The state of the fight: 

  • The Bill & Melinda Gates Foundation will invest up to $120 million to accelerate access to Merck’s molnupiravir for lower-income countries.
     
  • Valneva’s inactivated vaccine candidate generated superior neutralizing antibody titer levels to those induced by the AstraZeneca/Oxford shot, according to a Phase 3 readout.
     
  • U.S. regulators cleared booster shots of the J&…

Emergent BioSolutions has launched a U.S.-based Phase 3 trial of its CHIKV VLP single-dose chikungunya virus-like particle vaccine in healthy people ages 12-64, the Maryland-based company announced last week.

The announcement follows Phase 2 persistence data that showed people who received a dose of the adjuvanted candidate maintained neutralizing antibody titers for two years at levels 19 times higher than pre-vaccination.

Rivals…

Entasis Therapeutics’ investigational sulbactam-durlobactam (SUL-DUR) antibiotic was non-inferior versus standard colistin at preventing 28-day all-cause mortality in people with carbapenem-resistant A. baumannii infections, the Massachusetts-based biotech announced Monday, citing new Phase 3 data. The topline results also showed that SUL-DUR patients had higher clinical cure rates and lower rates of nephrotoxicity compared to those receiving…

GSK has launched a Phase 1/2 trial of a Shigella vaccine candidate against S. sonnei and S. flexneri serotypes 1b, 2a and 3a, the company announced Tuesday.

According to ClinicalTrials.gov, the company will first study its altSonflex1-2-3 vaccine candidate in adults ages 18-50 in Europe before trialing the shot in a shigellosis-endemic population in Africa.

The shot uses the Generalized Modules for Membrane Antigens (GMMA)…

A new J&J subsidiary established by the pharma giant to hold its cosmetic talc litigation liabilities has filed for voluntary Chapter 11 bankruptcy, Johnson & Johnson announced last week.

J&J’s press release said the filing is intended to resolve claims “in a manner that is equitable to all parties, including any current and future claimants” and is “not a concession of liability.” Nevertheless, J&J will provide…

Mentions: J&J, litigation

Regulators delivered good news to Merck last week.

Firstly, the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of the company’s 15-valent pneumococcal conjugate vaccine in adults. The U.S. FDA approved the shot in July.

Meanwhile, the FDA approved Merck’s blockbuster cancer immunotherapy, Keytruda, to be used in combination with chemotherapy, with or without bevacizumab (Roche’s Avastin), for the…

Three pharmas published environmental, social and governance commitments this week.

First, BD released its 2021 Together We Advance strategy, promising to achieve carbon neutrality across direct operations by 2040, to work with supply chain partners on labor and environmental practices, and to improve ethnic and gender diversity at its management and executive levels by 1% year over year, among other measures.

Next up, GSK’s HIV…

Mentions: GSK, ViiV, BD, BMS, CSR, ESG, DEI, governance

The U.S. FDA expanded the age indication of Seqirus’ cell-based seasonal quadrivalent influenza vaccine, Flucelvax, to include children age 6 months and older, the New Jersey-based company announced last week.

Supporting the approval, a Phase 3 study demonstrated that the shot was safe and immunogenic in children ages 6 months to 5 years, according to the Seqirus press release.

Xiamen Innovax’s bivalent HPV vaccine has won WHO prequalification, PATH announced Tuesday.

The quality mark allows UNICEF and other international agencies to buy the shot—and breaks Merck’s and GSK’s hold over Gavi supply.

PATH—which provided technical assistance to China-based Innovax during the WHO review process—is also sponsoring a Phase 3 trial (underway in Bangladesh and Ghana) to evaluate regimens of the shot with fewer…

The state of the fight: 

  • A U.S. FDA advisory panel recommended booster shots of the J&J and Moderna vaccines for select groups.
     
  • CureVac will abandon development of its first-generation mRNA-based vaccine candidate.
     
