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Regulatory

Latest Headlines

Latest Headlines

AZ's Onglyza should highlight heart failure risks, FDA panel advises

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.

Quick China dealmaking as TVM, Lummy tie with Argos on oncology candidate

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's latest move in China online drug sales is $2.51B shift of Tmall

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.

Takeda, AstraZeneca diabetes drugs need warnings on heart risk, FDA says

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.

Smoke and mirrors on visas to increase U.S. FDA inspectors in China, WSJ says

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.

Onglyza's label should flag heart failure risks, FDA panel says

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 joins St. Jude in leadless pacemaker market thanks to CE mark

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 health insurance exchange calls for copay caps on pricey meds

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 eyes China drug discovery going global

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.

IDT Australia release on FDA nod for 23 generics begs the question: Where's the beef?

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.