MEC152x Keyboard and Embedded Controller for Notebook PC

MCHP Announces Note Exchanges

ATWILC/ATWINC Serial Bridge Application Note

IS206X Introduction to DSP Configuration tool and AEC Tuning Guide Application Note

AN2316 Configuration Options for the USB58xx and USB59xx Application Note

Artist Ken Rinaldo encourages the bacteria on banknotes to grow and spread to explore colonialism in his touring show, Borderless Bacteria/Colonialist Cash

Mark O'Connell's book Notes from an Apocalypse is an exploration of doomsday preparation from Mars colonists to fallout shelter estate agents

Mark O'Connell's book Notes from an Apocalypse is an exploration of doomsday preparation from Mars colonists to fallout shelter estate agents

Title: Nanotechnology Might Help Fight Deadly 'Cytokine Storm' of COVID-19
Category: Health News
Created: 4/28/2020 12:00:00 AM
Last Editorial Review: 4/29/2020 12:00:00 AM

Purpose:

KEYNOTE-158 (ClinicalTrials.gov identifier: NCT02628067) investigated the efficacy and safety of pembrolizumab across multiple cancers. We present results from patients with previously treated advanced well-differentiated neuroendocrine tumors (NET).

Patients and Methods:

Pembrolizumab 200 mg was administered every 3 weeks for 2 years or until progression, intolerable toxicity, or physician/patient decision. Tumor imaging was performed every 9 weeks for the first year and then every 12 weeks. Endpoints included objective response rate (ORR) per RECIST v1.1 by independent central radiologic review (primary) and duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety (secondary).

Results:

A total of 107 patients with NETs of the lung, appendix, small intestine, colon, rectum, or pancreas were treated. Median age was 59.0 years (range, 29–80), 44.9% had ECOG performance status 1, 40.2% had received ≥3 prior therapies for advanced disease, and 15.9% had PD-L1–positive tumors (combined positive score ≥1). Median follow-up was 24.2 months (range, 0.6–33.4). ORR was 3.7% (95% CI, 1.0–9.3), with zero complete responses and four partial responses (three pancreatic and one rectal) all in patients with PD-L1–negative tumors. Median DOR was not reached, with one of four responses ongoing after ≥21 months follow-up. Median PFS was 4.1 months (95% CI, 3.5–5.4); the 6-month PFS rate was 39.3%. Median OS was 24.2 months (95% CI, 15.8–32.5). Treatment-related adverse events (AE) occurred in 75.7% of patients, 21.5% of whom had grade 3–5 AEs.

Conclusions:

Pembrolizumab monotherapy showed limited antitumor activity and manageable safety in patients with previously treated advanced well-differentiated NETs.

A collection of recently published news items.

Call of Duty Modern Warfare players can today download a brand new update for Warzone and Modern Warfare multiplayer. Here are the patch notes for PS4, Xbox One and PCs.

Dear readers, Speakeasy will no longer be updated as of July 2017. Visit our Arts section for the latest coverage and follow us on Twitter for news and analysis of the entertainment world. Additionally, you can download the WSJ app for iOS or Android to follow your favorite reporters and columnists and receive notifications when they publish new articles.

The best digital pens let you take notes the old fashioned way while saving them to your phone or computer.

After many delays

1. Redmi Note 9 Pro Max sales begin on May 12 in India - GSMArena.com news  GSMArena.com
2. Xiaomi spinoff Poco has an event next week to announce the long-rumored F2 Pro  Android Police
3. Xiaomi Redmi Note 9 Pro Max first sale in India to take place on May 12  Hindustan Times
4. Xiaomi’s Redmi Note 9 Pro Max to go on first sale: Details here  Livemint
5. POCO F2 Pro to be launched globally on May 12  XDA Developers
6. View Full coverage on Google News

As many provinces move towards slowly reopening non-essential businesses, employers and employees are looking ahead to plan what the new normal could look like in the workplace, including whether those who have tested positive for COVID-19 will have to provide a doctor's note to return to work.

Saturday's instalment of 'SNL at home' brilliantly acknowledged the gravity of our times while poking fun at quarantine culture

Continue reading...

With a mission to make India to among the top 3 Industrial AI hubs in the world by 2021, Flutura Co-Founder, Derick Jose, shares a crisp note which outlines the journey so far and the vision going forward.

Keep on reading: Industrial AI Consortium Note

A WAD of fake $50 notes has been splashed across southern Tasmania with police receiving 20 separate reports of the counterfeit currency.

Baynote software provides personalized shopping experiences that help drive conversions. Let us help improve your customers' experiences today.

