The FDA will vote for or against the breast cancer drug by April 13, 2015.
The drugmaker is poised to cut 14 pipeline projects loose.
Inversion rules have Medtronic asking for a Covidien do-over, Roche's Perjeta has "unprecedented success," while AstraZeneca's Iressa does not.
Lilly's weekly GLP-1 shot is approved, BI expands its lung-cancer portfolio, GSK's China investigation closes, NY proposed Sovaldi triage and India imposed price limits on 36 new medicines.
Keytruda was the first of the new PD-1 class of immuno-oncology drugs to reach the US, but Bristol-Myers Squibb and Ono could run away with the competition, according to one analyst.
The first-in-class PD-1 was approved only last week.
The FDA approved the drug previously known as pembrolizumab, now known as Keytruda, for patients with unresectable or metastatic melanoma who have taken Bristol-Myers Squibb's Yervoy (ipilimumab).
The FDA froze the clinical trial of anti-Fzd7 vantictumab in July over concern about "bone-related adverse events."
Roche backs away from Chugai but embraces InterMune, Merck rumored on track to score first PD-1 approval, a new Ebola strain may have surfaced and JNJ scoops up experimental anti-TNF.
The goal is to develop companion diagnostics to match patients with cancer treatments.
UK drug-cost watchdog backs Sovaldi, Achillion touts HCV interim results, Avastin's latest cancer indication, Ebola outbreak worsens, COPD drug gets panel nod, and study links quick reviews and black-box warnings.
Amgen now hopes a separate study will be enough to support the drug's advancement to a second-line therapy, but the lackluster results may impinge on its EU filing schedule.
Cologuard was the first approved fecal-based screening test for the disease, and it was also the first product the FDA and CMS approved on the very same day through the so-called Parallel Review program.
Britain's National Institute for Health and Care Excellence has followed through on its Kadcyla objections and has said Roche's breast cancer drug will remain off the National Health Services formulary because it is too expensive.
Approved in May 2013, the cancer drug earned $57 million in the second quarter, and the firm expects it will hit annual sales of $1.31 billion.
Blood-cancer drug Kyprolis outperformed standard treatment in a late-stage trial testing the drug in patients with multiple myeloma, said Amgen.
Novartis is apologizing to Japan after the Ministry of Health, Labor and Welfare said the company had dragged its feet reporting adverse events for two of its cancer drugs.
Stand Up To Cancer is kicking off a PSA that features Grammy-winner Jennifer Hudson and a Genentech scientist.
The FDA slapped a Breakthrough Therapy label on the CLL indication pursuit in February.
AstraZeneca's hope is that the blood test could replace tissue samples and be used to identify patients who could benefit from its lung drugs.
The drug did not hit its Phase III primary target of improving progression-free survival.
The company attributed part of the Eliquis boost to the BMS-Pfizer DTC and education efforts.
The FDA greenlighted the drug for three cancers.
It's the second for this cancer drug in two weeks.
HPV testing provides an edge over Pap screenings when it comes to detecting cervical cancer risk.
The FDA granted Priority Review for consideration of Avastin for some cervical-cancer patients.
Cyramza patients had more favorable overall survival rates than placebo patients, but the differences were not statistically significant.
Bristol-Myers Squibb is moving forward with its FDA filing of PD-1 Opdivo (formerly known as nivolumab) for patients with advanced melanoma who have been previously treated with the BMS drug Yervoy.
UnitedHealthcare finds drug costs more than doubled.
The regulator wants men to be part of breast cancer clinical trials.
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