Bloomberg reports that the European Medicines Agency (EMA) has agreed to a rolling review of the marketing application for AstraZeneca (AZN -0.3%) and the University of Oxford's COVID-19 vaccine (AZD1222/ChAdOx1).
The timing of the filing should be next year since topline data from two pivotal large-scale studies will not likely be available until then.
ADMA Biologics (NASDAQ:ADMA) could be worth up to $16 per share in a buyout, according to Jefferies.
That note on the thinly-traded $190M market cap name had the stock up about 15% to $2.52 in a manner of minutes. At current pixel time, it's ahead 4.3% to $2.29.
ADMA at the start of September launched its COVID-19 ImmunoRank Neutralization MICRO-ELISA, a proprietary immunoassay that detects SARS-CoV-2 neutralizing antibodies in plasma.
https://seekingalpha.com/news/3618495-volatile-action-in-adma-biologics-jefferies-talks-takeout
The U.S. Bureau of Labor Statistics predicts 20 occupations will see the fastest growth through 2029, including healthcare jobs.
Below are the seven healthcare occupations forecast to see the fastest growth through 2029, ranked by projected growth rate, along with the 2019 median annual wages of these positions:
Nurse practitioners
Projected growth rate: 52 percent
Median annual wage: $109,820
Occupational therapy assistants
Projected growth rate: 35 percent
Median annual wage: $61,510
Home health and personal care aides
Projected growth rate: 34 percent
Median annual wage: $25,280
Physical therapist assistants
Projected growth rate: 33 percent
Median annual wage: $58,790
Medical and health services managers
Projected growth rate: 32 percent
Median annual wage: $100,980
Physician assistants
Projected growth rate: 31 percent
Median annual wage: $112,260
Substance abuse, behavioral disorder and mental health counselors
Projected growth rate: 25 percent
Median annual wage: $46,240
Adults started drinking more alcohol during the COVID-19 pandemic, but women not only drank more frequently, but also reported significant increases in heavy drinking and alcohol-related problems, a national survey found.
Overall frequency of alcohol consumption among adults ages 30-80 increased 14% versus 2019, with increases of 17% for women, reported Michael Pollard, PhD, of RAND Corporation in Santa Monica, California, which administers the survey, and colleagues.
Other demographic groups experiencing increases in frequency of alcohol consumption included non-Hispanic whites (up 19% vs 2019) and adults ages 30-59 (up 10%), the team wrote in a research letter in JAMA Network Open.
Nielsen surveys showed a 54% increase in national sales of alcohol for the week of March 21 versus a year ago, Pollard and colleagues noted, as stay-at-home orders began in U.S. states and the World Health Organization warned that alcohol use during this time may "exacerbate health concerns and risk-taking behaviors."
"Health systems may need to educate consumers through print or online media about increased alcohol use during the pandemic and identify factors associated with susceptibility and resilience to the impacts of COVID-19," Pollard and co-authors wrote.
They examined data from the RAND Corporation American Life Panel, a nationally representative probability-sampled panel of 6,000 English or Spanish-speaking participants, weighted to match certain demographic characteristics. In this study, the investigators looked at 2,615 panel members ages 30-80.
Overall, 1,771 completed the wave 1 baseline survey from April 29 to June 9, 2019, and wave 2 data were collected from May 28 to June 16, 2020. The completion rate for wave 2 was 58.9% of all wave 1 invitations.
Heavy drinking was defined as five or more drinks for men and four or more drinks for women within a couple of hours and the average number of drinks consumed in the last 30 days. The 15-item Short Inventory of Problems looked at adverse consequences tied to alcohol use in the past 3 months.
The current sample of 1,540 adults had a median age of 56, about 57% were women, and 71% were non-Hispanic white.
Frequency of alcohol consumption in the past 30 days among adults increased by 0.74 days over the baseline of 5.48 days in 2019. Women had a 2019 baseline of 4.58 days, with a 0.78 day increase in 2020, and non-Hispanic whites had a baseline of 6.46 days, with a 0.66 day increase in 2020.
