A booster dose of Sanofi’s Dengvaxia tetravalent dengue vaccine “does not elicit a consistent, meaningful booster effect” against all dengue serotypes in people previously exposed to the virus, according to a Phase 2 non-inferiority study published Tuesday in The Lancet Infectious Diseases.
The Sanofi-funded study—conducted in Colombia and the Philippines—tested an additional dose of the live attenuated shot administered one or two years after a two- or three-dose primary series in…
Newly revealed data have called into question last year’s exuberant claims from AstraZeneca and Sanofi about nirsevimab, their single-dose monoclonal antibody (mAb) to prevent RSV in infants, Endpoints News reported last week. Published in the New England Journal of Medicine, the Phase 3 data showed that the mAb’s effects on hospitalization were not statistically significant.
Hospitalization is a “key metric” for the potentially lucrative mAb because RSV manifests in most kids “as…
Fourteen leading pharma companies released fourth-quarter and full-year 2021 financial results in February. (Figures exclude exchange rate and portfolio changes where applicable.)
Leading the pack, SK Bioscience generated an unprecedented $375 million in fourth-quarter revenues—a 573% jump from the same period in 2020—driven by its CMO drug substance manufacturing business, which contributed to AstraZeneca/Oxford and Novavax Covid-19 vaccine production. The South Korean company also…
The state of the fight:
Sanofi and GSK’s vaccine candidate demonstrated 58% efficacy against symptomatic Covid-19 in Phase 3.
The U.S. FDA lifted its clinical hold on Bharat Biotech’s Covaxin, clearing the way for the inactivated vaccine to…
WHO reportedly added two vaccines to its prequalification list in recent weeks.
Sanofi’s meningococcal ACYW tetanus toxoid-based conjugate vaccine, MenQuadfi, notched PQ status last month, according to WHO records.
Meanwhile, a CNBG announcement last week on Chinese social media stated that its Sabin-based inactivated polio vaccine (sIPV) had won the designation. With this approval, CNBG’s shot beats out Sinovac’s product to become the second prequalified sIPV after LG Chem’s…
Moderna’s mRNA-based RSV vaccine candidate (mRNA-1345) has advanced to Phase 3 in adults age 60 and older, the Massachusetts-based company announced Tuesday. The U.S. FDA Fast Track-designated shot joins RSV candidates from J&J and Pfizer in late-stage trials. Numerous other vaccine makers are also in the race to bring the first RSV jab to market.
In other RSV news, Enanta Pharmaceuticals last week touted positive Phase 2 data on EDP-938, the Massachusetts-based firm’s N-protein…
The state of the fight:
Moderna and Pfizer/BioNTech launched trials of Omicron-specific vaccine candidates.AUTHORIZED VACCINES
New data on rates of myocarditis following mRNA-based vaccination trickled in this week, highlighting an increased risk of the heart inflammation side effect in young men…
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 studies and focusing on clinical trials’ most “…
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 Sangamo’s product is “far behind” a rival gene…
Two pharmas closed out 2021 with large M&As.
In the biggest deal of the year, Melbourne-based CSL announced last week an all-cash acquisition of Swiss specialty pharma Vifor worth $11.7 billion. The purchase will help “expand our presence in the rapidly growing nephrology market,” CSL’s CEO said in a press release.
Next, Sanofi struck a billion-dollar deal with California-based Amunix, the French company announced Tuesday. The merger supports “Sanofi’s efforts to accelerate…