"The current financial crisis requires a well-coordinated, proactive law enforcement response that draws on all the resources of the federal government. The appropriate role of the Department of Justice in responding to this crisis is clear: We will be relentless in our investigation of corporate wrongdoing, and will not hesitate to bring charges, where appropriate, for criminal misconduct on the part of businesses and business executives."

"Over the last quarter century, asset forfeiture and money laundering prosecutions have become integral to our country’s law enforcement strategy," said Assistant Attorney General Breuer.

Stewart David Nozette, a scientist who once worked for the Department of Energy, the Department of Defense, the National Aeronautics and Space Administration and the White House’s National Space Council, pleaded guilty today to attempted espionage for providing classified information to a person he believed to be an Israeli intelligence officer.

Stewart David Nozette, 54, a scientist who once worked for the Department of Energy, the Department of Defense, the National Aeronautics and Space Administration and the White House’s National Space Council, was sentenced today to 13 years in prison for attempted espionage, conspiracy to defraud the United States and tax evasion.

These day-to-day efforts by the Justice Department and our counterparts around the world might not be visible to the public, but the fruits of these efforts are.

"Why is health care enforcement so important? A major reason is the importance of the health care industry itself. From compliance officers to physicians, from corporate executives to nurses and researchers, you contribute to producing the drugs and medical devices on which we and our loved ones rely. Your efforts help to ensure that, when we are sick, the medicines we take will heal us effectively; that when we are in pain, we can obtain relief safely," said Assistant Attorney General Delery

Attorney General Eric Holder will deliver the keynote address at the Department of Justice’s 50th anniversary celebration of the Civil Rights Act of 1964. Secretary of Labor Thomas Perez, Secretary of Education Arne Duncan, Congresswoman Eleanor Holmes Norton, Deputy Attorney General James Cole, Associate Attorney General Tony West, Ambassador Andrew Young and Howard University Interim President Dr. Wayne A.I. Frederick will also deliver remarks at the event co-hosted by Howard University, on TUESDAY, JULY 15, 2014, at 10:00 a.m. EDT, to honor the civil rights movement and celebrate the groundbreaking act

Q: If Notes to File can be regulatory red flags, should we quit using them?
A: No, and here's why...

Regulatory inspections are often conducted long after the conclusion of the study. When an FDA investigator asks you a question about an anomaly five years after it’s happened, will anyone recall the circumstances well enough to satisfy the regulator’s concerns? You’ll be doing yourself a huge favor if you write NTFs that answer the questions regulators might one day be asking you.



NTFs can be used to effectively explain an irregularity, locate a document, or note a change in procedures. While there are no regulations or guidances that govern NTFs per se, ICH E6(R2) 2.10 states “All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification.” A well-written NTF will not only describe an event, but will document who made the notation and when, why the problem occurred, what was done to fix it, and what changes were made to keep it from happening in the future. That’s a lot, so it’s a good idea to develop an NTF template to remind authors to include these elements.

Example of a poorly written NTF:
Informed Consent for study BH-90210 was revised by the IRB 01/7/2017. Subject 867-5309 was not re-consented at her next study visit, as per IRB instructions.

This NTF does nothing more than document the deficiency.

Improved NTF:
Informed Consent for study BH-90210 was revised by the IRB 01/07/2017 to include lab procedures on Visit 5. IRB instructions required a re-consent for all enrolled subjects at next study visit. Subject 867-5309 was not re-consented at her next (2nd) study visit, but was re-consented at her 3rd visit.

This version of the NTF gives us a little more context and lets us know that the subject was re-consented before the new lab procedures were performed. The oversight was corrected in time to preserve Jenny’s* rights, but we still don’t know why it happened; there’s not enough information to satisfy a regulator that failure to re-consent was not a pervasive problem. What were the site’s re-consenting procedures at the time of this study? Were they being followed? Who do we ask?


Complete NTF Using Template



Since the subject was consented before the additional lab procedures were performed, there was no violation of informed consent regulations. This was an oversight with no ill-effects, not a significant break with procedures. Discussing it at the departmental meeting is an appropriate, proportional response. (Note that if the subject had not been re-consented before the new lab procedures were performed, the site would have been in violation of consent regulations and an NTF would not have been sufficient. Both the IRB and the sponsor would have needed to be informed of the failure to consent.)

A poorly written NTF – one that doesn’t provide enough information, one that identifies a problem but no solution, one that is inadequately standing in for proper record keeping – won’t satisfy a regulator’s concerns. These are the sorts of NTFs that can actually do more harm than good. A well-written NTF, on the other hand, is something your future self will thank you for.