Mean heavy drinking days for women increased 41% (0.18 days) from the 2019 baseline of 0.44 days per month. Women also showed a 39% increase in Short Inventory of Problems scores -- "indicative of increased alcohol-related problems independent of consumption level for nearly 1 in 10 women," the researchers wrote.
Limitations to the data, Pollard and co-authors said, include that it was self-reported and subject to social desirability bias, and that not all baseline respondents contributed to wave 2 data.
"Nonetheless, these results suggest that examination of whether increases in alcohol use persist as the pandemic continues and whether psychological and physical well-being are subsequently affected may be warranted," the researchers concluded.
Disclosures
Pollard disclosed support form the National Institute of Alcohol Abuse and Alcoholism.
Primary Source
JAMA Network Open
Source Reference: Pollard MS, et al "Changes in Adult Alcohol Use and Consequences During the COVID-19
https://www.medpagetoday.com/infectiousdisease/covid19/88864
Apple’s latest ad campaign for its Apple Watch makes much of its ability to monitor health functions – but researchers are concerned it may encourage people to seek medical attention prematurely.
A study of people who consulted a doctor after an abnormal pulse was detected by their device suggests it could lead to false positives that mean unnecessary healthcare visits, according to the team from the Mayo Clinic.
The study – published in the Journal of the American Medical Informatics Association (JAMIA) – found that it would take seven consultations based on the Watch’s pulse monitoring function to yield one case that warranted medical follow-up.
The authors say the FDA should consider the unintended consequences of widespread screening for ‘silent’ atrial fibrillation (AFib) using the Apple Watch abnormal pulse detection function “by populations in whom the device has not been adequately studied.”
The FDA has approved the latest versions of Apple’s device – which include a pulse monitor and single-lead electrocardiogram (ECG) – for use of these features, but has said it is concerned about false positive results leading to additional unnecessary medical procedures.
The approval emphasises that the device should not be used to replace traditional methods of diagnosis or treatment.
The regulator also specified that the ECG and irregular rhythm notification functions are not intended to be used by people under the age of 22, a group which made up around 9% of the 264-subject sample, or those previously diagnosed with AFib.
Pre-existing AFib was found in 58 (22%) of the sample, but an “actionable cardiovascular diagnosis of interest” was established in only 30 – or just over 11%. That included six out of 21 patients (15%) who had received a specific alert from the Apple Watch, according to the researchers. Most patients were symptomatic at the time an abnormal pulse was detected.
“False positive screening results have the potential to lead to excessive healthcare resource utilisation and anxiety among the ‘worried well’,” write the study authors.
“Stricter access controls are encouraged to ensure real-world use conforms with FDA guidance,” they add.
Earlier this year, Apple and partner Johnson & Johnson started enrolling patients in a study that will investigate whether the Apple Watches could be used to detect early signs of AFib.
J&J and Apple want to see if the Apple Watch can be used alongside an app developed by the pharma company to “accelerate the diagnosis and improve health outcomes of the 33 million people worldwide” living with the disease.
Apple now has a couple of competitors in the market for its ECG-enabled Watch, including the FitBit Sense, Samsung Galaxy Watch, Nokia unit Withings’ Move ECG sensor and ScanWatch, and AliveCor’s KardiaMobile devices.
https://pharmaphorum.com/news/false-positives-with-apple-watch-could-tie-up-health-resources/
Thinly traded AtriCure (ATRC -9.4%) is under modest pressure out of the gate this morning on the heels of a bearish report from Kerrisdale Capital Management who believes its growth drivers face headwinds. Key points:
The company's Convergent procedure is unlikely to gain traction considering its poor safety profile and lack of incremental benefit compared to catheter-based procedures.
The total available market for its surgical ablation products is much smaller that it claims and is almost completely saturated.
Other approaches, real-time mapping and pulse-field ablation, are set to revolutionize catheter ablation to the detriment of Convergent and the company's core surgical devices business.
https://seekingalpha.com/news/3618422-atricure-down-9-on-kerrisdale-short-call
