By: Benedette Cuffari, BS Toxicology Candidate c/o 2015 – Hemophilia B is an inherited bleeding disorder that is caused by a substantially reduced or complete lack of blood clotting factor IX. Therefore, people suffering from hemophilia B experience bleeding episodes that cause pain, irreversible joint damage, and life threatening hemorrhages. Approximately 28,000 people are currently…

By: Nancy Simon, PharmD c/o 2016 – Last November, the Food and Drug Administration (FDA) submitted a proposal for a Generic Drug Labeling Plan.  This new plan will allow generic drug companies to use the same process as the one used by brand drug companies to update their medication labels to reflect new safety information.1…

By: Kevin Lin, PharmD Candidate c/o 2015 — The FDA recently completed an observational cohort study that compared Pradaxa® (dabigatran) to warfarin for rates of ischemic stroke, intracranial hemorrhage, major gastrointestinal bleed, myocardial infarction, and death. The study enrolled more than 134,000 patients, with 64% over the age of 65 and found a lower risk…

By: Melissa Roy Co-Copy Editor [Graphics focused] – Our dedicated preceptor Kimberly Defronzo, RPh, MS, MBA is currently a Consumer Safety Officer at the Food and Drug Administration (FDA). She attended the University of Connecticut School of Pharmacy for her Bachelors of Pharmacy. She then went to St. John’s University College of Pharmacy and Health…

By: Davidta Brown, Senior Staff Editor – A new therapeutic device has seemingly leapt from the pages of a science fiction novel and into the hands of migraine sufferers around the world. Worn over the forehead and sending electromagnetic stimulation directly into the supraorbital trigeminal nerves, the cranial nerve stimulator offered by Belgian biotechnology company…

By: Erica Dimitropoulos Co-Copy Editor [Content- Focused]  – On February 14, 2014, elosulfase alfa (Vimizim™) became an FDA-approved enzyme replacement therapy for Morquio A Syndrome, a type of mucopolysaccharidosis (MPS IVA).1 Elosulfase alfa was granted priority review and was also the first drug to receive the Rare Pediatric Disease Priority Review Voucher that motivates the development…

By: Fawad Piracha, PharmD Candidate c/o 2016 – Rho Chi Society held its 90th annual meeting on Sunday, March 30, 2014 at the Hyatt Regency Orlando, paralleling the American Pharmacists Association (APhA) 2014 Annual Meeting and Exposition that took place the same weekend. In attendance were delegates and advisors of Rho Chi chapters from pharmacy…

By: Daniel Mathan, PharmD Candidate c/o 2016, Anita Kachappilly, PharmD Candidate c/o 2016, & Amrita Singh, PharmD Candidate c/o 2015 – Systemic lupus erythematosus (SLE) is a debilitating autoimmune disease that affects multiple organs in the body and can potentially become life threatening.1 The incidence of SLE is about 50 cases for every 100,000 people; it…

By: Beatrisa Popovitz, Senior Staff Editor – On January 31st 2014, the FDA announced the release of a revolutionary new drug, tasimelteon (Hetlioz®). Tasimeleton is the first developed treatment of non-24-hour sleep-wake cycle syndrome in blind individuals.1 Formulated by Vanda Pharmaceuticals Inc., this melatonin receptor agonist works by binding to and activating the MT1 and…

By: Davidta Brown, Senior Staff Editor – As the world of healthcare and its provision evolves, laws which organize and oversee the ways that patients receive health services must develop at the same pace. Last November, a new bill establishing clearer protocol for the compounding and tracking of medications became national law. The Drug Quality…

By: Davidta Brown, Senior Staff Editor – In 21st century medicine, pharmaceuticals have come to include compounds derived through novel and complex methods. Some of the most recent innovations have been in the form of biologics, therapeutic compounds produced through biological processes.1 Biologics are derived from living cell lines which may be bacterial, yeast, animal,…

By: Fatema Elias, Staff Writer – With the New Year and everyone committing to their New Year resolutions, more and more patients are coming into the pharmacy asking for recommendations, particularly for weight loss dietary supplements. I hesitate to recommend an over-the-counter dietary supplement for weight loss. However, we as pharmacists and pharmacy students have…

