access to medicines

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…

WHO announced Monday that the COVAX partnership’s first Covid-19 mRNA vaccine technology transfer hub will launch with a South African consortium comprising Biovac, Afrigen Biologics and Vaccines, a “network of universities,” and the Africa Centres for Disease Control and Prevention.

A press release quoted WHO Director-General Tedros Adhanom Ghebreyesus as saying Covid-19 had “highlighted the importance of local production to address health emergencies,” while South Africa’s…

JAMA Network Open published a Yale-led study last week that showed new medicines and vaccines approved for use in the United States are often unavailable in countries that hosted their clinical trials, raising “concerns about the equitable distribution of research benefits,” according to a university press release.

The cross-sectional study examined clinical trials sponsored by large companies for 34 novel drugs approved by the U.S. FDA in 2012 and 2014. Five years after their U.S.…

ViiV Healthcare has started a rolling submission for U.S. FDA approval of long-acting, injectable cabotegravir for HIV pre-exposure prophylaxis (PrEP), the GSK subsidiary announced Tuesday. The U.S. regulator awarded Breakthrough Therapy Designation to the PrEP formulation in November 2020, after Phase 3 data showed that an injection every two months was 89% more effective than Gilead’s daily Truvada (emtricitabine/tenofovir disoproxil fumarate) in preventing HIV acquisition in women.

Sanofi CEO Paul Hudson announced on Tuesday the creation of a nonprofit unit, Sanofi Global Health, which will provide 40 lower-income countries with access to 30 of the company’s “most essential medicines,” including cardiovascular, diabetes, tuberculosis, malaria and cancer treatments.

An accompanying press release said Sanofi Global Health will be the cornerstone of the Paris-based company’s corporate social responsibility strategy for “access to medicines, support for vulnerable…

The Access to Medicine (AtM) Foundation last week published a pediatric analysis of additional results from its 2021 AtM Index, finding just 7% of pharmaceutical companies’ R&D is for children under 12, despite significant gaps in treatment options for children.

The report praised GSK, Johnson & Johnson and Sanofi for being “the most active” in developing pediatric versions of products, and also named examples of drugs that “could each make a big difference” for LMICs: Eli…

CARB-X published compulsory guidance on Monday to ensure that new antibacterial products brought to market by its funded companies are used responsibly and made available to people in LMICs.

The Stewardship and Access Plan Development Guide—created by the Boston University-led nonprofit and its partners, including the Access to Medicine Foundation, the Gates Foundation, the Global Antibiotic Research and Development Partnership, the Global Antimicrobial Resistance Innovation Fund, and…

The Lundquist Institute announced Monday that the Bill & Melinda Gates Medical Research Institute will develop its synthetic lung surfactant formulation for use in preterm infants with respiratory distress syndrome in low- and middle-income countries.

The Los Angeles-based research institute currently maintains patents on the therapy in Canada, Europe and the United States.

Novartis announced Wednesday a collaboration with the Gates Foundation to develop an accessible in vivo gene therapy for sickle cell disease (SCD) that could potentially be administered once, directly to a patient, without the need to modify the cells in a lab. The collaboration aims to provide affordable and practical gene therapy for low-resource settings, the press release said.

In other SCD news, Massachusetts-based Bluebird Bio announced Tuesday that it has temporarily suspended…

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,…