FDA Issues Final Guidance on Pathway for Interchangeable Biologics – Drug for nerve pain boosts high for opioid abusers.

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FDA Issues Final Guidance on Pathway for Interchangeable Biologics – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

In an effort to promote competition in the biologic market, officials with the FDA today released a final guidance on the pathway for interchangeable biosimilar products.

According to a statement released by acting FDA Commissioner Ned Sharpless, MD, the final guidance will provide clarity for developers who want to demonstrate that their proposed biological products meet the statutory interchangeability standard under the Public Health Service Act. Ultimately, the goal is to help patients by making more treatment options available.

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Generic Therapy Launched for Metastatic NSCLC and Pancreatic Cancer – Drug for nerve pain boosts high for opioid abusers.

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Generic Therapy Launched for Metastatic NSCLC and Pancreatic Cancer – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

Mylan Pharmaceuticals has received final approval from the FDA for its Abbreviated New Drug Application (ANDA) for Erlotinib Hydrochloride Tablets, 25 mg, 100 mg and 150 mg, and the product has been launched in the United States market. This product is a generic version of Genentech’s Tarceva.

Erlotinib hydrochloride tablets are indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least 1 prior chemotherapy regimen.

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Combination Nasal Spray Demonstrates Results in Treating Children with Seasonal Allergic Rhinitis – Drug for nerve pain boosts high for opioid abusers.

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Combination Nasal Spray Demonstrates Results in Treating Children with Seasonal Allergic Rhinitis – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

Positive results were collected from a Phase 3 study of an investigational fixed-dose combination nasal spray for the treatment of seasonal allergic rhinitis (SAR), according to Glenmark Pharmaceuticals.

The olopatadine hydrochloride [665 mcg] and mometasone furoate [25 mcg] nasal spray (Ryaltris, Glenmark) has been conditionally accepted by the FDA.

Also known as GSP 301 Nasal Spray, the drug met its primary endpoint in achieving clinically meaningful and statistically significant change from baseline in average morning and evening Reflective Total Nasal Symptom Score (rTNSS) compared to placebo in patients aged 6 years to under 12 years that participated in the study, according to Glenmark.

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First Treatment for Children with Lambert-Eaton Myasthenic Syndrome Receives FDA Approval – Drug for nerve pain boosts high for opioid abusers.

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First Treatment for Children with Lambert-Eaton Myasthenic Syndrome Receives FDA Approval – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

Officials with the FDA have approved amifampridine (Ruzurgi, Jacobus) tablets, the first treatment for children with the rare autoimmune disorder Lambert-Eaton myasthenic syndrome (LEMS), according to a press release.

In LEMS, the body’s immune system attacks the neuromuscular junction and disrupts the ability of nerve cells to send signals to muscle cells. The disorder causes weakness and other symptoms in affected patients. Although the prevalence of LEMS in children is not known, the overall prevalence is estimated to be 3 per million individuals worldwide, according to the FDA.

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Treatment for Transthyretin Amyloid Cardiomyopathy Receives FDA Approval – Drug for nerve pain boosts high for opioid abusers.

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Treatment for Transthyretin Amyloid Cardiomyopathy Receives FDA Approval – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

Officials with the FDA have approved tafamidis meglumine and tafamidis (Vyndaqel and Vyndamax, Pfizer) for transthyretin amyloid cardiomyopathy (ATTR-CM), a rare and life-threatening disease that is defined by restrictive cardiomyopathy and progressive heart failure, according to a press release.

Both treatments, which are oral formulations of transthyretin stabilizer tafamidis, are approved to treat either wild-type or hereditary ATTR-CM. There are approximately 100,000 individuals in the United States with ATTR-CM, of whom only 1% to 2% are diagnosed today, according to Pfizer.

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Beta Interferon Treatment Shown to Improve Long-Term Survival in Patients with MS – Drug for nerve pain boosts high for opioid abusers.

