Topic:

Regulatory

Latest Headlines

Latest Headlines

Senate bill would set NIH budget floor, raise funding over 7 years

A decade of flat funding compounded by last year's federal sequester cuts has put U.S. biomedical research in a pinch in recent years, but under a new bill the National Institutes of Health would be spared the budget ax.

Sanofi dengue vaccine filings could come as soon as next year's Q1, CEO says

Sanofi's in line to rack up blockbuster sales after hitting a wide-open market with its dengue vaccine, analysts predict. And company CEO Chris Viehbacher thinks those sales could start rolling in before next year is out.

Lilly, Boehringer win FDA approval for once-rejected diabetes drug

After a manufacturing issue scuttled their first attempt, Eli Lilly and Boehringer Ingelheim have won the FDA's blessing to market their new diabetes drug, a late entrant into a crowded space.

FDA comes around on Boehringer, Lilly's diabetes med Jardiance

The FDA is changing its tune on Jardiance, a Boehringer Ingelheim diabetes med it hasn't been so keen on in the past. After rejecting the drug in the face of a manufacturing issue, the agency Friday gave it approval to treat Type 2 diabetes.

Can Boehringer carve out space in a crowded COPD market with new approval?

The COPD market has its fair share of contenders, but that's not stopping Boehringer Ingelheim from joining the party. The German drugmaker has nabbed FDA approval for its own entrant, which will go up against the likes of Glaxo's aging giant Advair in a market-share showdown. But despite the competition, BI is hoping it can still find its corner.

UPDATED: Germany gives an initial 'no additional benefit' on Biogen Idec's Tecfidera

Biogen Idec's multiple sclerosis blockbuster Tecfidera for a second time has hit a roadblock in its effort to replicate in Europe the kind of runaway success it has had in the U.S. Germany's price watchdog IQWIG says it has found "no additional benefit" for the treatment compared to existing options, a preliminary decision that could deny it premium pricing there.

Venrock unveils a $450M new fund with eyes on biotech

Well-heeled venture capital firm Venrock has pieced together a 7th fund, banking $450 million in new investments as it sets out to grow its portfolio of promising startups.

Vertex scores 250 new Kalydeco patients with EMA approval

Vertex' patient pool for cystic fibrosis drug Kalydeco is getting wider--250 patients wider, to be specific. The European Medicines Agency has green-lighted the drug--originally approved for CF patients with at least one copy of the G551D mutation--for 8 additional mutations, spelling new revenue potential for the orphan drugmaker.

Industry, Dems and GOP clash on looming diagnostics regulations

Stakeholders unleashed competing reactions to FDA's long-anticipated move towards regulating laboratory developed tests announced July 31, reflecting the financial and political fault lines of the proposed framework. 

FDA panel green-lights Baxter and Halozyme's drug on a second pass

A group of FDA advisers has given its blessing to a previously rejected immunodeficiency treatment from Baxter and Halozyme Therapeutics, setting the stage for an approval after years of delay.