Amgen and AstraZeneca have racked up their third straight Phase III win for brodalumab in plaque psoriasis, beating J&J's Stelara in a head-to-head study. The news comes just two weeks after the pharma partners posted their latest positive results, positioning them for a run at regulators on both sides of the Atlantic.
Bristol-Myers Squibb announced a new project in Ireland earlier this month, followed by Amgen's completion of a continuous processing facility in Singapore. Now AstraZeneca says it needs more biologics capacity and will spend in excess of $200 million to build out a facility in Maryland.
Amgen is calling off all clinical studies on rilotumumab in advanced gastric cancer after a peek at Phase III data revealed that the drug was actually making matters worse for patients, further marring the value of the company's oncology pipeline.
Amgen CEO Robert Bradway hinted several years ago that the company was on the "cusp" of a new manufacturing process for making cell-based drugs that would upend the industry, being faster and cheaper. Today, Amgen said that time has arrived, with completion in Singapore of a $200 million plant that incorporates continuous processing.
In the race to commercialize a new class of potential cardiovascular blockbusters, Amgen and its team of lawyers have filed a patent suit to fend off the advance of rivals Sanofi and Regeneron. But, looking at the patents in question and the history of such challenges, one analyst figures Amgen is unlikely to succeed in keeping its competitors off the market.
Amgen and its Big Pharma partner AstraZeneca have roped in another round of promising Phase III plaque psoriasis data for their IL-17 blockbuster contender brodalumab, which beat Johnson & Johnson's big earner Stelara in a head-to-head study.
Ever since Dendreon's lackluster Provenge launch, the Washington-based biotech's failures have cast a pall over the troubled cancer vaccine field. And the company's bankruptcy won't help with that.
Amgen now has a deadline in place for an FDA decision on its cholesterol-lowering drug evolocumab. The Big Biotech put out the word Monday morning that the FDA has accepted its BLA application on the PCSK9 drug for review, giving regulators until August 27, 2015 to issue their decision on marketing the therapy.
The patent provisions of the Hatch-Waxman Act are familiar to both sides of the branded-generic fence by now. Not so when it comes to similar procedures related to biosimilars. In fact, as a lawsuit over Sandoz's knockoff version of the Amgen therapy Neupogen shows, the two sides don't even agree on the rules.
Amgen reported today that its late-stage cancer drug trebananib missed the goal on a significant improvement for overall survival among patients suffering from platinum-resistant ovarian cancer. These new data follow a successful hit on the goal for progression-free survival.