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Applications are due Friday, September 13th. Submit your nominations today. 비아그라 구입 Pharma Sanofi, Eisai join Lilly's SCOTUS bid to save Cialis from 'overly broad' patent claims by Kyle Blankenship | Jul 9, 2019 10:35am Sanofi and Eisai are throwing their weight behind Eli Lilly's SCOTUS bid to protect Cialis' patent protection in BPH. (Eli Lilly) 나누기FacebookTwitterLinkedInEmailPrintEli Lilly has a message for the U.S. Supreme Court: We aren’t going to take a $20 million patent loss for Cialis sitting down. Now, Lilly can count on a couple of friends ready to join the fight—and it's a fight that the rest of pharma might want to watch. On Monday, Sanofi and Eisai Pharma threw their weight behind a lawsuit seeking to overturn a claim by Erfindergemeinschaft Uropep GBR (EUG) that ended Cialis’ patent protection in benign prostatic hyperplasia (BPH), a $20 million indication. Lilly called EUG’s original claim a “particularly egregious example of functional claiming,” in the suit (PDF). Both Sanofi and Eisai doubled down on Lilly’s “functional claim” argument, saying EUG’s claim effectively roped off any drug formulations used to treat BPH through an enzyme inhibitor, a category Cialis falls under. FREE DAILY NEWSLETTER Like this story? Subscribe to FiercePharma! 시알리스 구입 Biopharma is a fast-growing world where big ideas come along daily. Our subscribers rely on FiercePharma as their must-read source for the latest news, analysis and data on drugs and the companies that make them. Sign up today to get pharma news and updates delivered to your inbox and read on the go. SUBSCRIBE NOWIt's the sort of broad patent claim at issue in a variety of outstanding court cases, so it's no surprise other drugmakers want in. Lilly's lawsuit could have big implications for companies who've fallen prey to claims that rely on results rather than precise formulations. In fact, fighting "overly broad" patent claims is at the heart of Sanofi and Regeneron's fight to market PCSK9 inhibitor Praluent, which a Delaware jury said in February infringed on Amgen's older patent for Repatha. RELATED: Eli Lilly throws SCOTUS hail mary in Cialis patent infringement fight In this case, Sanofi and Eisai argued that the federal appeals court’s argument upholding EUG’s claim was at odds with decades of SCOTUS precedent. “This will continue to occur indefinitely unless addressed … providing patent protection beyond what the inventor conceived of or disclosed to the public, breaking the essential bargain with the public that underlies our patent system,” Sanofi said in a legal brief Monday. The French drugmaker also has a vested interest in Cialis patent rights. The company owns the rights to market over-the-counter Cialis in the U.S., U.K., Canada and Australia. Sanofi could also see shades of its own past in the Cialis fight after generic challengers to its Uroxatral gutted the drug’s chances in BPH back in 2012, an $81 million market at the time. Kissei and Allergan’s own BPH alpha-blocker, marketed as Urief and Rapaflo in Japan and the U.S., respectively, also lost its battle with generic challengers in late 2018. RELATED: Top 10 U.S. patent losses of 2017 - Cialis Lilly’s SCOTUS bid is the last line of defense for the drug after the arrival of generic challengers stateside and abroad has largely ended the drug’s blockbuster sales hopes. In 2018, Cialis saw a 20% drop in worldwide sales to $1.85 billion, driven by the drug’s loss of U.S. and European patent protection in late 2018 and 2017, respectively. In 2016, Cialis cleared $2.47 billion worldwide. https://viagra-onlineshop.com/ For the first quarter, Cialis raked in a little more than $308 million worldwide—a 38% drop from the previous year. U.S. sales took the worst of that decrease with sales plummeting to $143 million—a 54% drop from the year before. Editor's Note: This story has been updated to correct a mistake. 출처 : https://www.fiercepharma.com/pharma/sanofi-eisai-join-eli-lilly-s-scotus-bid-to-protect-cialis-patent-bph
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Eli Lilly's erectile dysfunction drug Cialis shows signs of reversing heart failure in sheep9/12/2019 Eli Lilly’s Cialis (tadalafil) is best known as an erectile dysfunction (ED) therapy. But University of Manchester scientists are interested in proving it can reverse heart failure, and they have promising evidence from a sheep study that they may be right. 비아그라 구매 Cialis slowed the progression of heart failure in sheep models of the disease and reversed breathlessness, one of the most troublesome symptoms, the researchers reported in the journal Scientific Reports. The findings may not be a total surprise. This class of drugs, PDE5 inhibitors, which also includes Pfizer’s Viagra and Bayer’s Levitra, was originally developed for cardiac disease. Then the scientists developing Viagra discovered the drug relieved ED. FREE DAILY NEWSLETTER Like this story? Subscribe to FierceBiotech! Biopharma is a fast-growing world where big ideas come along every day. Our subscribers rely on FierceBiotech as their must-read source for the latest news, analysis and data in the world of biotech and pharma R&D. Sign up today to get biotech news and updates delivered to your inbox and read on the go. SUBSCRIBE NOW“We do have limited evidence from human trials and epidemiological studies that show Tadalafil can be effective in treating heart failure,” said the study’s lead author, Andrew Trafford, in a statement. “This study provides further confirmation, adds mechanistic details and demonstrates that Tadalafil could now be a possible therapy for heart failure.” It’s possible that patients taking Cialis for ED have already unknowingly benefited from the drug’s protective effect on the heart, he added. Heart failure is characterized by the heart’s inability to pump enough blood to meet the body’s needs, which can lead to fluid accumulation in the lungs and cause the feeling of being short of breath. Trafford’s team used sheep to study the effects of PDE5 inhibition because their hearts are similar to human hearts. After inducing heart failure in the animals, the team administered Cialis at a dose similar to what’s used to treat ED in people. They observed that Cialis restored the heart’s ability to respond to adrenaline—and that improved its ability to pump blood. 