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Coronavirus (COVID-19) Update: May 11, 2021 | FDA
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-may-11-2021

May 11th, 2021 - For Immediate Release: May 11, 2021 The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic: As part of the FDA’s effort to protect consumers, on May 6, 2021, the agency issued a warning letter to Covalon Technologies Inc. for selling unapproved products with fraudulent COVID-19 claims. Consumers concerned about COVID-19 should consu...

FDA Approves Higher Dosage of Naloxone Nasal Spray to Treat Opioid Overdose | FDA
https://www.fda.gov/news-events/press-announcements/fda-approves-higher-dosage-naloxone-nasal-spray-treat-opioid-overdose

May 11th, 2021 - For Immediate Release: April 30, 2021 Español The U.S. Food and Drug Administration announced today the approval of a higher dose naloxone hydrochloride nasal spray product to treat opioid overdose. The newly approved product delivers 8 milligrams (mg) of naloxone into the nasal cavity. The FDA had previously approved 2 mg and 4 mg naloxone nasal spray products. Naloxone is a medicine that can ...

FDA In Brief: FDA Finalizes Guidance with Internationally Harmonized Recommendations to Further Support Safe, High-Quality Human Drug Products | FDA
https://www.fda.gov/news-events/press-announcements/fda-brief-fda-finalizes-guidance-internationally-harmonized-recommendations-further-support-safe

May 11th, 2021 - For Immediate Release: May 11, 2021 The following quote is attributed to Michael Kopcha Ph.D., R.Ph., director of the FDA’s Office of Pharmaceutical Quality “The FDA is continually working to promote drug innovation and improvement, strengthen quality assurance, safety and supply of drug products and enable more efficient use of industry and regulatory resources. Through the harmonization of re...

FDA Clears Cap Device for 'Smart' Insulin Pens for Diabetes
https://www.medscape.com/viewarticle/950892

May 10th, 2021 - The US Food and Drug Administration (FDA) has cleared the Bigfoot Unity Diabetes Management System, a cap device that connects to insulin pens and translates continuous glucose data into dosing recommendations, for use in individuals aged 12 and older. The Bigfoot Unity System has three primary components — proprietary smart pen caps for both rapid- and long-acting insulin, a mobile app, and an...

Opioid Addiction Meds May Curb Growing Problem of Kratom Dependence
https://www.medscape.com/viewarticle/950924

May 10th, 2021 - Medications typically used to treat opioid use disorder (OUD) may also be effective for the growing public health problem of kratom addiction, new research shows. Dr Saeed Ahmed Results of a comprehensive literature review and an expert survey suggest buprenorphine, naltrexone, and methadone are effective for kratom use disorder (KUD) and that the indication for these medications "should be ext...

Tips for Navigating Prior Authorization and Out-of-Pocket Costs for HFrEF Medications
https://www.medscape.com/viewarticle/950209

May 10th, 2021 - As clinicians, we know the importance of promptly initiating treatment for our patients with heart failure with reduced ejection fraction (HFrEF) to improve survival, rehospitalization, and medication adherence. Several generic drug combination therapies are available to increase patient access and treatment. Such cost-effective regimens include angiotensin-converting enzyme (ACE) inhibitors, b...

NSAIDs Don't Make COVID-19 Worse in Hospitalized Patients
https://www.medscape.com/viewarticle/950919

May 10th, 2021 - Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center. NSAIDs don't boost the risk of more severe disease or death in hospitalized patients with COVID-19, a new study finds.

UK Study Confirms NSAIDS Do Not Result in Worse COVID-19 Outcomes
https://www.medscape.com/viewarticle/950889

May 10th, 2021 - The use of non-steroidal anti-inflammatory drugs (NSAIDs) does not lead to higher rates of death or severe disease in patients who are hospitalised with COVID-19, according to a new observational study of more than 72,000 people in the UK published in the Lancet Rheumatology journal. The ISARIC CCP-UK (International Severe Acute Respiratory and emerging Infection Consortium Clinical Characteris...

HHS Prohibits Discrimination Against LGBTQ Patients
https://www.medscape.com/viewarticle/950878

May 10th, 2021 - The Biden administration is reversing a Trump-era policy that allowed healthcare providers to bar services to lesbian, gay, bisexual, transgender, or queer (LGBTQ) patients. The US Department of Health and Human Services (HHS) gave notice on Monday that it would interpret the Affordable Care Act's Section 1557 — which bars discrimination on the basis of sex — to include discrimination on the ba...

Emergence of New Digital ADHD Intervention Tools
https://www.medscape.com/viewarticle/950902

May 10th, 2021 - New digital tools are on the horizon to help patients with attention-deficit/hyperactivity disorder (ADHD) manage the condition. Speakers at the World Congress on ADHD – Virtual Event described innovations aimed at improving medication compliance or reducing symptoms through the use of smartphone technology such as apps and text messaging, and video games. Some of these technologies have shown ...

