Seattle Genetics Announces TUKYSA (tucatinib) Approved Within Months for All Countries Participating in FDA’s Project Orbis Initiative – BioSpace

Aug. 12, 2020 12:00 UTC

BOTHELL, Wash.--(BUSINESS WIRE)--Seattle Genetics, Inc., Inc. (Nasdaq:SGEN) today announced that Australian regulatory authorities have approved TUKYSA (tucatinib) in combination with trastuzumab and capecitabine for the treatment of patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting. Australia joins U.S., Switzerland, Canada and Singapore that approved TUKYSA under Project Orbis, an initiative of the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence that provides a framework for concurrent submission and review of oncology drugs among participating international regulatory agencies.

In April, TUKYSA became the first new medicine approved in the United States under Project Orbis, and its approval is currently under review in the European Union. TUKYSA is an oral, small molecule tyrosine kinase inhibitor (TKI) of HER2, a protein that contributes to cancer cell growth.1,2

The rapid approval of concurrent global reviews under FDAs Project Orbis for TUKYSA will allow for accelerated market entry of this new best-in-class treatment to HER2-positive breast cancer patients in need, said Clay Siegall, Ph.D., Chief Executive Officer at Seattle Genetics. As our company continues to expand globally, we look forward to bringing TUKYSA to patients around the world.

The approvals are based on results from the pivotal trial HER2CLIMB, a randomized (2:1), double-blind, placebo-controlled trial that enrolled 612 patients with HER2-positive unresectable locally advanced or metastatic breast cancer who had previously received, either separately or in combination, trastuzumab, pertuzumab, and ado-trastuzumab emtansine (T-DM1). The study results were published in The New England Journal of Medicine in December 2019. The company is pursuing a broad development strategy for TUKYSA in earlier stage HER2-positive breast cancer and other solid tumors.

About HER2-Positive Breast Cancer

Patients with HER2-positive breast cancer have tumors with high levels of a protein called human epidermal growth factor receptor 2 (HER2), which promotes the growth of cancer cells. In 2018, more than two million new cases of breast cancer were diagnosed worldwide, including nearly 523,000 in Europe.3 Between 15 and 20 percent of breast cancer cases are HER2-positive.4 Historically, HER2-positive breast cancer tends to be more aggressive and more likely to recur than HER2-negative breast cancer.5,6,7 Up to 50 percent of metastatic HER2-positive breast cancer patients develop brain metastases over time.8,9,10

About TUKYSA (tucatinib)

TUKYSA is an oral medicine that is a tyrosine kinase inhibitor of the HER2 protein. In vitro (in lab studies), TUKYSA inhibited phosphorylation of HER2 and HER3, resulting in inhibition of downstream MAPK and AKT signaling and cell growth (proliferation), and showed anti-tumor activity in HER2-expressing tumor cells. In vivo (in living organisms), TUKYSA inhibited the growth of HER2-expressing tumors. The combination of TUKYSA and the anti-HER2 antibody trastuzumab showed increased anti-tumor activity in vitro and in vivo compared to either medicine alone.11 In the U.S., TUKYSA is approved in combination with trastuzumab and capecitabine for adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases (disease that has spread to the brain), who have received one or more prior anti-HER2-based regimens in the metastatic setting.

TUKYSA is approved in the U.S., Switzerland, Canada, Singapore and Australia and is under review for approval in the EU.

U.S. Important Safety Information

Warnings and Precautions

If diarrhea occurs, administer antidiarrheal treatment as clinically indicated. Perform diagnostic tests as clinically indicated to exclude other causes of diarrhea. Based on the severity of the diarrhea, interrupt dose, then dose reduce or permanently discontinue TUKYSA

Monitor ALT, AST, and bilirubin prior to starting TUKYSA, every 3 weeks during treatment, and as clinically indicated. Based on the severity of hepatoxicity, interrupt dose, then dose reduce or permanently discontinue TUKYSA.

Adverse Reactions

Serious adverse reactions occurred in 26% of patients who received TUKYSA. Serious adverse reactions in 2% of patients who received TUKYSA were diarrhea (4%), vomiting (2.5%), nausea (2%), abdominal pain (2%), and seizure (2%). Fatal adverse reactions occurred in 2% of patients who received TUKYSA including sudden death, sepsis, dehydration, and cardiogenic shock.

Adverse reactions led to treatment discontinuation in 6% of patients who received TUKYSA; those occurring in 1% of patients were hepatotoxicity (1.5%) and diarrhea (1%). Adverse reactions led to dose reduction in 21% of patients who received TUKYSA; those occurring in 2% of patients were hepatotoxicity (8%) and diarrhea (6%).

The most common adverse reactions in patients who received TUKYSA (20%) were diarrhea, palmar-plantar erythrodysesthesia, nausea, fatigue, hepatotoxicity, vomiting, stomatitis, decreased appetite, abdominal pain, headache, anemia, and rash.

Lab Abnormalities

In HER2CLIMB, Grade 3 laboratory abnormalities reported in 5% of patients who received TUKYSA were: decreased phosphate, increased ALT, decreased potassium, and increased AST. The mean increase in serum creatinine was 32% within the first 21 days of treatment with TUKYSA. The serum creatinine increases persisted throughout treatment and were reversible upon treatment completion. Consider alternative markers of renal function if persistent elevations in serum creatinine are observed.

Drug Interactions

Use in Specific Populations

For more information, please see the full Prescribing Information for TUKYSA here.

About Seattle Genetics

Seattle Genetics, Inc. is a global biotechnology company that discovers, develops and commercializes transformative cancer medicines to make a meaningful difference in peoples lives. ADCETRIS (brentuximab vedotin) and PADCEV (enfortumab vedotin-ejfv) use the companys industry-leading antibody-drug conjugate (ADC) technology. ADCETRIS is approved in certain CD30-expressing lymphomas, and PADCEV is approved in certain metastatic urothelial cancers. TUKYSA (tucatinib), a small molecule tyrosine kinase inhibitor, is approved in certain HER2-positive metastatic breast cancers. The company is headquartered in Seattle, Washington area, with locations in California, Switzerland and the European Union. For more information on our robust pipeline, visit http://www.seattlegenetics.com and follow @SeattleGenetics on Twitter.

