CHICAGO--Amgen's big Phase III effort on the viral cancer vaccine talimogene laherparepvec may have fallen just shy of hitting the mark for a key metric on overall survival, but after hitting the primary goal on durable response rates for patients with melanoma, the big biotech says it plans to move ahead and seek an approval to start selling the treatment. And investigators here at ASCO have also begun to add some new data to back up its potential as a combination cancer therapy.
The cancer vaccine field has seen its share of late-stage disappointments and outright flops, but a number of hopefuls are lining up to present new research backing their experimental shots at this year's upcoming American Society of Clinical Oncology Annual Meeting in Chicago.
Qiagen gained FDA approval for a companion diagnostic test that will help spot patients with metastatic colorectal cancer who might benefit most from Amgen's drug Vectibix. The regulatory milestone represents another advance in the Dutch company's growing focus on personalized medicine.
The FDA has OK'd the use of Amgen's Vectibix as a first-line treatment for wild-type KRAS metastatic colorectal cancer. The agency approved the frontline use of the drug in combination with Folfox chemotherapy.
The company will reformulate drugs already approved for humans and market them for pets, and expects FDA approval for three drugs for dogs by the end of the year.
After the markets closed Friday, Amgen and AstraZeneca announced that their top psoriasis contender, brodalumab, scored a win in Phase III, with a large majority of patients in both dosage arms clearing the bar on a standard measure for efficacy.
Over the past few years, the bottom-line number on R&D spending among the big 10 pharma companies--about $70 billion--has remained about the same. But behind the steady collective figure lies...
AstraZeneca is none too thrilled with Pfizer's £58.8 billion ($98.7 billion) takeover proposal, it said Monday. Analysts do see some potential white knights that could offer up their own bids for the British drugmaker. But the problem for AstraZeneca is this: They don't match up as well as Pfizer does, they say.
Now that the Big Pharma breakup craze has moved down the drugmaker food chain to Baxter International, should Big Biotech jump on the trend? Maybe one of that group, an analyst suggests. As Forbes reports, Bernstein analyst Geoffrey Porges figures Amgen offers a decent opportunity for a breakup.
Amgen is getting aggressive with one of its midstage leukemia drugs. In its earnings call with analysts the big biotech's R&D chief called out blinatumomab, saying that recent Phase II data might warrant an early approval.