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Beta Interferon Treatment Shown to Improve Long-Term Survival in Patients with MS – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

A new study indicates that beta interferons, one of the most commonly prescribed disease-modifying drugs for multiple sclerosis (MS), may be tied to improved survival outcomes in patients.

In the first and largest study of its kind, researchers from the University of British Columbia (UBC) and Vancouver Coastal Health Research Institute aimed to assess mortality associated with beta interferons for the treatment of MS. The study, which was published in Brain, found that patients taking beta interferons had a longer survival rate than those who did not take the drug, with the strongest effect seen in patients who took beta interferons for more than 3 years.

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Adjuvant Treatment for HER2+ Early Breast Cancer Receives FDA Approval – Drug for nerve pain boosts high for opioid abusers.

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Adjuvant Treatment for HER2+ Early Breast Cancer Receives FDA Approval – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

Officials with the FDA have approved ado-trastuzumab emtansine (Kadcyla, Genentech) for post-surgery treatment of people with HER2-positive early breast cancer (EBC) who have residual invasive disease after neoadjuvant taxane and trastuzumab (Herceptin)-based treatment.

“This approval is a significant treatment advance for HER2-positive early breast cancer,” said Sandra Horning, MD, chief medical officer and head of Global Product Development, in a prepared statement. “With every step forward in reducing the risk of disease recurrence, we come closer to the goal of helping each person with early breast cancer have the greatest opportunity for cure.”

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Ivosidenib as Monotherapy Granted FDA Approval for Certain Patients with IDH1 Mutant AML – Drug for nerve pain boosts high for opioid abusers.

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Ivosidenib as Monotherapy Granted FDA Approval for Certain Patients with IDH1 Mutant AML – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

Officials with the FDA have approved a supplemental New Drug Application (sNDA) to update the US Prescribing Information for Agios Pharmaceuticals’ ivosidenib (Tibsovo), an isocitrate dehydrogenase-1 (IDH1) inhibitor, to include adult patients with newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test. The update is indicated for these patients who are age 75 years and older or who have comorbidities that preclude use of intensive induction chemotherapy.

The sNDA was granted Priority Review and accepted under the agency’s Real-Time Oncology Review pilot program, which aims to make the review of oncology drugs more efficient by allowing the FDA access to clinical trial data before the information is formally submitted to the agency. Ivosidenib received initial FDA approval in July 2018 for adult patients with relapsed or refractory (R/R) AML and an IDH1 mutation,according to Agios.

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Multiple Sclerosis Drug Treatment May Be Effective for Epilepsy – Drug for nerve pain boosts high for opioid abusers.

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Multiple Sclerosis Drug Treatment May Be Effective for Epilepsy – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

A drug commonly used to treat multiple sclerosis may one day be used to treat patients with Dravet Syndrome, a rare form of epilepsy, according to a new research from the Sackler Faculty of Medicine and Sagol School of Neuroscience at Tel Aviv University (TAU).

There has been research surrounding the brain functions within a narrow range of activity between status epilepticus and coma, according to the press release. However, it has largely remained unknown as to how neural circuits maintain stable activity in a constantly changing environment.

According to professor Inna Slutsky, the research into neuronal homeostasis began nearly 25 years ago, but there is still very little known about it.

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FDA Approves First Vaccine for Dengue Disease Prevention in Endemic Regions – Drug for nerve pain boosts high for opioid abusers.

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FDA Approves First Vaccine for Dengue Disease Prevention in Endemic Regions – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

Officials with the FDA has approved Dengue Tetravalent Vaccine, Live (Dengvaxia, Sanofi Pasteur), the first vaccine approved for the prevention of dengue disease caused by all dengue virus serotypes (1, 2, 3 and 4) in people ages 9 through 16 years who have laboratory-confirmed previous dengue infection and who live in endemic areas.

The drug application was granted the FDA’s Priority Review designation, as well as a Tropical Disease Priority Review Voucher under a program intended to encourage development of new drugs and biologics for the prevention and treatment of certain tropical diseases.

Dengue is endemic in the United States territories of American Samoa, Guam, Puerto Rico and the US Virgin Islands.

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