Forward Looking Statements

Certain statements made in this press release are forward looking, such as those, among others, relating to the therapeutic potential of TUKYSA including its efficacy, safety and therapeutic uses including the potential use of TUKYSA in combination with trastuzumab and capecitabine for the treatment of patients with metastatic HER2-positive breast cancer, who have previously received two or more anti-HER2 regimens in any setting, and the potential to bring TUKYSA to patients in Australia, Canada, Singapore and Switzerland. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include reimbursement processes, the extent of reimbursement, the possibility of adverse events or safety signals, the possibility that the ultimate utilization and adoption of TUKYSA by prescribing physicians may be limited, including due to impacts related to the COVID-19 pandemic, the possibility of difficulties in supplying and commercializing a new therapeutic agent, and the possibility of adverse regulatory actions. More information about the risks and uncertainties faced by Seattle Genetics is contained under the caption Risk Factors included in the companys Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 filed with the Securities and Exchange Commission. Seattle Genetics disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

1 TUKYSA [package insert]. Bothell, WA: Seattle Genetics, Inc.2 Anita Kulukian, Patrice Lee, Janelle Taylor, et al. Preclinical Activity of HER2-Selective Tyrosine Kinase Inhibitor Tucatinib as a Single Agent or in Combination with Trastuzumab or Docetaxel in Solid Tumor ModelsMol Cancer Ther 2020;19:976-987.3 Breast. Globocan 2018. World Health Organization. 2019. https://gco.iarc.fr/today/data/factsheets/cancers/20-Breast-fact-sheet.pdf 4 Slamon D, Clark G, Wong S, et al. Human breast cancer: correlation of relapse and survival with amplification of the HER-2/neu oncogene. Science. 1987; 235(4785): 177-82.5 Loibli S, Gianni L. HER2-positive breast cancer. Lancet. 2017; 389(10087): 2415-29.6 Slamon D, Clark G, Wong S, et al. Human breast cancer: correlation of relapse and survival with amplification of the HER-2/neu oncogene. Science. 1987; 235(4785): 177-82.7 Breast Cancer HER2 Status. American Cancer Society website. https://www.cancer.org/cancer/breast-cancer/understanding-a-breast-cancer-diagnosis/breast-cancer-her2-status.html. Accessed March 9, 2020.8 Freedman RA, Gelman RS, Anders CK, et al. TBCRC 022: a phase II trial of neratinib and capecitabine for patients with human epidermal growth factor receptor 2-positive breast cancer and brain metastases. J Clin Oncol. 2019;37:1081-1089.9 Olson EM, Najita JS, Sohl J, et al. Clinical outcomes and treatment practice patterns of patients with HER2-positive metastatic breast cancer in the post-trastuzumab era. Breast. 2013;22:525-531.10 Bendell JC, Domchek SM, Burstein HJ, et al. Central nervous system metastases in women who receive trastuzumab-based therapy for metastatic breast carcinoma. Cancer. 2003;97:2972-2977.11 TUKYSA [package insert]. Bothell, WA: Seattle Genetics, Inc.

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Seattle Genetics Announces TUKYSA (tucatinib) Approved Within Months for All Countries Participating in FDA's Project Orbis Initiative - BioSpace

OpGen Group Company Ares Genetics Demonstrates Feasibility of CLIA-compliant Next Generation Sequencing Workflow for Identification of Bacterial…

Accurate identification of antibiotic resistance markers based on the ARESdb QIAGEN CLC Module leveraging Ares Genetics proprietary antibiotic resistance database

Pathogens correctly identified with 100% sensitivity and specificity, antibiotic resistance markers with >95% sensitivity and >99% specificity, respectively

Study paves the way for routine clinical diagnostic application of next-generation sequencing (NGS) in timely as well as accurate infectious disease testing and drug susceptibility prediction

VIENNA, Austria, and GAITHERSBURG, Md., Aug. 11, 2020 (GLOBE NEWSWIRE) -- Ares Genetics GmbH (Vienna, Austria; Ares Genetics), a subsidiary of OpGen, Inc. (Nasdaq: OPGN, OpGen), announced today the publication of a peer-reviewed study that demonstrates the feasibility of a highly accurate and reproducible sample-to-insight workflow for various clinical microbiology assays including the molecular identification of bacterial pathogens and their genetic markers of antibiotic resistance (Ref. 1).

The combined laboratory and bioinformatics workflow was developed following requirements of the U.S. Clinical Laboratory Improvement Act (CLIA) for laboratory-developed tests (LDTs). The bioinformatics analysis workflow leverages the QIAGEN CLC Microbial Genomics ARESdb Module for detection of antibiotic resistance (AMR) markers (Ref. 2). Powered by artificial intelligence, Ares Genetics ARESdb is a comprehensive, global and continuously updated proprietary knowledgebase on AMR markers and their diagnostic relevance. Under a license from Ares Genetics, the QIAGEN CLC Microbial Genomics ARESdb Module provides users information about diagnostic performance parameters for individual AMR markers at antibiotic compound resolution and thereby addresses a key limitation of public AMR databases (Ref. 3).

The workflow was validated in a study focused on particularly challenging and clinically prevalent multi-drug resistant ESKAPE pathogens (Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, Enterobacter cloacae) including the WHO priority 1 pathogens (Ref. 4). In this study, the workflow demonstrated >99% repeatability, reproducibility, and accuracy. Pathogens were correctly identified with 100% sensitivity and specificity, AMR markers with >95% sensitivity and >99% specificity, respectively.

Dr. Andreas Posch, CEO of Ares Genetics and corresponding author of the study, commented, This study demonstrates that next-generation sequencing in combination with a standardized bioinformatics workflow and a curated interpretation database enables a wide array of clinical microbiology assays with the performance and quality that meet the high standards required for human diagnostic use. We are very pleased to reach this important milestone in our development of universal molecular diagnostic solutions for the timely detection of pathogens and accurate prediction of antibiotic susceptibility.

Ares Genetics currently offers NGS-based clinical microbiology assays for epidemiology, infection control and research via its AI-powered bioinformatics platform ares-genetics.cloud under the brand name ARESupa - Universal Pathogenome Assay. In a recently published multi-center study, Ares Genetics demonstrated that ares-genetics.cloud can also accurately predict antibiotic susceptibility based on complex DNA signatures that are interpreted by combining ARESdb with artificial intelligence (Ref. 5). The combination of high-resolution NGS and AI-powered data interpretation can enable accurate as well as comprehensive molecular antibiotic susceptibility testing and has the potential to provide information on antibiotic therapy response much faster than current culture-based approaches.

Dr. Andreas Posch added: Highly standardized laboratory workflows like the one we realized in this study, are an important prerequisite for fast and reliable molecular solutions for pathogen identification and antibiotic susceptibility prediction in the clinical routine. They allow locally performed NGS analysis for expeditious turnaround times and cloud-based AI-powered data interpretation for clinical decision support. This enables new business models combining traditional IVD instrument and reagent business with SaaS business and hence paves the way for digital diagnostic companies like Ares Genetics.

Microbial infections and antibiotic resistance have become major healthcare challenges with rapidly spreading antimicrobial resistance estimated to have caused 700,000 deaths globally in 2016, a number that is projected to dramatically increase to 10 million deaths annually by 2050 if no countermeasures are taken (Ref. 6). While on July 9th 2020, more than 20 leading biopharmaceutical companies announced the launch of the AMR Action Fund aiming to bring two to four new antibiotics to patients by 2030, a recent white paper by Ares Genetics highlights the urgent need for novel diagnostic approaches to allow for rapid identification of causative pathogens and their susceptibility to available antibiotic options, in order to guide appropriate treatment of patients while enabling prudent and informed use of existing or future new antibiotics (Ref. 7).

