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April 10, 2014
04:55 EDTTHOR, THOR, THOR, THOR, HTWR, HTWR, HTWR, HTWR, GILD, GILD, GILD, GILD, DNA, DNA, DNA, DNA, BAYRY, BAYRY, BAYRY, BAYRY, ALIOF, ALIOF, ALIOF, ALIOF, SSH, SSH, SSH, SSH, UTHR, UTHR, UTHR, UTHRInternational Society for Heart & Lung Transplantation to hold annual meeting
34th Annual Meeting of ISHLT is being held in San Diego, California on April 10-13.
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September 30, 2015
18:07 EDTTHORS&P announces changes to the S&P 400, 500 indices
S&P 500 constituent Joy Global (JOY) will replace Thoratec (THOR) in the S&P MidCap 400, and Verisk Analytics (VRSK) will replace Joy Global in the S&P 500 after the close of trading on Wednesday, October 7. S&P 500 constituent St. Jude Medical (STJ) is acquiring Thoratec in a deal expected to be completed on or about that date, pending final approvals. Joy Global has a market capitalization more representative of the mid-cap market space.
17:19 EDTTHORJoy Global to replace Thoratec in S&P 400 as of 10/7 close
09:59 EDTGILDActive equity options trading on open
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06:03 EDTUTHRUnited Therapeutics announces settlement of patent litigation with Sandoz
United Therapeutics announced that it has entered into a Settlement Agreement with Sandoz relating to ongoing litigation concerning certain patents relating to United Therapeutics' product, Remodulin Injection, and Sandoz's Abbreviated New Drug Application, or ANDA, seeking approval by the FDA to market a generic version of Remodulin. Under the Settlement Agreement, United Therapeutics granted to Sandoz a non-exclusive license to manufacture and commercialize the generic version of Remodulin described in its ANDA filing in the United States beginning on June 26, 2018, although Sandoz may be permitted to enter the market earlier under certain circumstances. The license included in the Settlement Agreement does not permit Sandoz the right to manufacture a generic version of any other United Therapeutics product, such as Tyvaso Inhalation Solution or Orenitram Extended-Release Tablets, nor does it grant any rights with respect to any technology associated with the Remodulin Implantable System being developed by the Company and Medtronic Inc., or the pre-filled semi-disposable pump system being developed by the Company and DEKA Research & Development Corp. The Settlement Agreement does not grant Sandoz any rights other than those required to launch Sandoz's generic version of Remodulin. In accordance with the Settlement Agreement, the parties will submit the Settlement Agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review.
September 29, 2015
16:00 EDTGILDOptions Update; September 29, 2015
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11:11 EDTGILDStocks with call strike movement; CELG GILD
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09:35 EDTGILDActive equity options trading on open
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September 28, 2015
16:00 EDTGILDOptions Update; September 28, 2015
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15:22 EDTGILDGilead volatility at 52-week high
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09:36 EDTGILD Active equity options trading on open
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07:52 EDTBAYRYIIR Holdings to hold a conference
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07:38 EDTDNABox to hold a user conference
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07:27 EDTDNAFDA and the Parental Drug Association to co-host a conference
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September 27, 2015
17:29 EDTTHORThoratec reports HeartMate 3 CE Mark trial met primary endpoint
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14:20 EDTBAYRYBayer says receives FDA approval for Betaconnect autoinjector
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September 25, 2015
16:35 EDTGILDStocks end week lower as biotechs sink, Volkswagen crashes
Stocks ended the week lower after concerns about drug prices were reignited, sinking biotech stocks, an emissions scandal engulfed Volkswagen (VLKAY), dragging down shares of automakers and their suppliers, and Caterpillar (CAT) announced that it may eliminate as many as 10,000 jobs in the next three years as commodity prices continue to slump. MACRO NEWS: Following the Federal Reserve's decision last week to wait before raising rates, the central bank made a concerted effort to give the market more clarity this week. Over last weekend, three Federal Reserve officials - San Francisco Fed President John Williams, St. Louis Fed President James Bullard and Richmond Fed President Jeffrey Lacker - all argued that an interest-rate increase is still warranted this year. Then, on Thursday night, Fed Chair Janet Yellen said during a speech at UMass Amherst that the central bank remains inclined to hike rates this year. Yellen's remarks were incrementally hawkish, but welcomed by the market, since they helped clarify the message the Fed delivered a week ago... In the U.S., Markit's flash manufacturing purchasing manager's index was flat at 53.0 in September, which was slightly better than the expectation for it to dip to 52.8. Durable goods orders for August declined 2.0%, versus expectations for a drop of 2.3%. When transportation items were removed, the core reading was breakeven, versus expectations for a rise of 0.1%. The third estimate of second quarter GDP showed the economy grew 3.9% quarter-over-quarter, versus expectations for the GDP growth estimate to stay at 3.7%. Personal consumption in Q2 is now believed to have grown 3.6%, up from the prior estimate of 3.1%. The final University of Michigan consumer sentiment reading for September came in at 87.2, which was down from August's 91.9 but above the expected 86.2 reading... The Asian Development Bank cut its growth forecast for the region, citing a weaker outlook for China and India and a delayed recovery in the world's advanced economies. The bank now sees the Chinese economy growing 6.8% this year and 6.7% next year, down from its previous forecasts of 7.2% and 7%, respectively. Markit's flash manufacturing PMI for China fell to 47.0 in September from 47.3 last month. Meanwhile, Japanese Prime Minister