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. In its CRL, the FDA asked for additional chemistry, manufacturing, and controls information and related data about the drug, testing methods and manufacturing process, according to the companies. The agency did not identify any clinical safety or efficacy issues.

NIH’s Bertagnolli vows to improve data gaps in US health system

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. The increase in morbidity and decline in lifespan are “concerning overall trends,” especially given the U.S. spends considerably more per capita on health care than any of its peers. At the same time, ill health reduces the productivity and competitiveness of the U.S. “I represent NIH and it is up to us to conduct the research needed to deliver health and to overcome these problems,” Bertagnolli said. “Our work is not finished when we deliver scientific discovery; our work is finished when all people are living long and healthy lives,” she told attendees of the recent American Associations for the Advancement of Science annual conference in Denver.

Alteogen names MSD as partner in revised, potential $3.8B+ deal

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. To BioWorld, an Alteogen spokesperson confirmed that a key revision revolves around Alteogen granting MSD, which is known as Merck & Co. Inc. in the U.S. and Canada, exclusive rights to its human recombinant enzyme, ALT-B4, to develop and commercialize a subcutaneous formulation of MSD’s blockbuster PD-1 immunotherapy, Keytruda (pembrolizumab). In turn, Alteogen will receive an additional, new up-front payment of $20 million (₩26.7 billion) and up to $432 million in additional milestone payments, along with royalties.

UK trade group urging faster, equitable access for new therapies

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 examine a number of cases where access has been limited and set out recommendations to address the challenges of equity, uptake and health inequalities.

Sparsentan and two bird flu vaccines in EU positive opinion list

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 recommended conditional marketing authorization. If approved, sparsentan – which is marketed as Filspari in the U.S. – will be Europe’s first non-immunosuppressive, single-molecule, dual endothelin angiotensin receptor antagonist to treat IgAN.

January launches with 252 clinical trial updates

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. The number of trial updates is also a 10% drop compared to January 2023, which recorded 281 updates as well.

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Also in the news

Arcturus, Artiva, Ashvattha, Bristol Myers Squibb, Cinphloro, Curia, Elevation Oncology, Enveric, Everest Medicines, Frontier Medicines, Galapagos, Immune-Onc, Intrommune, Irlab, Kancera, Limmatech, Medivir, Oncoc4, Pfizer, Pharvaris, Protagonist, Quolet, Sanofi, Servier, Silence, Tarsus, TC, TME, Vir