Advertisement

Glaxo hit by US regulatory delay

GlaxoSmithKline has been hit by a delay to one of the six key drugs on which it was awaiting regulatory decisions this year.

GlaxoSmithKline has been hit by a delay to one of the six key drugs on which it was awaiting regulatory decisions this year.

The US Food and Drug Administration (FDA) moved the date when it will votes on whether to approve or reject GSK's experimental cancer drug Trametinib back to September 3rd 2013.

Advertisement - Article continues below

The Prescription Drug User Fee Act (PDUFA) date has been delayed extended by three months in order to allow the FDA more time to analyse and review the submission.

Chief executive Sir Andrew Witty last month said 2013 is "a key year for R&D pipeline delivery", with GSK counting on regulatory decisions on six drugs to help it boost sales by 1.0% this year.

The group filed for US approval for trametinib in August 2012 and in February 2013 for European regulatory approval.

Shares in GlaxoSmithKline had dipped 2.00p to 1,658.5p at 13.05 on the day of the announcement.

OH

Advertisement
Advertisement

Recommended

Broker safety – your questions answered
Investment strategy

Broker safety – your questions answered

Cris Sholto Heaton answers more of your questions about the safety of stockbroker accounts
25 Mar 2020
How demographics affects stock valuations
Investment strategy

How demographics affects stock valuations

New research suggests that stock and bond valuations are driven by the age of the population – at least in the US.
24 Feb 2020
Do you own shares in Sirius Minerals? Here’s what you need to do now
Stocks and shares

Do you own shares in Sirius Minerals? Here’s what you need to do now

Mining giant Anglo American has proposed a cash takeover of Yorkshire-based minnow Sirius Minerals. Unhappy shareholders must decide whether to accept…
20 Feb 2020
Why investors should be “cautiously bullish” for 2020
Stockmarkets

Why investors should be “cautiously bullish” for 2020

Analysts have been out in force making rosy predictions for stockmarkets in 2020, but while there is certainly a case for optimism, investors should r…
17 Jan 2020

Most Popular

An economics lesson from my barber
Inflation

An economics lesson from my barber

On reopening his shop after lockdown, Dominic Frisby’s barber doubled his prices. It’s all part of the post-Covid inflation process – and we’re going …
8 Jul 2020
Three ideas for Lloyds Bank's new boss
UK stockmarkets

Three ideas for Lloyds Bank's new boss

The Black Horse needs whipping into shape. A change at the top provides a great opportunity, says Matthew Lynn.
12 Jul 2020
What gold, bonds and tech stocks have in common
Stockmarkets

What gold, bonds and tech stocks have in common

"Risk off" or "safe haven" assets such as gold and government bonds have been doing well lately. But so have riskier tech stocks. That seems to defy c…
10 Jul 2020