As COVID-19 and its variants continue their attack, the agency maintains its position of overseer and giver of advice on various treatments and vaccines.
The US Food and Drug Administration continues to review potential preventatives and treatments for the virus, and to offer advice to life-sciences professionals and civilians alike.
The US Food and Drug Administration has kept its staff busy with approvals, authorizations, and warnings related to various coronavirus-centered products.
The CRO is offering an expanded range of post-authorization solutions designed to help developers with treatments and vaccines in their product pipeline
Valneva and Pfizer have initiated a Phase 2 study for their Lyme disease vaccine candidate: which is the only active Lyme disease vaccine in clinical development today.
As the COVID-19 vaccines continue the early stages of circulation in the US, the agency keeps an eye on industry actions and offers advice to key players.
As healthcare providers and other high-priority patients begin receiving the vaccines, the agency continues to act to help the national pandemic response.
Merck to invest in its North Carolina facilities as it expands production capacity to meet demand for its HPV vaccine Gardasil, and grow its packaging operations
Researchers describe a technique to quantify a person’s “immune age,” information which could help design and analyze clinical trials – improving the drug development process, among other “impressive” possibilities, says industry expert.
The two companies will combine technologies to create solid-dose, needle-free vaccines for a number of infectious diseases and emergent threat pathogens.
Messenger RNA is demonstrating success in vaccine manufacturing and CureVac is giving it the place to do so with the development of a prophylactic vaccine with mRNA at its core.
InvVax’s universal flu vaccine candidate has demonstrated preclinical success as the company prepares for a Phase I clinical trial, supported by a Series A fundraising round.
The Coalition for Epidemic Preparedness Innovations announced a collaboration with IDT Biologika for MERS vaccine development in which IDT will receive up to $36m.
Vector-based vaccine tech firm Vaccitech has secured £20m ($27.1m) in venture capital with investors Google Ventures, Sequoia China, Neptune Ventures and Oxford Sciences Innovation.
The team behind a microneedle patch designed to administer influenza vaccines say it has increased thermostability compared to needle and syringe immunisation methods.
Avista Pharma Solutions, Inc. has been contracted to manufacture an opioid-derived small molecule, which is a component of a conjugate vaccine being developed to treat opioid addiction.
Long life-cycles and significant consolidation in the manufacturing space have led to a lack of skilled workers in the vaccine space, says Sanofi Pasteur.
Two Bill & Melinda Gates Foundation grants will be used to develop a polio and measles rubella vaccine delivered through microneedles on a sustained-dermal patch.
Accinov has teamed up with Canadian clinical research organisation (CRO) Biodextris to provide a transatlantic biomanufacturing ‘plug and play’ service for biopharmaceuticals—with a particular expertise in vaccines.
US public health programmes will use lower dose vaccines administered over longer periods from 2017 if President elect Donald Trump adheres to a plan he outlined last year.
PharmaJet has inked a multi-year deal with the World Health Organization for its needle-free technology, which uses 80% less vaccine than traditional methods.
INC Research has launched a Vaccine Catalyst Site network as part of the company’s Catalyst program, which was introduced earlier this year to strengthen collaborations with clinical research sites.
Inovio Pharmaceuticals and GeneOne Life Science have dosed the first patient in the multi-center, phase I clinical trial of the companies’ Zika vaccine.
A recently opened facility will double production of Sanofi Pasteur’s vaccine Stamaril which could alleviate shortages in the wake of recent yellow fever outbreaks in parts of Africa.
Sanofi Pasteur, the vaccines division of Sanofi, has launched a vaccine research and development project targeting the prevention of Zika virus infection and disease.
An influenza vaccine produced in tobacco plants could make a big impact in the market if it reaches the market in the US in time for the 2018-19 flu season, says a market analyst.
Sanofi Pasteur has launched a Zika vaccine project, levering its experience in developing vaccines for similar viruses, as the US government pushes for “intensified research.”
A Zika vaccine is a long way off according to a UK academic who suggested vaccines for related viruses could be used as delivery vectors to accelerate development.
Mucosis has been awarded a Wellcome Trust grant of €3.7m ($4m) to help develop a Respiratory Syncytial Virus (RSV) vaccine using its intranasal delivery platform.
