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.
TVM Capital Life Science moved quickly to tap a new $50 million venture capital fund with investment from Chinese partner Lummy Co. in a licensing deal for an oncology dendritic vaccine.
Alibaba Group Holding aims to ramp up fledgling online drug sales in China by placing online drug retailer Tmall under its listed healthcare unit in a shuffle estimated at $2.51 billion, the company said in a press release.
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.
Remember all the post-heparin-scare hoopla about the U.S. FDA increasing the number of inspectors on the ground in China to 26? Seven years later, it still has only three drug inspectors working full time and two temporarily, the total down from 8 last year, the Wall Street Journal reports.
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.
Medtronic has officially joined the European leadless pacemaker market thanks to the CE-mark approval of its Micra Transcatheter Pacing System. It is one-tenth the size of conventional pacemakers, making it the world's smallest device in the overall category.
California's health insurance exchange staff is laying out a proposal that would cap copays for specialty drugs at a maximum of $500 per prescription, Capital Public Radio reports. And the caps would be even lower for some patients depending on their plan.
Australia's George Clinical closely tracks China's growing number of domestic Contract Research Organizations and notes that of the estimated 250-odd companies, 90% are focused on domestic work. But George Clinical, based in Sydney, also looks ahead to the day the Chinese CROs and drug companies take bigger leaps into the global business.
Australia Stock Exchange-listed IDT Australia has issued another in a series of announcements about acquiring 23 generic drugs marketed in the United States, the latest release stating the U.S. FDA has noted the transfer of ownership to IDT.