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April 16, 2013
11:36 EDTGSK, RHHBY, BIIBAppeals court upholds ruling in patent suit between Glaxo, Biogen
Biogen Idec (BIIB) and Roche's (RHHBY) Genentech unit appealed a district court’s construction of a disputed claim term, “anti-CD20 antibody,” that narrowed the term in their patent dispute with GlaxoSmithKline (GSK). An appeals court concluded that "the district court did not err in finding a clear and unmistakable disclaimer" and affirmed the lower court's decision. Reference Link
News For BIIB;RHHBY;GSK From The Last 14 Days
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September 30, 2015
17:48 EDTRHHBYPacific Biosciences launches new sequencing platform
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12:41 EDTGSKGlaxoSmithKline exercises option for Liquidia Technologies' inhaled therapeutics
Liquidia Technologies announced that GlaxoSmithKline has exercised its option under a Collaboration and Option Agreement signed in 2012 to exclusively license the right to research, develop, and commercialize inhaled therapeutics derived from the company's proprietary PRINT technology. Through this collaboration, Liquidia and GSK will continue to work together with the goal of advancing inhaled therapeutics into clinical studies. According to the agreement signed in June 2012, Liquidia was granted an upfront payment comprised of cash and equity, R&D funding, and potential development milestones and royalties. As a result of the GSK decision to exercise the option, Liquidia will receive an option fee, continued R&D funding, and potential product-based development and regulatory milestone payments. Liquidia has also retained the ability to independently develop an inhaled treatment for a particular disease field.
11:39 EDTBIIBStocks with call strike movement; BIIB HAL
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September 29, 2015
12:33 EDTBIIBOn The Fly: Top stock stories at midday
Stocks on Wall Street were slightly higher at midday as the market seeks to break its losing streak, helped by an improvement in consumer confidence that came despite the recent market volatility. ECONOMIC EVENTS: In the U.S., consumer confidence unexpectedly rose in September. Analysts expected the consumer confidence reading to pull back to 96.8 from the prior 101.5 figure, but it actually strengthened to 103.0. The S&P/Case-Shiller 20-city composite home price index was up a seasonally adjusted 0.2% month over month in July, versus the consensus forecast for a rise of 0.1%. Stocks sold off in much of Asia last night, with China's Shanghai composite index sliding 2% while Japan's Nikkei dropped 4%, erasing year-to-date gains in the process. COMPANY NEWS: Shares of Yahoo (YHOO) advanced 3% after its board authorized the company to continue to pursue its spin-off of Aabaco Holdings, a newly formed independent registered investment company that will hold all of Yahoo's remaining holdings in Alibaba Group (BABA). MAJOR MOVERS: Among the notable gainers was Radius Health (RDUS), which rose nearly 10% after Ben Harrington of the Betaville blog stated during an appearance on Tip TV that he has heard that "something will be happening" in terms of M&A involving the company over the "next few weeks." Also higher were several recently beaten down biotech stocks that were seeing some bounceback, including Vertex Pharmaceuticals (VRTX), which gained 5%, and Biogen (BIIB), which advanced 4%. Notably, both of them, along with Amgen (AMGN), were mentioned in a note to investors by Cowen analyst Ken Cacciatore as "hypothetical" targets for Allergan (AGN). Among the noteworthy losers was OvaScience (OVAS), which dropped 38% after saying it now longer expects to meet its 2015 goal of 1,000 Augment cycles. Esperion (ESPR) also fell 38% after the company warned that the FDA could require it to undertake new studies before its ETC-1002 is approved. INDEXES: Near midday, the Dow was up 7.27, or 0.05%, to 16,009.16, the Nasdaq was up 7.38, or 0.16%, to 4,551.35, and the S&P 500 was up 4.56, or 0.24%, to 1,886.33.
08:57 EDTBIIBCowen lists Vertex, Biogen and Amgen as hypothetical Allergan targets
Cowen analyst Ken Cacciatore noted that the price agreed for Allergan's (AGN) generic divestiture to Teva (TEVA) is fixed and that the cash value from this deal has not depreciated in any way while the corresponding valuations of potential targets have corrected, increasing the potential value creation available for Allergan as it decides how to deploy its capital. To illustrate the value creation that Allergan's capital deployment could generate, Cacciatore estimates the type of accretion potential that might be seen if the company were to buy Vertex with an acquisition price of $36.5B, if it were to acquire Biogen (BIIB) at a price of $91B or if it were to purchase Amgen (AMGN) with an acquisition price of $140B. Although the market correction has lowered Allergan's stock, the decline could be viewed as a near-term positive, given that a key component of its strategy and business model is to seek to aggressively deploy its capital, Cacciatore argues in a note to investors. The analyst keeps an Outperform rating and $400 price target on Allergan shares.
