Articles by Pharma IQ

The Asia Pacific region is fast becoming the growth center of the worldwide pharmaceuticals market. By 2015, these markets are projected to account for almost a third of the total pharmaceutical sales worldwide.  But with this increased demand comes an intensified focus on pharmacovigilance and drug safety. Pharma IQ takes a look at 5 challenges that continue to plague the pharmacovigilance...Full Article »

Last month, long-awaited draft guidance from the Food and Drug Administration was published titled Drug Interaction Studies - Study Design, Data Analysis, Implications for Dosing and Labeling Recommendations. In it the paper provides recommendations for sponsors of new drug applications (NDAs) and the process of biologics license applications (BLAs) for those who are regulated by the Center for...Full Article »

In the coming years, biologics are expected to make up a greater proportion of revenue growth for pharmaceutical companies, with some figures placing it as high as 60 per cent.  The US Food and Drug Administration last year approved a total of 24 new molecular entities and six new biologics, the greatest number approved since 2004. This new batch of drugs includes a number that...Full Article »

Pharma merger and acquisition (M&A) activity soared back to pre-recession levels in 2011 as companies began to feel the heat of the patent cliff, new figures show. International law firm Freshfields Bruckhaus Deringer calculated the value of M&As reached $224 billion (£141 billion) last year, the highest recorded since 2007, when values hit $255 billion.  As with much of what...Full Article »

New and novel compounds lie at the heart of the drug discovery process. So much so, that drug discovery materials management has emerged as a discipline within itself. The pharmaceutical industry is undertaking a greater number of partnerships and licensing deals and increasing its global footprint. Companies are keen to beef up their pipelines in the face of blockbuster patent expiries and the...Full Article »

Poorly soluble candidates now account for 60 percent of drugs in the pipeline, and as technologies become more complex, the figure continues to increase. Pharmaceutical companies are now stepping up investment in the technologies which will boost bioavailability, expedite time to market and ultimately boost revenues at a time when blockbuster drugs can no longer be relied upon to bring in cash...Full Article »

On average, it now takes pharmaceutical companies ten years and $1 billion (£0.6 billion) to develop just one drug. In a bid to cut these costs, companies are increasingly turning to third-party collaborations, which is now being recognised as the new watch phrase when it comes to outsourcing. These collaborations are spawning an increasingly popular field of research and development;...Full Article »

While licensing deals have perhaps been born out of necessity – the patent cliff coupled with a dwindling pipeline has left big pharma in a tricky position – they are more than proving their worth, and necessity is the mother of all invention. Figures published by CBR Pharma Insights show that since 2007 the number of licensing deals has been increasing every year.  The largest...Full Article »

Cases of counterfeit pharmaceuticals being discovered entering the United States are on the up. Up 200 percent to $11 million (£7 million) in 2011 to be precise, based on the domestic value of seizures from the Customs and Border Protection (CBP) last year. This significant rise comes in part as a result of what the CBP calls a 'number of successful enforcement efforts' that led to...Full Article »

The Nordic area is incredibly popular for clinical trials, with several thousand occurring at any one time. However the biotech and pharmaceutical industry is undergoing a huge period of change, with many organisations looking to expand geographically. According to a number of studies over the last 18 months, while clinical trial activity in the Nordic region remains strong, it is levelling off....Full Article »

The number of clinical trials being outsourced is increasing and the industry is working together to develop ground-breaking partnerships that focus on creative contracting and effective oversight. According to a recent Pharma IQ survey, 43 per cent of Pharma professionals do not think the oversight of their clinical trial vendors is effective and 100 per cent claimed that the...Full Article »