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The shifting regulatory landscape impacts the review of new medicines

Major improvements in the regulatory environment in the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) countries over the last decade has led to a decrease in the time to approval as well as an increase in the number of medicines that have become available.

Partnering priorities: Do your homework, tell your story

Companies use meetings like BIO CEO and BIO International as sounding boards for fine-tuning company strategy, weighing, for example, the wisdom of taking an asset all the way through to commercialization or teaming up with a strategic partner.

Innovation comes with hefty price tag as biopharma R&D spend climbs

To keep biopharmaceutical innovation churning requires mountains of cash. Companies will need to invest as much as $2.5 billion over a 10- to 15-year period in order to bring a new therapy to the marketplace, according to a 2014 study conducted by the Tufts Center for the Study of Drug Development.

Roche’s Ocrevus to dominate the multiple sclerosis market

As it enters the market, Ocrevus (ocrelizumab) is a drug set not only to top the multiple sclerosis (MS) field, but also to be 2017’s biggest future-blockbuster entrant. The 2017 edition of the annual Drugs to Watch report forecasts that seven new drugs including Ocrevus will enter the market in 2017 and achieve blockbuster sales of more than 1 billion by 2021, as evaluated by consensus sales forecast data from Clarivate Analytics Cortellis Competitive Intelligence (source Thomson Reuters I/B/E/S).

The 3 Rs of cancer research: rigor, reproducibility and robustness

As scientists gathered at the 2017 meeting of the American Association for Cancer Research (AACR) in Washington in early April to learn about the latest advances in cancer research, one of the questions was how much of that research would hold up to attempts to reproduce it.

New drug development: finding the balance between quality and quantity

Much has been said about the precipitous drop in FDA approvals during 2016, and in fact retiring FDA new drugs director John Jenkins reported in December that as of Dec. 9, 2016, the U.S. agency had approved just 19 NDAs and BLAs, the lowest number since 2007 (Fig. 1). By year-end, that number had increased […]