It is not just the major national sports leagues and events being stalled by coronavirus, with everyone from semi-professional all the way to junior athletes across the country caught up in the storm.

Australia's toughest off-road motorsport event is called off for the first time in its 44-year history amid concerns competitors or visitors might spread coronavirus to remote communities.

The Wildcats are awarded the NBL championship, with the league announcing their decision two days after the grand final series against the Kings was cancelled because of the coronavirus crisis.

Almost every major sporting league around the world is on hiatus. But esports can fill the sporting void in your weekend schedule. Here's how to get into it, and what to watch this weekend.

When Georgie Rowe hopped on her indoor rowing machine, she had no intention of breaking a world record. But she has just overtaken an Olympic gold medallist.

Assistant coaches are among those doing it tough in Australia's football codes during the coronavirus shutdown, as they learn to adapt to a challenging environment, writes Richard Hinds.

Imagine an Australia where every sporting club in the country had players with autism and intellectual disability playing on teams, serving on committees, and helping run events.

Perth Wildcats star Bryce Cotton has walked out on the final year of his contract with the club, citing unforeseen circumstances, after the NBL announced big pay cuts in response to the COVID-19 crisis.

The cries of football fans demanding players return to the field under any circumstances have become shrill as the craving for lockdown distraction turns from stoical whimsy to rank desperation, writes Richard Hinds.

TikTok, a popular based social video app owned by China-based ByteDance, has seen explosive growth this year amid the coronavirus crisis. The company has plans to hire more people, including at its Culver City office.

Texas reopens restaurants, Utah reopens salons. As several states lift coronavirus restrictions, many warn of a second wave if social distancing ends too soon.

As states lift coronavirus restrictions, none has met federal benchmarks, a health expert warns. The COVID-19 death toll in the U.S. surpasses 73,000.

Titans from the stage and screen perform the composer's greatest musical hits online.

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.

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.

#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.

Adhesives specialist Intertronics has launched the preeflow eco-DUOMIX, a system that mixes and dispenses two-part materials.

FDA working with manufacturers to prevent shortages

First up: monthly depot formulation from Indivior

British multinational GlaxoSmithKline have hired computational drug design expert Dr Kim Branson as the company’s new Senior Vice President, Global Head of Artificial Intelligence and Machine Learning.

In his new role, the biotech veteran will oversee projects which use AI to identify novel targets for potential medicines.

Dr Branson brings to the role more than 15 years’ worth of experience in biotech and academia having held positions at a number of Silicon Valley firms including Gliimpse, Lumia and Hessian Informatics.

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Dr Reshma Kewalramani has been made the new Vertex CEO.

Vertex’s Chief Medical Officer Dr Kewalramani will succeed current CEO Jeffrey Leiden who has is now stepping aside from the role after seven years as Chief executive at the Boston-based firm. In stepping down Leiden will serve as executive chairman until the first quarter of 2023.     

Fourty-six year old Dr Kewalramani, who has been at Vertex since 2017, will thus become the first woman to head the firm. Prior to joining Vertex, Kewalramani spent more than 12 years at Amgen.

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Pfizer’s executive chairman Ian Read, is to be succeeded by CEO Albert Bourla with a date to start the post being January 1st 2020.

Mr Bourla, who joined Pfizer’s animal health division in 1993, succeeded Mr. Read from Chief Operating Officer as Chief Executive earlier this year in January, and will now go on to serve as Executive Chairman.

Mr Read has spent nine years in the role and has been at the company for a total of 41 years, first arriving in 1978 and becoming CEO in 2010, joining the board the following year.

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In this video explainer, Christopher Robertson discusses the Right to Try Act and off-label use of pharmaceuticals with Alison Bateman-House.

The post Access to Drugs Before FDA Approval: Video Explainer with Christopher Robertson appeared first on Bill of Health.

The technology enables sponsors to continue gathering cardiac data for clinical trials without interruption or risk to patient safety.

Today’s guest post comes from Miranda Gill, Senior Director of Provider Network at CoverMyMeds.

Miranda reviews how the pandemic affects the ability of healthcare workers to complete administrative responsibilities like prior authorization. She then outlines how electronic automation is helping patients get needed medications while face-to-face interactions are restricted.

Learn more about healthcare IT solutions for providers and patients in CoverMyMeds’ 2020 Medication Access Report, or schedule a virtual meeting.
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This week, I’m rerunning some popular posts while I prepare for this Friday’s video webinar: Industry Update and COVID-19 Impact: PBMs & Payers.

Life was very different when I originally published today’s article. 2020 is not turning out to be quite what any of us expected. However, the pandemic has exposed some intriguing pros and cons of vertical consolidation. Click here to see the original post and comments from December 2019.

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The largest insurers, PBMs, and specialty pharmacies have now combined into vertically-integrated organizations. As I explain below, these companies have also been rapidly integrating with healthcare providers.

I also provide an updated look at these companies and highlight strategies that they are using—or could use—to control the channel. I believe that these insurer / PBM / specialty pharmacy / provider organizations are poised to restructure U.S. drug channels by exerting greater control over patient access, sites of care/dispensing, and pricing.

