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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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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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Olly Murs apologises after 'offensive' Pringles can prank

The Troublemaker singer has spoken out after pranking his girlfriend on TikTok during lockdown




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Kelvin Fletcher undergoes dramatic lockdown makeover

Kelvin Fletcher has taken a leaf out of Paddy McGuinness's book




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Christine McGuinness says lockdown has stopped arguments with husband Paddy

The Real Housewives star says lockdown has brought her closer to husband Paddy




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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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M.R. Asks 3 Questions: Pantelis Kalogiros, Co-Founder & VP, Fyusion

Fyusion's technology may not scream “artificial intelligence” to the general public, but it does provide an intuitive, lifelike experience for consumers. It's their consumer-friendly technology that makes Co-Founder, Pantelis Kalogiros's view on purchasing behaviour worth listening to - especially for those integrating AI into their commerce businesses.  

Keep on reading: M.R. Asks 3 Questions: Pantelis Kalogiros, Co-Founder & VP, Fyusion




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7 Little-Known Amazon EBS Features You Should Be Using

Whether you're a new or established user of Amazon's EBS here are seven functions you may not know about that can be used to optimize your system and ROI.

Keep on reading: 7 Little-Known Amazon EBS Features You Should Be Using




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Quick Answers to Quick Questions: In Conversation with Chris Luttrell, COO, IDology

COO, Chris Luttrell shares her wealth of information about the current state of fraud, what IDology research is revealing about patron's trust and the forecasted impact of recent privacy legislation on consumers and businesses.

Keep on reading: Quick Answers to Quick Questions: In Conversation with Chris Luttrell, COO, IDology




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M.R. Asks 3 Questions: Tim Page, CEO, Datrium

CEO at Datrium, Tim Page has a sharpness for how enterprises can protect and prepare their data and operations for disaster recovery - especially when it comes to ransomware.

Keep on reading: M.R. Asks 3 Questions: Tim Page, CEO, Datrium




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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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Ongoing unraveling of a continental fauna: Decline and extinction of Australian mammals since European settlement [Environmental Sciences]

The highly distinctive and mostly endemic Australian land mammal fauna has suffered an extraordinary rate of extinction (>10% of the 273 endemic terrestrial species) over the last ∼200 y: in comparison, only one native land mammal from continental North America became extinct since European settlement. A further 21% of Australian...




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Proceedings of the National Academy of Sciences




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Google Cloud vs. AWS: Who Has The Best Pricing?

When evaluating public cloud providers on pricing, it is easy to get hung up on the differences. AWS and Google Cloud each have their own service catalog, terminology and purchasing variations. But do these differences actually impact the final bill?

Keep on reading: Google Cloud vs. AWS: Who Has The Best Pricing?




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M.R. Asks 3 Questions: Jay Chapel, CEO, ParkMyCloud

The challenges businesses and services are facing right now vary from wild fluctuations in supply chains; to enormous digital demand on the technologies and platforms that enable us to stay connected and live productive lives. This is why Jay Chapel is looking for ways to help organizations reduce costs across the board. Collecting information from great companies, we hope our conversation shares some ideas that may help in some small way.

Keep on reading: M.R. Asks 3 Questions: Jay Chapel, CEO, ParkMyCloud




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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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Changes Made to the Federal Food, Drug, and Cosmetic Act by the CARES Act

By: Daniel Logan and Justine Johnson The Coronavirus Aid, Relief, and Economic Security Act, or “CARES” Act (Pub. L. No. 116–136) makes numerous changes to the Federal Food, Drug, and Cosmetic Act (FDCA).  The CARES Act made substantial changes related to the regulation of over-the-counter (OTC) drugs (see KKB’s alert here dedicated to summarizing these

The post Changes Made to the Federal Food, Drug, and Cosmetic Act by 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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DCGI extends validity of registration of BA/BE study centres




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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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PPE suppliers providing unauthentic certificates to buyers including govt procurement agencies




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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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Union health minister directs all states to ensure uninterrupted voluntary blood donation




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




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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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FPME hails proactive measures by Centre to assist trade & industry to tide over crisis induced by COVID─19 pandemic




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MTaI urges govt to provide relief to medical devices cos to come out of COVID─19─induced financial crisis and logistics bottlenecks




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AIOCD urges govt to provide insurance cover to chemists to strengthen fight against COVID─19




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DCGI directs state DCs to take stock of issues in procurement & prices of HCQ, azithromycin and paracetamol APIs




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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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Gujarat pharma industry upbeat as around 900 out of 1,100 plants start operations despite lockdown




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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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TS health dept contemplating to home deliver medicines to patients suffering from chronic diseases




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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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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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Cleanbox Uses UVC to Decontaminate 100 Surgical Masks Per Hour

In the era of COVID-19, surgical masks are a necessity for all healthcare workers and an effective way to curtail the spread of the virus within the general public. Since surgical masks are still in relatively short supply, companies and researchers have been working on ways to make available masks last longer. Cleanbox Technology, based […]