By: Davidta Brown, Senior Staff Editor – As the world’s largest market for pharmaceuticals, the United States receives many medications manufactured abroad.1 Patients, physicians, and pharmacists defer the responsibility of ensuring the quality of these imported drugs to the FDA, but it only takes one report of deceit in the pharmaceutical industry for this trust…

By: Jenny Park, PharmD Candidate c/o 2015 – On July 12, 2013, the FDA approved afatinib (GilotrifTM) as a new first-line treatment for patients with late-stage non-small cell lung cancer (NSCLC), a type of carcinoma where specific types of epidermal growth factor receptor (EGFR) gene mutations are expressed.1 The drug afatinib irreversibly blocks EGFR, also…

By: Ada Seldin, Staff Editor – On November 22, 2013, simeprevir (Olysio®), a new agent to treat chronic hepatitis C, received approval under the FDA’s priority review program. Simeprevir is an NS3/4A protease inhibitor that blocks the replication of the hepatitis C virus. Two other drugs from the same class, boceprevir and telaprevir, which were…

By: Rebecca Gilene, PharmD Candidate c/o 2014, St. Louis College of Pharmacy – The FDA approved macitentan (Opsumit®) on October 18, 2013 for the treatment of pulmonary arterial hypertension.1 Pulmonary arterial hypertension, often referred to as PAH, is a disease characterized by high blood pressure in the arteries between the heart and lungs. An increase…

By: Sang Hyo Kim, Staff Editor – Near the end of December, the pharmaceutical company, MannKind Corp, will submit their clinical data to the U.S Food and Drug Administration for the approval of an inhaled dosage form of insulin, Afrezza®.1 Administered with the Dreamboat inhaler, this inhaled dosage form delivers insulin packaged into single dose…

By: Sherine Jaison, PharmD Candidate c/o 2015 –  The leukemia chemotherapy drug ponatinib (Iclusig) has just been taken off the market. The drug was under investigation by the Food and Drug Administration (FDA) following several reports of serious and life threatening blood clots and narrowing of the blood vessels.1 Ponatinib is a BCR-ABL tyrosine kinase…

By: Ramya Mathew, PharmD Candidate c/o 2015 – Vertex Pharmaceuticals, an American biotechnology company based in Cambridge, Massachusetts, has been researching a new “nuke” for the treatment of Hepatitis C called VX-135. This nucleotide polymerase inhibitor is currently undergoing clinical trials, but the FDA has put the research on a partial hold due to findings…

By: Ada Seldin, Staff Editor – On August 12,2013, a new weapon against HIV-1 infection was added to the existing armada. Dolutegravir, the third integrase strand transfer inhibitor to attain FDA approval, targets a protein essential to HIV replication. HIV-1 is the predominant type of HIV virus, the other being HIV-2, which is endogenous to…

By: Tamara Yunusova, Senior Staff Editor – After a lengthy fifteen-year hiatus in recombinant drug approvals, FDA-approved Recombinant Coagulation Factor IX (Rixubis) has mounted to the forefront of Hemophilia B drug therapy. The recombinant coagulation factor gained orphan drug approval on June 26, 2013 for routine prophylaxis, control of bleeding episodes, and perioperative management in…

By: Sang Hyo Kim, Staff Editor – On March 29th 2013, the U.S Food and Drug Administration approved canagliflozin (Invokana®), a new form of a diabetic drug for patients with type 2 diabetes mellitus.1 Canagliflozin is in a new class of medications called sodium glucose co-transporter 2 (SGLT2) inhibitors and is the only oral, once-daily…

By: Sang Hyo Kim, Staff Editor – This year, on July 23rd, FDA advisers voted 7 to 6, with one abstention, in favor of approving the drug certolizumab (Cimzia®) for the indication of axial spondyloarthritis (axSpA). axSpA is a chronic imflammatory condition that includes ankylosing spondylitis (AS) and non-radiographic axial spndyloarthristis (nr-axSpA).1,2 axSpA, AS and…

By Omar Khalid Pharm.D. Candidate c/o 2014 – The outpour of a multitude of new oral anticoagulants in recent years has health care professionals questioning whether they should switch the patients over, and what new agents should be used. With the recent addition of dabigatran (Pradaxa®) in October 2010, rivaroxaban (Xarelto®) in November 2011, and…