The studies by Ares Genetics were supported through funding provided by the Vienna Business Agency and the Austrian Research Promotion Agency.

References

About OpGen, Inc.

OpGen, Inc. (Gaithersburg, MD, USA) is a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease. Along with subsidiaries, Curetis GmbH and Ares Genetics GmbH, we are developing and commercializing molecular microbiology solutions helping to guide clinicians with more rapid and actionable information about life threatening infections to improve patient outcomes, and decrease the spread of infections caused by multidrug-resistant microorganisms, or MDROs. OpGens product portfolio includes Unyvero, Acuitas AMR Gene Panel and Acuitas Lighthouse, and the ARES Technology Platform including ARESdb, using NGS technology and AI-powered bioinformatics solutions for antibiotic response prediction.

For more information, please visit http://www.opgen.com.

Forward-Looking Statements by OpGen

This press release includes statements regarding a validation study of next-generation sequencing based tests provided by OpGens subsidiary, Ares Genetics GmbH. These statements and other statements regarding OpGens future plans and goals constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control, and which may cause results to differ materially from expectations. Factors that could cause our results to differ materially from those described include, but are not limited to, our ability to successfully, timely and cost-effectively develop, seek and obtain regulatory clearance for and commercialize our product and services offerings, the rate of adoption of our products and services by hospitals and other healthcare providers, the realization of expected benefits of our business combination transaction with Curetis GmbH, the success of our commercialization efforts, the impact of COVID-19 on the Companys operations, financial results, and commercialization efforts as well as on capital markets and general economic conditions, the effect on our business of existing and new regulatory requirements, and other economic and competitive factors. For a discussion of the most significant risks and uncertainties associated with OpGen's business, please review our filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which are based on our expectations as of the date of this press release and speak only as of the date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

OpGen Contact:Oliver SchachtCEOInvestorRelations@opgen.com

Press Contact:Matthew BretziusFischTank Marketing and PRmatt@fischtankpr.com

Investor Contact:Megan PaulEdison Groupmpaul@edisongroup.com

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OpGen Group Company Ares Genetics Demonstrates Feasibility of CLIA-compliant Next Generation Sequencing Workflow for Identification of Bacterial...

Genes take side in the battle of the sexes – Science News – Deadline News

Men may have a surprising genetic advantage over women, according to new research carried out at the University of St Andrews.

The study, published today inProceedings of the Royal Society Series B Biological Sciences, focused on genes that are present on the X chromosome.

These are carried by individuals of both sexes but with females typically having a double dose.

Traditionally, the over-representation of the X chromosome among females has been thought to lead to it favouring a genetic blueprint that benefits females at the expense of males.

But the St Andrews team have shown that, in many cases, the X chromosome instead sides with males in the battle of the sexes.

The research didnt specifically focus on human genetics and instead applies to all creatures that exhibit sex differences.

Across the animal kingdom males and females of the same species can differ remarkably in their size, shape, life-history and behaviour.

Males of the blanket octopus, for instance, are barely the size of the females eye, and males of the rusty tussock moth grow large ochre wings while females have tiny vestigial ones.

However, despite these striking differences, the two sexes generally share the same genome the set of genetic instructions that act as a blueprint for building an organism.

This can lead to problems, as the genome that encodes the best male might not be the one that encodes the best female, and any evolutionary advance that better serves the interests of males is likely to come at the expense of females.

This all depends on where in the genome they are found and on aspects of the species lifestyles, such as whether mums tend to be younger than dads.

Thomas Hitchcock said: The average ages of mothers and fathers in the population can also tilt the balance of genes interests in favour of one sex. If, as in humans, the average father is older than the average mother, then our model shows that this will lead almost all genes to shift their interests towards what works best for males.

Professor Andy Gardner, added: In general, these different parts of the genome will disagree about how best to balance the fitness of females against males.

This can lead to an interesting intragenomic conflict, where an individuals own genes can go to war against each other, and the fallout from that is expected to be harmful for both females and males.

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Animal Genetic Products Market Research Provides an In-Depth Analysis on the Future Growth Prospects and Industry Trends Adopted by the Competitors |…

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Genus Plc, Hendrix Genetics BV, Alta Genetics, CRV Holdings B.V., Neogen Corporation, VatGen, Animal Genetics Inc., Zoetis, Urus, and Envigo.

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Regional Bifurcation of the Market: North America, Europe, Asia-Pacific, Latin America, and Middle East & Africa.

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Thank you for reading our report. For further information or query regarding customization, kindly get in touch with us. Our team will make sure the report is customized according to your needs.

David is an Experience Business writer who regularly contributes to the blog, He specializes in manufacturing news

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Anatomy of the perfect transfer saga – RTE.ie

The blockbuster summer transfer.

It's one of the most bloated, soap-operatic, indulgent parts of professional football.

And yet, it's a sirens' call to a lot of supporters. You want to resist its nonsense, but it's hard not to be lured towards the mysterious waters of a rumour mill.

Even if a lot of the juiciest ones turn out be red herrings or ploys from a player to get a few more zeroes added to their currentcontract, every so often a big shark jumps pooland the ripples change the game.

Certainly Neymar's 222m move to PSG from Barcelona in 2017 had that kind of impact.

It led to Barca shelling out 160m for Philippe Coutinho, and Liverpool in turn making Virgil van Dijk the most expensive defender of all time when they paid Southampton 84m for the Dutchman's services.

They later forked out 75m for Roma's Alisson, a record fee for a keeper. Chelsea smashed that a couple of weeks later when they brought Kepa Arrizabalaga in from Athletic Bilbao for 80m, while the following year Manchester United eclipsed the Van Dijk fee after they stumped up 87m for Leicester centre-half Harry Maguire.

The hysteria around these transfers isn't a modern phenomenon either. In 1984, Napoli paid Barcelona 11m to lure volatile genius Diego Maradona to Italy, triggering scenes of adulation on a religious scale. Seventy-five thousand supporters wedged intoSan Paolo Stadium for the Argentinian's unveiling.

In England, it took a while for such mammoth fees to become a regular occurrence.

The record transfer fee was broken there in 1995 when Andy Cole left Newcastle United for Manchester United in a 7m deal.

A year and a half later, Alan Shearer's 15m switch to the Magpies from Blackburn Rovers blew that out of the water.

Right now Jadon Sancho's on-again off-again move to Manchester United is the most glamorous bit of tittle-tattle around.How will it end? Time will tell. But if Sancho does leave Borussia Dortmund before the extended window ends in October, it'll be done with all the usual fanfare these stunningly expensive dealsbring.

Expect it to tick a few familiar boxes...

THE BOMBSHELL

A rumour; a whisper; a leak from a well-placed source- the initial talk of a big switch usually comes from enigmatic manouevres in the background as the various parties of interest make their move.

In the summer of 2000 though, it was a public declaration of intent that seemed too outlandish to believe.

