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FDA Requiring Labeling Changes for Benzodiazepines
via drugs.comSeptember 23, 2020 -- The U.S. Food and Drug Administration announced today in a Drug Safety Communication that it is requiring an update to the Boxed Warning, the agency’s most prominent safety warning, and requiring class-wide... -
J&J COVID-19 Vaccine Begins Final Stage of Clinical Trials
via drugs.comWEDNESDAY, Sept. 23, 2020 -- The final stage of clinical trials for Johnson & Johnson's COVID-19 vaccine have started, the company announced Tuesday.
The phase 3 trials will include 60,000 people and be the largest for a COVID-19 vaccine in the... -
U.S. COVID-19 Death Toll Hits 200,000 as Cases Climb in 22 States
via drugs.comWEDNESDAY, Sept. 23, 2020 -- The U.S. COVID-19 death toll reached the tragic milestone of 200,000 on Tuesday, with at least 22 states now reporting a rise in new cases. Just last Monday, only nine states were reporting increases in new COVID-19... -
Stricter Vaccine Approval Rules Coming From FDA
via drugs.comWEDNESDAY, Sept. 23, 2020 -- Stricter guidelines for emergency authorization use of a vaccine against the new coronavirus could soon be issued by the U.S. Food and Drug Administration.
The guidelines would outline more specific criteria for clinical... -
J&J COVID-19 Vaccine Begins Final Stage of Clinical Trials
via drugs.comWEDNESDAY, Sept. 23, 2020 -- The final stage of clinical trials for Johnson & Johnson's COVID-19 vaccine have started, the company announced Tuesday.
The phase 3 trials will include 60,000 people and be the largest for a COVID-19 vaccine in the... -
Genetically Predicted BMI Increases Rheumatoid Arthritis Risk
via drugs.comWEDNESDAY, Sept. 23, 2020 -- Genetically predicted body mass index (BMI) significantly increases the risk of rheumatoid arthritis (RA), according to a study published online Sept. 22 in Arthritis & Rheumatology.
Bowen Tang, from the Karolinska... -
As Flu Season Approaches, Clinicians Brace for Potential 'Twindemic'
via drugs.comWEDNESDAY, Sept. 23, 2020 -- Flu shots may be more important than ever this year, as COVID-19 presents new challenges for clinicians and communities this flu season. HD Live! spoke with Nadia Eltaki, M.D., director of clinical operations at Sibley... -
More Than 2.2 Million Women Live in Maternity Care Desert Status Areas
via drugs.comWEDNESDAY, Sept. 23, 2020 -- More than 2.2 million women live in areas with severely limited to no access to maternity care (maternity care desert status), according to a report published Sept. 23 by the March of Dimes.
Researchers updated the... -
SARS-CoV-2 Mortality Mainly Linked to Older Age, Comorbidity
via drugs.comWEDNESDAY, Sept. 23, 2020 -- For U.S. veterans with COVID-19, mortality is mainly associated with older age, male sex, and comorbidity, according to a study published online Sept. 23 in JAMA Network Open.
George N. Ioannou, B.M.B.Ch., from the... -
Risk for Autism Increased With Preterm, Postterm Birth
via drugs.comWEDNESDAY, Sept. 23, 2020 -- Preterm and postterm birth are associated with an increased risk for autism spectrum disorder (ASD), according to a study published online Sept. 22 in PLOS Medicine.
Martina Persson, M.D., Ph.D., from the Karolinska... -
Red Blood Cell Distribution Width, Mortality Tied in COVID-19
via drugs.comWEDNESDAY, Sept. 23, 2020 -- For patients with COVID-19, elevated red blood cell distribution width (RDW) is associated with increased mortality risk, according to a study published online Sept. 23 in JAMA Network Open.
Brody H. Foy, D.Phil., from... -
Oral Steroids May Raise Risks for Diabetes, HTN, VTE in Children
via drugs.comWEDNESDAY, Sept. 23, 2020 -- Children with current glucocorticoid exposure have increased risks for diabetes mellitus, hypertension, and venous thromboembolism (VTE), according to a study published online Sept. 9 in the American Journal of... -
Negative Pressure Does Not Cut C-Section Infection Risk in Obese
via drugs.comWEDNESDAY, Sept. 23, 2020 -- Compared with standard wound care, prophylactic negative pressure wound therapy does not lower the risk for surgical-site infection in obese women following cesarean delivery, according to a study published in the Sept.... -
Most People With SARS-CoV-2 Do Not Remain Asymptomatic
via drugs.comWEDNESDAY, Sept. 23, 2020 -- Most people infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) do not remain asymptomatic, and the secondary attack rate is lower among contacts of people with asymptomatic infection, according to... -
Metformin May Slow Cognitive Decline in Seniors With T2DM
via drugs.comWEDNESDAY, Sept. 23, 2020 -- For older adults with type 2 diabetes, cognitive decline is slower and dementia risk reduced for those receiving metformin, according to a study published online Sept. 23 in Diabetes Care.
Katherine Samaras, M.B.B.S.,... -
Fewer Women Aware of Heart Disease as Leading Cause of Death
via drugs.comWEDNESDAY, Sept. 23, 2020 -- From 2009 to 2019, there was a decrease in awareness among U.S. women that heart disease is the leading cause of death (LCOD) among women, according to a special report from the American Heart Association, published... -
CDC: Women More Likely to Experience Anxiety, Depression
via drugs.comWEDNESDAY, Sept. 23, 2020 -- Women are more likely to experience anxiety and depression, and women and older children are more likely to receive mental health treatment, according to new statistics from four data briefs published by the U.S. Centers... -
>2.2 Million Women Live in Maternity Care Desert Status Areas
via drugs.comWEDNESDAY, Sept. 23, 2020 -- More than 2.2 million women live in areas with severely limited to no access to maternity care (maternity care desert status), according to a report published Sept. 23 by the March of Dimes.
Researchers updated the... -
FDA hands BMS and bluebird bio a priority review for ide-cel
Updated review accepted after refuse-to-file letter was issued in May -
Janssen’s EGFR-targeting treatment regimen shows early benefit in lung cancer
Positive interim results presented at 2020 ESMO virtual congress -
Relief Therapeutics seeks US emergency approval for COVID-19 drug
If granted, EUA would give approval for use in severely ill patients with no alternative treatment options -
Pharmaspectra Group Limited Partners with IBM Watson Health to Help Life Sciences Companies with Stakeholder Management
London, United Kingdom, 23rd September 2020 - Pharmaspectra, the world’s largest collection of medical science, today announced it has entered into a partnership with IBM Watson Health. Through the partnership agreement, IBM Watson Health is withdrawing IBM Stakeholder Manager® from its portfolio and offering a transition path for its clients to Pharmaspectra’s product, LINK, the global leader in key opinion leader (KOL) management solutions. Pharmaspectra’s LINK solution c
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