What is a Biosimilar and How Does it Differ Compared to Drug Development?

Many of today’s most important medications are biologics. Among the notable conditions treated by biologics are rheumatoid arthritis, anemia, low white blood cell counts, inflammatory bowel disease, skin conditions and various forms of cancer. As you probably perceive, biosimilars are to biologics what generic drugs are to brand-name drugs. However, there are major differences between…

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Sanders, Cummings Announce Congressional Investigation into Marathon’s Recently Approved Emflaza® (deflazacort)

On February 9, FDA announced approval of a new drug to treat Duchenne muscular dystrophy. In fact, NDAs 208684 and 20685 (oral tablets 6, 18, 30, and 36 mg and oral suspension 22.75 mg/mL), both orphan drugs, were approved that day.  However, by February 13, Reuters reported that “Marathon pauses Duchenne drug launch amid price outcry”.…

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Download Our Latest Paper: A drug development overview of pharmacokinetic principles related to ANDA/505(b)(2) submissions

As pharmaceutical consultants, the scientists and regulatory professionals at PDG® design pharmacokinetic (PK) protocols for a wide variety of applications. This paper has been written to provide the reader with a basic review of pharmacokinetic and pharmacodynamics (PD) principles as well as an exposure to a cross section of the utility of PK studies.  Click…

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Statin Side Effects Implicated as Strongest Link to Unmet Cholesterol Targets

ScienceDaily reports on a new study from the European Society of Cardiology: “Statin side effects are the strongest predictor of failure to meet low-density lipoprotein (LDL) cholesterol targets, according to research published today in the European Journal of Preventive Cardiology. Other predictors were statin non-adherence and use of weaker statins…Patients with side effects were more than…

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Research at Emory University Reveals New Cancer Drug Development Possibilities

World Pharma News reports that “Scientists at Winship Cancer Institute of Emory University have mapped a vast spider web of interactions between proteins in lung cancer cells, as part of an effort to reach what was considered “undruggable.” This approach revealed new ways to target cells carrying mutations in cancer-causing genes. As an example, researchers…

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Generic Pharmaceutical Association (GPhA) Now Association for Accessible Medications (AAM)

GPhA announced at the 2017 Annual Meeting that they are adopting a new name.  Now known as Association for Accessible Medications (AAM), PDG extends its sincere thanks to their staff and fellow participants for making the meeting a good one.  We congratulate our $100 Visa gift-card winner, and particularly enjoyed the keynote speaker, Captain “Sully” Sullenberger. …

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