시알리스 구매 RELATED: Repairing heart damage by targeting the stress response Most heart failure medications can slow the progression of the disease and lower the probability of deadly cardiac events. But actually reversing heart failure is difficult, especially without surgery or the assistance of medical devices. Various groups of scientists are exploring methods for reversing heart failure with drugs. A team at Imperial College London recently found that blocking the MAP4K4 protein could reduce heart damage. In a 2017 Nature study, Baylor College of Medicine researchers discovered that the Hippo signaling pathway can prevent damaged heart muscle from repairing itself, and by blocking it, they restored pumping ability in mouse hearts. But the University of Manchester researchers believe the best strategy may be to return to the original goal in PDE5 inhibition. “We seem to have gone full-circle, with findings from recent studies suggesting that [ED drugs] may be effective in the treatment of some forms of heart disease—in this case, heart failure,” said Metin Avkiran, associate medical director of the British Heart Foundation, which funded the study. "The evidence from this study, that a Viagra-like drug could reverse heart failure, should encourage further research in humans to determine if such drugs may help to save and improve lives.” https://viagra-onlineshop.com/ 출처 : https://www.fiercebiotech.com/research/sheep-study-shows-cialis-might-reverse-heart-failure Prosecutors say that from 2011 to 2017, a Walnut resident illegally imported powdered tadalafil — the active ingredient in the prescription drug Cialis, above.
(BSIP / UIG via Getty Images) 비아그라 구입 By ASSOCIATED PRESS AUG. 19, 2019 10:18 PMA Southern California man who smuggled $11 million worth of erectile dysfunction drugs into the U.S. from China has been sentenced to more than eight years in federal prison for conspiracy and smuggling contraband.시알리스 구입 Prosecutors say the drugs sold by 41-year-old John Lee of Walnut were dangerous black-market creations falsely advertised as herbal remedies, and some customers suffered permanent injuries. Lee also was ordered Monday to pay $550,000 in restitution to victims. Prosecutors say from 2011 to 2017, Lee illegally imported powdered tadalafil — the active ingredient in the prescription drug Cialis. Lee made 5½ million pills, some containing 14 times the level of the drug found in Cialis. He pleaded guilty in February. More than a dozen other associates and companies have pleaded guilty to conspiring with Lee. https://viagra-onlineshop.com/ 출처 : https://www.latimes.com/california/story/2019-08-19/california-man-erectile-dysfunction-drugs-sentence LOS ANGELES — A Walnut man was sentenced Monday to eight years and four months in federal prison for illegally importing and selling $11 million worth of pharmaceutical-grade erectile dysfunction drugs that were falsely marketed as herbal remedies for men, some of whom suffered permanent injuries after consuming them.비아그라 구매
John Seil Lee, 41, was sentenced by U.S. District Judge Percy Anderson, who ordered him immediately taken into federal custody. Anderson — who also ordered Lee to pay more than $552,000 in restitution to men who were injured by the misbranded pills — remarked on Lee’s “callousness” and how his scheme “has literally ruined lives.” “It’s obvious to me that this defendant has little or no respect for the law or the harm he caused numerous victims,” Anderson said from the bench. Lee pleaded guilty in February to three felony counts of conspiracy, as well as importing contraband into the United States and filing a false tax return, according to the U.S. Attorney’s Office. 시알리스 구매 Lee’s companies — KHK International Trade Enterprise and SHH World Trading Enterprises — each were sentenced to five years’ probation. KHK was fined $100,000 and SHH was ordered to pay victims $115,484 in restitution. Guilty pleas were entered in February on behalf of Lee’s companies to two felony counts of introducing misbranded drugs into interstate commerce, federal prosecutors said. Lee sold at least $11 million worth of pills across the United States – – under names such as X Again, X Monster and Royal Master — with labels that did not disclose the presence of Tadalafil and falsely stated that no prescription was necessary, according to court documents. Lee also continued selling the pills despite U.S. Food and Drug Administration announcements that the pills were tainted because they contained undeclared Tadalafil. In order to evade federal regulators, Lee relabeled the tainted pills in response to FDA announcements about their safety, prosecutors said. In August 2016, for example, after the FDA announced that SHH’s One More Knight pills contained undisclosed Tadalafil, Lee rebranded the same pills as Own the Knight and continued selling them, according to the U.S. government. Sponsored Videoby Donor Network WestTadalafil under the name of Cialis is used to treat impotence and symptoms of an enlarged prostate. Another brand of tadalafil is Adcirca, which is used to treat pulmonary arterial hypertension. In addition to the convictions of Lee, KHK and SHH, federal prosecutors obtained 13 guilty pleas from individuals and companies who conspired with Lee to distribute his misbranded erectile dysfunction drugs. Those defendants are scheduled to be sentenced by Anderson over the next several months. Hidden active pharmaceutical ingredients have been identified in products promoted not only for sexual enhancement, but also for bodybuilding, pain relief and weight loss. The FDA has issued hundreds of public warnings and recall announcements related to these types of fraudulent products. https://viagra-onlineshop.com/ 출처 : https://www.sgvtribune.com/2019/08/19/walnut-man-gets-8-plus-years-in-prison-for-selling-drugs-falsely-labeled-as-herbal-remedies-for-men/ |
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