Talking himself up before the Real Madrid presidential elections, candidateFlorentino Perez said that if he landed the role he would sign the jewel in the crown of arch-rivals Barcelona: Luis Figo.

Perez played the whole thing beautifully. He set up a deal through Figo's agent that lured the Portuguese star into agreeing to move to Real if Perez won the election. Figo's people did not believe it would happen, andPerez reportedly promised the payer a considerable sum (1.7m) if he didn't get the presidency.

It looked like easy money. However, if Perez did win and Figo didn't move, he'd have to pay Perez a penalty fee of 22m.

Perez was voted in,Figo and his agent were left in an impossible situation, and he headed for the Bernabeu in what remains one of the most contentious transfers of all time.

In 1990, there was a famous fallout to rival it. On the eve of the World Cup, Juventus broke the world transfer record to sign Roberto Baggio from Fiorentina, the 10m deal leading to riots in Florence.Supporters took to the streets to vent their anger at losing Il Divin Codino (The Divine Ponytail), with around 50 people suffering injuries in the chaos.

They threw bricks, chains and petrol bombs, leading to clubpresident Flavio Pontello locking himself inside the ground to take refuge from the mob.

On his return to Florence the next season with Juve, Baggio declined to take a penalty kick that his team had won when trailing 1-0.

They missed it anyway,and Baggio later picked upa Fiorentina scarf that had been tossed onto the pitch just after he was subbed in what was perceived to be a warm gesture towards his former club.

Two days later, a couple of hundred Juve fans came to the training ground to give Baggio a piece of their mind and remind him where his loyalties should lie.

You can't please them all.

THE SULK

Players who don't get the big move they want have a tendency to throw some toys out of the pram. Van Dijk and before him Dejan Lovren both made life difficult for Southampton after Liverpool came calling.

The Merseysiderswere on the other side of it when Luis Suarez wanted to go to Arsenal in 2013. Had the Gunners bid a bit more than the 40m and one pound they wrongly believed was enough to trigger his buyout clause, they would have gotten the Uruguayan.

Instead Suarez stayed put, stewed in the reserves for a while as punishment before re-emerging and almost leading Brendan Rodgers' men to the title.

Then there'sPeter Odemwingie, the unwitting star of a marvellously bizarre deadline day saga.

The West Brom striker drove from Birmingham down to London to try and complete a move to QPR.

But the deal collapsed as QPR failed to get it over the line by the 11pm deadline. "(Afterwards) I said I'm going to play a song from Akon, Lonely, and drive home. I wish it all didn't happen, but that's life," said Odemwingie who had to return to the Baggies with his tail between his legs.

Still, nothing defines the absurdity of life as a top-level earner in the game better than Ashley Cole's infamous reaction to Arsenal's contract offer of 55,000-a-week in 2005 [he'd previously been on around 27,000 but wanted 60,000].

"I nearly swerved off the road," he writes in his autobiography."'He [Arsenal vice-chairman David Dein] is taking the piss, Jonathan!' I yelled down the phone. I was so incensed. I was trembling with anger. I couldnt believe what Id heard. I suppose it all started to fall apart for me from then on."

By the summer of 2006, he was a Chelsea player.

THE SLANGING MATCH

Things get testy when managers are trying to keep a hold of their prized assets.

In December 2008 when Real Madrid were circling around Cristiano Ronaldo, United boss Alex Ferguson came out swinging.

"Do you think I would enter into a contract with that mob?" he said. "Absolutely no chance. I would not sell them a virus.There is no agreement whatsoever between the clubs." Ronaldo was gone for 80m by the following June.

Back in 1998, Aston Villa's John Gregory didn't takethe departure of Dwight Yorke to Old Trafford particularly well. "A couple of weeks ago Dwight openly stated to me that he wanted to play for Manchester United and not Aston Villa. That really hurt me, and if I had had a gun I would have shot him," he deadpanned after Ferguson got the attacker for 12.6m.

And Ferguson was involved in another heated affair in 1993 when he angered Blackburn Rovers manager Kenny Dalglish by swooping for Roy Keane very late in the day. The Corkman had told Dalglish he would go to Ewood Park from relegated Nottingham Forest but once United got in his ear, the midfielder had a change of heart.

"You've made a bad move," Dalglish growled at Keane.

Twenty-five years later, when reflecting on the transfer, Dalglish was able to laugh it off, telling Keane on Sky Sports:"The next time I saw you, you'd won about three [league titles] and a European Cup. I said,'I told you you'd made a mistake'."

THE FANS' ABANDONMENT OF ALL RATIONALE

All bets are off once your team is linked to an exotic new signing.

The presence of cameras around the various grounds in the hours before the deadline day cut-off point has attracted nosy supporters keen to get involved in the excitement.

It's led to many an ashen-faced reporterstiffly soldiering through an update surrounded by a gurning crowd hellbent on going viral. Some outlets have actually stopped the practice now after things got a little too... colourful.

In this age of endless scrutiny, fanbases have developed an almost comical level of sophistication when it comes to staying in the loop.

In 2018, 32,000 Arsenal fans spent an an hour and a half watchinga virtual screen trackinga private jet from Dortmund to London.

Why?The Flightradar24 Twitter account had claimed that strikerPierre Emerick Aubameyang was on board and heading to England to sign a deal.

The constant monitoring of footballers' social media activity is another favoured tactic.

Last October, eagle-eyed Liverpool supporters spotted that Kylian Mbappe liked an Instagram post from Mo Salah, who'd published a photo of himself with Jordan Henderson after a 2-1 win against Spurs.

It could only mean one thing, right? Well, wrong. Despite giving Salah a virtual love heart, Mbappe has yet to make a move to Merseyside.

THE LATE TWIST

In recent years TV coverage of transfer deadline day has become this weird assault on the senses where we're told absolutely anything could happen but, often, nothing really does.

There's been exceptions in fairness. Manchester City upset the old order in 2008 whenSheikh Mansour took over the club and immediately started to spend his money on a scale the Premier League had never seen before.

They tried, and failed, to hijack Manchester United's move for Dimitar Berbatov but offset that very quickly by pulling off an outrageous deal to sign Robinho from Real Madrid. The Brazilian looked certain to link up with compatriot Felipe Scolari at Chelsea until the newly minted Citizens threw down a huge offer to get him north.

As revealed in a lengthy piece on Robinho in The Athletic, when faxing through their offerCity put the paper in the wrong way and it came out the other side blank. "Try again," Real told them. They did, and they got him.

Robinho may not have taken off at City in the way they would have hoped but his capture signalled the dawn of a new era at the Etihad.

In 2011 we had one of the barmiest sequence of big-money moves ever. Chelsea, who had long admired Liverpool superstar Fernando Torres, finally got their man for 50m.

The Redswere desperate to make a statement of their own after losing their poster boy and ended up paying an eye-watering 35m for Newcastle's Andy Carroll - and this came after they'd swooped for the then lesser know Suarez, who arrived for 22.5m from Ajax.

