Cabozantinib Granted FDA Approval for Advanced HCC – APhA submits compounding comments to FDA.

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Cabozantinib Granted FDA Approval for Advanced HCC – APhA submits compounding comments to FDA. – (866) 348-2889.

The FDA has approved cabozantinib (Cabometyx, Exelixis) as a treatment for patients with hepatocellular carcinoma (HCC) who previously received sorafenib (Nexavar, Bayer), according to Exelixis, the company developing the therapy.

The approval was based on findings from the phase III CELESTIAL trial, in which overall survival (OS) was improved by 2.2 months with cabozantinib versus placebo. Median OS with cabozantinib was 10.2 versus 8.0 months for placebo, representing a 24% reduction in the risk of death (HR, 0.76; 95% CI, 0.63-0.92; P = .0049).

Results from the CELESTIAL trial were first presented at the 2018 Gastrointestinal Cancers Symposium. The study was stopped in October 2017, following a positive interim analysis that showed a significant improvement in OS for cabozantinib. The stoppage was preplanned if the P value for OS reached ≤.021.

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CDC Provides Estimates on How Many Patients Have Had Flu So Far This Season – Drug for nerve pain boosts high for opioid abusers.

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CDC Provides Estimates on How Many Patients Have Had Flu So Far This Season – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

Between 6 and 7 million people have been sick with influenza so far during the 2018-2019 season, according to data released on Jan. 11, 2019 from the CDC.

Up to half of those who have or had influenza have sought medical care for their illness, and between 69,000 and 84,000 people have been hospitalized from flu.

These data are derived using the same mathematical model used to generate previous end-of-season estimates, but this is the first time the data are being released during the season, CDC officials said. Calculations are based on adjusted rates of laboratory-confirmed, influenza-associated hospitalizations collected through a surveillance network that covers approximately 8.5% of the U.S. population, or about 27 million people.

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National Pharmacist Day Elicits Pride for the Profession – APhA submits compounding comments to FDA.

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National Pharmacist Day Elicits Pride for the Profession – APhA submits compounding comments to FDA. – (866) 348-2889.

On National Pharmacist Day, public awareness is generated for everything these health care providers do for patients, as well as behind the scenes. The day is also an opportunity for these professionals to express pride in their work and share aspects of the job that keep them motivated.

August Troccia II, PharmD, at Elmira Psychiatric Center in New York, is proud to work alongside other health care providers, helping patients improve their overall health and quality of life.

“Although our [pharmacist] focus is primarily medication-related, there are often opportunities to form a personal, yet professional connection with the patients,” Troccia, wrote in an email interview.

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Midwestern University Announces Creation of Pharmacometrics Center – Drug for nerve pain boosts high for opioid abusers.

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Midwestern University Announces Creation of Pharmacometrics Center – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

In response to a growing demand for personalized medicine, the Midwestern University Chicago College of Pharmacy earlier this week announced the establishment of a Pharmacometrics Center of Excellence on the school’s Downers Grove Campus.

As an institution dedicated to pharmacometrics—the quantitative study of medication effects on both humans and animals—the Pharmacometrics Center of Excellence at Midwestern University will focus on personalized and precision medication approaches while designing strategies to optimize medication efficacy and safety of medications, according to a press release.

The creation of the Center is part of an effort to research and develop therapies that are tailored to individual patients, the press release notes. The Center’s mission is also aligned with the FDA’s recent initiative to move away from “one size fits all” approaches to medication and towards customized treatments.

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Vulvodynia Study Endorsing Gabapentin for Pelvic Muscle Pain: An In-depth Look – APhA submits compounding comments to FDA.

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Vulvodynia Study Endorsing Gabapentin for Pelvic Muscle Pain: An In-depth Look – APhA submits compounding comments to FDA. – (866) 348-2889.

Sexual pain in women remains a difficult and elusive medical condition to treat. Provoked vulvodynia current recommended therapies include pelvic floor physical therapy and psychological interventions including cognitive behavioral therapy (CBT) and sexual counseling.1 Pharmacologic options remain limited to topical lidocaine, hormonal cream (typically estrogen + testosterone), and tricyclic antidepressants and their evidence for use remains mixed at best. Vulvodynia etiology is multifactorial and likely involves central sensitization, muscle and tissue nociception, and mucosal mechanoreceptor dysfunction.

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Treatment App Available by Prescription for Adults With Opioid Use Disorder – Drug for nerve pain boosts high for opioid abusers.

