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Tanya Bardsley has put her luxurious Cheshire mansion up for sale

The Real Housewives of Cheshire star's home with footballer husband Phil Bardsley is on the market




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The Voice contestants team up for NHS song after coronavirus stopped live shows

The show was postponed last month because of the COVID-19 pandemic




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Piers Morgan forced off Good Morning Britain as he awaits coronavirus test results

The ITV host told his Twitter followers on Sunday night that he had been feeling unwell over the weekend




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Helen Flanagan rescued after breaking down on the motorway while delivering PPE

The Coronation Street star is a volunteer during the coronavirus crisis




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Coronation Street star Jack P Shepherd explains his first-day blunder

The Corrie star got a telling off for his gaffe




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Former Love Island contestant says she's 'glad' the show has been cancelled

Mental health advocate Malin Andersson reacted to the news that the ITV2 dating show has been shelved




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Jason Manford 'livid' after being knocked back by Tesco for a job

The Salford comic applied for a job at the Aldery Road Express store in Wilmslow




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Tesco issues lovely response to Jason Manford after he is rejected for job

Jason, from Salford, joked that he was 'livid' at the response but admitted he did genuinely apply for the supermarket job




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Iceland has given Jason Manford a very generous offer after Tesco knockback

Iceland has put in a job offer for the Salford comic after Tesco didn't hire him




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Adele's former personal trainer speaks about star's dramatic weight loss

The singer shared a post on Instagram to mark her 32nd birthday, revealing her slimmer frame




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Corrie star Colson Smith almost unrecognisable after incredible weight loss

The Corrie favourite has stunned fans with his new look after taking up running




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Molly-Mae and Tommy Fury's anger as dozens ignore lockdown rules in Ancoats

The pair shared video of people gathering in the sunshine




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5 strategic priorities for CIOs in 2020

As we close out 2019 and focus our attention to the forecasts of 2020, here is a sneak peek into what's IT leaders have on their roadmaps for 2020.

Keep on reading: 5 strategic priorities for CIOs in 2020




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4 Tech Trends for the New Hotel Age

For businesses serving the hospitality sector, growth relies on implementing and capitalizing modernized systems to improve processes and increase guest satisfaction. These are the four most important strategies to achieve this goal in 2020.

Keep on reading: 4 Tech Trends for the New Hotel Age




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Quick Answers to Quick Questions: In Conversation with Cal Evans, Senior Consultant, E.I.C.C., Inc.

With 34 years of programming experience in various organizations, Cal shares what he's observed of leaders who are looking to be reinvigorated, what to do when job-inspiration is lost and taking an educated leap of faith.

Keep on reading: Quick Answers to Quick Questions: In Conversation with Cal Evans, Senior Consultant, E.I.C.C., Inc.




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The Enterprise 2020 Report: Software CEO Briefing

At the annual invite-only 2020 Enterprise Retreat in Half Moon Bay, CA, 100 enterprise leaders gathered in a social-media free environment, to network, discuss hot topics and dive into provocative, insightful off-the-record 'State of the Union' presentations. This report details their findings.

Keep on reading: The Enterprise 2020 Report: Software CEO Briefing




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FDA AMENDS THE DEFINITION OF “BIOLOGICAL PRODUCT” AND PREPARES FOR THE CONCLUSION OF A DECADE-LONG TRANSITION PERIOD

By Jennifer A. Davidson and Justine E. Johnson On February 21, 2020, FDA published a final rule that, effective March 23, 2020, amends the regulatory definition of “biological product” consistent with the statutory definition under the Biologics Price Competition and Innovation Act of 2009 (BPCIA), as amended by the Further Consolidated Appropriations Act, 2020 (FCAA),

The post FDA AMENDS THE DEFINITION OF “BIOLOGICAL PRODUCT” AND PREPARES FOR THE CONCLUSION OF A DECADE-LONG TRANSITION PERIOD appeared first on Kleinfeld Kaplan & Becker LLP.




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FDA Waives Certain Adverse Event Reporting Deadlines Across Product Industries During Pandemics

By Suzan Onel and Vanessa Fulton On March 19, 2020, FDA issued a guidance document communicating its policy regarding postmarket adverse event reporting during a pandemic (“Guidance”).  The Guidance provides recommendations that affect adverse event reporting obligations for drugs, biologics, medical devices, combination products, and dietary supplements. To summarize, FDA states in the Guidance that

The post FDA Waives Certain Adverse Event Reporting Deadlines Across Product Industries During Pandemics appeared first on Kleinfeld Kaplan & Becker LLP.




