DNDi

The state of the fight: 

Medicines Patent Pool sublicensed Pfizer’s Paxlovid to 35 generics manufacturers.
  Key WTO members reached a tentative agreement to waive some IP rights on Covid-19 vaccines.
  Moderna and Pfizer asked the U.S. FDA to authorize fourth doses of their respective jabs.   AUTHORIZED VACCINES

 
Medigen’s protein subunit vaccine (MVC-COV1901) offered similar safety and immunogenicity for adolescents as it did for adults, the Taipei-based…

A consortium seeking to optimize existing cryptococcal meningitis therapy flucytosine has launched a South African Phase 1 trial to evaluate a new formulation of the antifungal, the Drugs for Neglected Diseases Initiative (DNDI) announced last week.

With funding from the European & Developing Countries Clinical Trials Partnership, DNDI and other members of the 5FC HIV-Crypto consortium will assess three sustained-release formulations that can be taken orally or via nasogastric tube…

The state of the fight: 

Pfizer/BioNTech’s Comirnaty appeared to offer only 12% effectiveness against Omicron in children ages 5-11.
  South Africa’s Biovac partnered with nine development institutions to boost local vaccine manufacturing capacity.
  Eli Lilly’s arthritis drug Olumiant reduced the risk of death by 13% in hospitalized Covid-19 patients.   AUTHORIZED VACCINES

 
Pfizer/BioNTech’s Comirnaty is far less protective against infection in children ages…

The state of the fight: 

A Lilly mAb active against Omicron won a U.S. FDA emergency use nod.
  Novavax’s shot proved 80% efficacious in adolescents ages 12-17, according to a Phase 3 readout.
  Vaxxinity’s UB-612 vaccine candidate performed better against Omicron than an mRNA-based comparator jab.

 

AUTHORIZED VACCINES

 
J&J’s single-dose shot was only 53% efficacious against moderate to severe Covid-19 (28 days post-injection) in a final analysis…

Japan’s Global Health Innovative Technology (GHIT) Fund will invest $6.6 million in diagnostics, drugs and vaccines development, the nonprofit announced last week.

One award will advance an ongoing Chagas disease drug development project by the Drugs for Neglected Diseases Initiative (DNDI). The five other are new projects: a TB diagnostic, a placental malaria vaccine, a malaria drug, and two separate Chagas drugs (by DNDI/Takeda and DNDI/Daiichi Sankyo).

GHIT Fund’s portfolio…

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…