By: Tamara Yunusova, Senior Staff Editor – Approximately 3.2 million Americans have chronic hepatitis C infection.1 While acute cases are not common, rates of chronic hepatitis C continue to surge due to the recent discovery of the virus in 1989 and consequently, the establishment of a test screening for HCV antibodies in 1992.1 HCV has…

Davidta Brown, PharmD Candidate c/o 2017 –      The debate on the nature of compounding practice and the extent to which it ought to be regulated has come to the forefront of public attention.  Those who regularly follow American news and politics are familiar with the series of events that have led to the present…

By: Ada Seldin PharmD Candidate c/o 2015 – On April 16th, 2013, the FDA approved the labeling change for the reformulated OxyContin® (oxycodone hydrochloride controlled-release) tablets, made by Pharma L.P. This change reflects the abuse-deterrent properties of the reformulated OxyContin®, which were not present in the original formulation approved by the FDA in 1995. OxyContin®…

By: Erica Dimitropoulos, Senior Staff Editor – Lupus is highly unpredictable and occurs without warning; there is no known cause and no known cure. It affects over 1.5 million Americans, 90% of whom are women between the ages of 15 – 44.1 No two cases of lupus are alike, making it a very difficult disease…

By: David Ong, Pharm.D. Candidate c/o 2014 – Our current healthcare system receives much criticism from the press as well as the public. Big pharmaceutical companies (“Big Pharma”) have consistently been characterized as part of the problem. Most of the blame for high drug costs is levied on Big Pharma. One of the criticisms is…

By: Andy Zhang, PharmD Candidate c/o 2015 – On March 28, 2013, the U.S. Food and Drug Administration announced the approval of Tecfidera™ (dimethyl fumarate) for the treatment of relapsing forms of multiple sclerosis (MS) in adults.1 Tecfidera™ (dimethyl fumarate) will be the third oral drug used for the treatment of MS. The manufacturer Biogen…

By: Hayeon Na, Co-Copy Editor [Content-Focused] – On March 22, 2013, Public Broadcasting Service (PBS) aired an episode of “Need to Know” on the safety of low to moderate risk medical devices. The episode closely followed the lawsuit of patient Linda Gross who has pelvic organ prolapse and was advised by her doctor to undergo…

By: Bansri Patel – As of May 1st 2013, Plan B®, the brand name emergency contraception pill will now be available to women aged fifteen and older. It will also be sold in the drug store aisles, as opposed to its current location behind the pharmacy counter. When levonorgestrel (Plan B®) first entered the market,…

By Nancy Rizkalla, PharmD candidate c/o 2015 –        Percutaneous coronary intervention (PCI) with subsequent stent implantation is a highly effective approach in reducing the risk of death or ischemic complications following a myocardial infarction as well as improving the quality of life in patients with stable angina. PCI is ultimately performed in 60 –…

By: Tamara Yunusova, Staff Editor – On December 3, 2012, the U.S. Second Circuit Court of Appeals became the first court in the nation to authorize off-label drug promotion under the First Amendment.  The heavily-disputed ruling, which is headed for further appeal, will have far-reaching implications for pharmaceutical companies and drug regulation policy. In a…

By: Bhavini Shah, PharmD Candidate c/o 2013  – Fycompa® (perampanel) has received the U.S. Food and Drug Administration (FDA) approval for the adjunctive treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy aged 12 years and older.1  The drug, manufactured by Eisai Inc., is already approved for use in Iceland,…

By: Bethsy Jacob, PharmD Candidate 2014 – On January 18, 2013, the U.S. Food and Drug Administration (FDA) announced a new approval for Botox, generically known as OnabotulinumtoxinA. Patients diagnosed with urinary incontinence due to an overactive bladder can be prescribed Botox, if they are unable to take or are unresponsive to anticholinergic medications.  This…

By: Alexandra Alleva, PharmD candidate c/o 2013 – As of December 28th, Bristol-Myers Squibb and Pfizer’s brand name oral anticoagulant, Eliquis® (apixaban), attained FDA approval.1  This occurred one month after its approval in  Europe and Canada, following longer than expected waits in the US due to further investigation requests by the FDA.2 The much-anticipated anticoagulant is…

 The College of Pharmacy and Allied Health Professions has officially changed its name to the College of Pharmacy and Health Sciences.  This is the college’s second name change since it was established in 1929. In order to truly encompass the current and future educational goals of the College of Pharmacy and Allied Health Professions, the…

