Topic:

Regulatory

Latest Headlines

Latest Headlines

Europe's CHMP recommends 10 drugs in 1 week

It was a very, very big week in Europe for drugmakers. The European Committee for Medicinal Products for Human Use (CHMP) recommended 10 drugs for approval, including two biosimilars, it said today.

Europe gives Sanofi's MS drugs big push

Sanofi's Genzyme got a double dip of good news Friday for its expansion in the multiple sclerosis market. First Europe's drug regulator gave a nod to Lemtrada for treating the disease. Then, as a bonus, it gave a designation to Genzyme's potential blockbuster Aubagio that will keep its patent protected longer.

Bayer, Raptor reel in endorsements from EMA for new therapies

The European Medicines Agency's experts have backed approval for two drugs that have already gained green lights for the U.S. market.

FDA sends J&J CRL on Xarelto for stent thrombosis

The FDA keeps offering up tough news to Johnson & Johnson for its warfarin replacement, Xarelto. It has twice turned it down for treatment of acute coronary syndrome (ACS), and today the company said it had a complete response letter for use of the bloodthinner to prevent stent thrombosis in patients with ACS.

Roche Diagnostics scores another FDA victory

With the FDA's blessing, Roche Diagnostics is the first test maker cleared to let clinicians load samples straight from vials onto the company's genotyping analyzer to screen for HPV, allowing Roche to expand its already mighty presence in the U.S. diagnostics market.

Industry: Tightening EU device regs will strangle business

After a headline-grabbing breast implant scandal rocked the continent, EU regulators are considering a more stringent approach to medical device regulation, a proposal industry leaders say would hamstring Europe's successful medical device sector.

Glaxo grabs coveted breakthrough drug status for muscular dystrophy drug

GlaxoSmithKline has landed the FDA's coveted breakthrough therapy designation for drisapersen, a late-stage treatment for Duchenne muscular dystrophy that is engaged in a fierce clinical race with Sarepta's closely watched DMD drug eteplirsen.

International sweep gets $41 million in counterfeit drugs

Once a year, global law enforcement agencies pull together for a week to take a whack at the problem of burgeoning illegal online drug sales and remind counterfeiters that they have not been forgotten.

Medtronic warns over pump tied to 14 deaths

Medtronic has issued four warnings over its SychroMed infusion pumps, detailing problems that have attracted the FDA's most-serious label and led to 14 deaths over 17 years.

India yanks Takeda's Actos on safety concerns

Why now? That's a fair question about India's move to suspend the sale of three drugs, including Takeda Pharmaceuticals' now-off-patent blockbuster, Actos. The country's health ministry also banned Analgin, a decades-old painkiller, and Deanxit, a combination pill for depression.