After leapfrogging pharma stalwarts like Eli Lilly and Bristol-Myers Squibb with its 2014 revenue haul, Amgen is enjoying its new status as one of the industry's top-selling drugmakers. And it's hoping new regulatory filings for multiple myeloma drug Kyprolis can help it keep the sales leaps coming.
Amgen, a big R&D spender facing calls for a breakup, is headed for a major referendum on its strategy in 2015 as a slew of its pipeline assets come up for regulatory review or late-stage results.
Fast on the heels of the FDA's approval of Blincyto (blinatumomab), Amgen's new leukemia fighter that uses a bispecific T cell engager system to flag cancer cells for the immune system to destroy, the Big Biotech has partnered up with MD Anderson in Texas on a new program aimed at identifying targets for this technology in myelodysplastic syndrome.
NextCODE has made a sharp exit. Just 15 months after some ex-deCode Genetics executives struck a deal with Amgen to create NextCODE, Chinese CRO WuXi PharmaTech has bought the genomic analysis startup for $65 million in cash.
A group of FDA advisers unanimously recommended approval for Novartis' knockoff of a blockbuster Amgen treatment, clearing the way for what would be the first U.S. approval of a copycat biologic medicine.
Those looking for a window into the FDA's thoughts on biosimilars got their first direct peek Monday. The agency released briefing documents for an upcoming panel meeting on Novartis' biosimilar of Amgen's Neupogen. The takeaway? The FDA seems to be softpedaling on whether the biosim is "interchangeable" with Neupogen itself, allowing approval to be based on biosimilarity instead.
Novartis' copy of Amgen's top-selling Neupogen matched up well with the original, FDA reviewers said, recommending what would be the first U.S. approval of a biologic knock-off.
Amgen has found a CAR-T development partner. The Big Biotech is partnering up with Kite Pharma on new drugs that use Kite's chimeric antigen receptor tech, which turns T cells in the immune system into cancer-cell attack weapons. And they're both putting up some major milestone cash to fuel the work.
Given that the industry has hundreds of billions of dollars invested in plants that do batch manufacturing, it has been hard for the industry to commit to a new way of making drugs, even one with the potential to cut costs dramatically. But at a major conference in May, the industry coalesced around the need to adopt continuous manufacturing.
We now have a new record price for cancer treatment. Amgen's leukemia drug Blincyto, approved by the FDA this month to treat an uncommon form of the disease, will cost $178,000 per patient. It's the latest in a new round of expensive treatments, each of which seems to top the last.