Improving the solubility of poorly water-soluble drugs is of crucial importance for developing and successfully commercializing new drug compounds. Combinatorial chemistry and high-throughput screening methods in drug discovery has increased the number and diversity of molecules of potential interest in drug development. That larger pool of candidates, although potentially beneficial, also creates challenges, namely more compounds  of poor solubility. According to some industry estimates, approximately 70% of new chemical entities under development may be classified as BCS Class II compounds (i.e., high permeability and low solubility) (1). An upcoming webcast by Pharmaceutical Technology examines one technology to address low bioavailability: pharmaceutical melt extrusion. Read more »

The Pharma ChemOutsourcing conference, an annual event that brings together pharmaceutical companies, CROs, and CMOs to discuss industry trends and perspectives, was held in Long Branch, New Jersey, last week. The central question at the heart of many of the discussions was a fundamental but important one: where is the opportunity in pharmaceutical outsourcing, specifically in pharmaceutical chemical development and manufacturing? Read more »

As Congress returns from summer recess, and national campaigns begin, job creation is undoubtedly the theme for the near term. Debates over the role of government in stimulating economic growth through fiscal and regulatory policy are inviting opinions from all sides of the political spectrum. Despite all the contention that is and will continue to ensue, there is generally one agreed-upon precept: innovation is a valuable tool to create and sustain economic growth. But how does the quest for innovation square with government regulation? That debate is taking shape not only broadly but in the nascent field of synthetic biology, where scientific, public-health, and business interests are converging. Read more »

Roche took a step forward in personalized medicine with the approval earlier this month of a new drug and related diagnostic to treat certain forms of metastatic melanoma. Roche’s strategy of developing drugs and related diagnostics shows the potential business and therapeutic value of personalized medicines. Read more »

Good news on the drug-approval front. Through the end of July, FDA’s Center for Drug Evaluation and Research had approved 21 new drugs (new molecular entities and new biologics license applications), which equals the total number of new drugs approved in all of 2010. Although not enough to claim a reversal of the recent downward trend in drug R&D productivity, the numbers are a good sign for the industry. Read more »

The recent volatility in financial markets, combined with reports of stagnant US economic growth, point to less-than-optimistic prospects for a recovery. The underlying weakness in the US economy reveals structural flaws, which are not likely to be amerliorated in the short term, one of which is a lack of private-sector investment in domestic manufacturing. Are there lessons that can be learned from emerging markets in fostering growth in domestic manufacturing? Read more »

Identifying influenza strains each year and developing the appropriate vaccines to combat those strains has been the strategy of combating influenza, including potential pandemics. Finding a way to develop a universal vaccine has been a desired, but elusive goal, but several researchers have recently reported on promising developments for developing a universal influenza vaccine. Read more »

As the White House and Congress battle the looming deadline to raise the country’s debt ceiling, what are the potential implications of the various debt-reduction proposals on the pharmaceutical industry? Read more »

Free trade, always a subject of concern for business, has been a topic of particular interest for the pharmaceutical and allied industries this past week as individual companies and trade associations weigh in on the debate on several free-trade measures. Read more »

Pharmaceutical companies’ interest in furthering their positions in emerging markets is no secret, and this past week, two companies, Novartis and AstraZeneca, offered updates of current projects in one country, Russia. Read more »