Back in April, Amgen's cancer-fighting viral vaccine stumbled in Phase III, missing on overall survival, a secondary endpoint. But that won't stop the California company from seeking regulatory approval, it announced early this week.
Breaking up Big Pharma is all the rage these days. Jami Rubin at Morgan Stanley and Bernstein's Tim Anderson have kept a fire burning under Pfizer's board that has steadily built pressure on the company to break up. Abbott split off its drug arm and made AbbVie. And the recent major league trade between Novartis and GlaxoSmithKline relied on the same sort of financial dissection.
For an idea of what kind of year a drug developer had, take a look at what it paid its head of R&D. Click through our roundup for a look at who ranks where in the biopharma R&D world. Read more >>
Amgen's in-development cardio drug came through in two more late-stage trials, significantly lowering bad cholesterol in patients with genetic disorders that put them at serious risk.
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.