06:06 EDTBIIBBiogen volatility at 52-week highs
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September 28, 2015
10:43 EDTRHHBYRoche to hold an analyst briefing with a conference call hookup
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07:52 EDTRHHBY, GSKIIR Holdings to hold a conference
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05:35 EDTBIIBBiogen implied volatility of 52 at upper end of index mean range
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05:15 EDTRHHBYGenentech announces Phase III study of ocrelizumab met primary endpoint
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September 27, 2015
17:02 EDTRHHBYNewLink Genetics reports early Phase 1a data on GDC-0919
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16:58 EDTGSKGlaxoSmithKline, Theravance report Phase 3 data on Anoro Ellipta for COPD
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16:42 EDTRHHBYRoche present Phase 2 results on atezolizumab for urothelial cancer
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16:40 EDTRHHBYRoche reports results from two Phase 2 studies on atezolizumab
Genentech, a member of the Roche Group, announced results from two Phase 2 studies that evaluated the investigational cancer immunotherapy atezolizumab -- or anti-PDL1; MPDL3280A -- in people with advanced non-small cell lung cancer. In the randomized Phase 2 study POPLAR, atezolizumab met its primary endpoint and showed a statistically significant survival benefit compared to chemotherapy in people with recurrent NSCLC whose tumors expressed medium and high levels of PD-L1, which corresponded with people living 7.7 months longer than people who received docetaxel chemotherapy. A separate, single-arm Phase 2 study, BIRCH, met its primary endpoint and showed that atezolizumab shrank tumors in up to 27% of people whose disease had progressed on prior medicines and also expressed the highest levels of PD-L1. Median survival had not yet been reached. In both studies of atezolizumab, adverse events were consistent with those observed in previous studies. "We plan to submit these results to global health authorities to bring this potential new option to people as soon as possible," said Chief Medical Officer Sandra Horning.
September 25, 2015
12:38 EDTBIIBOptions with increasing implied volatility
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07:55 EDTBIIBBiogen, Sobi receive position opinion for Elocta from CHMP
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07:42 EDTRHHBYExelixis: CHMP adopts positive opinion for cobimetinib, vemurafenib combination
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07:32 EDTBIIBBiogen, Sobi receive positive CHMP opinion for Elocta for Hemophilia A
Biogen and Swedish Orphan Biovitrum AB received a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use for the marketing authorization of ELOCTA. ELOCTA is a recombinant factor VIII Fc fusion protein product for the treatment of hemophilia A that, if approved, would be the first hemophilia A treatment with prolonged circulation available in the European Union. The positive opinion was based on results from the pivotal, Phase 3 A-LONG clinical study, which examined the efficacy, safety and pharmacokinetics of rFVIIIFc in previously treated males 12 years of age and older with severe hemophilia A, and from the Phase 3 Kids A-LONG clinical study, which evaluated the efficacy and safety of rFVIIIFc in previously treated male children with hemophilia A under 12 years of age. The Committee's positive opinion is now referred to the EC, which grants marketing authorization for medicines in the EU. ELOCTA is the European trade name for rFVIIIFc, which is also known as ELOCTATE in the U.S., Canada, Australia, New Zealand and Japan, where it is approved for the treatment of hemophilia A. Commonly reported adverse drug reactions in the clinical studies were arthralgia, malaise, myalgia, headache and rash. Development of Factor VIII neutralizing antibodies may occur following administration of ELOCTA. Biogen and Sobi are collaboration partners in the development and commercialization of ELOCTA/ELOCTATE for hemophilia A. Last year, Sobi exercised its opt-in right to assume final development and commercialization of ELOCTA in the Sobi territories. Biogen leads development for ELOCTA/ELOCTATE, has manufacturing rights, and has commercialization rights in North America and all other regions in the world excluding the Sobi territories.
07:22 EDTRHHBYEuropean Society for Medical Oncology to hold a conference
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06:23 EDTRHHBYRoche CEO: Will see growth regardless of setbacks, Reuters reports
Roche Holding's product lineup is so good that the company will see growth regardless of setbacks, Reuters reports, citing an interview with CEO Severn Schwan with Finanz und Wirtschaft. "Roche could have six new active pharmaceutical ingredients approved within two years. We never had this before," Schwan said. Reference Link
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