News

Allegheny General Hospital joins Sanofi's Cdiffense PhIII trial

The race to a Clostridium difficile vaccine has been dominated by Big Pharmas Sanofi and Pfizer, whose candidates were fast-tracked by the FDA in 2010 and 2014, respectively. Allegheny General Hospital in Pittsburgh announced on Wednesday that it will participate in Phase III trials for Sanofi's investigational vaccine.

FDA puts clinical hold on Advaxis' cervical cancer vaccine

On Sept. 18, Advaxis reported "encouraging" data from a Phase II trial of its cervical cancer vaccine, axalimogene filolisbac, dubbed ADXS-HPV. Now, the biotech is reporting an FDA clinical hold on the candidate--5 days after the FDA placed the hold.

With PhII data, Genocea's herpes jab continues on blockbuster path, CEO says

Targeting a patient population in the millions, Cambridge, MA-based Genocea this week released results of its genital herpes vaccine hopeful that CEO Chip Clark says affirm the jab's potential to one day break the $1 billion sales mark.

BARDA provides funding to Vaxart, U. of Cambridge for flu vaccine improvements

As part of its responsibility to prepare for public health threats, the U.S. Department of Health and Human Services' BARDA unit is seeking more effective influenza vaccines to incorporate into its pandemic strategy. Now, it's funding two projects it hopes will help the state of affairs.

PRA Health joins with clinical research network to improve vaccine studies

Seeking to accelerate the process of getting new vaccines to market, PRA Health Sciences partnered with the Alliance for Multispecialty Research to look for ways to help vaccine studies run more efficiently and effectively. 

Focusing on neoantigens, Neon Therapeutics launches with a $55M Series A

Fresh off of a $55 million Series A financing round, Neon Therapeutics jumped into the cancer vaccines space today with the aim of utilizing neoantigen biology to unlock a powerful immune response against the disease.

BiondVax, EU's UNISEC team up for universal flu jab PhIIb

Less than a month after pairing with the NIAID on a Phase II trial of its universal flu vaccine in the U.S., BiondVax is looking to Hungary for its next trial, this time in conjunction with an overseas public health authority.

Advaxis targets HER2 cancers with first-in-human vaccine trial

Following up on data from a Phase I study in canines with osteosarcoma, Advaxis is taking its HER2 cancer vaccine into human trials.

Novavax's RSV jab protects infants in PhII, nets $89M Gates Foundation grant

Novavax reported on Tuesday that topline results from a Phase II trial in pregnant women showed that its respiratory syncytial virus vaccine protected infants via maternal immunization. It also announced that it won a potential $89 million grant from the Bill & Melinda Gates Foundation to get its candidate through Phase III.

UPDATED: NewLink wins $26.1M in government funding to advance Ebola vaccine

NewLink Genetics won a total of $26.1 million in funding to further the development of its candidate Ebola vaccine from the DOD's Defense Threat Reduction Agency and HHS' BARDA in the span of just over a week. The company has licensed the research, development and manufacturing of the jab to Merck.

GAVI selects next board chair in Ngozi Okonjo-Iweala

The vaccine alliance, GAVI, named Dr. Ngozi Okonjo-Iweala, former Nigerian Minister of Finance, its board chair-elect after an international competitive search process; she'll assume the role in January.

IDRI, Wellcome Trust to take tuberculosis jab to PhIIa in South Africa

With multidrug-resistant forms of tuberculosis on the rise, and the variable efficacy of the generic BCG vaccine, it is getting harder and harder to treat the disease. The Infectious Disease Research Institute (IDRI) is stepping up to the plate and taking its TB candidate to Phase IIa trials in South Africa.

Scripps Florida nets 4-year, $6M grant from Gates Foundation for HIV vaccine

In June, a team from The Scripps Research Institute in La Jolla, CA, met with federal regulators to discuss human trials for its investigational HIV vaccine. Now, researchers from the Scripps campus in Florida have won a four-year grant of up to $6 million from the Bill & Melinda Gates Foundation to develop a vaccine for HIV/AIDS that researchers there have been working on.

Serum Institute sets out for dengue fast track

Asia's largest vaccinemaker just made a play that could affect the race for a vaccine protecting against dengue fever, a common affliction that has a big impact in the region.

Inovio-led team picks up $24M from DARPA to develop Ebola vaccine, treatments

Just 5 months after it scored $21 million of a potential $45 million grant for the development of Ebola treatments, Inovio Pharmaceuticals picked up the remaining $24 million from DARPA, the company announced on Monday. The DOD's Defense Advanced Research Projects Agency chose Inovio to lead the development of Ebola treatments and preventive measures, including a DNA-based vaccine against the disease.

Advaxis reports 'encouraging' PhII cervical cancer vaccine data

Operating in a field that can leave patients with few options, Advaxis rolled out data for its cervical cancer vaccine this week that represent a "meaningful step" for those afflicted, according to one expert.

Takeda joins consortium that accelerates R&D for malaria, TB vaccines

On Monday, Takeda announced its participation in WIPO Re:Search, a consortium to accelerate research and development of new drugs, vaccines and diagnostics for malaria and tuberculosis.

Vaxent and PREVENT kick off Strep A vaccine trials

There is no licensed vaccine for Group A Streptococcus, which is commonly associated with mild illnesses such as strep throat, but can cause life-threatening disease, including toxic shock syndrome and necrotizing fasciitis. Memphis, TN-based Vaxent and the University of Saskatchewan's Pan-Provincial Vaccine Enterprise (PREVENT) are kicking off Phase I trials for StreptAnova.

Mayo Clinic secures $13.3M DOD grant to test TapImmune breast cancer vax

For women with triple negative breast cancer, treatment options are limited, and now TapImmune and the Mayo Clinic are looking to change that.

FDA panel recommends Fluad, possibly the first U.S. boosted flu jab

The U.S. may be getting its first adjuvanted flu vaccine. On Tuesday, an FDA panel recommended accelerated approval of Novartis' Fluad--now owned by CSL's flu vaccine subsidiary--in individuals 65 and older.