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March 29, 2012
13:55 EDTBAX, BAX, BAYRY, BAYRY, BIIB, BIIB, PBTH, PBTH, NVO, NVOLeerink's biotech analyst holds an analyst/industry conference call
Biotech Analyst Schimmer discusses the outlook for long-acting factor replacements in hemophilia on an Analyst/Industry conference call. Relevant covered companies BAX, BAYRY, BIIB, PBTH and NVO may be included on the Analyst/Industry conference call to be held on March 29 at 2 pm.
News For BAX;BAYRY;BIIB;PBTH;NVO From The Last 14 Days
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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
07:52 EDTBAYRY, NVOIIR 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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September 27, 2015
14:20 EDTBAYRYBayer says receives FDA approval for Betaconnect autoinjector
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September 25, 2015
18:59 EDTNVONovo Nordisk confirms FDA approval of Tresiba
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14:52 EDTNVONovo Nordisk gets FDA approval for diabetes mellitus treatments
The U.S. FDA announced that it approved Tresiba and Ryzodeg 70/30 to improve blood sugar control in adults with diabetes mellitus. Tresiba is a long-acting insulin analog indicated to improve glycemic control in adults with type 1 and 2 diabetes mellitus. Ryzodeg 70/30 is a mixture of insulin degludec, a long-acting insulin analog, and insulin aspart, a rapid-acting human insulin analog. It is indicated to improve glycemic control in adults with diabetes mellitus. Tresiba and Ryzodeg are manufactured by Novo Nordisk.
14:51 EDTNVONovo Nordisk gets FDA approval for diabetes mellitus treatments
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12:38 EDTBIIBOptions with increasing implied volatility
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09:07 EDTBAYRYBayer says Eylea recommended for EU approval in additional indication
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07:55 EDTBIIBBiogen, Sobi receive position opinion for Elocta from CHMP
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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 EDTBAYRYEuropean 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
September 24, 2015
07:45 EDTBAYRYFDA Obstetrics and Gynecology Devices Panel to hold a meeting
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September 23, 2015
10:24 EDTBIIBOptions with increasing implied volatility
Options with increasing implied volatility: SNCR PTCT SRPT AMZN CREE CMG ISRG QLIK SNKD BIIB JNPR
09:55 EDTBIIBActive calls on open: BIIB FCX X F INTC
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09:33 EDTBIIBActive equity options trading on open: AAPL BBRY BIDU BIIB
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07:53 EDTBAXUBS medical supplies & devices analyst holds an analyst/industry conference call
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