Barely a month after reporting promising Phase II results for its respiratory syncytial virus (RSV) jab and netting an $89 million Gates Foundation grant, Gaithersburg, MD-based Novavax is going full steam ahead, initiating a Phase III trial for its RSV candidate.
AstraZeneca says it has a prime late-stage drug contender in the clinic that has the potential to compete for the lupus market. But it is lining up against GlaxoSmithKline, which has been touting promising Phase III data this week for a new subcutaneous formulation of Benlysta, a drug that has frequently disappointed analysts who have been tracking its sales over the years.
One of Agios Pharmaceuticals' blood cancer treatments demonstrated promise in a Phase I study against solid tumors, but the results fell short of some investors' expectations, sending the company's share value down about 10%.
A little more than two years ago Amgen and its partner Cytokinetics were hit by a backlash as their IV version of the heart drug omecamtiv mecarbil failed a key Phase IIb trial for heart disease. A follow-up study of an oral version of the drug, though, proved positive, the partners announced over the weekend, opening up a potential path forward into late-stage studies.
Bavarian Nordic makes most of its money from its smallpox business, but it is working to expand its reach with moves in the cancer vaccine arena. Toward that end, the Danish company announced on Tuesday the results from a National Cancer Institute-sponsored Phase I study of its new cancer vaccine candidate, MVA-BN Brachyury.
GlaxoSmithKline has struck a deal to trial its anti-OX40 monoclonal antibody in combination with Merck's Keytruda. The Phase I study is part of a slate of programs that GSK is hoping will support filings for up to 20 new drug approvals in the coming years, the success rate of which will go a long way to deciding whether the company can bounce back from its recent travails.
Scientists in the U.K. say that AstraZeneca's drug olaparib, approved by the FDA late last year to treat ovarian cancer and sold as Lynparza, has demonstrated distinct signs of efficacy in a small and very targeted group of prostate cancer patients who share a distinct type of genetic mutation.
Drug R&D is a tough business. The odds are almost always against success, and the price to be paid for being wrong is cruelly high. That said, it did seem a little harder than usual this year to...
Israeli biotech Macrocure posted another clinical failure for its blood cell-derived regenerative medicine, a final blow that has management pondering how to move forward with what cash the company has left.
Intercept Pharmaceuticals' new drug for the pervasive liver disease NASH came up short in a Phase II trial in Japan, seeding some worries about an ongoing late-stage study designed to support future FDA approval.