Topic:

Regulatory

Latest Headlines

Latest Headlines

Is uniQure's gene therapy worth $1.4M?

The Federal Joint Committee is assessing uniQure's Glybera, the first-ever gene therapy approved in Europe, and now the world's most expensive drug at €1.1 million ($1.4 million). And the questions raised in Germany offer a preview of reimbursement conversations in other countries, about this and other uber-pricey gene therapies.

Novo, Baxter spar over hemophilia patent amid ITC probe

Baxter said back in March that Novo Nordisk's recently launched hemophilia med infringed some of its patents, spurring an investigation from the U.S. International Trade Commission. But the Danish drugmaker doesn't see what all the fuss is about.

China academy plans clinical trials on artemisinin derivative aimed at lupus

The Chinese Academy of Sciences says it is set to begin clinical trials on a drug it invented, SM934, a derivative of artemisinin for treating lupus. The only other drug developed specifically for the disease has been an antibody-based drug.

Japan eyes higher target for generics despite missing earlier aims

Although it has not even reached its goal of generics comprising 60% of drugs prescribed in Japan, the government is about to raise it to 80% or 90%, according to reports.

Pluristem snags spot on EMA's nascent fast-track scheme

Pluristem Therapeutics has bagged itself a spot on the European Medicines Agency's adaptive pathways pilot project. The EMA's decision gives Pluristem a shot at slashing the time it takes to bring its PLX cell program in critical limb ischemia to market in a subpopulation.

Gilead's Sovaldi faces renewed advocacy CL pressure, this time for China and Russia

China and Russia have become new targets for compulsory-licensing campaigns as an activist group widens its global challenge to Gilead's expensive Sovaldi (sofosbuvir) hepatitis C drug.

Chicken producer Sanderson says FDA's crackdown on antibiotics lacks 'reliable science'

Joe Sanderson, CEO of chicken producer Sanderson Farms, says he's telling his chicken farmers to continue using antibiotics to treat sick birds and prevent illnesses, because he believes FDA's concerns are overblown, according to the Wall Street Journal.

Hep C landscape shifts again as BMS combo nabs breakthrough tag

Gilead Sciences and AbbVie caught a break for their hepatitis C treatments when the FDA rescinded breakthrough designations earlier this year for potential competitors being developed by Merck and Bristol-Myers Squibb.

The root of Orexigen's Contrave data blunder: CEO's 'I have to see it' choice

A couple of years back--before Orexigen's recent data leak landed it in hot water with regulators, researchers and marketing partner Takeda--CEO Mike Narachi said he believed data from a large cardiovascular outcomes study should be kept among "a small team." But he also believed he should be on that team.

InVentiv invests in compliance as regulations shift for real-world studies

CRO inVentiv Health is amping up its capacity in regulatory compliance to prepare for changes in European trial rules, unveiling a global database it claims can help sponsors avoid costly confusion.