Archive for the 'Biotech' Category

PhRMA Defends US Innovation

PhRMA Senior Vice-President Matthew Bennett released a statement today on the state of the biopharmaceutical industry, in response to an analysis in the British Medical Journal. Bennett states that while the US may be lagging behind in spurring innovation programs, he believes the passage of the Prescription Drug User Fee Act (PDUFA) will improve the situation.

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BIO Combats Doping at 2012 Olympics

Athletics and drugs do not share the spotlight often, but when the two combine, it usually turns heads. At the center of this spectrum is the omnipresent controversy of performance-enhancing drugs. An issue that was once conveniently covered up in order to pack ballparks and, thus, maximize profits (e.g., the inflated power numbers in Major League Baseball in the late 1990s and early 2000s) is now the subject of hyper-scrutiny by professional sports leagues, athletic committees, and even the US federal government—courtesy of taxpayer-funded revenue.

In 2012, this issue takes center stage on the international level leading up to the 30th Olympiad in London, which opens today. The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), the global Biotechnology Industry Organization (BIO), and the World Anti-Doping Agency (WADA) have announced the launch of the 2 FIELDS 1 GOAL: Protecting the Integrity of Science and Sport campaign, a program that aims to achieve the goals of the Joint Declaration on Cooperation in the Fight against Doping in Sport.

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Another Loss for New Jersey Life Sciences

Amy RitterRoche’s recent announcement that it will be closing its venerable Nutlley, NJ R&D site is the latest in a string of mergers and reorganizations that have resulted in the loss of thousands of life-sciences jobs from New Jersey, and an exodus of both R&D and manufacturing from a state known as the home of big Pharma. Read more »

Single-Cell Genomics Advancing Molecular Biology

Patricia Van Arnum PharmTech editorThe potential of single-cell genomics took a step forward recently with the announcement by The Broad Institute and Fluidigm Corporation of a new research center focused on developing research methods and discoveries in mammalian single-cell genomics. The Single-Cell Genomics Center is expected to act as a hub for collaboration among single-cell genomics researchers in many fields, including stem cells and cancer biology. Read more »

Abbott Requests Indefinite Protection from Biosimilars Competition

Amy RitterAbbott Laboratories submitted a Citizen’s Petition to FDA, requesting that the agency not consider any applications for biosimilar versions of its monoclonal antibody therapeutic, Humira. Read more »

An Important Addition to the National Bioeconomy Blueprint

Patricia Van Arnum PharmTech editor The Obama Administration released last week the National Bioeconomy Blueprint. The report outlines steps that federal agencies will take to drive the bioeconomy—economic activity powered by research and innovation in the biosciences—and details  ongoing efforts across the federal government to realize this goal. Given the importance of biotechnology to the pharmaceutical industry, does the plan do enough? Read more »

Supreme Court Considers the Affordable Care Act

What Does Overturning ACA Mean to Pharma?

Guest blog written by Reid Paul.

In contentious three days of hearing on the Affordable Care Act, the Supreme Court now seems far more likely to overturn the landmark legislation. Given the strong support the bill originally received from the industry, does overturning it benefit or hurt pharma? Read more »

JOBS Act Passage—A Boost for Biopharma?

Amid one of the most divisive eras in our nation’s political history, one thing we can all pretty much agree on is the fact that our stalled economic engine needs a jumpstart. Read more »

Crisis Averted, But No Long-Term Fix

Amy RitterA critical drug that has experienced shortages is Genzyme’s, Fabrazyme (agalsidase beta), the only enzyme replacement therapy approved in the US for Fabry disease. The drug was originally produced at the company’s Allston, Massachusetts plant. The Allston plant was plagued with quality problems, which resulted in a consent decree, temporary closure of the plant in 2010, and rejection of some lots of Fabrazyme for quality reasons. In January of 2012, FDA granted approval for Genzyme to start producing Fabrazyme at its Framingham, Massachusetts plant, bringing to an end a shortage that left patients without an adequate supply of medication for nearly two years. Read more »

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