DNDi

Sanofi announced Monday that the U.S. FDA has approved its oral sleeping sickness treatment, fexinidazole, in patients age 6 and older and weighing at least 20 kilograms. According to the press release, the approval also nets a tropical disease Priority Review Voucher for Sanofi’s co-developer, the Drugs for Neglected Diseases Initiative. Sanofi and DNDI will share the PRV benefits.

The EMA approved the drug in 2018.

The Drugs for Neglected Diseases Initiative (DNDI) announced Monday that Malaysia has become the first country to grant conditional registration to ravidasvir as part of a two-drug treatment for adults with chronic hepatitis C. The collaborators plan to sell the treatment—combining the antiviral, licensed from Presidio Pharmaceuticals to DNDI and Egypt’s Pharco Pharmaceuticals, with a Pharco-produced version of Gilead’s sofosbuvir—at an “affordable” price (between $300 and $500 for a 12-week…

Japan’s Global Health Innovative Technology (GHIT) Fund on Tuesday announced $8.8 million in drug and diagnostic development investments for neglected tropical diseases.

Two awards will support new projects for separate Buruli ulcer and Chagas disease tests. Meanwhile, two additional awards will fund new partnerships between the Drugs for Neglected Diseases Initiative and Japanese partners for leishmaniasis drug discovery and development.

GHIT Fund’s portfolio now includes 61…

The Lancet Infectious Diseases published Phase 2 results on Tuesday comparing different durations and doses of benznidazole (a standard of care for Chagas disease) alone or in combination with the antifungal fosravuconazole. According to a press release from the Drugs for Neglected Diseases initiative (DNDi), which led the study, a two-week benznidazole Chagas treatment had “similar efficacy and significantly fewer adverse effects” than the current standard eight-week regimen of the…

Japan’s Global Health Innovative Technology Fund announced $21 million in product development investments on Wednesday.

More than two-thirds of the awards will help advance six ongoing projects, while the rest fund four new investments: a leishmaniasis drug from Takeda and the Drugs for Neglected Diseases initiative; a malaria therapy from Eisai, the Medicines for Malaria Venture and the University of Dundee; a tuberculosis drug from Daiichi Sankyo RD Novare and the TB Alliance; and a…

TB Alliance announced a collaboration Monday with ZebiAI to discover, develop and deliver “better, faster-acting and affordable” tuberculosis drugs using the Massachusetts-based company’s machine learning platform.

The project joins a trend in global health: artificial intelligence-driven discoveries in recent years include potential Chagas treatments identified through a Drugs for Neglected Diseases initiative collaboration and an MIT-discovered compound that kills a broad range of…

Sanofi announced an extension on Tuesday of its 20-year partnership with WHO on human African trypanosomiasis (HAT), valuing the new commitment at $25 million over the next five years.

The funds will support disease management, population screening, an awareness campaign, capacity building and drug donation, according to a press release.

Sanofi produces the current HAT standard-of-care—the oral, 10-day fexinidazole regimen—and is working with the Drugs for Neglected Diseases…

Mentions:

The state of the hunt:

The efficacy of AstraZeneca’s AZD1222 vaccine candidate may reach 90%, but critics questioned the reported results.
  New, more detailed data on Russia’s Sputnik V vaccine indicates 91.4% efficacy.
  Regeneron’s mAb cocktail secured U.S. FDA Emergency Use Authorization.

 

Vaccines


Phase 3 candidates

AstraZeneca’s two-shot vaccine regimen showed 90% efficacy when given at a lower dose and 62% efficacy as two full…

The Drugs for Neglected Diseases initiative (DNDi) announced new funding this week from Spain’s la Caixa: a grant of $1.2 million over three years to identify “novel natural products” as potentially effective treatments for leishmaniasis and Chagas disease.

DNDi will share the funding with project coordinator Fundación MEDINA and Institut Pasteur Korea, the joint press release said.

The Drugs for Neglected Diseases initiative (DNDi) announced Friday that it is working again with Sanofi to improve human African trypanosomiasis (HAT) treatment. DNDi and Sanofi successfully licensed their first 10-day HAT regimen, fexinidazole, in November 2018.

This new collaboration will see DNDi complete clinical development of its novel drug acoziborole—taken as a single dose at the point of diagnosis and currently in Phase 2/3 in the Democratic Republic of the Congo and Guinea.…