As the New Year progresses, drug manufacturers are seeking to navigate changing—and increasingly stringent—governmental, financial, and commercial environments. Several recent studies and reports provide useful data and insights. The average cost of developing a new drug has jumped tenfold.
The U.S. Food and Drug Administration cannot determine whether its four-year-old Risk Evaluation and Mitigation Strategies program is working because drug companies have not provided key information when requested and the agency has not taken enforcement action against them.
In the last issue’s Policy and Projection’s column, Ted Agres wrote about the allure of pharmerging markets—17 countries that have shown, and are expected to continue to show, strong growth, but still have a modest per capita gross domestic product. With sales projections in the United States and Europe forecast to slow and shrink respectively, the idea of a foreign port in the storm is an attractive one.
Ten major pharmaceutical companies have established a nonprofit organization aimed at accelerating the development of new drugs, beginning with improving the efficiency of clinical trials. Through it, drug manufacturers and biotech companies will seek to identify and solve common drug development challenges.
Global pharmaceutical sales are expected to grow about 3% annually from $955 billion in 2011 to nearly $1.2 trillion in 2016, with 17 “pharmerging” countries—led by China, Brazil, Russia, and India—accounting for more than two-thirds of the increase, or about $151 billion.
Pharming—the production of inexpensive, plant-based therapeutic proteins, antibodies, and vaccines—achieved a major milestone in May when the U.S. Food and Drug Administration (FDA) approved Elelyso (taliglucerase alfa), an injectable enzyme to treat Type 1 Gaucher disease.
The U.S. Food and Drug Administration published draft guidance entitled Drug Interaction Studies - Study Design, Data Analysis, Implications for Dosing, and Labeling Recommendations.
Who, how, when, or even if. These are questions at the heart of the international debate over the genetic manipulation of the deadly H5N1 strain of bird flu to make it more transmissible.
Pharmaceutical companies that provide products covered by Medicare, Medicaid, or CHIP will be required to disclose to the federal government the name of any physician and researcher to whom a monetary payment "or other transfers of value" had been made.
As lawmakers continue to grapple with the nation’s burgeoning federal budget deficit, healthcare spending has moved into the cross-hairs of fiscal and legislative debate.
The U.S. Food and Drug Administration will soon send Congress its recommendations for reauthorizing the Prescription Drug User Fee Act. The law allows the agency to hire additional staff to speed the review of applications for new drugs and biological products.
The Food and Drug Administration, lawmakers, and industry officials are attempting to curtail an impending crisis in the availability of critical drugs. Legislation is pending that would require pharmaceutical manufacturers to give the FDA advance notice of possible shortages.
Nature is winning the microbial battle against current antibiotics. Legislative and regulatory incentives may be needed to entice developers back into the fight.
After more than half a dozen years of wrangling, Congress is moving closer to approving the first major update to the U.S. patent system in nearly six decades.
Big Pharma must change how it conducts R&D to counter the effects of generic competition and to replenish its depleted pipelines.
Joint development of investigational drugs could speed combination drugs to market, if legal issues don’t overwhelm scientific challenges.
The worldwide pharmaceutical market is expected to grow by 5% to 7% in 2011 to $880 billion, a welcome rebound over last year’s 4% to 5% growth.
Fifteen academic medical centers, research institutes, and major pharmaceutical companies are collaborating to enhance the speed and quality of clinical trials by harnessing patient data emerging from the coming widespread adoption of electronic health records.
Biosimilars now have a regulatory pathway, but are the directions to approval clear?
The development of pharmaceuticals derived from cannabis took a major step forward in June when the UK’s Medicines and Healthcare Products Regulatory Agency approved the prescription use of Sativex to treat spasticity due to multiple sclerosis.
The I-SPY adaptive clinical trial could set a new course for drug development.
Industry-Academia collaborations may pay off with hESC-based drug screening advances.
Next-generation sequencing is the secrect to the success of personalized medicine.
Debate continues within the government and scientific communities over how best to balance the often-competing interests of security and research freedom when it comes to potential bioterror pathogens such as Bacillus anthracis and Botulinum neurotoxins.
The National Institutes of Health (NIH) has been stung in recent years by numerous reports of financial conflicts of interest involving staff scientists and drug, biotech, and medical device companies.
For the pharmaceutical and biotech industries, 2010 is likely to bring an increase in financial and regulatory pressures caused by continuing patent expirations of blockbuster drugs, dwindling product pipelines, increasingly cautious government regulators—not to mention company downsizings.