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Policy & Projections
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The Lead

How Outgoing FDA Chief Oversaw Food, Drugs and Tobacco

February 6, 2015 8:41 am | by Associated Press | News | Comments

FDA Commissioner Margaret Hamburg announced Thursday that she will step down next month after nearly six years overseeing the agency, which regulates products making up 25 percent of the U.S. economy. Read more...       

Vaccine Skeptics Find Unexpected Allies in Conservative GOP

February 6, 2015 8:34 am | by Nicholas Riccardi - Associated Press | News | Comments

As vaccine skeptics fight laws that would force more parents to inoculate their kids, they are...

Vaccine Debate Tests First-Time White House Hopefuls

February 4, 2015 11:16 am | by Julie Pace - AP White House Correspondent | News | Comments

Long-held positions can look different under the glare of the national spotlight. Read more......

President Obama Announces Precision Medicine Initiative

January 22, 2015 11:59 am | by Ryan Bushey, Associate Editor | Articles | Comments

The President mentioned this project during the State of The Union, but did not provide...

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Government Healthcare Website Quietly Sharing Personal Data

January 20, 2015 4:56 pm | by Ricardo Alonso-Zaldivar and Jack Gillum - Associated Press | News | Comments

The government's health insurance website is quietly passing along consumers' personal data to outside websites, just as President Barack Obama is calling for stronger cybersecurity protections. Read more...         

Researchers: IMF Policies Hindered Ebola Response

December 30, 2014 9:36 am | by Michelle Faul - Associated Press | News | Comments

Professors say International Monetary Fund policies favoring international debt repayment over social spending contributed to the Ebola crisis by hampering health care in the three worst-hit West African countries. Read more...       

Orphans No Longer

January 9, 2014 9:11 am | by Ted Agres, Contributing Editor | Articles | Comments

With worldwide markets for prescription drugs stagnating, pharmaceutical companies are eyeing small-population “orphan drugs” as big moneymakers. Despite their relatively limited populations, drugs for rare diseases have already demonstrated significant financial value. Read more...

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Policy & Projections: More to Share

December 20, 2013 10:40 am | by Ted Agres, Contributing Editor | Articles | Comments

Facing ongoing fiscal challenges, Big Pharma companies are becoming increasingly willing to share precompetitive and noncompetitive data and software in hopes of speeding drug discovery and increasing their chances of clinical success. 

Oldies But Goodies

August 22, 2013 8:30 am | by Ted Agres, Contributing Editor | Articles | Comments

Not only is it getting harder and more expensive to bring a drug to market, it now appears that newer drugs are far less effective than those developed 40 or 50 years ago. A new study concludes that drugs tested in placebo-controlled clinical trials in 1971-80 were more than 4.5 times as effective as placebo in treating their primary outcomes, whereas drugs tested in 2001-10 were only 36 percent more effective than placebo.

Blocking Biosimilars

June 6, 2013 4:29 pm | by Ted Agres, Contributing Editor | Articles | Comments

As the U.S. Food and Drug Administration finalizes regulations to establish a pathway for approving biopharmaceutical or biosimilar drugs, branded drug manufacturers are looking ahead and lobbying state legislatures to enact laws that would limit the substitution of biogenerics for brand-name drugs.

Questioning the Value of REMS

April 12, 2013 3:59 pm | by Ted Agres, Contributing Editor | Articles | Comments

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.

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.

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Developing Balance

December 6, 2012 3:11 pm | by Peter A. Bennett | Articles | Comments

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. 

Shifting Clinical Trials into High Gear

November 30, 2012 3:06 pm | by Ted Agres, Contributing Editor | Articles | Comments

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.

Pharmerging Markets to Drive Future Sales

October 8, 2012 10:52 am | by Ted Agres, Contributing Editor | Articles | Comments

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.

Pharmers Plow Their Way Towards Protein Success

August 9, 2012 3:37 pm | by Ted Agres, Contributing Editor | Articles | Comments

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.

A Step Behind Globalization

June 11, 2012 9:26 am | by Ted Agres, Contributing Editor | Articles | Comments

The FDA lacks the capabilities necessary to ensure the safety of imported finished drugs and APIs used to manufacture drugs in the United States.

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Bigger Role. Bigger Target.

May 14, 2012 4:18 pm | by Ted Agres, Contributing Editor | Articles | Comments

Lawmakers are finalizing legislation to reauthorize the Prescription Drug User Fee Act , the five-year law that allows the FDA to collect fees from pharmaceutical and biotech companies.

One, Two, Three...

April 12, 2012 3:42 pm | by Ted Agres, Contributing Editor | Articles | Comments

The U.S. Food and Drug Administration has taken an important step in establishing the long-awaited regulatory pathway to evaluate and approve the marketing of biosimilar drugs in the United States.

Transporter Draft Guidance

March 21, 2012 6:33 pm | Articles | Comments

The 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 | Comments

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.

Shine a Light on It

February 21, 2012 11:07 am | by Ted Agres, Contributing Editor | Articles | Comments

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.

Trimming the Fat

January 25, 2012 9:13 am | by Ted Agres, Contributing Editor | Articles | Comments

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.

Pushing the Approval Pace

December 7, 2011 10:37 am | by Ted Agres, Contributing Editor | Articles | Comments

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.

When the Well Runs Dry

October 7, 2011 12:33 pm | by Ted Agres, Contributing Editor | Articles | Comments

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.

Fixing the Crisis in Antibiotics

June 3, 2011 11:47 am | by Ted Agres, Contributing Editor | Articles | Comments

Nature 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 | Comments

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.

Escape Strategy

March 9, 2011 10:48 am | by Ted Agres, Contributing Editor | Articles | Comments

Big 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 | Comments

Joint development of investigational drugs could speed combination drugs to market, if legal issues don’t overwhelm scientific challenges.

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