Two phase III stumbles of Iterum Therapeutics plc’s sulopenem have cast the company’s future in doubt. The latest problem is the failure of the penem anti-infective compound, with oral and I.V. formulations, failing to achieve statistical noninferiority relative to ertapenem in treating complicated urinary tract infection (cUTI).
DUBLIN – Johnson & Johnson’s Janssen Biotech arm is on the brink of a historic first vaccine approval, having secured a positive vote May 29 from the EMA’s Committee for Medicinal Products for Human Use (CHMP) for its prime-boost Ebola virus vaccine combo, Zabdeno (Ad26.Zebov) plus MVABEA (MVA-BN-Filo).
Intravenous artesunate, the international standard of care to treat severe malaria, has finally won full FDA approval for the condition, which affects about 300 of the approximately 2,000 people diagnosed with malaria in the U.S. each year.
LONDON – MGB Biopharma Ltd. is looking for new investors or a commercialization partner to take its lead program, MGB-BP-3, through to market, after reporting 100% initial and sustained cure of Clostridium difficile infections in a phase IIa dose-ranging study.
A global HIV prevention study comparing a long-acting injectable antiretroviral from Viiv Healthcare Ltd. to a daily pill from Gilead Sciences Inc. has stopped early after Viiv's cabotegravir proved 69% more effective than the current standard of care, Gilead's Truvada (emtricitabine/tenofovir), in preventing HIV acquisition (95% CI 41%-84%).
CAJICA, Colombia – Previous research to develop vaccines for dengue and Zika virus could become the cornerstone for a vaccine against COVID-19, which the Autonomous University of Mexico (UNAM) is working on.
The devastating societal and economic effects caused by the ongoing COVID-19 pandemic should sound a warning bell on how ill-prepared we are in our ability to fight lethal infectious diseases for which no effective therapies or vaccines currently exist. Indirectly, the intense public attention on companies that are engaged in developing COVID-19 cures is also spilling over to companies researching to uncover new anti-infectives that will be needed to replace the diminishing arsenal of effective therapies to combat drug-resistant bacteria and fungi. This is certainly evident among public companies in the space, with the BioWorld Infectious Diseases index showing an increasing upward trend since the beginning of the year. At market close on May 11, the index had, in fact, grown in value by a whopping 47%.
Rebiotix Inc. said RBX-2660, its standardized, non-antibiotic, microbiome-based therapy designed to reduce Clostridioides difficile (C. diff) infection recurrences, notched positive preliminary results on the primary efficacy endpoint of its ongoing pivotal phase III trial.
DUBLIN – Shares in Valneva SE rose by as much as 32% during early trading April 30 on news that Pfizer Inc. is paying $130 million up front to in-license its Lyme disease candidate vaccine, VLA-15.
A pair of good-news items from Chimerix Inc. pushed the Durham, N.C.-based company’s stock (NASDAQ:CMRX) to $2.15, closing up 64 cents, or 42%, higher as backers reacted to near-term NDA plans for smallpox countermeasure brincidofovir (BCV) and the start of a phase II/III trial with dociparstat sodium (DSTAT) in COVID-19 patients with acute lung injury (ALI).
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