By: Marina Yermolayeva, PharmD Candidate c/o 2013 – “I’m allergic to the generic; I need the brand name medication,” is a common claim heard by many health care providers.  Managed care organizations get numerous calls from doctors and patients requesting prior authorizations to approve brand name medications whilst there are generic alternatives available on formulary.…

By: Michael Cronin, Pharm.D.  Candidate c/o 2014 – The Drug Information Association (DIA) student chapter at St. John’s University College of Pharmacy and Health Sciences began in March of 2012 to provide a local forum for cultivating awareness of opportunities within the pharmaceutical industry among doctor of pharmacy and allied health professions candidates.  Within two…

By: Maria A. Sorbera, Pharm.D. Candidate c/o 2013 –   Maria Sorbera was the 2011-2012 President of the Rho Chi Beta Theta Chapter at the Arnold & Marie Schwartz College of Pharmacy at Long Island University (LIU). She is a strong advocate of networking with fellow pharmacists regardless of their area of expertise, as well…

By: Mahdieh Danesh Yazdi, with Special Thanks to: Dr. Tomasz Jodlowski – In previous issues, we discussed an upcoming $29.1 billion merger between Express Scripts Inc. and Medco Health Solutions. The merger had been previously delayed by the Federal Trade Commission (FTC). The FTC wanted to verify that this upcoming merger would not violate any antitrust…

By: Kathlynn Ferrer, Pharm.D. Candidate c/o 2013 – Nabiximols (Sativex®) is a buccal spray that has been approved for use in the UK, Spain, Germany, Denmark, New Zealand, and Canada. The active ingredients in this product are Tetrahydrocannabinol and Cannabidiol, two kinds of cannabinoids1. Cannabinoids are chemical compounds that stimulate cannabinoid receptors and are the…

By: Alexandra Alleva, Pharm.D. Candidate c/o 2013 – On February 17, 2012, the US Food and Drug Administration (FDA) approved the first medication indicated specifically for patients with endogenous Cushing’s syndrome, a hormone disorder characterized by elevated blood levels of cortisol.  Mifepristone (Korlym®) is for the treatment of glucose intolerance and Type 2 Diabetes Mellitus…

By: Mohamed Dungersi – Starting July 1, 2012, Albertans will be able to have their prescriptions renewed at their local pharmacies and pharmacists will receive reimbursements for the service.  Patients will be able to renew medications for blood pressure, birth control, and asthma (particularly, inhalers) without waiting weeks to get into their family doctor’s office.…

By: Mahdieh Danesh Yazdi – Express Scripts Inc., one of the nation’s top pharmacy benefit managers (PBMs), has announced a $29 billion deal to take over one of its top competitors, Medco Health Solutions Inc.  Medco shareholders re-approved the merger on December 21.  For finalization, it needs the approval of Express Scripts’ shareholders and the…

By: Neal Shah – Anticlotting agents are staples in the prevention and treatment of thrombotic disorders, such as deep vein thrombosis, stroke, pulmonary embolism, myocardial infarction, and atrial fibrillation.1  Intravenous medications, such as unfractionated heparin (UFH), low molecular weight heparin (LMWH), and direct thrombin inhibitors (DTI), are commonly used in, both, inpatient and outpatient settings.…

By: Mahdieh Danesh Yazdi – We have all heard the mortifying tales of recent attacks on pharmacies by addicts looking to steal prescription pain-killers. Most notable perhaps, was the case of David Laffers. Mr. Laffers walked into Haven Drugs in Medford, NY and killed the pharmacist, a store clerk, and two customers, who happened to…

By: Khilna Patel, Pharm.D. Candidate c/o 2012 – On October 25 of this year, Eli Lilly and Company announced a worldwide market withdrawal of Xigris (drotrecogin alfa), a drug previously indicated to treat severe sepsis in high-risk patients.  Drotrecogin alfa is a recombinant form of human activated protein C.  The efficacy of drotrecogin alfa was…

By: Neal Shah – Dr. Ashby is a well-known Pharmacology professor for student pharmacists studying in their professional years. He graduated from the University of Louisville with a BA in Biology and Psychology in 1983. After obtaining his PhD in Pharmacology from the University of Louisville in 1987, he continued his education by obtaining a…