Policy & Projections
The Lead
Rough Seas Ahead
February 14, 2013 2:09 pm | by Ted Agres, Contributing Editor | Articles | Comments
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.
Questioning the Value of REMS
April 12, 2013 3:59 pm | by Ted Agres, Contributing Editor | Articles | CommentsThe 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.
Developing Balance
December 6, 2012 3:11 pm | by Peter A. Bennett | Articles | CommentsIn 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.
Shifting Clinical Trials into High Gear
November 30, 2012 3:06 pm | by Ted Agres, Contributing Editor | Articles | CommentsTen 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.
Pharmerging Markets to Drive Future Sales
October 8, 2012 10:52 am | by Ted Agres, Contributing Editor | Articles | CommentsGlobal 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.
Pharmers Plow Their Way Towards Protein Success
August 9, 2012 3:37 pm | by Ted Agres, Contributing Editor | Articles | CommentsPharming—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.
Transporter Draft Guidance
March 21, 2012 6:33 pm | Articles | CommentsThe U.S. Food and Drug Administration published draft guidance entitled Drug Interaction Studies - Study Design, Data Analysis, Implications for Dosing, and Labeling Recommendations.
Grappling with "What If"
March 16, 2012 4:04 pm | by Ted Agres, Contributing Editor | Articles | CommentsWho, 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.
Shine a Light on It
February 21, 2012 11:07 am | by Ted Agres, Contributing Editor | Articles | CommentsPharmaceutical 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.
Trimming the Fat
January 25, 2012 9:13 am | by Ted Agres, Contributing Editor | Articles | CommentsAs 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.
Pushing the Approval Pace
December 7, 2011 10:37 am | by Ted Agres, Contributing Editor | Articles | CommentsThe 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.
When the Well Runs Dry
October 7, 2011 12:33 pm | by Ted Agres, Contributing Editor | Articles | CommentsThe 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.
Fixing the Crisis in Antibiotics
June 3, 2011 11:47 am | by Ted Agres, Contributing Editor | Articles | CommentsNature is winning the microbial battle against current antibiotics. Legislative and regulatory incentives may be needed to entice developers back into the fight.
Clearing a Path for Patents
May 9, 2011 8:56 am | by Ted Agres, Contributing Editor | Articles | CommentsAfter 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.
Escape Strategy
March 9, 2011 10:48 am | by Ted Agres, Contributing Editor | Articles | CommentsBig Pharma must change how it conducts R&D to counter the effects of generic competition and to replenish its depleted pipelines.
Two Is Better Than One
February 18, 2011 5:11 am | by Ted Agres, Contributing Editor | Articles | CommentsJoint development of investigational drugs could speed combination drugs to market, if legal issues don’t overwhelm scientific challenges.
Dodging the Unavoidable
January 11, 2011 11:18 am | by Ted Agres, Contributing Editor | Articles | CommentsThe 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.
Mining for Trial Participants
October 11, 2010 7:42 am | by Ted Agres, Contributing Editor | Articles | CommentsFifteen 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.
Instruction Manual
September 15, 2010 7:26 am | by Ted Agres, Contributing Editor | Articles | CommentsBiosimilars now have a regulatory pathway, but are the directions to approval clear?
Cannabis in the Mainstream?
August 13, 2010 7:45 am | by Ted Agres, Contributing Editor | Articles | CommentsThe 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.
Trial on the Fly
June 8, 2010 10:13 am | by Ted Agres, Contributing Editor | Articles | CommentsThe I-SPY adaptive clinical trial could set a new course for drug development.
Unlocking hESC Success
May 18, 2010 10:00 am | by Ted Agres, Contributing Editor | Articles | CommentsIndustry-Academia collaborations may pay off with hESC-based drug screening advances.
Promises and Pitfalls
April 13, 2010 12:18 pm | by Ted Agres, Contributing Editor | Articles | CommentsNext-generation sequencing is the secrect to the success of personalized medicine.
Bioinsecurity
March 16, 2010 8:20 am | by Ted Agres, Contributing Editor | Articles | CommentsDebate 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.
Conflicts of Interest
February 11, 2010 4:28 am | by Ted Agres, Contributing Editor | Articles | CommentsThe 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.
Pharma Outlook
February 2, 2010 10:58 am | by Ted Agres, Contributing Editor | Articles | CommentsFor 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.
