News

GSK's vax revenues jump in 2015 while profit, margin slip

Thanks to flailing pharma revenues and its decision to ship away its oncology assets, GlaxoSmithKline has a lot riding on vaccines. And in 2015, the unit delivered with 19% revenue growth, although profit and operating margin both fell.

Affinivax nets another $2.5M from Gates Foundation to advance Prevnar competitor

Cambridge, MA-based Affinivax launched in November 2014 with a $4 million Gates Foundation investment and plans to develop a pneumococcal vaccine that it believes could go beyond Prevnar, the best-selling vaccine in the world. Now, the biotech is announcing $2.5 million in follow-on funding from the Gates Foundation, which it will use to advance its lead candidate, CEO Steve Brugger told FierceVaccines.

UT Southwestern team creates new drug that could aid in vaccine development

Researchers at UT Southwestern Medical Center have discovered a new drug that could help in vaccine development. It activates the innate immune system in a novel way.

NCI's Cancer Centers join in HPV vaccination push

All 69 of the United States' National Cancer Institute-designated centers have joined together to issue a statement urging an increase in HPV vaccinations, declaring the vaccines "tragically underused" and calling low uptake a "public health threat."

Merck, J&J, Pfizer consider joining Zika vaccine race

While the early entrants to the race for a Zika vaccine have been on the smaller side--think Hawaii Biotech, NewLink Genetics and Inovio Pharmaceuticals--the big guns are now joining in. Just one day after Sanofi announced a firm plan to develop a vaccine for the mosquito-borne disease, a parade of Big Pharmas has joined GlaxoSmithKline in "evaluating their technologies" for the potential of developing a Zika vaccine.

Pfizer's vaccine sales leap in 2015 thanks to Prevnar 13

Riding Prevnar 13 uptake, Pfizer's vaccines unit capped off a big growth year on Tuesday, reporting Q4 sales increases of 45% and full-year 2015 growth of 44%.

Sanofi's Brandicourt mulls pulling the plug on Merck JV: Bloomberg

Back in 1994, Merck and Pasteur Merieux Connaught--now Sanofi Pasteur--teamed up on a joint venture to develop and market vaccines in Europe. Now, as Sanofi chief Olivier Brandicourt reorganizes the French pharma's operations in a cost-cutting bid, the 21-year-old partnership could be on the chopping block.

Sanofi launches Zika vaccine R&D effort

As the global alarm continues to sound about the Zika virus, Sanofi said on Tuesday that it's getting involved. In doing so, it became the first major pharmaceutical company to get involved in the Zika vaccine race, launching a program to develop a jab just after receiving the first regulatory approvals for its dengue shot.

UPDATED: Private clinics seeing shortage of GSK's Bexsero in U.K.

GlaxoSmithKline has been experiencing a high demand for its meningitis B vaccine Bexsero that has led to a shortage of doses for U.K. private clinics outside of the country's National Health Service.

U.K. committee warns that country is unprepared for an epidemic

The most recent Ebola outbreak exposed the U.K.'s inadequate ability to respond to an infectious disease epidemic, the country's Commons Science Committee said on Monday. While Ebola did not spread beyond West Africa, the world may not be so lucky next time.

U.K., Gates pledge $4.3B to take malaria fight beyond vax

While the European Medicines Agency gave the world's first malaria vaccine a regulatory nod last July, the vaccine isn't perfect, conferring only partial immunity that wanes over time. On Monday, Bill Gates and Chancellor George Osborne, the British finance minister, announced a £3 billion fund ($4.28 billion) to support research and efforts to eradicate malaria.

Case Western, Merck team spotlights vaccine response predictors

Using a "systems vaccinology" approach, researchers at Case Western Reserve University School of Medicine and Merck Research Laboratories have published findings that suggest a new way to predict and enhance vaccine effectiveness, in particular with hepatitis B vaccination.

Takeda's Hib vaccine gets Japanese approval

Almost 7 years after licensing it from Novartis, Takeda picked up a regulatory green light from Japan's Ministry of Health, Labour and Welfare for its Haemophilus influenzae type B (Hib) vaccine. The vaccine, Vaxem Hib, is approved for use in children aged two months to under 5 years.

Zika outbreak triggers R&D attention from pharma, governments

As the Zika virus continues to grab headlines and its spread threatens, governments and industry are urgently committing resources and analyzing vaccine development options.

Dengue vaccine developed at NIH enters PhIII in Brazil

A dengue fever vaccine developed by scientists at the National Institute of Allergy and Infectious Diseases is entering a Phase III in Brazil that aims to enroll nearly 17,000 people in 13 cities. 

Merck to submit Ebola vaccine for regulatory approval in 2017

Merck's candidate is the furthest along in the quest for an Ebola vaccine, having posted interim Phase III data showing 100% efficacy last July. Now, the Big Pharma has won $5 million from Gavi, the global vaccine alliance, to help see its candidate through late-stage trials, licensure and prequalification by the WHO, and plans to submit the vaccine for regulatory approval by the end of 2017.

Sanofi Pasteur joins other industry, academic players in Human Vaccines Project

Sanofi Pasteur has become the latest industry player to join up with the Human Vaccines Project--a global consortium seeking to address prominent issues hindering vaccine development--announcing late last week it's contributing funds for scientific and administrative activities.

FDA expands indication for GSK's Hib vaccine, Hiberix

In 2009, GlaxoSmithKline worked with U.S. health authorities to bring its Haemophilus influenzae Type b (Hib) vaccine, Hiberix, to market. Now, the FDA has expanded the indication of GSK's Hiberix from a booster to a full-series, four-dose vaccine to immunize children aged 6 weeks to four years.

Baltimore's Profectus BioSciences starts PhI trial of Ebola vaccine

Back in October 2014, Profectus BioSciences scored $9.5 million in Department of Defense funding to manufacture its trivalent vaccine to protect against Ebola and Marburg viruses. Now, the Baltimore-based biotech is taking its Ebola candidate to Phase I trials.

Sanofi working with health authorities on dengue vaccine strategies

Sanofi Pasteur spent 20 years and $1.5 billion researching its dengue fever vaccine, Dengvaxia, and now it's looking to maximize the vaccine's impact. To do that, the French pharma's vaccine division is working with regulators and health officials to identify implementation strategies, program head Guillaume Leroy told FierceVaccines.