Archive for the 'Biotech' Category

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 »

FDA Gives Biosimilars Update

Angie Drakulich PharmTech editorRachel Sherman, MD, Associate Director for Medical Policy, within FDA’s Center for Drug Evaluation and Research, gave a press briefing today. Below is a summary. Read more »

Generic Drug and Biosimilar User Fees Gain Traction

Patricia Van Arnum PharmTech editor FDA issued last week its recommendations for three user-fee programs: the fifth authorization of the Prescription Drug User Fee Act (PDUFA) and new user-fee programs for human generic drugs and biosimilar biological products. The recommendations were transmitted to Congress, which will evaluate the recommendations. Read more »

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