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FDA ISSUES FINAL RULE ON GRAPHIC WARNINGS FOR CIGARETTE PACKAGES AND ADVERTISEMENTS

By: Stacy Ehrlich and Justine E. Johnson On March 18, 2020, the Food and Drug Administration (FDA) published a final rule (21 C.F.R. Part 1141) requiring textual and graphic health warnings to be included on all cigarette packages and advertisements.[1]  FDA simultaneously published two related guidance documents: (1) Required Warnings for Cigarette Packages and Advertisements,

The post FDA ISSUES FINAL RULE ON GRAPHIC WARNINGS FOR CIGARETTE PACKAGES AND ADVERTISEMENTS appeared first on Kleinfeld Kaplan & Becker LLP.




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Shortage of PPE and other Devices During COVID-19 Pandemic – Is 3D Printing the Answer?

By: Suzan Onel FDA issued a Press Release on March 28, 2020, reiterating what we all have seen in the news, there is a severe shortage of personal protective equipment (PPE) in health care facilities across the country.  In response to the shortages, FDA has issued Emergency Use Authorizations (EUAs) for respirators, ventilators, ventilator tubing

The post Shortage of PPE and other Devices During COVID-19 Pandemic – Is 3D Printing the Answer? appeared first on Kleinfeld Kaplan & Becker LLP.




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New Opportunities for OTC Monograph Drugs under the CARES Act

By: Daniel Dwyer and Daniel Logan On March 27, 2020, the President signed into law the Coronavirus Aid, Relief, and Economic Security Act, or “CARES” Act (Pub. Law 116-136), which includes a comprehensive revision of the rules governing over-the-counter (OTC) drugs currently marketed under monographs published by the Food and Drug Administration (FDA).  This law

The post New Opportunities for OTC Monograph Drugs under the CARES Act appeared first on Kleinfeld Kaplan & Becker LLP.




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TTB Finalizes Portions of Modernization of Advertising and Labeling Regulations for Wine, Distilled Spirits, and Malt Beverages Rule

#TTB just made changes to modernize the way that #wine, #distilledspirits, and #maltbeverages are labeled and advertised. KKB associate Dan Logan and partner Dan Dwyer highlight some of the key changes (and proposals that were rejected).

The post TTB Finalizes Portions of Modernization of Advertising and Labeling Regulations for Wine, Distilled Spirits, and Malt Beverages Rule appeared first on Kleinfeld Kaplan & Becker LLP.




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KLEINFELD, KAPLAN & BECKER WELL REPRESENTED ON THE WASHINGTON, DC, 2020 SUPER LAWYERS LIST FOR “FOOD AND DRUGS”

We are pleased to announce that KKB partners Dan Dwyer, Stacy Ehrlich, Peter Mathers, and Suzan Onel were selected for the annual Super Lawyers list for Washington, DC.  They make up more than 20% of the 18 DC attorneys listed in the “Food and Drugs” category.  In addition, for the sixth year in a row, KKB

The post KLEINFELD, KAPLAN & BECKER WELL REPRESENTED ON THE WASHINGTON, DC, 2020 SUPER LAWYERS LIST FOR “FOOD AND DRUGS” appeared first on Kleinfeld Kaplan & Becker LLP.




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NIAB develops portable 'ECovSens' tool for diagnosis of COVID─19 antigens from saliva




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DCGI grants approval to PGIMS, Rohtak to start clinical trials on BCG vaccine for treatment of COVID─19




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Potential of Ayurveda should not be ignored in the fight against COVID─19: Dr Saravadekar




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KRPA urges state govt to bring pharmacists under insurance cover on lines of healthcare workers engaged in treating COVID─19 patients




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PCI assures govt of services of pharmacists as health workers in case COVID─19 cases rise alarmingly




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Pradhanmantri Jan Aushadhi Kendras achieve record sales of Rs. 52 crore in April 2020




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Pune's Ayush CoE, CRD & Dr DY Patil Univ to propel possible potential of Ayurveda─Yoga as preventive medicine for COVID─19




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Ayurvedic drug Zingivir─H gets approval for clinical trial to treat COVID─19 patients