Inovio Says COVID-19 Vaccine Candidate Safe, Effective in Midstage Trial
https://www.medscape.com/viewarticle/950815

May 10th, 2021 - (Reuters) - Inovio Pharmaceuticals Inc said its COVID-19 vaccine candidate was safe, well-tolerated and produced immune response against the new coronavirus in a mid-stage clinical trial, sending the drug developer's shares up over 3%. The trial, which enrolled about 400 participants aged 18 and above, helped the company confirm an appropriate dose for testing in a late-stage Phase 3 trial, Ino...

Immediate Treatment of M. Abscessus Urged for Cystic Fibrosis
https://www.medscape.com/viewarticle/950846

May 10th, 2021 - NEW YORK (Reuters Health) - An analysis of whole genome data from cystic fibrosis patients reveals how multi-drug resistant pathogens evolve and suggests that Mycobacterium abscessus infection be treated promptly, contrary to current medical practice. "Our study highlights how environmental bacteria can evolve into specialized human pathogens," Dr. R "We therefore need to consider frequent scre...

ADHD in Preschool Kids: Adrenergic Agonists May Be a Better Fit
https://www.medscape.com/viewarticle/950879

May 10th, 2021 - A new study finds that α2-adrenergic agonists may be of benefit and have fewer side effects than stimulant medications for the treatment of attention deficit/hyperactivity disorder (ADHD) in preschool-age children. The study was published online May 4 in JAMA. "While our study focused on how well medications work and how well they are tolerated when used to treat preschool-age children with ADH...

States Ready Plans to Get Pfizer COVID Vaccine to Younger Teens
https://www.medscape.com/viewarticle/950943

May 10th, 2021 - Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center. State health officials today shared plans to distribute Pfizer's COVID-19 vaccine to 12- to 15-year-olds after the FDA authorized its use in this age group late Monday. Maine is readying four types of distribution sites for the vaccines: primary care offices, Walgreen's and CVS pharmacies, mass ...

New Clues Show How the Immune System Fights COVID-19
https://www.medscape.com/viewarticle/950939

May 10th, 2021 - When the immune system detects an invading virus like COVID-19, it sends swarms of antibodies to latch on to it, blocking its ability to attach to cells and marking it for destruction by other cells. Now, new research shows in striking detail how that process works in people who have successfully recovered from COVID-19 and offers new insights to help others. So far, scientists have focused on ...

Coronavirus (COVID-19) Update: FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Adolescents in Another Important Action in Fight Against Pandemic | FDA
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-pfizer-biontech-covid-19-vaccine-emergency-use

May 10th, 2021 - For Immediate Release: May 10, 2021 Today, the U.S. Food and Drug Administration expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to include adolescents 12 through 15 years of age. The FDA amended the EUA originally issued on Dec...

FDA In Brief: FDA to Hold Meeting of its Vaccines and Related Biological Products Advisory Committee to Discuss Pediatric Use of COVID-19 Vaccines | FDA
https://www.fda.gov/news-events/press-announcements/fda-brief-fda-hold-meeting-its-vaccines-and-related-biological-products-advisory-committee-discuss

May 10th, 2021 - For Immediate Release: May 10, 2021 The following quote is attributed to Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research “Vaccines continue to be an important public health measure in fighting the COVID-19 pandemic. To date, the FDA has authorized three COVID-19 vaccines for emergency use that have met our rigorous standards for quality, safety, and ...

AAD Unveils New Guidelines for Actinic Keratosis Management
https://www.medscape.com/viewarticle/950849

May 9th, 2021 - New guidelines from the American Academy of Dermatology strongly recommend the use of either 5-fluorouracil (5-FU) or imiquimod for the field treatment of actinic keratosis (AK). They also conditionally recommend the use of photodynamic therapy (PDT) and diclofenac for the treatment of AK, both individually and as part of combination therapy regimens. Those are two of 18 recommendations made by...

Blood Biomarker a 'Promising Predictor' of Psychosis Relapse
https://www.medscape.com/viewarticle/950869

May 9th, 2021 - Copeptin, a small peptide secreted with the hormone vasopressin, appears to be one of the first promising biomarkers for predicting psychosis relapse, results of an observational study suggest. An analysis of plasma copeptin levels in patients with schizophrenia showed those with high plasma levels of the peptide were about three times more likely to experience psychotic relapse compared with t...

Mandrola Previews the 2021 (Virtual) American College of Cardiology Scientific Sessions
https://www.medscape.com/viewarticle/950797

May 9th, 2021 - The first trial presented on the opening day of late-breaking clinical trials often brings big news. Post-MI Renin-Angiotensin Blockade The PARADISE-MI trial comparing sacubitril/valsartan to ramipril in patients with a left ventricular ejection fraction of 40% or less after myocardial infarction (MI) and clinical evidence of heart failure might have given Novartis another market for their angi...