first_imgMylan Technologies Inc,Mylan Inc (Nasdaq: MYL) today confirmed that the company has been sued by Vivelle Ventures LLC, Noven Pharmaceuticals Inc. and Novartis Pharmaceuticals Corporation in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Estradiol Transdermal System, USP (Twice-Weekly), 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day and 0.1 mg/day. This product is the generic version of Vivelle-Dot®, which is indicated for the treatment of symptoms associated with menopause, the treatment of hypoestrogenism and the prevention of postmenopausal osteoporosis. Mylan has a plant in St Albans which manufactures Transdermal patches and pharmaceutical labels.Mylan believes it is the first company to have filed a substantially complete ANDA containing a Paragraph IV certification for all strengths and expects to qualify for 180 days of marketing exclusivity upon final FDA approval. The plaintiffs filed the lawsuit in the U.S. District Court for the Southern District of New York and the U.S. District Court for the District of Vermont.Vivelle-Dot had U.S. sales of approximately $215 million for the 12 months ending Dec. 31, 2010, according to IMS Health. Currently, Mylan has 169 ANDAs pending FDA approval representing $97.9 billion in annual sales, according to IMS Health. Forty-seven of these pending ANDAs are potential first-to-file opportunities, representing $24.8 billion in annual brand sales, for the 12 months ending June 30, 2010, according to IMS Health.This press release includes statements that constitute “forward-looking statements,” including with regard to the expected first-to-file status and pending litigation. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: the use of legal, regulatory and legislative strategies by competitors or other third parties to delay or prevent product introductions; risks inherent in legal and regulatory processes; and the other risks detailed in the company’s filings with the Securities and Exchange Commission. The company undertakes no obligation to update these statements for revisions or changes after the date of this release.Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 150 countries and territories. The company maintains one of the industry’s broadest and highest quality product portfolios supported by a robust product pipeline; operates one of the world’s largest active pharmaceutical ingredient manufacturers; and runs a specialty business focused on respiratory, allergy and psychiatric therapies. For more information about Mylan, please visit www.mylan.com(link is external). For more information about generic drugs, please visitwww.ChoosingGenerics.com(link is external).SOURCE Mylan Inc. PITTSBURGH, March 1, 2011 /PRNewswire/last_img read more

first_imgTexas regulator says state coal production fell 30% in 2018 compared to prior year FacebookTwitterLinkedInEmailPrint分享Houston Chronicle:Coal production fell sharply last year as coal-fired power plants closed and natural gas provided a cheaper and cleaner alternative for electricity generators.The state’s 12 active coal mines produced 25 million tons of coal in 2018, down nearly 30 percent from the 35 million tons in 2017, according to the Railroad Commission of Texas. Each of the mines produced significantly less. At the state’s largest coal mine, the Kosse Mine in Limestone County near Waco, production fell 16 percent to 8.7 million tons from 10.1 million tons.The Kosse mine is owned by Luminant, the merchant power unit of the Irving company, Vistra Energy. Luminant, citing economic reasons, shut down three coal plants last year with a combined generating capacity of more than 4,000 megawatts — enough to power more than 800,000 Texas homes on a hot summer day. Another coal-fired plant, the Gibbons Creek Generating Station about 20 miles from Bryan, will close for good in October.The number of active coal mines in the United States has fallen by more than half over the past decade to 671 mines in 2017 from 1,435 mines in 2008, according to the Energy Department. Last year, domestic coal consumption fell to the lowest level since 1978, the Energy Department said.Coal’s share of power generation is falling, too. In the first half of 2019, coal-fired plants generated about 21 percent for the state’s electricity, compared to 22 percent from wind and 44 percent generated by natural gas, according to the state’s power grid manager, the Electric Reliability Council of Texas.More: Coal production falls sharply in Texaslast_img read more

first_imgLOS ANGELES — A group of Colorado Rockies players visited Treyarch Studios, the Santa Monica headquarters of the global video game developer, on Tuesday. Call of Duty: Black Ops 4 won’t be released until October, but the players hunkered down in a dark, glossy room encircled with screens and dove into the new game.There was a baseball game that night too, and first pitch at Dodger Stadium was still several hours away. Playing video games wasn’t a part of everyone’s game-day routine, but iPads were waiting in the dugouts, a standard tool for major league teams in 2018. Televisions hung in the players’ cafeterias. Smartphones were ubiquitous. Just by going about his day, the average baseball player took in more screens than your company’s HR department.A new book claims this is a serious problem.The author is Tommy John, a chiropractor based in San Diego. He is less famous than the elbow ligament replacement surgery that also bears his father’s name. In “Minimize Injury, Maximize Performance,” John attempts to reverse a recent explosion in surgeries through a set of guidelines for youth athletes designed to, well, minimize their injuries and maximize their performance. The guidelines are not catchy. They aren’t specific to any one sport. The book probably won’t make Tommy John the author more famous than Tommy John the pitcher or Tommy John the surgery.