News

Aduro nabs FDA 'breakthrough' nod for pancreatic cancer vaccine combo

Aduro BioTech's GVAX, a previously failed cancer vaccine, is finding new life in a combination treatment that the Berkeley-based company is testing in patients with pancreatic cancer.

AstraZeneca inks deal with Advaxis for immunotherapy-vaccine combo trial

AstraZeneca's MedImmune has joined up with immunotherapy maker Advaxis to evaluate the Big Pharma's antibody MEDI4736 in conjunction with the Princeton, NJ-based biotech's lead cancer vaccine in patients with HPV-related cancers.

SEC charges CytoGenix CEO, 'serial con artist' with fraud

According to the SEC, vaccine company CytoGenix was foundering financially when two men hatched a plan to convince investors otherwise. And now, the pair is facing charges.

Fluviral, FluLaval Tetra production on hold at Glaxo's troubled Quebec plant

GlaxoSmithKline is in the process of reviewing regulatory results from a June inspection that found that 10 areas of its Ste. Foy, Quebec, vaccine manufacturing plant needed improvements. But in the meantime, Health Canada has imposed a condition on the facility's license, requiring notice before Glaxo resumes production of Fluviral and FluLaval Tetra.

GSK submits world's first malaria vaccine for EMA approval

It's taken 30 years, but GlaxoSmithKline's experimental malaria vaccine is finally ready for regulatory review. Looking to bring the world's first shot for the mosquito-borne disease to market, the pharma giant said Thursday that it has submitted its candidate for approval.

The top 5 vaccine makers by 2013 revenue

Vaccines, which can be complicated and expensive to manufacture, haven't always been the moneymakers they are for some drugmakers today. Last year, the global vaccines market topped $25.56 billion according to Evaluate Pharma, with the world's 6 top-selling shots each cracking the blockbuster barrier.

Sinovac nabs Chinese vaccine tenders for hep A, influenza

It's a good week to be Sinovac, which has won a pair of vaccine tenders in China.

Germany's immatics bags $30M for cancer vaccine trial

Though the cancer vaccine field has seen more setbacks than successes, some companies are forging ahead with ambitious plans to push their therapeutics toward regulatory approval.

Extra dose of inactivated polio vaccine provides greater protection in children

As polio flare-ups in central Asia, the Middle East and Central Africa continue, a new study suggests that an extra dose of the inactivated polio vaccine could further protect children under 5 years old in high-risk countries.

Microbix sues Novartis for patent infringement in Europe

Canada-based Microbix has slapped Novartis with a lawsuit in Europe, where it says the Swiss pharma giant has infringed its patent on Virusmax--a technology used for increasing virus yields in egg-based vaccine manufacturing.

Novartis' soon-to-be-Glaxo's vaccine unit sees mounting losses, diving sales in Q2

After years of waiting for a turnaround in its vaccines unit, it looks like Novartis may have sold it off at the right time. The Basel-based drugmaker Thursday reported stepped-up operating losses and flagging sales for the division, much of which will be on its way to former rival GlaxoSmithKline when the companies' $7.1 billion deal closes next year.

As Glaxo begins 2014-15 flu vaccine shipments, manufacturing questions linger

While GlaxoSmithKline is eyeing a strong performance from Fluarix Quadrivalent in its sophomore year, it may have to rely on Fluarix more than it would like if it doesn't make peace with regulators over quality issues at its FluLaval plant.

Solid PhIII brings Sanofi closer to blockbuster dengue sales

A new batch of results from a large-scale Phase III trial of Sanofi's dengue candidate holds mostly good news for French drugmaker, which is on track to produce the world's first vaccine for the deadly disease. But while the candidate showed itself to be by-and-large safe and effective, it once again faltered against serotype 2, the same variant that tripped it up in an earlier trial.

U.S. bioterror readiness highlighted after NIH smallpox discovery

The discovery of vials of "variola," commonly known as smallpox, in a storage room at the National Institutes of Health in Bethesda, MD, has raised new concerns that the virus could be used in a bioterrorism attack.

Ongoing Ebola outbreak sparks debate on experimental vaccine testing

International debate is brewing over whether to give experimental vaccines to people in regions of the current Ebola outbreak in West Africa in an effort to thwart the spread of the deadly virus.

Could soaring vaccine prices spark Sovaldi-style payer pushback?

With the expense of vaccine production often higher than the manufacturing costs for pharmaceuticals, vaccines once led losses for their manufacturers. But today, vaccines--like Pfizer's Prevnar 13, which scored more than $4 billion in worldwide sales last year--can be highly profitable.

No link between Merck's Gardasil and blood clots, study says

Worries over Gardasil's safety are just one of the issues that have hampered uptake of Merck's best-selling vaccine for HPV. But now, a study published in JAMA says patients need not worry about an increased risk of deadly blood clots.

Report: Manufacturing, logistical challenges to weigh down cancer vaccine market through 2022

The therapeutic vaccines segment of the immunotherapy market is primed for growth, with a new report pegging their major-market sales at $1.2 billion in 2022. But vaccine makers will have their fair share of challenges navigating that market--not to mention the hurdles they'll have to clear to make it there in the first place.

Canada gives GSK 30-day deadline for turnaround plans at FluLaval plant

Last month, the FDA chided GlaxoSmithKline over issues at its Canadian flu vaccine plant, home to production of seasonal product FluLaval. Now, it's got another regulator on its case, too: Health Canada wants to see GlaxoSmithKline lay out plans for correcting problems at the facility, and it's giving the company 30 days to do it.

Novartis starts shipping Flucelvax ahead of upcoming flu season

Novartis has started shipping vaccines for customers in the U.S. in advance of the next flu season, which doesn't include a quadrivalent offering like many of its competitors. But the shipments will include Flucelvax, which now has an FDA-licensed American plant that's poised for production whenever flu shots are needed.