Valneva has launched an additional Phase 3 trial in Brazil of its VLA1553 live attenuated, single-dose chikungunya vaccine, the French company announced Monday.
The announcement follows previous Phase 3 data showing the Coalition for Epidemic Preparedness Innovations (CEPI)-backed shot produced neutralizing antibodies in 98.5% of participants and was well-tolerated in adults.
The new study tests the jab in adolescents ages 12 to…
The state of the fight:
AUTHORIZED VACCINES
New data on rates of myocarditis following mRNA-based vaccination trickled in this…
Germany’s IDT Biologika will invest $113 million to increase its vaccines and biopharmaceuticals manufacturing capacity, the CDMO announced last week.
The expansion is part of a multiyear program that will increase space for drug substance manufacturing, aseptic liquid filling, packaging capabilities and automated visual inspection, the press release said.
IDT provides CDMO services for a handful of Covid-19 vaccine developers…
The University of Washington’s Institute of Health Metrics and Evaluation (IHME) last week released what it described as “the first comprehensive assessment” of the global burden of antimicrobial resistance. Published in The Lancet, the study finds AMR “a leading cause of death around the world, with the highest burdens in low-resource settings.”
IHME said AMR was directly responsible for an estimated 1.27 million deaths in 2019—far…
Leyden Labs has raised $140 million in Series B financing, the intranasal therapeutic specialist announced Tuesday.
Leyden will use the funds to advance PanFlu, its preclinical monoclonal antibody influenza treatment candidate. Last week, the Netherlands-based company licensed PanFlu for mucosal administration from J&J’s Janssen, per a separate press release.
Former Vir executive Suha Jhaveri, who joined Leyden as chief…
Candidate oral rotavirus vaccine RV3-BB was efficacious when administered in neonatal or routine infant schedules, according to results from a Phase 2 trial in Malawi published last week in The Lancet Infectious Diseases.
The 711-participant study found that a mid-titer vaccine generated “similar” IgA seroconversion to a high-titer shot, fulfilling non-inferiority criteria and suggesting an opportunity “to enhance manufacturing capacity…
Seres Therapeutics’ oral microbiome treatment for C. difficile infections (CDI) proved superior to placebo in reducing CDI recurrence, according to Phase 3 data published last week in the New England Journal of Medicine. Touting the “first-ever positive pivotal clinical results for a targeted microbiome drug,” the Massachusetts-based company said in a press release it would finalize its U.S. FDA Biologics License Application for SER-109 in…
Protas, a British not-for-profit organization aiming to design large, inclusive, randomized clinical trials “at a fraction of current costs,” has launched with an investment of up to $6.8 million from Sanofi, the organization announced Monday.
The NHS-supported firm plans to streamline therapeutics R&D for conditions including heart, lung and respiratory disease, arthritis, cancer, depression, and dementia by designing its own…
The state of the fight:
AUTHORIZED VACCINES
The Chilean health ministry released data on the…
The wave of CDMO capacity expansions continued into the new year with contract manufacturer ZhenGe Biotech raising $100 million in series C funding to build “multiple” 15,000-liter production lines, according to its press release last week.
Founded in 2017, the Shanghai-based company—which also has facilities in Maryland—claims expertise in monoclonal and bispecific antibodies, antibody-drug conjugates, fusion proteins and vaccines.…
Current winners of the Covid-19 vaccine race previewed plans for their windfalls at last week’s 40th J.P. Morgan Healthcare Conference, which took place virtually for the second consecutive year.
Moderna trumpeted $17.5 billion in 2021 Covid-19 product sales and sounded an optimistic note about the year ahead, claiming $18.5 billion in advance purchase agreements for vaccine or booster doses for delivery in 2022. Also, CEO Stéphane…
GSK Chief Scientific Officer Hal Barron will depart in August to head San Francisco-based startup Altos Labs, the multinational announced Wednesday. He will be succeeded by Senior VP of Medicinal Science and Technology Tony Wood, a longtime Pfizer veteran.
The press release said Barron will remain on GSK’s board as he transitions to the $3 billion-funded biotech focused on cellular rejuvenation and reversing disease.
Barron’s move…
Decreased Shigella prevalence may “partly explain the mortality benefit” observed in children under age 5 who received azithromycin in the Africa-based MORDOR trial, according to a study published last week in Clinical Infectious Diseases.
The new study analyzed samples from child participants in 30 villages in Niger and found a 64% reduction in Shigella infections after two years in those who received Pfizer’s Zithromax tablet…
Vir Biotechnology announced last week that the Gates Foundation is giving the San Francisco-based biotech $10 million in grant funding and a $40 million equity investment to back the development of platform technologies that can produce broadly neutralizing antibodies to treat HIV and prevent malaria.
The new initiative will trial the “potential impact of broadly neutralizing antibodies engineered to inhibit viral replication and spread…
The state of the fight:
AUTHORIZED VACCINES
Two doses of Pfizer/BioNTech’s…
A battery-operated TB test designed for low-resource, high-burden settings has earned a nod from the Global Fund’s Expert Review Panel for Diagnostics, the test’s co-developer announced Monday.
Qiagen’s QIAreach QuantiFERON-TB test, co-developed with Australia-based Ellume, offers “ultrasensitive digital detection” of latent tuberculosis infection, according to an Ellume press release. The approval clears the way for the test’s…
Merck KGaA will bolster its mRNA contract manufacturing business with the $780 million acquisition of Exelead, an Indiana-based CDMO, the multinational announced last week.
Exelead’s specialties include lipid nanoparticle-based drug delivery technology used in mRNA-based therapeutics, according to a Merck press release.
Ghana-based pharmaceutical supply chain startup mPharma has locked up $35 million in Series D funding, TechCrunch reported last week.
A portion of the funds will fuel the expansion of mPharma’s Mutti pharmacies in eight African markets, per the article, which said the pharmacies will offer a first point of care for patients, with services including medical consultations and diagnostics.
The new investments bring mPharma’s total…
Dosing has begun in a British Phase 1 trial of a lymphatic filariasis and onchocerciasis drug candidate, AWZ1066S, the Liverpool School of Tropical Medicine (LSTM) announced last week.
Developed through a partnership between Japan’s Eisai, LSTM and the University of Liverpool, the therapy targets symbiotic Wolbachia bacteria in adult worms rather than killing the worms themselves, an approach that may reduce treatment time and…
Sanofi is backing out of a collaboration with Sangamo Therapeutics to develop a gene-edited sickle cell disease therapy, California-based Sangamo announced last week.
The news came weeks after Sangamo touted favorable proof-of-concept data on SAR445136 from a Phase 1/2 trial. In the press release, Sanofi’s R&D chief attributed the move to a strategic focus on “universal genomic medicine approaches.” But BioPharma Dive noted that…