Three Smart Multi-Channel Marketing Resolutions for 2016


How pharma marketers can make this the year be more efficient with multi-channel MLR submissions, go mobile, and leverage vendor partners to the fullest – all with the end goal of better engaging targets while complying with FDA marketing requirements
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The Biggest Drug Regulatory Story of 2015


The biggest pharmaceutical regulatory story of 2015 began in the final weeks of 2014, as companies large and small throughout the pharmaceutical industry worked overtime, rushing to submit their Abbreviated New Drug Applications (ANDAs) before the end of the year. By the time they were finished, nearly 600 more ANDAs had been filed in Fiscal Year 2014 than in FY 2013. The following year, the number of ANDA submissions dropped by a factor of approximately 2.7.
 
The reason for the staggering rise and fall in the number of ANDA submissions is clear: the end of 2014 saw the newest guidance on Stability Testing go into effect, causing companies with products under development to rush to get their filings in before the change so as not to have to redo their processes in an environment with more rigorous requirements for generic companies filing ANDAs. The result is a backlog of filings that the FDA is still in the midst of addressing, complicated by the arrival of new ANDAs, which may result in delays for the “old” filings, even with the Generic Drug User Fee Act (GDUFA).
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New Year’s Resolutions for Pharma: Review Production Procedures for IP Opportunities


The New Year brings new business opportunities. What can you resolve to do to make your pharmaceutical business more prosperous in 2016 and beyond? One suggestion is to review improvements in your compliance and quality control analytics to maximize your patent protection over competitors. Recent legal developments have provided new opportunities for both brand and generic pharmaceutical companies to obtain and enforce valuable patent protection.
 
Patents grant limited monopolies by the government to protect inventors against those who copy their improvements, in exchange for full disclosure in the patent specification of how to make and use that improvement. Of course, patents on new API molecules, metabolites, formulations, indications and manufacturing methods can be the key to keeping the competition out of the market, and every company should have a patentability review procedure in place for evaluating these developments and filing patent applications whenever possible.
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Clinical Trials Sponsors and Sites Come to Terms with Medicare Reporting Law


Section 111 of the Medicare, Medicaid and SCHIP Extension Act (MMSEA) of 2007 impacted both clinical trials sponsors and clinical trials sites, but as awareness and compliance among the Pharma 15 has grown, the pharmaceutical industry has adjusted and trial sites are becoming more accustomed to providing the required patient information. This article will address both the sponsor’s requirement to report and the impact and advantages to clinical trial sites of reporting.
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2015: The Year that Personalized Medicine Became a Household Name


Medicine is no stranger to the swinging pendulum of buzz – if ‘population health’ was a key industry concept and growth area in 2014, it only took a few weeks in 2015 for an unlikely source, President Obama, to raise the profile of ‘personalized medicine’ during his state of the union address.
 
Personalized medicine was seemingly everywhere in 2015, with great attention being paid to the promise of therapies that can do away with one-size-fits-all treatments in favor of essentially one-size-fits-one. Major academic institutions such as Vanderbilt and Harvard received multi-million dollar gifts or grants to advance the field, while the FDA also got involved, establishing a genomic database to aid researchers in the field and assist with the distribution of data.
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Biosimilar Naming Conventions Ain’t Broke, So Don’t Fix Them


The federal government is allowing for the creation of biosimilar drugs in an effort to make life-saving treatments available to patients at a reduced cost. From a clinical perspective, these drugs are not significantly different than their referenced counterparts. So, with their introduction, clinicians will be able to provide patients with a comparable treatment at a much reduced cost.
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