The U.S. Food and Drug Administration announced that, for the first time, it has authorized the marketing of products through the modified risk tobacco product (MRTP) pathway. The authorizations are for eight Swedish Match USA, Inc. snus smokeless tobacco products sold under the “General” brand name.
U.S. Food and Drug Administration and the Federal Trade Commission posted a joint warning letter to Rooted Apothecary LLC, of Naples, Florida, for illegally selling unapproved products containing cannabidiol (CBD) online with unsubstantiated claims that the products treat teething pain and ear aches in infants, autism, attention-deficit/hyperactivity disorder (ADHD), as well as Parkinson’s and Alzheimer’s disease, among other conditions or diseases.
Affordable access to medicines is a public health concern and more generic drug competition can help reduce prices, improve access and benefit the public health. Safe, effective and high-quality generic drugs play a vital role in our health care system. Generic drugs account for about 90% of all prescription drug purchases in the U.S. In 2018, competition from generic drugs saved the health care system about $293 billion.
U.S. Food and Drug Administration allowed marketing of a rapid diagnostic test (RDT) to detect Ebola virus antigens (proteins) in human blood from certain living individuals and samples from certain recently deceased individuals suspected to have died from Ebola (cadaveric oral fluid). The OraQuick Ebola Rapid Antigen Test is the first rapid diagnostic test the FDA has allowed to be marketed in the U.S. for the Ebola Virus Disease (EVD). The test provides a rapid, presumptive diagnosis that must be confirmed.
The U.S. Food and Drug Administration announced it has awarded two new research grants for natural history studies in rare diseases. The FDA is providing over USD 4.1 million over the next four years to fund these studies. Information from natural history studies can facilitate design of efficient clinical trials to test future treatments.
Natural history studies closely look at how specific diseases progress over time. The natural history of a disease is the course a disease takes from its onset, through the presymptomatic and clinical stages, to a final outcome in the absence of treatment.
The FDA received 31 grant applications that were reviewed and evaluated for scientific and technical merit by more than 45 rare disease, natural history, regulatory and statistical experts, that included representatives from academia, patient groups, the National Institutes of Health and the FDA. The grants were awarded to:
• University of Texas MD Anderson Cancer Center (Houston, Texas), Elizabeth Grubbs, prospective study in medullary thyroid carcinoma, approximately USD 1.7 million over four years
The study seeks to leverage a multi-institutional registry to characterize disease variables and patient perspectives that inform decisions regarding initiation of and adherence to chemotherapy in medullary thyroid cancer. Such critical knowledge can be incorporated into the design of clinical trials of emerging therapies for this disease.
• Vanderbilt University Medical Center (Nashville, Tennessee), Jonathan Soslow, prospective study in cardiac disease in Duchenne muscular dystrophy, approximately USD 2.4 million over four years.
This study aims to focus on cardiomyopathy (heart muscle disease), which is the leading cause of death in Duchenne muscular dystrophy. The study will combine genetic differences with imaging and blood biomarkers to identify surrogate biomarkers that predict the risk of cardiac dysfunction in Duchenne muscular dystrophy and other related diseases. This information has the potential to improve future clinical trial efficiency in these diseases by decreasing their size and cost.
The U.S. Food and Drug Administration granted approval to Scenesse (afamelanotide) to increase pain-free light exposure in adult patients with a history of phototoxic reactions (damage to skin) from erythropoietic protoporphyria.
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The U.S. Food and Drug Administration announced that it has awarded 12 new clinical trial research grants totaling more than USD 15 million over the next four years to enhance the development of medical products for patients with rare diseases. The grants were awarded to principal investigators from academia and industry across the country.
The FDA awarded the grants through the Orphan Products Clinical Trials Grants Program, funded by Congress to encourage clinical development of drugs, biologics, medical devices and medical foods for the treatment of rare diseases. The grants are intended to substantially contribute to marketing approval of products to treat rare diseases or provide essential data needed for development of such products.
The FDA received 89 clinical trial grant applications that were reviewed and evaluated for scientific and technical merit by more than 100 rare disease experts, including members of academia.
The grants awarded are focused on supporting product development to meet the needs of patients impacted by a variety of rare diseases, mainly those affecting children and cancers.
The recipients, principal investigators and approximate funding amounts, listed alphabetically, are:
• Chemocentryx, Inc. (Mountain View, California), Peter Staehr, phase 2 study of avacopan for the treatment of complement 3 glomerulopathy – USD 1 million over two years
• Cincinnati Children’s Hospital Medical Center (Cincinnati, Ohio), Maryam Fouladi, phase 1 study of PTC596 for the treatment of diffuse intrinsic pontine glioma & high-grade gliomas -- USD 750,000 over three years
• Cincinnati Children’s Hospital Medical Center (Cincinnati, Ohio), Parinda Mehta, phase 2 study of quercetin chemoprevention for the treatment of squamous cell carcinoma in patients with Fanconi Anemia – USD 1.7 million over four years
• Columbia University Health Sciences (New York, New York), Gary Brittenham, phase 2 study of daily vitamin D for the treatment of sickle-cell respiratory complications – USD 2 million over four years
• Cumberland Pharmaceuticals, Inc. (Nashville, Tennessee), Ines Macias-Perez, phase 2 study for oral ifetroban for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy – USD 1 million over three years
• Massachusetts General Hospital (Boston, Massachusetts), Sara Pai, phase 2 study of anti-PD1 therapy for the treatment of HPV-associated recurrent respiratory papillomatosis – USD 1 million over three years
• New York Medical College (Valhalla, New York), Mitchell Cairo, phase 2 study of viral specific cytotoxic T-lymphocytes for the treatment of refractory viral infections and T-cell immunodeficiency – USD 1.7 million over four years
• Privo Technologies, LLC. (Peabody, Massachusetts), Manijeh Goldberg, phase 1/2 study of cisplatin patch (PRV111) for the treatment of oral cancer – USD 2 million over four years
• Targeted Therapy Technologies, LLC (Somerset, New Jersey), Ricardo Carvalho, phase 1 study of episcleral topotecan for the treatment of retinoblastoma – USD 660,000 over three years
• University of Alabama at Birmingham (Birmingham, Alabama), Gregory Friedman, phase 1 study of oncolytic engineered herpes simplex virus therapy for the treatment of pediatric malignant cerebellar brain tumors – USD 750,000 over three years
• University of California San Diego (La Jolla, California), Jason Sicklick, phase 2 study of temozolomide for the treatment of gastrointestinal stromal tumor – USD 1.5 million over three years
• University of Texas MD Anderson Cancer Center (Houston, Texas), Michael Andreeff, phase 1/2 study of the imipridone (ONC201) for treatment of acute myeloid leukemia – USD 1 million over four years
The U.S. Food and Drug Administration approved Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg) in at-risk adults and adolescents weighing at least 35kg for HIV-1 pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection from sex, excluding those who have receptive vaginal sex. Descovy is not indicated in individuals at risk of HIV-1 infection from receptive vaginal sex because the effectivness in this population has not been evaluated.
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Torrent Pharmaceuticals Limited is expanding its recall for Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity while testing the below finished product batches manufactured utilizing active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited using the old Route of Synthesis.
The U.S. Food and Drug Administration approved Rituxan (rituximab) injection to treat granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) in children 2 years of age and older in combination with glucocorticoids (steroid hormones).
It is the first approved treatment for children with these rare vasculitis diseases, in which a patient’s small blood vessels become inflamed, reducing the amount of blood that can flow through them. This can cause serious problems and damage to organs, most notably the lungs and the kidneys. It also can impact the sinuses and skin.
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