Topic:

Clinical Trials

Latest Headlines

Latest Headlines

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.

Sunesis shares crushed in a rout after leukemia PhIII ends in defeat

Shares of South San Francisco-based Sunesis were crushed this morning after the biotech put out word that its drug vosaroxin had flunked a Phase III test for acute myeloid leukemia. The stock plunged about 70% on the news that the experimental therapy had failed to significantly improve survival rates compared to a placebo.

EMA adopts open trial data policy to begin Jan. 1

The European Medicines Agency adopted a new policy on Oct. 2 that requires drug companies to make public certain clinical data that predicate drug approvals.

Merck Gardasil follow-up could block 90% of cervical cancers--if uptake improves, that is

Merck's investigational, 9-valent HPV vaccine has the potential to block about 90% of invasive cervical cancer cases worldwide, new research shows. But getting there will be no walk in the park. First, the company will have to solve some uptake problems that have been plaguing the candidate's predecessor, Gardasil, since it rolled out in 2006.