The 1.1.68 version of Wimoweh for Mac is provided as a free download on our website. The program lies within Productivity Tools, more precisely Timekeeping. This free Mac app is a product of CCRN Ltd. Our antivirus check shows that this Mac download is malware free. Dakar legend Hubert Auriol passes away aged 68 Jan 11, 2021, 11:10 AM Hubert Auriol, a three-time winner of the Dakar Rally and the first person to win the legendary event on both two wheels.
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On May 6, 2020, the Food and Drug Administration granted accelerated approval to capmatinib (TABRECTA, Novartis) for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test.
Today, FDA also approved the FoundationOne CDx assay (Foundation Medicine, Inc.) as a companion diagnostic for capmatinib.
Efficacy was demonstrated in the GEOMETRY mono-1 trial (NCT02414139), a multicenter, non-randomized, open-label, multicohort study enrolling 97 patients with metastatic NSCLC with confirmed MET exon 14 skipping. Patients received capmatinib 400 mg orally twice daily until disease progression or unacceptable toxicity.
The main efficacy outcome measures were overall response rate (ORR) determined by a blinded independent review committee using RECIST 1.1 and response duration. Among the 28 treatment-naïve patients, the ORR was 68% (95% CI: 48, 84) with a response duration of 12.6 months (95% CI: 5.5, 25.3). Among the 69 previously treated patients, the ORR was 41% (95% CI: 29, 53) with a response duration of 9.7 months (95% CI: 5.5, 13.0).
The most common adverse reactions (≥ 20% of patients) were peripheral edema, nausea, fatigue, vomiting, dyspnea, and decreased appetite. Capmatinib can also cause interstitial lung disease, hepatotoxicity, photosensitivity, and embryo-fetal toxicity. Based on a clear positive signal for phototoxicity in early laboratory studies in cells, patients may be more sensitive to sunlight and should be advised to take precautions to cover their skin, use sunscreen, and not tan while taking capmatinib.
The recommended capmatinib dose is 400 mg orally twice daily with or without food.
View full prescribing information for TABRECTA.
This indication is approved under accelerated approval based on overall response rate and response duration. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
This review used the Assessment Aid, a voluntary submission from the applicant to facilitate FDA’s assessment. The FDA approved this application 3 months ahead of the FDA goal date.
FDA granted capmatinib orphan drug and breakthrough therapy designation. A description of FDA expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.
Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.
For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email [email protected].
For information on the COVID-19 pandemic, see the following resources:
Follow the Oncology Center of Excellence on Twitter @FDAOncology.
WordPress 5.7 Beta 1 is now available for testing! ?
This software is still in development, so it’s not recommended to run this version on a production site. Consider setting up a test site to play with the new version.
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You can test the WordPress 5.7 Beta 1 in two ways:
The current target for final release is March 9, 2021. That’s just five weeks away, so your help is vital to making sure that the final release is as good as it can be.
So what’s new? ?
Improvements in Core
Lazy-load iframes
Now you can enable lazy-loading of iframes by adding the loading='lazy' attribute to iframe tags on the front-end.
Migrating from HTTP to HTTPS is streamlined
Switching a WordPress site from HTTP to HTTPS has proven to be a pain for all involved. While on the surface, the Site Address and WordPress Address have to be updated, content with embedded HTTP URLs remains unchanged in the database. With this release, migrating a site to HTTPS is now a one-click interaction. URLs in the database are automatically replaced when the Site and WordPress Address are both using HTTPS. Also, Site Health now includes an HTTPS status check.
Standardize colors used in WP-Admin CSS to a single palette
This change collapses all colors used in the CSS to one of the available shades of blue, green, red, yellow, grey, black, and white. The palette makes it simpler than ever to build components your users can read, because half the range gives you great contrast with white type and a half with black, according to current accessibility guidelines.
Ongoing cleanup after update to jQuery 3.5.1
jQuery deprecations in WordPress Core and bundled themes show up a lot less often, and the notifications make more sense to the user.
New Robots API
The new Robots API allows the filter directives to be included in the ‘robots’ meta tag. Also, the directive max-image-preview:large is now included by default to allow large image previews to be displayed in search engines (unless the blog is marked as not being public).
Improvements in the Editor
Wimoweh 1 1 68 Full EpisodesHow You Can Help
Watch the Make WordPress Core blog for 5.7-related developer notes in the coming weeks, which will break down these and other changes in greater detail.
So far, contributors have fixed 143 tickets in WordPress 5.7, including 68 new features and enhancements, and more bug fixes are on the way.
Do some testing!
Testing for bugs is a vital part of polishing the release during the beta stage and a great way to contribute. ✨
Wimoweh 1 1 68 Full Izle
If you think you’ve found a bug, please post to the Alpha/Beta area in the support forums. We would love to hear from you! If you’re comfortable writing a reproducible bug report, file one on WordPress Trac. That’s also where you can find a list of known bugs.
1+1 Online
Props to @hellofromtonya, @sarahricker, @webcommsat, @marybaum, @jeffpaul, and @audrasjb for your peer revisions and @desrosj, @davidbaumwald, @cbringmann, and @chanthaboune for final review on this exciting news.
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