News

GSK Duchenne drug gets ‘breakthrough’ status

The US Food and Drug Administration has granted breakthrough therapy designation to GlaxoSmithKline’s drisapersen for the potential treatment of patients with Duchenne muscular dystrophy.

Roche inks cancer pact with UK’s Immunocore

Roche has signed up to get access to the T cell receptor technology created by Immunocore, an oncology deal which could prove to be highly lucrative for the UK firm.

Safety warnings over US Supremes’ generic drug ruling

The US Supreme Court has ruled that generic drugmakers cannot be sued by patients who suffer adverse reactions caused by their products, because the companies did not develop the drugs nor seek their initial approval.

Aspen signs $1bn deal with MSD

South Africa’s generic drug giant Aspen has hit the acquisition trail again, this time snapping up a selection of drugs and a manufacturing plant from MSD for around $1 billion.

FDA approves Baxter’s Rixubis for haemophilia B

The US Food and Drug Administration has given the green light to Baxter International’s Rixubis, the first new recombinant factor IX approved for haemophilia B in more than 15 years.

Ireland: first reference prices set for November

Ireland’s new legislation to establish systems of reference pricing and generic substitution takes effect this week, and the first reference prices, for atorvastatin product, will be implemented in November, Ministers have said.

KKR funds acquiring PRA International

PRA International is sticking with private ownership after announcing that funds managed by investment firm KKR will acquire the US-based clinical research organisation from Genstar Capital.

NIHR CRN hosts 17% more commercial studies in 2012/13

The number of new commercial-contract studies supported by the National Institute for Health Research Clinical Research Network (NIHR CRN) in England rose by 17% year on year to 455 in 2012/13, the Network’s latest annual statistics show.

Sprout resubmits ‘female Viagra’ to FDA

Some three years after regulators in the USA rejected flibanserin, Sprout Pharmaceuticals has resubmitted the female sexual dysfunction drug acquired from Boehringer Ingelheim to the Food and Drug Administration.