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Finance ministry set to extend anti─dumping duty on import of sodium citrate from China




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Maharashtra FDA allays fears of shortage of HCQ tabs either in govt hospital pharmacies or in retail pharmacies




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Maharashtra FDA issues licenses to 7 more cos to produce medical oxygen for treating critically ill COVID─19 patients




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Indian pharma & machinery sector sees Smart Factory model to mitigate future challenges of COVID─19 like lockdowns




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WBPC soon to open DIC at Council office to provide information on medication & safety measures to combat COVID─19




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Health ministry releases guidelines on management of COVID─l9 suspect or confirmed cases in govt earmarked railway coaches




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Union health minister calls upon all scientific depts to develop enhanced synergy for better results




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IMA Sirsa unit issues notice to pharma cos to restrain field staff from meeting doctors till May 31 for product promotion




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ICMR notifies NIMHANS as mentor institution for RT─PCR test protocol for COVID─19




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Gujarat FDCA initiates action against 2 companies based in Patan and Ahmedabad for illegal sale of drugs




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Soft Actuator and Sensor for Underactive Bladder Treatment

Researchers at the National University of Singapore have developed a soft sensor and actuator to monitor bladder volume and help empty it on-demand. The device is intended to be implanted on the bladder surface during a surgical procedure to treat patients who cannot completely empty their bladders voluntarily. Patients can suffer from an underactive bladder […]




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Stanford Bioengineers Innovate Multiple Solutions to Tackle COVID-19

The current pandemic is revealing the level of commitment needed from multiple sectors to deliver innovative solutions to tackle severe shortages of personal protective equipment, ventilators, and raw materials. Researchers at the Prakash lab at Stanford University are no stranger to taking up extreme challenges, and they have kept up their reputation by coming up […]




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Aquadex Ultrafiltration for Critical COVID Patients: Interview with John Erb, CEO at CHF Solutions

As the COVID-19 pandemic continues, many healthcare facilities around the world are inundated with critically ill patients, and resources such as equipment and staff are stretched thin. Shortages of critical equipment, such as ventilators, can mean the difference between life and death for patients, and the need to keep critically ill patients comfortable and alive […]




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New Fluorescence Microscopy Technique for Nanostructure Visualization Within Cells

Researchers at Purdue University have developed a new technique to dramatically enhance the resolution achievable when imaging intracellular structures with super-resolution fluorescence microscopy. The technique uses the distortions created by a specimen to pinpoint the location of individual molecules, and thereby infer the location of intracellular structures. The technique could be particularly useful in studying […]




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BioButton to Help Track COVID, Ensure Safe Return to Work

BioIntelliSense, a Silicon Valley company, is unveiling its FDA cleared BioButton device that may help with tracking symptoms of COVID-19 in potential patients and help society return to a normal state of affairs. The BioButton is about the size of a large coin and, with the help of accompanying applications and triage dashboards, it can […]




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A Multinational Effort to Reduce Neonatal Mortality: Interview with Dr. Maria Oden, Co-director of Rice 360° Institute for Global Health

According to the World Health Organization, 47% of childhood deaths worldwide occur in the first four weeks of life. This neonatal mortality rate is particularly prevalent in sub-Saharan Africa, where nearly one million newborns die every year. Many of these deaths can be prevented with medical devices that more developed countries often take for granted, […]




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LifeSignals Receives CE Mark for ECG Remote Monitoring Patch

LifeSignals, based in Fremont, California, announced that it received the CE Mark for its LifeSignals ECG Remote Monitoring Patch. The patch, integrated with a remote monitoring platform, is designed as a continuous electrocardiography (ECG) and heart rate monitor. The ECG Remote Monitoring Patch is disposable and captures data for up to three days. The device […]




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VitalPatch Wins FDA Emergency Use Authorization for Cardiac Monitoring in COVID Patients

VitalConnect announced that it has received FDA Emergency Use Authorization status for use of its VitalPatch to detect changes in the QT interval of hospitalized patients undergoing drug treatment for COVID-19. Hydroxychloroquine and chloroquine, used to treat some COVID-19 patients, are associated with risk of prolonged QT interval that can lead to life-threatening arrhythmias. VitalPatch allows […]




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How Compounding Solutions are meeting the demand for medical materials during Covid-19

Since early February, custom material solutions provider, Compounding Solutions, has been working hard to meet material demands related to Covid-19.