On the helicopter to Liverpool to complete the deal, Carroll had his agent Google the Liverpool squad because he only knew two of his new team-mates - Steven Gerrard and Jamie Carragher.

"That's actually a true story," he said years later. "Its bad because its Liverpool players, but its not disrespectful - I just literally didnt watch football, so I didnt know."

Maybe we take this stuff too seriously.

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Anatomy of the perfect transfer saga - RTE.ie

When Will ‘Grey’s Anatomy’ Season 17 Pick Up? – TVInsider

Get ready for a bit of a time jump whenGrey's Anatomy Season 17 begins.

The new episodes pick up "a month and a half into full COVID, so it's going to take place a little bit beyond where we left off," Giacomo Gianniotti, who plays Dr. Andrew DeLuca, told ET.

In terms of filling in the gaps in the story, "we might have some flashbacks. We might have some things where we're referencing last season." Filming is set to start in September, but that could change, as it already has; they were previously looking to begin this month.

While he hasn't read a script yet, he does have some sort of idea of what viewers will see on-screen, just in terms of keeping the actors safe."We're going to be wearing full [personal protective equipment] of course, as we're going to take place in coronavirus on the show when we start the season. All of our characters will be justifiably protected," Gianniotti explained. Because they play doctors, "we're uniquely lucky that we get to wear PPE."

(ABC/Kelsey McNeal)

Grey's recently promoted Richard Flood, who plays Dr. Cormac Hayes, to series regular, suggesting that we'll see more of Dr. Meredith Grey's (Ellen Pompeo) love triangle in Season 17. With his character the other part of it, Gianniotti expects that as well.

Last season, DeLuca and Meredith's relationship hit a rough patch, and as it ended, he was going through quite a bit in terms of his mental health. (The firefighter spinoffStation 19 appeared to confirm he's bipolar, through a conversation between his sister, Stefania Spampinato'sDr. Carina DeLuca, and her girlfriend, Danielle Savre's firefighter Maya Bishop.) According to Gianniotti, that may have opened the door for Hayes to be "much more desirable and stable and more of a compatible partner" for Meredith.

Grey's Anatomy, Season 17, Fall 2020, ABC

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When Will 'Grey's Anatomy' Season 17 Pick Up? - TVInsider

Grey’s Anatomy season 17, episode 1: When will Grey’s Anatomy return? – Express

Fans could also find out more about Owen's background in the upcoming season.

Little is known about him prior to being employed at Grey Sloan Memorial Hospital apart from the fact he had previously served in the army.

Showrunner Krista Vernoff opened up on Quaranstreaming: Comfort TV That Keeps Us Going panel about speaking to real-life doctors about the Covid-19 crisis.

She said: "The doctors come in and were the first people theyre talking to about these types of experiences theyre having.

"They are literally shaking and trying not to cry, theyre pale, and theyre talking about it as war a war that they were not trained for.

"And thats been one of our big conversations about Owen, is that hes actually trained for this in a way that most of the other doctors arent."

Grey's Anatomy is available to watch on ABC.

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Grey's Anatomy season 17, episode 1: When will Grey's Anatomy return? - Express

The anatomy of a city with a hate problem – Xtra Magazine

Four years ago, Jyssika Russell and two colleagues decided LGBTQ2 youth in Hamilton, Ontario, needed space. About an hours drive from Toronto, Hamilton has a population of nearly 750,000, a thriving arts scene, a large university. But there were no queer community centres. No gay bars. Some local non-profits ran LGBTQ2 programming, but nothing permanent that stood on its own. For a city of this size, we had nothing, Russell says.

Speqtrum is meant to be part of the solution. Russell and her co-founders designed the pilot project to provide active and social workshops for young LGBTQ2 people. Since then, Speqtrums offerings remain much the same. Our whole premise is to create and build community, primarily through activities, she says. The idea is that then that can help you connect and support each other.

But it is among the few offerings in Hamilton.

And that mattersespecially in a city where xenophobic protesters have made a routine out of demonstrating; where a former neo-Nazi leader worked at city hall, openly, for years; and where, in 2018, the most hate crimes were reported in the country.

That hatefulness was demonstrated in full force at Pride 2019 in Hamiltons Gage Park, when a group of protesters with homophobic signs showed up. According to the CBC, they physically clashed with counter-demonstrators who blocked them from the festivities. A number of people in pink masks identifying themselves as anarchists manoeuvered a portable barrier to block them, wrote CBC Hamilton reporter Samantha Craggs. Punching, shoving and hitting broke out between the two groups. Several people were injured.

Hamilton police were in attendance, but many felt they were slow to react. (An independent review of the incident, released in June 2020, found that the response to the violence was inadequate.) Meanwhile, Fred Eisenberger, Hamiltons mayor, and some of the city council came under heavy criticism for not more forcefully denouncing the protestersit took Eisenberger a week to release a formal statement. In the end, five people were charged: one of the homophobic demonstrators, and four of the counter-protesters.

A City of Hamilton spokesperson told Xtra that the city remains in solidarity with the LGBTQ2 community and is committed to being a Hamilton for All, where everyone in the city feels safe and welcome, and that they regret the violence that occurred at last years Pride event. Mayor Eisenberger and Hamilton Police Service Chief Eric Girt apologized for the pain and fear experienced that day by our Two-Spirit and LGBTQ+ communities, their friends and allies.

Hamilton is a city where marginalized communities have for years been trying to make space for themselvesthrough programs like Speqtrum and annual Pride events. But its also a city where hate has festered, particularly in the past few years. And its not alone: Research has found that right-wing extremism is growing worldwide. Thats why Hamiltons queer communitys fight against homophobia and racism isnt just their fightits everyones.

Hate does not emerge or operate in a vacuum, wrote Barbara Perry and Ryan Scrivens in their 2018 research paper on how organized hate groups emerge in Canada. The pair, both researchers of right-wing extremism, found three patterns: a community history and normativity of racism, a political climate of intolerance and a weak law enforcement response.

You can find these patterns in Hamilton. We have a history of hate groups in Hamilton that goes back over 80 years, as well as anti-Black racism within how we tell histories about Hamilton, and that is visible in leadership in Hamilton, across sectors, Ameil Joseph, an associate professor of social work at McMaster University, told CBC Hamilton in 2019.

In 2001, for example, just four days after 9/11, a mosque and a Hindu temple were targeted in acts of arson. Three men were arrested 12 years later, and all pleaded guilty to a lesser charge of mischief.

Theres a history of homophobia and intolerance toward LGBTQ2 people in the city, too. In the early 1990s, then-mayor Bob Morrow refused to declare Gay Pride Day; it would take a human rights tribunal ruling four years later to force him to recognize the day in Hamilton. Morrow, who was first elected in 1982, remains the longest serving mayor in Hamiltons historyhe didnt leave until he lost the 2000 election. (He also came back to serve as an appointed councillor after a city councillor died in 2014.) Even in his final year as mayor, he still did not attend Pride events, according to a local Hamilton Spectator report.

