LMICs

Germany’s BioNTech announced Monday that it is “evaluating sustainable mRNA vaccine production capacities in Africa” for a candidate malaria shot and other vaccines.

The company said in a press release it would select promising candidates for clinical development from “multiple vaccines featuring known [m]alaria targets” (such as the circumsporozoite protein) while also evaluating new antigens. First trials are planned for year-end 2022.

In the same press release, BioNTech said…

British diagnostics developer Mologic announced Monday that it plans to transform from a for-profit company into a social enterprise through an acquisition worth at least $41 million. The Soros Economic Development Fund is leading the takeover with support from the Gates Foundation, according to Mologic’s press release.

Under a new name—Global Access Health—the firm aims to expand affordable access to medical technology in LMICs, including tests for diseases such as bilharzia, Covid-…

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 Access to Medicine (AtM) Foundation released a new report last week highlighting some biotechs that are finding novel ways to get badly needed antibiotics to patients in low- and middle-income countries despite notoriously difficult market conditions.

Drawing on “new data and discussions with stakeholders,” the report said that small- and medium-sized companies (SMEs) now account for 75% of all late-stage antimicrobials in the R&D pipeline, with many large companies having…

Bayer announced last week that it is investing a total of $303 million to build a new pharmaceutical facility and modernize an existing plant, both in Finland.

The expansion will help Bayer meet its goal of providing 100 million women in low- and middle-income countries with access to family planning and modern contraception by the end of 2030, the press release said.

CARB-X announced Tuesday an award of up to $3.6 million (plus up to $10.2 million in milestones) to Maryland-based Novel Microdevices to develop a rapid, point-of-care, battery-powered diagnostic for sexually transmitted infections such as chlamydia and gonorrhea.

The test—which will also identify antibiotic resistance—will diagnose infections in about 25 minutes from a vaginal swab or urine sample and require no sample preparation, making it “particularly suited” for LMICs, according…

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 state of the hunt:

J&J’s single-dose vaccine scored unanimous endorsement from a U.S. FDA advisory committee, clearing the way for a likely EUA.
  The COVAX Facility made its first shipments, sending vaccine doses to Ghana and Ivory Coast.
  Moderna and Pfizer made progress toward clinical trials of modified, variant-specific vaccines.

 

Vaccines


Approved or authorized vaccines
  
Pfizer/BioNTech shot continues strong showing…

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 state of the hunt:

Regulators in Brazil, Canada and Europe commenced accelerated “rolling reviews” of AstraZeneca’s vaccine candidate even as the U.S. FDA widened its probe of the shot amid safety concerns.
  Serum Institute of India doubled its commitment of affordable Covid-19 vaccine doses to the COVAX AMC, pledging up to 200 million.
  The ACT Accelerator launched a partnership to provide 120 million Covid-19 rapid antigen tests to LMICs over six months.

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