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Treatment App Available by Prescription for Adults With Opioid Use Disorder – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

An FDA-approved mobile application for adults with opioid use disorder (OUD) is now available by prescription.1 Pear Therapeutics’ reSET-O app aims to increase patient retention for outpatient treatment programs.1-3

The new app, a cognitive behavioral therapy (CBT) that can be downloaded to a patient’s mobile device,2,3 is intended to be used in addition to outpatient treatment under the care of a health care professional. The app should also be used in conjunction with treatment that includes a behavior modification intervention that establishes a connection between new, targeted behavior; buprenorphine and contingency management; and the opportunity to obtain a desired reward, according to the FDA.2

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Viral Decision-Making Factors in Latent HIV Reservoirs Identified in Study – APhA submits compounding comments to FDA.

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Viral Decision-Making Factors in Latent HIV Reservoirs Identified in Study – APhA submits compounding comments to FDA. – (866) 348-2889.

Research efforts have targeted latent HIV reservoirs as a potential way to guide future treatments. In a new study published in Cell Reports, the authors aimed to distinguish between uninfected cells and latently infected cells, with hopes that eradicating the latent reservoirs could lead to a cure for the disease.

In its latent state, the virus remains transcriptionally silent, but can spontaneously reactivate and trigger reinfection of the cell after treatment with antiretroviral therapy ends. Researchers have attempted to develop drug treatments that can both reactivate and remove cells with latent provirus. Challenges such as incomplete reactivation of non-inducible provirus, uncertainty regarding clearance or death of cells after latent reversal, and coupling of migration and reactivation of latently infected T cells have caused barriers to developing a successful strategy.

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Vecuronium Bromide Powder Recalled Nationwide – Drug for nerve pain boosts high for opioid abusers.

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Vecuronium Bromide Powder Recalled Nationwide – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

Sun Pharmaceutical Industries, Inc. (SPI) is voluntarily recalling 3 lots of 10 mg vecuronium bromide for injection (lyophilized powder) and 1 lot of 20 mg vecuronium bromide for injection (lyophilized powder) to the hospital level. These products have been found to contain particulate matter identified as glass.

The administration of a glass particulate, if present in an intravenous drug, may result in local irritation or swelling in response to the foreign material. More serious potential outcomes include blockage and clotting in blood vessels, which may be life-threatening. To date, SPI has not received any reports of adverse events related to this recall.

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Breakthrough Therapy Designation Granted for Sickle Cell Disease Treatment – APhA submits compounding comments to FDA.

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Breakthrough Therapy Designation Granted for Sickle Cell Disease Treatment – APhA submits compounding comments to FDA. – (866) 348-2889.

Officials with the FDA have granted Breakthrough Therapy designation to Novartis’ crizanlizumab (SEG101) for the prevention of vaso-occlusive crises (VOCs) in patients of all genotypes with sickle cell disease (SCD), according to a press release.

Patients with SCD face a high economic burden, with annual costs of more than $30,000 for adults with the disease, according to Novartis. SCD can lead to VOCs, which are painful complications caused by clusters of cells that block or reduce blood flow.

“Painful sickle cell crises matter because they can disrupt patients’ lives, and often require hospital visits and medical attention,” Samit Hirawat, MD, head of Novartis Oncology Global Drug Development, said in a statement. “We look forward to working with the FDA over the coming months toward making crizanlizumab, a therapy that has the potential to prevent sickle cell pain crises, available in the US as soon as possible.”

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All Evolocumab Device Options Available At Reduced List Price – Drug for nerve pain boosts high for opioid abusers.

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All Evolocumab Device Options Available At Reduced List Price – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

All evolocumab (Repatha, Amgen) device options, including the Pre-Filled Syringe and Pushtronex® are now available at a lower list price of $5,850. The lower priced Repatha options are identical to the Repatha options currently available, but have been introduced to reduce out-of-pocket costs for patients, especially Medicare patients, according to a statement from Amgen officials.

Evolocumab is a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). Repatha binds to PCSK9 and inhibits circulating PCSK9 from binding to the low-density lipoprotein (LDL) receptor (LDLR), preventing PCSK9-mediated LDLR degradation and permitting LDLR to recycle back to the liver cell surface. By inhibiting the binding of PCSK9 to LDLR, the  increases the number of LDLRs available to clear LDL from the blood, thereby lowering LDL-C levels.

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