Shinzo Abe unveiled new economic targets, including a goal for a 20% increase in the target size of the Japanese economy to 600T yen, though he gave no timeframe for achieving this aspiration... In Europe, Markit's composite PMI for the eurozone came in at 53.9 in the first look for September, down from 54.3 in August and below expectations for a reading of 54.1. COMPANY NEWS: Biotech stocks declined after privately-held Turing Pharmaceuticals made headlines by enacting a 5,000% price increase on its treatment for toxoplasmosis, reigniting a debate around drug prices that previously embroiled costly Hepatitis C drugs including AbbVie's (ABBV) Viekira Pak and Gilead's (GILD) Sovaldi and Harvoni. Presidential candidate Hillary Clinton sent the debate to center stage by criticizing the "outrageous" prices of specialty drugs and laying out a plan to tackle "price gouging" in the specialty drug market. The NASDAQ Biotechnology index fell roughly xxx% for the week amid the attention paid to Turing's drug and Clinton's response... Volkswagen (VLKAY) shares trading in New York fell sharply to begin the week and ended the week far from where they'd been last Friday before the EPA said it found manipulations that violate U.S. environmental standards while testing certain of the automaker's diesel cars. The EPA said Volkswagen may face civil penalties of $37,500 for each vehicle not in compliance with federal clean air rules, which could total as much as $18B, according to Reuters. In the wake of the scandal, Chief Executive Officer Martin Winterkorn resigned, with the company's supervisory board subsequently praising the decision and selecting Matthias Mueller, the former head of Porsche (POAHY), as Winterkorn's successor as the company's new CEO... Caterpillar (CAT) shares dropped after the heavy machinery maker announced plans for job cuts and lowered its revenue guidance for this year and next. Caterpillar said that it would lay off 4,000-5,000 of its employees between now and the end of 2016 and could lay off up to 10,000 employees by 2018. Caterpillar cut its fiscal year 2015 revenue forecast by $1B and said its sees its fiscal year 2016 revenue to be 5% below this year, adding that it expects revenue declines in all three large segments next year... Online and mobile deal provider Groupon (GRPN) said it plans to cut 1,100 jobs relating primarily to the company's international operations... Nike jumped after the athletic gear giant reported better than expected earnings and futures orders, prompting numerous price target hikes and at least one upgrade at Street research firms. Among other companies reporting earnings this week, BlackBerry (BBRY), ConAgra (CAG), Carnival (CCL), and CarMax (KMX) fell immediately following their quarterly reports... Apple (AAPL), which has previously been reported to be working on an electric car via its "Project Titan," is speeding up those efforts and setting 2019 as a target to ship its first vehicle, according to The Wall Street Journal... Against the backdrop of China's President Xi Jinping visiting the U.S., Boeing (BA) announced deals to sell 300 planes to three Chinese companies and set up an aircraft factory in in the Asian nation, while Cisco (CSCO) announced a partnership with Chinese server maker Inspur Group... Lloyd Blankfein, Goldman Sachs (GS) Chairman and CEO, disclosed that he was diagnosed with lymphoma. "Fortunately, my form of lymphoma is highly curable and my doctors' and my own expectation is that I will be cured," Blankfein stated in an open letter that was shared by the bank... GoPro (GPRO) finished the week about xxx% lower after Barron's contended in a feature article last weekend that the company's stock could plunge another 30% to $25 as Apple, Sony (SNE) and others pressure the company's "one-hit wonder" products... On the M&A front, Atmel (ATML) agreed to be acquired by German chipmaker Dialog Semiconductor in a deal valued at roughly $4.6B and Starwood Waypoint (SWAY) announced a stock-for-stock merger agreement with Colony American Homes. INDEXES: The Dow lost about 0.43% to close at 16,314.67, the S&P 500 fell about 1.35% to close at 1,931.34, and the Nasdaq declined about 2.89% to close at 4,686.50.
09:07 EDTBAYRYBayer says Eylea recommended for EU approval in additional indication
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07:34 EDTGILDGilead says CHMP adopts poistive opinion for single tablet regimen Genvoya
Gilead Sciences announced that the Committee for Medicinal Products for Human Use has adopted a positive opinion on the company's Marketing Authorization Application for the investigational, once-daily single tablet regimen Genvoya for the treatment of HIV-1 infection. The data submitted in the MAA support the use of the regimen among adult and adolescent treatment-naive individuals, virologically suppressed adults who switch regimens and adults with mild-to-moderate renal impairment. The CHMP's recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for use in the 28 countries of the European Union. If authorized, Genvoya would be Gilead's first single tablet regimen to contain TAF. The MAA for Genvoya is supported by 48-week data from two pivotal Phase 3 studies in which the regimen met its primary objective of non-inferiority compared to Gilead's Stribild among treatment-naive adult patients. In the studies, Genvoya demonstrated improvement in surrogate laboratory markers of renal and bone safety as compared to Stribild. The MAA is also supported by data from additional Phase 3 studies evaluating the TAF-based regimen among adolescents, virologically suppressed adult patients who switched to Genvoya and adult patients with mild-to-moderate renal impairment.
07:22 EDTBAYRY, UTHREuropean Society for Medical Oncology to hold a conference
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06:12 EDTBAYRYFDA panel excoriates Bayer for Essure contraceptive device, NY Times reports
A panel of experts collected by the FDA criticized Bayer for manufacturing a contraceptive device, Essure, without collecting data that they say could have helped anticipate risks for women, the New York Times reports. The device has received thousands of complaints from women claiming they were hurt by it, the report says. Reference Link
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