recorded 281 updates. 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
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Ashvattha, Cinphloro, Elevation Oncology, Intrommune, Limmatech, Medivir, Oncoc4, Pharvaris, Protagonist, Quolet, Tarsus. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Astrazeneca, Bristol Myers, Enveric, Galapagos, GSK, Rayzebio, Silence, Vir. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arcturus, Artiva, Everest Medicines, Immune-Onc, Irlab, Pfizer, TC. Read More
