AstraZeneca's in-development lung cancer pill extended progression-free survival by more than a year in new Phase II data, a positive sign for a drug the company believes can bring in $3 billion in annual sales at its peak.
PatientsLikeMe has struck a 5-year deal to support R&D at AstraZeneca. The agreement tops off a busy and important 12 months for the patient network, in which it has also expanded relationships with Biogen, Roche's Genentech and Swiss biopharma Actelion.
AstraZeneca dodged a bullet Tuesday, when an FDA panel of experts almost unanimously backed Onglyza's cardiovascular safety. But the committee did recommend that the label of the diabetes therapy feature information about a potential risk of heart failure.
Diabetes drugs of Takeda Pharmaceutical and AstraZeneca should be labeled at risk of heart failure associated with them, a group of U.S. FDA advisers recommended. Nearly all of the members of an advisory panel voted for the added safety information on labels.
AstraZeneca escaped the worst with an FDA panel vote on Onglyza. The agency's expert advisers almost unanimously backed the drug's cardiovascular safety. But the panel also recommended that the diabetes drug's label include information about a potential risk of heart failure.
AstraZeneca has signed on to partner with PatientsLikeMe to cull data from its network of some 250,000 patients that will help guide drug development at the pharma giant.
FDA staff reviewers have raised serious concerns about the safety of AstraZeneca's Onglyza ahead of an advisory committee review Tuesday, which could result in a recommendation of a label change for Onglyza as well as other drugs in the DPP4 inhibitor class.
The FDA raised some alarming concerns tied to AstraZeneca's Onglyza ahead of a committee meeting to discuss the safety of so-called DPP-4 inhibitors, sounding a worrying note for a blockbuster class of drugs.
FDA experts will grill a couple of diabetes meds next Tuesday, and the outcome of that debate could put a damper on sales. The drugs: AstraZeneca's Onglyza and Takeda's Nesina, both DPP-4 blood sugar-fighters. The questions: Do they really increase the risk of heart failure? And if so, what's to be done about it?
Shares of Regulus spiked 10% Tuesday afternoon after its Big Pharma partner AstraZeneca stepped up to grab rights to a preclinical drug candidate for NASH with plans to steer it into clinical studies.