Topic:

Clinical Trials

Latest Headlines

Latest Headlines

Sanofi takes rotavirus vax into Phase III with eye on Indian market

India's rotavirus vaccines market is headed for a shake-up, and Sanofi's angling to get in on the action. It got one step closer this week, with its Indian affiliate commencing Phase III clinical trials for its own investigational vaccine.

Penn-Novartis team 'amazed' at remissions, responses in leukemia CAR-T study

Investigators working on Novartis' personalized CTL019 CAR-T program at the University of Pennsylvania say that 90% of a small group of children suffering from very advanced cases of treatment-resistant acute lymphoblastic leukemia achieved complete remission after being treated in the newly updated trial.

Smith & Nephew hit by setback as PhIII regenerative med study flops

Last spring a prominent analyst suggested that a successful late-stage study for Smith & Nephew's spray-on cell therapy for wound healing could be a catalyst to break up the company a la Abbott and Baxter. But today, the discussion of the much buzzed-about trigger event turned bitter after the company reported that the Phase III trial flopped.

AstraZeneca gets some upbeat asthma data to back would-be IL-5 blockbuster

After acknowledging a midstage setback for its key respiratory drug benralizumab in COPD last month, AstraZeneca's big MedImmune division has come back with positive, though somewhat mixed, Phase IIb data underscoring the effectiveness of knocking down eosinophils--white blood cells--in preventing asthma attacks.

Sanofi bird flu vax prompts immune response in PhII--but only with Novartis adjuvant

As it works to refine its vaccine strategy for the event of an avian flu pandemic, the NIH is trialing Sanofi's H7N9 vaccine at a range of doses and with a variety of adjuvant combinations. And now, it has one that looks promising.

Pfizer's meningitis B vaccine is effective when given with HPV jab

Hoping to boost its chances of FDA approval early next year, Pfizer has unveiled results from a Phase II clinical trial for its meningitis B vaccine, showing that the jab is safe and effective in adolescents when given alongside a licensed vaccine for human papillomavirus.

Biotechs angling for T-cell response in race for next-gen herpes vaccine

When Australian biotech Admedus announced Phase I results for its herpes simplex virus vaccine last week, it was far from the first company to do so. A whole new generation of vaccinemakers are trying their hand in a race that's heating up.

Chimerix scores promising antiviral data from a controversy-fueled PhIII pilot

Chimerix reports that its pilot Phase III study of the powerful antiviral brincidofovir has posted promising preliminary data, cutting the risk of death from lethal adenovirus infections by as much as half or more.

Chimerix, FDA scramble to launch a new clinical study of brincidofovir for Ebola

Back in March, Chimerix hustled to put together a small Phase III pilot program to test its closely watched antiviral brincidofovir for adenovirus infections. Today, CEO Michelle Berrey says the company is now scrambling to put together another overnight study plan for Ebola rather than risk getting hit with a fresh round of compassionate-use demands.

Positive PhIII PONV study brings little Acacia to a crossroads

Acacia Pharma says it gleaned positive results from a Phase III study of its experimental therapy designed to prevent postoperative nausea and vomiting. And now it's brought in the investment banker J.P. Morgan Cazenove to advise the board on what its next steps should be as it tries to position the treatment for regulatory approval and commercialization.