  • Brii Bio has submitted its monoclonal antibody cocktail to the U.S. FDA for Emergency Use Authorization.
Approved or authorized vaccines

 
WHO advisory group…

The African Medicines Agency (AMA) cleared a major threshold last week when Cameroon became the 15th country to formally confirm its participation, setting off a 30-day countdown for the agency’s establishment, according to a statement from the African Union.

The AMA aims “to provide support for weak regulatory systems,” promoting harmonized regulatory policies among members, per the statement. In an article on the development, Health…

BD announced last week that it has completed new needle and syringe manufacturing lines in its Holdrege, Nebraska facility more quickly than initially planned in order to meet surging U.S. demand spurred by the Covid-19 pandemic.

The $70 million project included $42 million in funding from the U.S. Biomedical Advanced Research and Development Authority, the press release noted.

Cocrystal Pharma has scored a nod from Australian regulators to begin a Phase 1 trial of its CC-42344 oral PB2 inhibitor for the treatment of pandemic and seasonal influenza A, the Washington state–based company announced last week.

The biotech’s discovery and development pipeline also includes antivirals for treating Covid-19, hepatitis C and norovirus, according to the press release, while the company website says it’s developing an…

Paul Stoffels, J&J’s chief scientific officer, will retire at the end of this year, the company announced Tuesday.

J&J’s press release credited Stoffels with launching Johnson & Johnson Global Public Health and spearheading the development of the company’s Covid-19 vaccine. A Wall Street Journal article on Tuesday said he pushed the company to pursue medicines for LMICs, “including one for multidrug-resistant tuberculosis…

Mentions: J&J, leadership

Moderna said last week that it will invest up to $500 million to build “a state-of-the-art mRNA facility” in Africa with the goal of producing up to 500 million vaccine doses per year, “to include drug substance manufacturing with the opportunity for fill/finish and packaging capabilities at the site.”

The press release said Moderna expects to begin country and site selection soon. However, company chair and co-founder Noubar Afeyan…

Mentions: Moderna

Some 47% of the world’s population has little or no access to basic diagnostics except those for HIV and malaria, according to a report issued last week by the Lancet Commission on Diagnostics. Access to diagnostics is the “single largest gap in the care pathway” and is most severe at the primary healthcare level, where only about 19% of people in LMICs have access to simple tests, the article said.

The Commission proposed 10…

Mentions: diagnostics, LMICs, UHC

The Lancet Microbe published an article last week by European academics arguing that funding for antibiotic innovation remains “insufficient to address the scale of antibiotic resistance.” As an alternative, the authors proposed a “mission-oriented” antibiotic trials infrastructure to protect new drugs from commercial failure.

Through the so-called Networked Institute Model (NIM), a collection of public institutes would conduct all…

WHO’s Strategic Advisory Group of Experts (SAGE) on Immunization gave the go-ahead on Monday to broader use of novel type 2 oral polio vaccine (nOPV2), making more countries eligible to deploy it, the Global Polio Eradication Initiative (GPEI) said in a press release.

The move comes after SAGE and WHO’s independent Global Advisory Committee on Vaccine Safety reviewed data from campaigns earlier this year that used more than 65 million…

Mentions: WHO, SAGE, Polio, vaccines, nOPV2, GPEI

The state of the fight: 

  • Countries raced to order Merck’s molnupiravir antiviral after positive Phase 3 results.
     
  • WHO released an independent strategic review of the Access to COVID-19 Tools Accelerator.
     
  • SII plans to ship bulk substance for its Covishield vaccine to AstraZeneca in the U.K. when it resumes exports.
Approved or authorized vaccines

 
European countries pause…

Seqirus announced on Tuesday that the U.S. Biomedical Advanced Research and Development Authority has picked the CSL subsidiary to develop two influenza A(H2Nx) vaccine candidates through Phase 1.

The $35 million deal will evaluate one cell-based and adjuvanted candidate and one self-amplifying mRNA (sa-mRNA) shot, the New Jersey-based company said in a press release.