Creator of Fraudulent Pharmacy Sentenced to 5 Years in Prison – Drug for nerve pain boosts high for opioid abusers.

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Creator of Fraudulent Pharmacy Sentenced to 5 Years in Prison – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

A fraudulent Chicago-area pharmacy creator has been sentenced to 5 years federal prison for his role in a $1.6 million health care fraud scheme in which he was reimbursed through Part D for hundreds of prescription claims for drugs that were never actually dispensed.

James Calhoun, 74, of Des Plaines, Illinois, was sentenced by US District Judge John Z. Lee of the Northern District of Illinois. Judge Lee also ordered Calhoun to pay $1.6 million in restitution. Calhoun pleaded guilty in September 2018 to 1 count of conspiracy to commit health care fraud.

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Match Day Pairs Thousands of Pharmacy Students With Residency Programs – APhA submits compounding comments to FDA.

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Match Day Pairs Thousands of Pharmacy Students With Residency Programs – APhA submits compounding comments to FDA. – (866) 348-2889.

March 15 marks Match Day, in which thousands of student pharmacists from across the United States are ‘matched’ to residency positions in hospitals and community pharmacies. Of the approximate 5,134 residency positions available, 4,697 are now filled, according to the American Society of Health-System Pharmacists’ (ASHP). The remainder of the open positions are expected to be filled in during Phase II of the Match.

“The 2019 Match results for Phase I demonstrate remarkable expansion in residency programs and available positions,” said Janet A. Silvester, Pharm.D., MBA, FASHP, Vice President, ASHP Accreditation Services Office, in a prepared statement. “PGY2 growth continues to outpace PGY1 growth, supporting the market demand for pharmacists with advanced training to fill medication expert roles on the patient care team.”

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Influenza Activity in the United States Slightly Decreased – Drug for nerve pain boosts high for opioid abusers.

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Influenza Activity in the United States Slightly Decreased – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

Influenza activity has been decreasing in recent weeks, but remains elevated in the United States, according to the CDC.

In the March 15, 2019 FluView update, the CDC reported a slight decrease in the percentage of respiratory specimens testing positive for influenza viruses in clinical laboratories, from the previous week. According to the agency’s preliminary data, 97% of the 10,591 positive specimens indicated Influenza A viruses, and 2.8% of the positive specimens showed Influenza B. Nationally, of the influenza A viruses, H3N2 was reported more frequently than H1N1 in the last 3 weeks.

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Inserts Containing Combination Therapy May Protect Women Against HIV – APhA submits compounding comments to FDA.

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Inserts Containing Combination Therapy May Protect Women Against HIV – APhA submits compounding comments to FDA. – (866) 348-2889.

Vaginal inserts containing tenofovir alafenamide fumarate (TAF) in combination with elvitegravir (EVG) may help protect women against HIV infection.

Data compiled from a recent study showed that this therapy was highly effective in preventing simian/HIV (SHIV) infection in a macaque model mimicking vaginal transmission of HIV. 1

Results of the study were presented last week at the Conference on Retroviruses and Opportunistic Infections in Seattle, Washington. 

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Texas Compounder Ordered to Stop Production by Federal Court – Drug for nerve pain boosts high for opioid abusers.

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Texas Compounder Ordered to Stop Production by Federal Court – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

A federal judge has ordered Guardian Pharmacy Services, a Texas-based company, to stop producing compounded drug products intended to be sterile until it complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other requirements.

U.S. Chief District Judge Barbara M.G. Lynn for the Northern District of Texas entered a consent decree of permanent injunction against JMA Partners, Inc., doing business as Guardian Pharmacy Services in Dallas, Texas, as well as the company’s owner, Jack R. Munn.

According to FDA Commissioner Scott Gottlieb, MD, although compounded drugs can serve a need for certain patients whose medical needs cannot be met by an FDA approved drug product, they do not undergo the same premarket review as FDA approved drug products. All drug compounders are required to comply with requirements, and compounders that violate the law by not adhering to requirements should be held accountable by law.

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FDA Officials OK New Generic Valsartan – APhA submits compounding comments to FDA.

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FDA Officials OK New Generic Valsartan – APhA submits compounding comments to FDA. – (866) 348-2889.