Since then, Hamiltons demographics have shifted significantly. Its become a bit of a joke in Toronto for people, fed up by sky-high housing and living costs, to claim they are going to pick up and move to Hamiltonand some of them are actually doing it. In 2016, a Hamilton Spectator report found that newcomers to the area were just as likely to be migrating from other parts of the province than from another country, and that the largest generational group of people living in the city were millennials. And nearly one in four people in Hamilton under the age of 15 are people of colour. Perry and Scrivens note that when newcomers arrive, they are often seen as scapegoats for all sorts of social ills by a small subset of people who are more likely to become radical.

Weve had a number of people and youth connect with us coming from other places in the [Greater Toronto Area] before they move here, mainly coming here because of cheaper rent, more services and transit options than the suburbs, says Russell. But, anecdotally, she noticed that some older LGBTQ2 people were doing the oppositemoving from Hamilton to Toronto for better access to safety and community.

Though the poverty level has lowered since the mid-90s, it remains high compared to the Ontario average. There are also massive income disparities at the neighbourhood level, according to the Spectator: 11 neighbourhoods in the lower inner city still have poverty rates of more than 30 percent.

Hamilton has a strong tradition of union activism and, at the federal and provincial level, the downtown ridings have been NDP strongholds since at least 2006, while more affluent areas of Ancaster and Dundas have typically voted for the Conservatives or Liberals. Yet, in 2018, Hamilton recorded the highest reports of hate crimes in the countryalmost triple that reported in Toronto, the biggest city in Canada.

It wasnt a surprise, says Michael Abraham, the lead at the SPACE Youth Centre, a drop-in centre for youth that provides programming for LGBTQ2 people. But it was so sad to see.

In 2018, there were 18 incidents of hate bias against the LGBTQ2 community; 58 were because of racial bias and 49 were because of the victims religion. That was a slight decrease in the number of incidents due to bias against sexual orientation from the previous year, when there were 22 incidents.

Hamiltons statistics in 2018 outstrip many other communities. Compared to the citywhich had 17.1 hate crimes per 100,000 peopleOttawa, the third ranked at the time Statistics Canada released the information, had only 9.8.

And Kojo Damptey, the interim executive director of the Hamilton Centre for Civic Inclusion, notes those numbers are also likely underreported. Those communities dont have a good relationship with the police, he says. Then theres the issue of hate crime reporting: For an incident to be officially counted as a hate-motivated crime, it must be proven beyond a reasonable doubt that an actual crime occurred, and that it was motivated by hate. If Im walking downtown and somebody uses a racial slur at me, there is no chance that that person is going to be arrested, says Damptey.

Meanwhile, the tenor of racist, homophobic and transphobic incidents in Hamilton seemed to be getting worse. Weve often had the usual sort of religious person standing up on the hill with a sandwich board [at Pride], says Cole Gately, who was among organizers of Hamiltons 2017 Pride events. But about three years ago, people Gately describes as street preachers came to protest, as well as people he believes may have been affiliated with white supremacist groups.

It was in late 2018 that the Yellow Vest movementa group originating in France, protesting high gas and living costs, but that soon, in parts of Canada, intermingled with alt-right groupsmade its way to city hall. The first recorded protest, in December that year, was against Canada signing the Global Compact for Safe, Orderly and Regular Migration, an international agreement on a common approach to international migration.

After that, the protests at city hall became a weekly event, escalating into the confrontation at Pridewhich left many people in vulnerable communities wondering why a public space had become a venue for xenophobia and intolerance. Most of the leaders in our city and politicians said nothing, says Cameron Kroetsch, who is on Hamiltons LGBTQ advisory committee and the Pride board of directors. That has been the status quo, from what I can tell, for a long time in Hamilton. The city did eventually look into whether it could legally bar the group from a public space. A City of Hamilton spokesperson says that the citys corporate security team continues to observe rallies and demonstrations that take place in municipal spaces such as the city hall forecourt, andif there is reasonable evidence to substantiate a complainta trespass notice can be issued. So far, the city has issued two trespass notices related to violence by hate groups.

But more incidents have only increased friction in Hamilton. In 2019, a Vice investigation found Marc Lemire, a former neo-nazi leader, had been working at Hamilton City Hall for years, his name left off most of the citys public facing records. (After this was disclosed, Hamiltons LGBTQ advisory committee asked the city council not to fly the Pride flag at City Hall during Pride; instead, they didnt have a flag raising ceremony.) And Paul Fromm, a known white supremacist, was spotted at the Yellow Vest protests, according to the CBC. Then came the Pride counter-protesters.

The overall situation became scary enough that some community organizers worried they were putting themselves at risk just by holding events. Chris Farias was the host of Drag Queen Storytime in Hamilton, performing as Ladybird Fancypants. After one performance at Carter Park in the fall of 2019, Farias came home to find they had messages from concerned friends after hearing that threats had been made against Ladybird Fancypants and the event. Suddenly, Farias had to weigh performing against the potential of putting children at risk. I was scared that I was drawing hate to [kids], they said. Since then, Farias has only held Drag Queen Storytime online or for private events.

This hate Hamilton is, in some ways, a microcosm of the troubling rise of right-wing extremism in pockets of North America. Perry and Scrivens note that across Western Ontario, Quebec, the lower British Columbia mainland and Alberta, the economic transition and the demographic transitions that have affected [southern Canada] more than [northern Canada] have created a whole raft of anxieties for some elements of society. London, Ontarioonly about an hour-and-half drive from Hamiltonalso had alt-right protests in 2017.Hate speech and hate-promoting activity became so problematic that, in 2017, the City of London announced that the managing director of parks and recreation would be able to refuse or revoke permission for events on city grounds if they believed it promoted hatred or discrimination, writes Eternity Martis in her book They Said This Would Be Fun, a memoir about her experiences with racism while attending university in the city. (Martis is also a senior editor atXtra.) Hate incidents in the city have been so shocking that theyve made national headlines.

Theres evidence that organizers of the Hamilton Yellow Vest protests wanted to spread their movement further afield. According to the Canadian Anti-Hate Network, last year Justin Long, a member of the group, said in a video that its his goal to clear anti-fascists out of Hamilton and then move on to another citymaybe Niagara Falls.

While not all white nationalists are homophobic, the majority of right-wing extremists are virulently anti-LGBT and share an anxiety and fixation on white birth rates, which are just barely keeping pace with racial minorities, writes Julie Compton for NBC News. And according to a 2020 United Nations Security Council Counter Terrorism Committee report, there has been a 320 percent rise in attacks by individuals affiliated with extreme right-wing terrorism in the last five years. This all combines to create a potentially dangerous situation for queer people.

That there are no permanent safe spaces for LGBTQ2 people wasnt always the case in Hamilton. The Well was Hamiltons queer community centre for 10 years. Embassy, one of a small handful of gay bars, was located smack downtown from the mid-1990s. Despite the best efforts of one former mayor, Pride festivities have been marked since the early 90s.