If they can effectively coordinate their sprawling business operations, they will pose a substantial threat of disruption to the existing commercial strategies of pharma companies.

Will they succeed by better managing care and costs, or merely by extracting higher profits from our convoluted system?
Read more »

The pressing need to find a solution to the pandemic means risks and shortcuts may have to be taken

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The stakes could hardly be higher; the prize still tantalisingly out of reach. It is no exaggeration to say that the fate of many millions of people rests on the discovery of a vaccine for Covid-19 – the only sure escape route from the pandemic.

Yet the optimism that accompanied the launch of Oxford University’s human trials this week has to be put in context, and the hurdles facing the scientists need to be understood.

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The European Medicines Agency’s Committee for Medicinal Products for Human Use has given its recommendation for the approval of Kalydeco for the treatment of children and adolescents with cystic fibrosis in a new indication, Vertex has revealed.

UK-based Mallinckrodt Pharmaceuticals has ended a trial of INOmax (nitric oxide) gas early due to positive…

The US Food and Drug Administration has granted accelerated approval for Retevmo (selpercatinib) capsules…

Jorge De Castro Font, 45, a former senator in the Commonwealth of Puerto Rico, pleaded guilty today to 20 counts of honest services wire fraud and one count of conspiracy to commit extortion.

The Department today announced that it has reached a consent decree with the Policía de Puerto Rico (Puerto Rico Police Department or PRPD) that will, if approved by the federal district court, resolve a complaint the Department filed in March 2008 alleging that the PRPD engaged in unlawful employment discrimination based on gender and retaliation, in violation of Title VII of the Civil Rights Act. Title VII prohibits employment discrimination on the basis of race, color, sex, national origin and religion, and also prohibits retaliation against persons for filing charges of discrimination.

Building upon the successes of earlier efforts, the Department today announced the opening in Bangkok of a regional conference of approximately 100 key law enforcement and industry officials from more than a dozen nations with the goal of strengthening international cooperation in fighting large-scale intellectual property crimes.

Alberto Goachet, 67, a political consultant and aide to former Puerto Rico Sen. Jorge De Castro Font, was sentenced today to three months in prison, three months of home detention and three years of supervised release. Goachet pleaded guilty on Dec. 4, 2008, to a one-count information charging him with conspiring with De Castro Font and others to launder money provided by a Puerto Rico businessman to De Castro Font.

Robert P. Merz, 45, was convicted by a federal jury in Philadelphia today of advertising, transporting, receiving and possessing child pornography.

Five defendants were sentenced this week for their participation in a corruption scheme involving the 2000 resident commissioner and 2004 gubernatorial campaigns of a former governor of Puerto Rico.

A federal jury in San Juan, Puerto Rico, found four San Juan Municipal Police Officers guilty today of felony federal civil rights charges related to the fatal beating of Jose Antonio Rivera Robles.

Robert P. Merz was sentenced to life in prison today for advertising, transporting, receiving and possessing child pornography.

Dr. Candido Negron Mella pleaded guilty and was sentenced today for his participation in a corruption scheme involving the 2000 Resident Commissioner campaign of a former governor of Puerto Rico.

Mark Edwin Cairnes of Jonestown, Texas, pleaded guilty today to advertising and possessing child pornography.

The Department announced this week that it has filed a lawsuit against TK Properties L.L.C., its officer, Scott Terveen, and two employees, Ann Wagner and Corey Anderson, for violating the Fair Housing Act by discriminating on the basis of race.

I authorized this significant step following a careful and thorough review process, and I did so only because I believe there is no way for this case to move forward without jeopardizing ongoing intelligence activities that we rely upon to protect the safety of the American people.

The department filed a lawsuit today in federal court for the Eastern District of Missouri alleging a pattern or practice of violations of the Fair Housing Act by the owner and managers of Forum Manor Apartments for refusing to rent to African-Americans and males, refusing to allow tenants to have African-American visitors, sexually harassing female tenants and retaliating against tenants who complained about such discrimination.

Mark Edwin Cairnes, 51, was sentenced today to 292 months in prison and lifetime supervised release following his prison term for advertising and possessing child pornography.

As a part of the tax conspiracy, Ronald Boyarsky assisted in paying approximately $2.6 million in commissions earned by a printing services broker to third parties, so that the broker and his companies could avoid paying taxes on the income they earned.

The Department will require Ticketmaster Entertainment Inc. to license its ticketing software, divest ticketing assets and subject itself to anti-retaliation provisions in order to proceed with its proposed merger with Live Nation Inc.

Attorney General Eric Holder today announced the formation of a new Department of Justice Task Force on Intellectual Property as part of a Department-wide initiative to confront the growing number of domestic and international intellectual property (IP) crimes.

"After a thorough review of the evidence, the division has determined that the proposed transaction is not likely to substantially lessen competition in the United States."

Among other things, Zazi admitted that he brought TATP [Triacetone Triperoxide] explosives to New York on Sept. 10, 2009, as part of plan to attack the New York subway system.