The world's top sellers of the world's top biologic meds haven't changed much in the last few years. Ranked by 2014 sales, it's your usual suspects--Roche, Amgen, Novo Nordisk, AbbVie. But as PMLiVE notes in its annual ranking, times are a-changing.
An internal FDA review of Amgen's study of its cancer-killing virus talimogene laherparepvec (T-Vec), released Monday morning, raises red flags for this drug, presenting some thorny questions for the company's regulatory team to answer.
Amgen and its partner AstraZeneca are winding up to deliver U.S. and European applications for their big blockbuster hopeful brodalumab for plaque psoriasis by midyear. But their last shot to push ahead with the drug in asthma ran into defeat, with Amgen announcing Tuesday afternoon that it pulled the plug on a Phase IIb following a futility assessment.
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.