But both The Well and Embassy closed in 2016. There have been some efforts to provide funds for LGBTQ2 communities: The city of Hamilton has a diversity and inclusion facilitator and, in 2018, installed rainbow sidewalks outside of city hall. But according to Joey Coleman, publisher of civic affairs news site The Public Record, there is no direct operational funding dedicated for LGBTQ2 programming aside from the facilitator position. A City of Hamilton spokesperson says that the citys enrichment fund applies an equity, diversity and inclusion lens to our grant process and engagement plans to ensure we are reaching all. This includes grants for Pride Hamilton.

Hamiltons lack of LGBTQ2 spaces is such an issue that while doing research for a survey of Hamiltons queer community, Suzanne Mills, one of the authors of the report and an associate professor at McMaster Universitys school of labour studies, noticed the town halls they were holding were very popular among queer and trans folks. [The attendees] didnt want to participate in the research at all, Mills says. They just wanted to meet people, that they would talk to about how they wanted social spaces and things to do. The study, released in 2019, found that while Two-Spirit and LGBTQ people generally have a strong connection to Hamilton, fewer felt that same connection to the citys queer community.

Mills research has also found that while LGBTQ2 folks generally feel safe in Hamilton, many do not feel safe outside or in places affiliated with religion. Racialized cisgender people and trans people felt less safe comparatively.

Creating space in the city has long been a unique challenge. But Adam George Palios and Steven Hilliard have tackled it headfirsta reversal of sorts on the headlines about hate in Hamilton. Their promo company, Adam and Steve, is one of the biggest organizers of LGBTQ2 events in Hamilton. Last year, they hosted a Pride party in this midst of all the strife. There was not a homophobic protester to be found. Instead, 500 people showed up to celebrate queerness. I remember walking around that night, genuinely in tears, seeing people I hadnt seen in years, who, for the first time in so long, came out to Pride to celebrate, says Hilliard. I think that that is the measure of where a community is going.

Just holding safer space [can] also be very healing, says Palios. Just to know that you can go somewhere and relax with your friends and you dont always have to be on edge. In the absence of a dedicated gay bar, Palios and Hilliard instead work on educating staff at local venues on how to be a safe space for the queer communitywhether thats the club where they bring alumni from RuPauls Drag Race, or the local sports bar where they host Dirty Bingo.

Having space can be crucially important to stopping hate. And having a united front also shows that the community has strength and support from others. Those sort of mechanisms [community centres] are so important for developing broader community support and developing allyship and solidarity, but also in deterring violence, says Barbara Perry.

Mills study of Hamiltons queer community found that there was a sizable minority of people who are leaving the city to access services and community spaces geared for LGBTQ2 peopleand almost all of them would prefer not to leave. Theres just a lot of people who feel lonely and disconnected, Mills says.

While Hamilton lacks something permanent, other organizations have stepped up to support the LGBTQ2 community in the last few years. The AIDS Network provides more generalized non-AIDS related programming, according to Mills study. The Hamilton-Wentworth District School Board hosts Rainbow Prom, a safe space for youth to celebrate. Kaleidoscope is an LGBTQ+ youth circle co-founded by Kiwanis Boys and Girls Clubs of Hamilton and NGen Youth Centre.

In May 2018, The SPACE Youth Centre introduced OQRA, an informal support group for queer and trans Black, Indigenous and racialized youth, after hearing concerns from the community that even what little was for offer in Hamilton was overwhelmingly white. (The Centre also offers Scope, an LGBTQ2 youth circle.) But Michael Abraham says the team is also trying to bring an intersectional lens to everything they do at SPACE. I think having spaces in which you can exist and flourish is a common need that pretty much anyone and everyone has, he says. So when you dont see yourself represented in your community, or the wider city, thats quite a challenge.

Speqtrums Jyssika Russell believes that this kind of organizing work is what can effectively stomp out hate in Hamilton. I think its just a perfect time to really highlight that whats going to stop a hate crisis in Hamilton is investing in community organizations, into mental health supports, into affordable housing and into addictions programs, Russell says. These are the things that will actually alleviate so many of those community issues.

Theres evidence that this kind of support for marginalized and vulnerable communities can push back against far-right radicalization. Perry and Scrivens reported that its often community activists who are able to see where hate is bubbling up and more effectively communicate that to authorities. One police officer in our study suggested that rights activists are crucial to counter-extremism initiatives because they fill in the gaps where police cant go, they wrote. (This, of course, depends on police having a trusting relationship with marginalized communitiesa reality that seems quite distant today.)

But funding remains an issue. Russell is currently fighting to keep Speqtrum going not only during a pandemic, but as the organizations provincial funds are set to run out.

A community hub space, first proposed by councillor Nrinder Nann, has received support from council. Mayor Eisenberger and several staff and councillors even visited Torontos 519 community centre, looking at it as a potential model for a centre in Hamilton. A community hub, however, was not in this years city budget, which passed before the COVID-19 pandemic began. (A city spokesperson said that as the city begins to reopen, this important work will continue.)

But the fight is far from over. I think sometimes people dont realize the amount of stress that this puts on people in our community, says Russell. The hate stuff is happening at the same time as our communities are hurting.

I think its incredible how resilient weve been able to be, she adds. But building these spaces, building community, takes a lot of time and energy and a lot of heart.

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The anatomy of a city with a hate problem - Xtra Magazine

Sinopsys Announces Issuance of European Patent Covering its Novel Stent for the Delivery of Dexamethasone and other Therapeutics to Key Sinus Anatomy…

The issuance of this patent recognizes the novelty of the underlying technology and complements the first-generation patent filings for Sinopsys, making it a key component of our intellectual property portfolio

BOULDER, Colo. (PRWEB) August 12, 2020

Sinopsys Surgical, Inc. (Sinopsys), a medical technology company focused on treatment of sinusitis and related conditions announced that the European Patent Office has granted EP Patent No. 2624876 covering Sinopsys implantable stent for the delivery of therapeutic agents including pharmaceuticals and saline. Previously-issued members of this patent family include US patents 9,022,967 and 9,308,358.

The Company previously received 510K clearance by the Food & Drug Administration (FDA) for use of the stent in the treatment of Epiphora (blocked tear ducts) and an Investigational Device Exemption (IDE) for the delivery of saline to the ethmoid sinuses via the stent in treatment of Chronic Sinusitis (CRS). With the stent now CE marked for the short or long-term treatment of CRS with saline, Sinopsys is planning its European product launch in H1 2021.

Sinopsys has a global patent estate covering its stent design, the implant procedure, and the use as a delivery device to the ethmoid sinus which studies have shown is a common source of infection for patients suffering from CRS.

The issuance of this patent recognizes the novelty of the underlying technology and complements the first-generation patent filings for Sinopsys, making it a key component of our intellectual property portfolio said Richard Babb, CEO of Sinopsys. Our approach overcomes the challenges of accessing the ethmoid sinus through a bottom up approach which often requires invasive, irreversible sinus surgery that, in some patients, is ineffective.

