The state of the hunt:

  • Pfizer/BioNTech asked the U.S. FDA to expand its authorization of their vaccine to adolescents.
     
  • Numerous countries restricted the use of the AstraZeneca/Oxford shot to older people—or discontinued it altogether—even as regulators concluded the benefits outweighed the risks.
     
  • COVAX affirmed that SII’s supply commitments to the initiative remain “legally binding” amid…

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,…

France’s bioMérieux has secured European CE marking for three fully automated immunoassays for dengue, the company announced Wednesday.

Performed on the company’s Vidas family platforms, the Vidas Dengue NS1 Ag, Anti-Dengue IgM and Anti-Dengue IgG are “cost-effective and suitable for low- and middle-income countries,” according to the press release.

The company plans to add a chikungunya assay to its diagnostic offerings, per the…

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…

Icosavax announced Wednesday the close of $100 million in Series B financing.

The funds will support the development of the biotech’s bivalent RSV and human metapneumovirus vaccine through initial clinical studies, continued evaluation of its virus-like particle (VLP) Covid-19 vaccine candidate, and expansion of its pipeline of other VLP vaccine candidates targeting respiratory diseases, the press release said.

Cidara Therapeutics announced Monday that J&J’s Janssen subsidiary will license the San Diego-based company’s universal influenza antiviral conjugate (AVC) technology—shelling out $27 million upfront (plus up to $753 million in milestone payments) for exclusive development and commercialization rights for Cidara’s CD388 and other influenza AVCs.

The novel immunotherapies have the potential to prevent and treat “all seasonal and…

Mentions: J&J, Janssen, Cidara, flu, drugs, AVCs

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…

The state of the hunt:

  • Pfizer and BioNTech plan to seek authorization of their vaccine for adolescents age 12-15 after promising Phase 3 results.
     
  • J&J agreed to supply up to 400 million doses of Janssen’s jab to the African Union.
     
  • Serum Institute of India launched clinical trials of its version of the Novavax vaccine candidate.

 

Vaccines


Approved or…

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 “…

Brii Biosciences announced $155 million last week in Series C financing.

The press release said the Sino-American biotech will use the proceeds to fund clinical studies and research for its therapies for hepatitis B, Covid-19, multi-drug resistant Gram-negative bacterial infection and HIV, as well as its central nervous system disease program.

CARB-X announced Monday an award of up to $2 million and up to $5.3 million more in milestones to the University of Oxford’s Jenner Institute for work on its gonorrhea vaccine candidate (dmGC_0817560 NOMV), currently in lead optimization.

The funds will support optimization, scale-up and production for first-in-human trials of “an affordable vaccine for global use,” the press release said.

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…

Local media reported Monday that Indian companies have inked an agreement with the Council of Scientific and Industrial Research’s Indian Institute of Chemical Technology (CSIR-IICT) to expand the use of mRNA as a vaccine development platform in the country.

The Hindu Business Line named vaccine supplier Bharat Biotech International Limited, animal health company Biovet, and biotech Sapigen Biologix as signatories.

Only Pune-…

Sanofi announced Wednesday it will invest over $700 million to build a new vaccine facility in Toronto—increasing supply of its market-leading Fluzone high-dose quadrivalent influenza shot in Canada, the United States and Europe.

The press release quoted CEO Paul Hudson as saying that the new facility “will be a key resource to assist against future pandemics.” Sanofi expects the plant to be operational in 2026.

Takeda has asked the European Medicines Agency to approve its tetravalent dengue vaccine candidate, the company announced last week. In parallel, the agency will consider recommending the shot for countries outside the European Union through the EU-M4all (previously Article 58) procedure, according to the press release.

Takeda said it plans to seek additional approvals for TAK-003 this year in Argentina, Brazil, Colombia, Indonesia,…

The state of the hunt:

  • The European Union and India made new moves to curtail vaccine exports.
     
  • COVAX warned of delivery delays.
     
  • Pfizer and BioNTech launched a pediatric trial of their vaccine in children as young as 6 months.

 

Vaccines


Approved or authorized vaccines
   
New data, new questions for AstraZeneca: If AstraZeneca thought higher-than-…

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…

GSK today fired veteran vaccines adviser Moncef Slaoui as board chair of its majority-controlled Galvani Bioelectronics over “substantiated” allegations of sexual misconduct. An investigation remains ongoing, according to the GSK press release.

Per the press release, Slaoui’s behaviors were “wholly unacceptable” and contrary to the “strong values that define GSK’s culture.”

Slaoui became well known in 2020 as chief scientist…

Citing increased demand for its products, Merck KGaA announced last week that the company is investing $29.5 million to equip its Alsace, France facility as an assembly production unit for Covid-19 vaccines and other therapies.

The press release quoted CEO-in-waiting Belén Garijo as saying the expansion “speaks of the company’s global commitment during and beyond this pandemic.”

South Korea’s Research Investment for Global Health Technology (RIGHT) Fund launched its sixth RFP on Monday: a new Technical Accelerator Award granting up to $440,000 (per project, for up to one year) for “original and innovative concepts” that tackle endemic and emerging infectious diseases in developing countries.

Applicants must include at least one Korean entity. Proposals for vaccines and therapeutics are due by April 9 and for…