“Nobody can sell the stuff that it takes,” the author said in a recent telephone interview. “It’s a bunch of mundane acts over and over. It’s constantly doing the small things over and over. But you can’t sell that. It’s not easy. It’s not one thing.”The “Tommy John solution,” as he calls it, offers a lot of nuggets culled from hard research and John’s own anecdotal evidence working with youth, college and pro athletes. John himself had a brief pro career as a pitcher before transitioning to chiropractics. He said his father never gave him a pitching lesson until he asked for one as a 12-year-old.“It was just ‘here, throw the ball here.’ Back up, ‘throw the ball here.’ It was so basic,” John said. “I wanted more.”The idea of not specializing in one sport year-round, and not focusing on any one sport-specific activity before puberty, is not new. Youth injuries are rising nonetheless. John cited a 2013 interview with Dr. James Andrews in which America’s most famous orthopedic surgeon estimated 40 percent of his patients were youth, up from 15 percent in the span of a decade. Newsroom GuidelinesNews TipsContact UsReport an Errorcenter_img Andrews is on MLB’s “Pitch Smart” committee, formed by the league to combat the youth injury epidemic. If the program is successful, MLB hopes, the bodies of future major leaguers will not be on the verge of collapse by the time they reach their 20s. Many of its guidelines overlap with the Tommy John Solution.So far, prolonged screen exposure is not an area of overlap.“We have looked at this issue with interest and further research is needed before definitive recommendations,” the league said in a statement.In “Minimize Injury, Maximize Performance,” John does not tread so lightly. He treats screen exposure like a Trojan horse, a subversive attack on the human brain.“Each time people answer a text, surf social media, use the latest app, or battle online against others, their brain is being bombarded by stimuli,” he writes. “Every bright color, high-definition pixel, pop-up ad, or unexpected sound is a trigger their brain has to react to, yet they can only process so much.”John says these stimuli throw our sympathetic nervous system – the body’s so-called “fight or flight” response – into overdrive, and being in a constant state of overdrive ultimately weakens the body’s immune system.The average healthy adult might not notice the consequences the same as someone who participates in a punishing physical activity – for example, throwing a baseball. John focuses on youth athletes, but he believes the consequences are the same for major leaguers.“I’ve worked with the highest level of professionals. The same rules apply,” John said. “You are at a detriment when you expose yourself to something like a screen. Your sympathetics are going to ramp up. We can’t use age groups. The 20-year-old today is not the 20-year-old of 20 years ago.”Keith Dugger, the Rockies’ head athletic trainer, said he’s tried educating players about the consequences of screen exposure. His staff might have control over players’ physical movements for several hours a day, for eight months a year. He can monitor things like stretching routines and weightlifting programs. But playing video games or using a smartphone?“We want them to limit the amount of time they’re in front of their gaming devices when they get home after a game,” he said. “We want a cutoff period. We’re not putting a curfew on them but we’re saying, ‘be responsible. Don’t stay up all night.’”Does he think they’re listening?“I think they listen a little bit, especially if there’s science that’s out there, documentation showing there’s an ill effect toward them or their gameplay. In reality, they’ll do anything if it’s not affecting their gameplay.”Rockies pitcher Bryan Shaw was among the group that visited Treyarch Studios on Tuesday. He already has the release date for Call of Duty: Black Ops 4 circled on his calendar.“October 20,” he said. “I’m ready. I’m excited. I think all of us that went are.”Shaw described the role of video games in his life in anything but dire terms. When the Rockies are on the road, he said, it’s a regular part of his pre- and postgame routine.“Usually we get back to the hotel, relax, play some games until you fall asleep,” he said. “I played some today. You wake up at 10 o’clock, whatever it is, go eat breakfast and sit in your room until you come to the field at 2, so yeah I jumped on today.”Shaw doesn’t think gaming impedes his sleep schedule, though traveling from coast to coast over the course of 162 games might. An eight-year veteran, Shaw is 30 years old and says he’s been playing video games all his life. He’s averaged 63 games and 59 innings a season and has never been placed on the disabled list.If convincing major leaguers to limit their screen exposure is any indication, John will face an uphill battle with teenagers.“That’s a fallacy,” Dodgers pitcher Walker Buehler said. “I don’t like it. I don’t believe it.”“I think I would almost argue the opposite, that we already do it so much that it can’t really (harm) us, or maybe it almost warms us up,” Dodgers pitcher Ross Stripling said. “But there’s a chance. I’ve got to think it depends on what you’re doing – playing a violent video game or watching a thriller probably burns you more than if you’re sitting there reading a Kindle.”Screen exposure might not be on the front lines of MLB’s injury-prevention battle yet. But if it ever gets there, medical staffs could be in for a battle.last_img read more