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.
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.
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 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.
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.
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.
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.
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'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.
Esperion Therapeutics has taken another big stride along the clinical path for its cholesterol drug. The biotech reports that its drug ETC-1002 slashed levels of the bad cholesterol LDL, particularly when it was combined with Merck's Zetia, in a Phase IIb trial. And now that the mid-stage program is complete, the Ann Arbor, MI-based biotech finds itself at the threshold of a late-stage program with a drug the company feels can thread the market needle between cheap generics and a looming wave of rival biologics.