CHAI

The Geneva-based Global Antibiotic Research and Development Partnership (GARDP) announced Tuesday that it has signed a memorandum of understanding (MOU) with the Clinton Health Access Initiative (CHAI) and Shionogi to accelerate LMIC access to the Osaka-based drugmaker’s antibiotic cefiderocol (Fetroja).

The collaboration will help introduce the drug—indicated for bacterial infections in patients with limited treatment options—into health systems and provide clinical guidance to…

The University of Oxford announced Monday that its Jenner Institute has launched a Phase 1 trial in Britain of its HIVconsvX novel “mosaic” vaccine candidate that targets a broad range of HIV-1 variants.

The trial—which will test a single dose of the T cell-inducing candidate followed by a booster at four weeks in HIV-negative adults considered not to be at high risk of infection—is the first in a series of evaluations of HIVconsvX as a “vaccine strategy in both HIV-negative…

The Clinton Health Access Initiative (CHAI) and the American Cancer Society (ACS) announced Monday that Biocon Biologics will join their Cancer Access Partnership (CAP), which aims to increase access to cancer treatments in low- and middle-income countries in Africa and Asia.

The addition of the Bangalore-based company—“India’s largest biopharma,” according to Biocon’s website—and an expanded portfolio of biosimilars from Pfizer will allow the partnership to offer affordable…

Pfizer announced Tuesday the launch of a new partnership with the Netherlands-based IDA Foundation to provide “equitable access to quality cancer treatments” in almost 70 low- and middle-income countries across Latin America, Asia, Africa and the Western Pacific region.

The agreement will allow developing country governments and non-governmental organizations to access 18 essential cancer treatments and 30 formulations from Pfizer’s portfolio, including options for treating breast,…

The IMPAACT4TB consortium announced Wednesday that it will roll out a new, patient-friendly preventive tuberculosis therapy in five high-burden countries, beginning in February.

Led by African NGO the Aurum Institute (with funding from Unitaid), the program will provide a fixed-dose combination of “3HP”—a short-course TB treatment combining rifapentine and isoniazid—to Ethiopia, Ghana, Kenya, Mozambique and Zimbabwe. An agreement between manufacturer Macleods, Unitaid and the Clinton…

Newly formed generics giant Viatris announced Monday that the U.S. FDA has tentatively approved its 10mg pediatric dolutegravir antiviral tablets for oral suspension for treatment of HIV-1.

According to the press release, the tentative approval—granted under the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR)—permits the distribution in certain PEPFAR countries of generic products still under U.S. patent or exclusivity protection.

Pfizer’s Upjohn generics subsidiary…

The state of the hunt:

With their mRNA vaccine showing an interim efficacy rate above 90%, Pfizer and BioNTech may have the necessary data to apply for U.S. FDA Emergency Use Authorization this month.
  Eli Lilly snagged the first FDA EUA for an anti-SARS-CoV-2 monoclonal antibody.
  Indonesia and Morocco laid out plans for Covid-19 mass immunization campaigns before year-end.

 

Vaccines


Phase 3 candidates:

Pfizer/BioNTech’s shot more…

Britain’s Department for International Development, Unitaid, the British government’s MedAccess, the Clinton Health Access Initiative (CHAI), the U.S. President’s Emergency Plan for AIDS Relief, the African Society for Laboratory Medicine, and the government of Zambia announced a deal at last week’s International AIDS Conference with Massachusetts-based Hologic Inc. to provide public sector programs in eligible countries with its molecular diagnostics for a single, all-inclusive price per…

Company announcements figured prominently this week at the 22nd International AIDS Conference, which closed today in Amsterdam in front of more than 15,000 delegates from academia, civil society, government and industry.

On HIV pre-exposure prophylaxis, Gilead touted new data on the impact of its emtricitabine and tenofovir disoproxil fumarate drug Truvada in the United States on the average number of HIV diagnoses. States with the highest utilization had significant declines, while…

Aurobindo Pharma and CHAI announced Thursday that Aurobindo has received U.S. FDA tentative approval for its generic version of HIV treatment dolutegravir, an integrase strand transfer inhibitor recommended for use in treatment-naïve patients by WHO.

The approval is a prerequisite for the Hyderabad-based company to supply PEPFAR countries. ViiV and Aurobindo signed an agreement in 2014 for Aurobindo to supply dolutegravir in 92 licensed countries, given local regulatory approval.