Vaccines

During a clinical trial of 48 participants, 100% of those that received the TV003 vaccine were protected from infection.

Vaccine R&D has grown exponentially in recent years, spurred by ethical and medical needs to combat lethal infectious outbreaks and increased funding from public and private agencies and organizations.

Seqirus, CSL Limited’s influenza vaccine business, announced the opening of their corporate headquarters in the United Kingdom.

South Africa’s Biovac Institute, which develops and produces vaccines for the country, launched a public-private partnership with Pfizer to enable local manufacturing of Prevenar 13, a vaccine against pneumonia-causing bacteria.

According to a third-quarter earnings report, Pfizer’s vaccine business contributed nearly 14% to its total revenue.

Univercells will integrate its single-use bioprocess with the Takeda vaccines production platform to allow local production.

CMC Biologics will manufacture monoclonal antibodies (mAbs) and provide process development services for the PATH Malaria Vaccine Initiative.

EMA gives GSK’s malaria candidate vaccine a positive opinion for the prevention of malaria in young children in sub-Saharan Africa.

GSK accelerates delivery timeline for US quadrivalent flu vaccine.

The European Medicines Agency reviews the safety of human papillomavirus vaccines.

A study now underway on vaccine manufacturing examines the effects of focusing on consistency during manufacturing, instead of post-production testing.

The divestment of Nimenrix and Mencevax was to satisfy regulatory clearances when GSK gained Novartis’ vaccines business in an asset swap in March 2015.

Medicago's new production facility will make plant-based vaccines and therapeutics.

A vaccine patch may eliminate the need for traditional means of vaccine distribution, according to an article in NPR.

Catalent’s Zydis technology will be used to develop thermo-stable and cold-chain independent vaccines.

GSK notifies CDC and FDA that it is recalling the remaining doses of its 2014–2015 flu vaccine, Flulaval Quadrivalent Thimerosal-free Pre-Filled Syringes, due to decreased potency.

GlaxoSmithKline announces global vaccines research and design facility to be based in Rockville, MD, USA.

NIH announced positive safety results from the vaccine, VSV-ZEBOV, and found that all patients in the study experienced a strong antibody response.

FDA has approved another indication for Eylea, a treatment for diabetic retinopathy in patients with diabetic macular edema.

Emergent BioSolutions announced FDA approval of Anthrasil, an inhalable treatment that targets Anthrax toxins, as well as a contract with BARDA to develop NuThrax, an anthrax vaccine candidate.

The agency provides guidance on determining the need for environmental assessments for gene therapies, vectored vaccines, and viral and microbial products.

The agency will employ a ring vaccination method similar to the one used to eradicate smallpox.

Government and industry efforts to address manufacturing challenges move Ebola vaccine candidates into larger clinical trials.

Baxter announced that it had entered into an agreement to sell its Vero cell technology and related assets to Nanotherapeutics.

The development and approval of new vaccines and antivirals to contain and treat the Ebola virus outbreak has become a top priority for the federal government and Congress, as seen in new policies to spur R&D and added funding for these efforts.

US Department of Health and Human Services announced a declaration to provide immunity to legal claims made in the US in relation to three investigational Ebola vaccines.

No evidence that Fluad vaccine caused deaths in Italy, says EMA.

Dalton Pharma Services announced it was awarded funding from ISTPCanada for its project to develop vaccines for respiratory syncytial virus and parainfluenza type 3.

Merck announced an agreement with NewLink Genetics to acquire exclusive rights to its experimental Ebola vaccine, rVSV-EBOV, for $50 million.

The divestment will create the number two player in the global influenza vaccine industry.