In case you missed it, our last post was about how GMP activities affect GCP study procedures.
___________________________________________________________________

* If you know why Subject 867-5309 goes by “Jenny," one of your friends wore a pink tux with shoulder pads to prom.

A version of this article originally appeared in InSite, the Journal of the Society for Clinical Research Sites.

Biotech venture funding metrics continue at historic highs, highlighting that the robust financing environment in the public markets continues to fuel the private markets as well.  – Bruce Booth, partner Atlas Venture in Data Snapshot: Venture-Backed Biotech Financing Riding High, April 2015 Here in Madison, Wisconsin, you might not know that was true if you

Yesterday’s conference sessions surfaced interesting questions and approaches regarding the post-acute sector, bundled payment, emergency medicine and anesthesia. Post-Acute Focus: With more and more focus on the need to rationalize and re-organize the post-acute sector, we have seen multiple industry leaders start to evolve their strategies.  I blogged yesterday about AccentCare’s interesting strategy in the...… Continue Reading

A large amount of wind, much discussion about the U.S healthcare, and the public getting soaked again – if you were thinking about Washington, DC and the new Congress, you’re 3,000 miles away from the action. This is the week of the annual JP Morgan Healthcare conference in San Francisco, with many thousands of healthcare...… Continue Reading

Addressing the Social Determinants of Health:  Is the healthcare industry pushing a rock up a hill?  We collectively are trying to provide healthcare with improved quality and reduced cost, but the structure of the nation’s healthcare system remains heavily siloed with the social determinants of health often falling wholly or partly outside the mandate and...… Continue Reading

Day 3 of the JPMorgan healthcare conference was one of striking contrasts between the old and the new. (And, by the way, the rain finally stopped for a day, but it will be back tomorrow to finish off the last day of the conference). The Old:  Sitting in the Community Health Systems (CHS) presentation and...… Continue Reading

Some interesting presentations on the last day of the JPMorgan Healthcare Conference that concentrated on common themes – the increasing importance of ancillary business line to bolster core business revenue and of filling in holes to achieve scale and full-service offerings. Genesis Healthcare – The largest U.S. skilled nursing facility (SNF) provider, which also is...… Continue Reading

Yokogawa Electric Corporation (TOKYO: 6841) and MetaMoJi Corporation announce that they have jointly developed SensPlus Note, a low cost and easy to implement solution for the digitization of plant data on mobile devices. SensPlus Note, a solution in Yokogawa's OpreX Operation and Maintenance Improvement family, improves the efficiency and quality of maintenance work and the precision of post-maintenance analyses by enabling data from plant field work to be used more efficiently. This solution will be released in all markets worldwide on January 31.

Flynote has only ₹2 crore left in the banks of the ₹14 crore raised last year.

The post India: Sequoia-backed travel firm Flynote lays off staff amid virus crisis appeared first on DealStreetAsia.

The move is seen to make the fundraising process easier and cost-effective for startups.

The post SC Malaysia eases norms for firms issuing convertible notes to VC, PE firms appeared first on DealStreetAsia.

This week in Class Notes: The Texas Top Ten Percent rule increased equity and economic efficiency. There are big gaps in U.S. early-life mortality rates by family structure. Locally-concentrated income shocks can persistently change the distribution of poverty within a city. Our top chart shows how income inequality changed in the United States between 2007 and 2016. Tammy Kim describes the effect of the…

This week in Class Notes: Fear of Ebola was a powerful force in shaping the 2014 midterm elections. Increases in the “sticker price” of a college discourage students from applying, even when they would be eligible for financial aid. The gender gap in housing returns is large and can explain 30% of the gender gap in wealth accumulation at retirement.…

This week in Class Notes: California's shelter-in-place order was effective at mitigating the spread of COVID-19. Asian Americans experience significant discrimination in the Harvard admissions process. The U.S. tax system is biased against labor in favor of capital, which has resulted in inefficiently high levels of automation. Our top chart shows that poor workers are much more likely to keep commuting in…

This week in Class Notes: California's shelter-in-place order was effective at mitigating the spread of COVID-19. Asian Americans experience significant discrimination in the Harvard admissions process. The U.S. tax system is biased against labor in favor of capital, which has resulted in inefficiently high levels of automation. Our top chart shows that poor workers are much more likely to keep commuting in…

This week in Class Notes: California's shelter-in-place order was effective at mitigating the spread of COVID-19. Asian Americans experience significant discrimination in the Harvard admissions process. The U.S. tax system is biased against labor in favor of capital, which has resulted in inefficiently high levels of automation. Our top chart shows that poor workers are much more likely to keep commuting in…