Amgen has won an FDA approval for the heart drug ivabradine, which will hit the market as Corlanor. This is the first approval for a new class of drug aimed at preventing hospitalization for a deteriorating heart, slowing down heart rates, and it's also the first in a badly needed string of approvals Amgen is counting on to finally quiet critics of its pricey R&D operations.
When Roger Perlmutter exited an early "retirement" from Amgen to join Merck as head of R&D two years ago, he was going back to a company with one of the weakest R&D records in Big Pharma. One of his first chores was to execute a major restructuring, aimed at slimming down the pharma giant's multibillion-dollar R&D budget. And he simultaneously hit the accelerator on the PD-1 drug Keytruda, which won a pioneering FDA OK last year.
In a year when several of his peers won big payoffs for one extraordinary reason or another, Amgen CEO Robert Bradway earned just about as much as he had the previous year, give or take a few hundred thousand. Small comfort--though some comfort, perhaps--to the thousands of employees facing job cuts as Amgen prepares for biosimilar competition to its top-selling meds.
Amgen's hoping its blood cancer med Kyprolis can win an FDA bump-up from third-line treatment to second-line, and it won't have to wait long to find out whether its hopes pay off.
Amgen's deCODE Genetics has released a glimpse of a future in which population-scale genome sequencing forms the basis of drug discovery programs. And while the initiative still has some technical shortcomings and has yet to prove to the outside world it is worth $415 million, it nonetheless sparked excitement in the genomics community.
It's official: Amgen is appealing last week's ruling in a fight over biosimilar Neupogen. The California-based biotech, aiming to protect its $1.2 billion branded drug, wants to bar Novartis from launching its biosimilar version, Zarxio.
Amgen's deCODE Genetics has published a series of papers that hint at how the the Big Biotech could begin to recoup the $415 million it paid for the population-scale sequencing pioneer. For Amgen, the meat of the project lies in the discovery of 8,000 human knockouts, people who lack a working version of one of 1,171 genes.
What's better than a new drug launch? A launch destined for greatness, of course. For sales and marketing teams, that's about as much job security as you can get.
Dako is extending its collaboration with pharma giant Amgen to develop companion diagnostic products for drug development and research. Neither side is revealing financial details, but Dako, now an Agilent company, said the deal will focus on personalized medicine and tests that pair patients with suitable treatments.
Japan's Astellas Pharma has filed with Japan's Pharmaceutical and Medical Devices Agency for approval of PCSK9 inhibitor evolocumab for high cholesterol under the Amgen Astellas BioPharma joint venture.