News

Winners of the prestigious PharmaTimes International Clinical Researcher of the Year competition were unveiled at a buzzing awards ceremony in London last night, with PRA Health Sciences striking gold in several categories, including the coveted Clinical Company of the Year 2015.

Novartis has reported first-quarter profit that beat analysts’ expectations, but results took a hefty hit from currency exchange effects. 

Novartis’ investigational heart drug LCZ696 (sacubitril/valsartan) has become the first non-cancer drug to get a foothold in the UK’s Early Access to Medicines Scheme.

Medicine is going small – nano-small in fact. This is medicine practiced on the scale of less than 100 nanometres, tiny when compared with the diameter of a human hair, which is 80,000 nanometres. But while nanomedicine is on the small side, it promises to be big business.

Off-label use of medicines has always been a vexed issue. In theory, treatments should only be used as indicated, where their safety and efficacy has been proven. Indeed, several pharma companies have received large fines for suggesting otherwise in their marketing efforts. Yet in practice off-label use is widespread and is, it seems, now officially endorsed in a growing number of countries.

After taking a 2% hit from negative exchange rates Roche posted a 3% rise in total first-quarter sales to 11.83 billion Swiss francs ($12.4 billion), overshooting an average forecast of 11.49 billion compiled by Reuters.

As we move into the heart of the UK General Election campaign, we are seeing politicians of all colours trying to distinguish themselves from each other. The issue of a possible future referendum on the UK’s membership of the European Union features regularly in election debates. 

2015 is being hailed as the year of the biosimilar. In the initial three months of this year the first monoclonal antibody biosimilars hit the market – Celltrion Healthcare’s Remsima and Hospira’s Inflectra, copycats of Janssen/MSD’s autoimmune blockbuster Remicade (infliximab) – while the USA has celebrated the approval of its first ever biosimilar, Sandoz’ Zarxio, a follow-on of Amgen’s white blood cell stimulator Neupogen (filgrastim). Commentators are singing biosimilars’ praises, claiming we have entered a new, more affordable healthcare era.     

Celgene’s Revlimid is now available in the UK for patients with newly-diagnosed myeloma.

Boehringer Ingelheim says it is now “positioned for future growth” leaving behind a “challenging year” in 2014 which saw sales dip and earnings remain flat.

Amgen has booked a 51% hike in profit to $1.62 billion for the first quarter of 2015, on the back of strong sales growth and lower operating expenses.

GW Pharmaceuticals has begun recruiting patients into a second late-stage trial evaluating the potential of its cannabinoid drug Epidiolex in treating a rare and severe form of treatment-resistant childhood epilepsy called Dravet syndrome.

Israeli drugmaker Teva has now stepped out with a $40-billion-bid for Mylan NV, proving the rumour mill right and continuing the current mergers and acquisitions trend in the industry.

Pfizer’s Xalkori has picked up a Breakthrough Therapy designation from the US Food and Drug Administration for treating patients with the rare ROS1-positive form of non-small cell lung cancer.

Sticking to scientific advice from the European Medicines Agency on clinical trial design cuts the overall assessment time for a new medicine and boosts its chance of approval, an analysis of marketing authorisation outcomes has found.