News

Pfizer's C. diff vaccine gains on Sanofi with FDA fast-track nod

Look out, Sanofi. Pfizer's Clostridium difficile candidate has just nabbed an FDA fast-track designation that should help it pick up some ground in the race to bring the first vaccine for the disease to market.

Mutated poliovirus found to beat vaccine protection

Though polio has been nearly eradicated from the globe, researchers have made a troubling discovery that underscores the need to boost vaccination rates in countries that have seen recent outbreaks as well as develop new, more potent vaccines.

Advaxis teams up with Merck to test its vaccine in prostate cancer

Just over a month after striking an immunotherapy pact with AstraZeneca, New Jersey biotech Advaxis is back with another Big Pharma agreement. This time, the company will be teaming up with Merck to test its cancer vaccine, ADXS-PSA, in combination with the latter's checkpoint inhibitor pembrolizumab.

Glaxo's Ebola vaccine trial set to begin in September

As the Ebola outbreak continues to claim victims in West Africa, governments and industry alike are racing toward a therapeutic or preventive drug that could help halt its deadly spread and avert future human crises involving the virus.

Does Pfizer still need AstraZeneca's vaccines business?

Earlier this year, when Pfizer made a play for rival pharma giant AstraZeneca, CEO Ian Read listed the British drugmaker's vaccines portfolio as a motivating factor. Now, rumors are swirling that the company could be eyeing Actavis as a backup plan. On the one hand, the New Jersey generics maker lacks vaccines offerings. And on the other, with the recent developments affecting Pfizer's unit, how much does that matter?

Diamyd diabetes vax, once spurned by J&J, gets an EU boost

There's a big patient pool waiting out there for any diabetes vaccine maker that can bring a product to market, but so far, it's been a rocky road. Diamyd Medical is among the companies that have seen their share of setbacks. But after a Phase III stumble back in 2011, the EU is putting forth some cash to test its vaccine in an ongoing combination study.

Vaccinogen raises $10M for work on colon cancer vaccine

Frederick, MD-based Vaccinogen has scored $10 million to fund work on its colon cancer candidate, OncoVax.

Measles vaccination more likely when child's, not society's, benefits are stressed

As the U.S. continues to experience the highest number of measles cases this year since the highly contagious viral illness was eliminated nationwide in 2000, health officials and researchers are looking for ways to keep vaccination rates in check.

Report: Takeda's dengue jab will be nipping at Sanofi's heels by 2020

The dengue vaccine market may not exist yet, but once it does, it's in for a big growth spurt within the next 6 years, a recent report says. And while market watchers expect Sanofi's candidate to lead the pack, by the time 2020 rolls around, Takeda could be right behind it in the battle for market share.

FDA approves first needle-free flu vaccine injection system

The PharmaJet injector delivers the vaccine by means of a narrow, precise fluid stream that penetrates the skin in about one-tenth of a second.

Chikungunya vaccine protects against virus in small Phase I study

With recent outbreaks in the Caribbean and the Pacific, the U.S. Centers for Disease Control and Prevention is concerned that the number of chikungunya cases among travelers will continue to rise. But results from an early-stage clinical trial point to a promising vaccine that may be able to prevent transmission of the disease.

Clinical failure for Merck KGaA's cancer vaccine dents subpopulation hopes

Back in 2012, researchers flagged some positive results for patient subgroups in a flunked trial of Merck KGaA's cancer vaccine. But now, the vaccine has hit another snag, failing to hit its primary endpoint--as well as three secondary endpoints--in a Japanese trial, partner Oncothyreon said Monday in an SEC filing.

FDA sets decision date for Pfizer's MenB candidate

Pfizer and Novartis are in a dead heat to become the first vaccinemaker to roll out a meningitis B vaccine for the U.S. market. But the New York pharma giant just became the first of the two to snag a decision date from the FDA, which says it will have an answer on Pfizer's candidate within the next 6 months.

Glaxo quietly edges toward Ebola vaccine but clinical barriers remain

As Africa continues to experience the most severe Ebola outbreak in the disease's short history, the World Health Organization has deemed it ethical to offer unregistered interventions as potential treatments or preventive therapies, including investigational vaccines.

Pfizer's Prevnar gets $2B boost with CDC nod in older adults

Let the uptake begin. Pfizer has snagged the CDC panel recommendation for Prevnar 13 it's been looking for--a nod for use in adults over the age of 65. And that should result in a sales lift that analysts say could touch $2 billion in peak additional sales potential--for now.

Sanofi's high-dose Fluzone beats standard-dose version in protecting seniors

Sanofi appealed to the FDA to change the labeling of its high-dose Fluzone vaccine to reflect superior efficacy data in people aged over 65, and now it has fresh trial results to back up its case that Fluzone High-Dose provides better protection in individuals in this age group compared to traditional flu jabs.

Health Canada signs off on GSK's plans to improve its flu vaccine plant

GlaxoSmithKline has submitted its plans to whip its troubled Quebec flu vaccine plant into shape to Health Canada, and the regulator says the action outline is up to snuff.

Researchers retract narcolepsy study linked to Glaxo's Pandemrix

Scientists thought they may have been on to something as far as deciphering the link between GlaxoSmithKline's pandemic swine flu vaccine and narcolepsy. But now, unable to replicate their findings, they've retracted the study.

Dendreon's debt plans could leave stockholders in the lurch

Shareholders knew Dendreon had debt problems. What they did not know until Monday was that the cancer vaccine maker is considering moves that could leave them empty-handed.

EMA accepts Pfizer app to expand Prevenar in adults

Sales of Pfizer's best-selling vaccine may soon be getting bigger. The European Medicines Agency (EMA) has accepted the company's application to expand the label on Prevenar 13 in adults to include the prevention of pneumonia caused by the 13 pneumococcal serotypes the vaccine contains.