Officials with the US Food and Drug Administration have approved a new generic of Diovan (valsartan), to help relieve the recent shortage of this critical medicine as a result of multiple recalls of generic valsartan products from several manufacturers. The recalls were prompted by a finding that certain lots of valsartan and other angiotensin II receptor blocker (ARB) medicines contain nitrosamine impurities.

For this approval, which was granted to Alkem Laboratories Limited, FDA officials gave a priority evaluation to the company’s manufacturing processes and also made sure they used appropriate testing methods to demonstrate that this valsartan product does not contain nitrosamine impurities.

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Fourth Trastuzumab Biosimilar Granted FDA Approval – Drug for nerve pain boosts high for opioid abusers.

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Fourth Trastuzumab Biosimilar Granted FDA Approval – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

Officials with the FDA have approved trastuzumab-qyyp (Trazimera, Pfizer), a biosimilar to trastuzumab (Herceptin), according to a press release.1

Trastuzumab is indicated for the treatment of human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

The agency’s approval of trastuzumab-qyyp was based on data, including results from the REFLECTIONS B327-02 trial, that showed a high degree of similarity between trastuzumab-qyyp and the originator product. In the study, trastuzumab-qyyp showed clinical equivalence and no clinically meaningful differences compared with the reference product in patients with first-line HER2 overexpressing metastatic breast cancer. As part of the REFLECTIONS clinical trial program, trastuzumab-qyyp has been studied in approximately 500 patients.1

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FDA Grants Breakthrough Designation to Chemotherapy-Free Combo Therapy for CLL – APhA submits compounding comments to FDA.

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FDA Grants Breakthrough Designation to Chemotherapy-Free Combo Therapy for CLL – APhA submits compounding comments to FDA. – (866) 348-2889.

Genentech and AbbVie have announced the submission of the supplemental New Drug Application to the FDA for venetoclax (Venclexta) in combination with obinutuzumab (Gazyva) for patients with previously-untreated chronic lymphocytic leukemia (CLL) and co-existing medical conditions, according to a press release. The sNDA has been granted Breakthrough Therapy Designation.

This is the fifth Breakthrough Therapy Designation for venetoclax, which is being studied across a range of blood cancers. Venetoclax has also been approved for the treatment of previously-treated adults with CLL or small lymphocytic lymphoma and in combination with azacytidine, decitabine, or low-dose cytarabine for certain adults with newly-diagnosed acute myeloid leukemia.

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FDA OKs Esketamine Nasal Spray for Treatment-Resistant Depression – Drug for nerve pain boosts high for opioid abusers.

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FDA OKs Esketamine Nasal Spray for Treatment-Resistant Depression – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

Officials with the FDA have approved esketamine CIII nasal spray (Spravato, Janssen Pharmaceutical Companies of Johnson & Johnson) for use in conjunction with an oral antidepressant in adults with treatment-resistant depression (TRD). This is the first new mechanism of action in 3 decades to treat major depressive disorder (MDD).1,2

The approval follows a phase 3 clinical trial with more than 1700 adults with TRD. In a short-term study, those who took Spravato and an oral antidepressant experienced superior improvement in depression symptoms at 4 weeks, compared to those who received a placebo and an oral antidepressant. In a long-term study, patients in stable remission taking the medication who continued treatment with the medicine were 51% less likely to relapse versus those who maintained a regimen of a placebo and an oral antidepressant.

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FDA Accepts Supplemental New Drug Application for Baloxavir Marboxil for Treating Flu in People at High Risk of Complications – APhA submits compounding comments to FDA.

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FDA Accepts Supplemental New Drug Application for Baloxavir Marboxil for Treating Flu in People at High Risk of Complications – APhA submits compounding comments to FDA. – (866) 348-2889.

Officials with the US Food and Drug Administration (FDA) have accepted a supplemental new drug application for baloxavir marboxil (Xofluza, Genentech) as a single-dose, oral treatment for people at high risk of complications from the flu, according to a statement from the manufacturer.

The sNDA is based on results from the phase 3 CAPSTONE-2 study of a single dose of Xofluza compared with placebo or oseltamivir 75 mg, twice daily for 5 days, in people 12 years of age or older who are at high risk of complications from the flu. The study compared Xofluza with placebo and oseltamivir in 2184 people and measured the time to improvement of influenza symptoms.

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