Mr. Babb continued: Sinopsys stent can be used for short or long-term treatment and easily removed by a medical professional when treatment is completed. Through clinical studies, our goal is to further expand the use of this innovative platform for other indications that may benefit from targeted saline and therapeutic delivery to the sinus anatomy.

About Sinopsys Surgical, Inc.Sinopsys stent is a sterile, single-use, long-term, surgically placed medical device composed of medical grade polydimethylsiloxane (PDMS), commonly known as silicone. The reversible, implant procedure takes under one hour without general anesthesia. The stent is designed to access the ethmoid sinus for the delivery of saline, for which it is currently approved in Europe, and for delivery of pharmaceutical therapeutics, for which additional clinical studies must be conducted. Additional information about the company can be found at http://www.sinopsyssurgical.com.

Forward-Looking StatementsTo the extent any statements made in this release contain information that is not historical, these statements are essentially forward-looking and are subject to risks and uncertainties, including the difficulty of predicting FDA (or other regulatory body) approvals, acceptance and demand for new products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, the regulatory environment, and other risks the Company may identify in the future.

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Sinopsys Announces Issuance of European Patent Covering its Novel Stent for the Delivery of Dexamethasone and other Therapeutics to Key Sinus Anatomy...

How Grey’s Anatomy, Last Man Standing, and Other Shows Are Planning to Put Coronavirus Into Their Storylines – TV Guide

The COVID-19 pandemic has forced many people to be spending a lot more time at home. In the initial days of quarantine and social distancing, the time at home meant you could catch up on things gathering dust on the DVR or the stack of programming in your various streaming service queues. However, it's been months since the initial social distancing guidelines were put into place in the U.S., shifting the perception of what "normal" will be when it is safe to socialize again. It seems the pandemic is also going to affect what "normal" is when it comes to TV shows as well.

Obviously, many shows have been shut down or placed on indefinite hold because those who make them are not allowed to gather in close quarters, as they normally would on a typically busy set. But, beyond merely being able to film, lots of shows are already thinking about how to incorporate COVID-19 storylines into their upcoming seasons. (It should be noted that plenty aren't thinking about incorporating coronavirus too; count American Horror Story among those that plan on staying way more than six feet away.) For a healthy segment of other shows though, COVID-19 might as well be a new guest star or a new big bad next season, because it's going to play a significant role. Here are all the shows we know of so far that are putting coronavirus storylines into their next season.

As Season 2 was concluding, creator and executive producer David Schulner told TV Guide that COVID-19 will absolutely be a part in Season 3. Especially since the virus impacted this show like no other some cast members got infected, such asDaniel Dae Kim, and an entire episode devoted to a separate pandemic was scrapped. "All our plans have been blown out of the window," Schulner said. "In Season 3 we have to rethink everything. Their priorities are going to change after this pandemic. I don't think we can force storylines on a new world we're living in it would ring false. They're going to change."

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NCIS New Orleans isn't shying away from COVID-19 and it's hitting close to home. In an interview with TV Line, CCH Pounder, who plays Dr. Loretta Wade, says her character will come face-to-face with the virus when someone she counseled on how to avoid it becomes infected. "It reflects on the first part of the [pandemic] situation with masks and people saying, 'No, I'm fine! I don't need to wear a mask.' All of those things you hear in the community. So it's quite a shock to her that she wasn't listened to, or that it wasn't that important to this person."

Executive producer John Wells told The Hollywood Reporter, "It's impossible to do a satirical comedy about the working poor without addressing what happened and what is going to happen to that community." So you can expect the Gallaghers to be dealing with some heavy problems in the series' final season.

Entertainment Weeklyreported that Grey's executive producerKrista Vernoffsaid in an Emmys panel, "We're going to address this pandemic for sure. There's no way to be a long-running medical show and not do the medical story of our lifetimes." Vernoff expanded on that quote during THR's "TV's Top 5" podcast, revealing that the show's upcoming COVID storylines won't be all bleak. "There's joy and fun to be had in people who are quarantining away from the hospital...Many of [these doctors] aren't going home to their families; they're getting Airbnbs and living together," she said. "There's a lot of story to tell that is sort of COVID-related but not about death and despair." Series star Giacomo Gianniotti toldET Onlinein August that Season 17, which hasn't started filming, will open a month and a half into the pandemic as the doctors adjust to the new reality of COVID-19.

Season 4 of the ABC drama will open with a COVID-19 storyline, TV Line reports, in a two-part season opener.

Executive producer on the creepy love story Greg Berlanti told THR we can probably expect to see COVID-19 in a new season, though it would probably happen in between seasons. "You're in a pact with your audience where you have to deal with real-life sh--," he said.

Of course noted germaphobe and master of awkward situations Larry David is going to make the pandemic part of a new season. Showrunner Jeff Schaffer told THR, "There's still plenty of aberrant behavior to look back on, like who said they were social distancing but clearly got a haircut every few weeks. Just because people were supposed to be in their houses and everyone says they were in isolation, were theyreally?"

Considering how many of the insane cases on 9-1-1 and and its spin-off are based on real headlines, it makes sense that COVID-19 would factor into future seasons.Tim Minear, the boss on Fox's explosive procedurals told THR,"If we pretend like it's an alter-universe where this thing hasn't happened, we'd quaint ourselves into irrelevance."

"What seems likely," Michelle King told THR, "is that regardless of when we broadcast, people are still going to experience the economic aftermath, so my expectation is that we'll at least touch on that."

Tim Allentold TV Guide earlier this year that there was no way LMS wouldn't make COVID-19 a part of the Baxter family story. "We kind of have to," he said. "We try to keep it as real as we can. The virus would have impacted the [Last Man Standing]universe. I'm going to have to look at, what happened to pot shops? What was that experience like? I guarantee you Outdoor Man will be facing the repercussions of the economy. How did lockdown affect outdoor equipment use? How are they going to re-open? We will ask ourselves all those questions to see how lockdown affected all of that."

Showrunner Dan Goor told THR at the end of Season 7"The question is how they have been affected by the virus and the pandemic as New York City residents and as first responders in New York City." The comedy reportedly had to start over on Season 8 after the start of the pandemic and the Black Lives Matter protests sparked by the death of George Floyd to address the current climate.

CreatorKenya BarristoldTHRthat he was sure the show, set in a fictional college, would incorporate the pandemic but he isn't currently sure how, "It's like, 'Do we start the year off, like, 'Senior year, bitches!' and then kids are at home studying online?" Online classes aren't the only dilemma to decide for the comedy. Last season ended with Zoey (Yara Shahidi) deciding to drop out of school to begin her fashion career but how can you style people in the current social distancing conditions?

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How Grey's Anatomy, Last Man Standing, and Other Shows Are Planning to Put Coronavirus Into Their Storylines - TV Guide