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News For MYL;NVS;RBXLY From The Last 14 Days
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October 7, 2015
07:23 EDTNVSEuropean Committee Treatment & Research in Multiple Sclerosis holds meeting
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October 6, 2015
13:32 EDTNVSBiotechs plummet with TPP seen as industry negative
Biotechs are falling intraday after reports that the Trans-Pacific Partnership, or TPP, has language that the exclusivity period for bioligics, or drugs derived from a biological sources, would be eight years, less than the twelve years it is currently in the United States. WHAT'S NOTABLE: In the U.S., biologics are protected from competition by follow-on products for twelve years from the time they are first granted marketing approval by the U.S. Food and Drug Administration, a protection that is distinct from patent protection. Recent reports on the TPP suggest that the protection will last five years with an additional safety monitoring period of up to three years before a biosimilar can be registered, which would effectively be an eight year exclusivity period. ANALYST REACTION: Piper Jaffray analyst Joshua Schimmer, however, said the development is a "step forward," especially since it does not overrule the 12 years' exclusivity for the drugs in the U.S. While the sector asked for twelve years' exclusivity to match the U.S., eight years is a "reasonable compromise," the analyst argued. His top picks were Alexion (ALXN), Celgene (CELG), and Amgen (AMGN) in the large-cap space, GW Pharmaceuticals (GWPH) and bluebird bio (BLUE) among mid-caps, and Flex Pharma (FLKS), Lion Biotechnologies (LBIO), Otonomy (OTIC), and Ignyta (RXDX) in the small-cap sector. Further, Schimmer stated that more names look "increasingly compelling" amid the selloff. NOTABLE DECLINERS: Alexion is lower by 2.53%, Celgene is down 4.32%, Amgen is declining 1.91%, Biogen (BIIB) is down 3.4%, and Gilead Sciences (GILD) is falling 2.22%. STOCKS TO WATCH: Other publicly traded companies in the pharmaceutical space include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY).
October 5, 2015
10:02 EDTMYLBofa/Merrill healthcare analysts hold an analyst/industry conference call
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05:25 EDTNVSAlcon receives FDA approval for AcrySof IQ Aspheric IOL
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October 1, 2015
11:06 EDTNVSXOMA price target raised to $1.50 from $1 at Piper Jaffray
Piper Jaffray analyst Edward Tenthoff raised his price target for XOMA (XOMA) to $1.50 after the company partnered a preclinical TGF-beta antibody with Novartis (NVS) for $37M upfront and up to $480M in milestones. The payment brings XOMA's pro forma cash to $88M, enabling the company to advance its endocrine antibody pipeline, including lead candidate XOMA 358 for hyperinsulinism disorders, Tenthoff tells investors in a research note. The analyst keeps a Neutral rating on the name. The stock is up 20c to 95c in early trading.
07:37 EDTNVSXOMA announces agreement for anti-TGFb program with Novartis
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September 30, 2015
17:04 EDTNVSNovartis says results of Phase 3 study of secukinumab met endpoints
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14:58 EDTMYLMylan volatility at 52-week high
Mylan October weekly put option implied volatility is at 70, October is at 57, November is at 54; compared to its 52-week range of 26 to 58, suggesting large price movement.
11:06 EDTMYLStocks with call strike movement; FSLR MYL
First Solar (FSLR) January 50 call option implied volatility decreased 5% to 47, Mylan (MYL) January 47 call option implied volatility increased 4% to 48 according to IVolatility.
September 29, 2015
12:35 EDTMYL, NVSPerrigo shareholders pressure company to explore sale, Reuters says
Certain Perrigo (PRGO) shareholders have requested that company explore a sale, hoping for an alternative to Mylan's (MYL) approximately $25B hostile bid, Reuters reports, citing people familiar with the matter. The pressure represents a challenge to Perrigo's defense strategy, the report says. Some of the company's shareholders view Novartis (NVS), Sanofi (SNY), Procter & Gamble (PG), and Colgate-Palmolive (CL) as potential suitors, the report says. Reference Link
08:46 EDTNVSNoven reports final decisions in IPRs challenging Novartis' Exelon patch patents
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September 28, 2015
12:22 EDTNVSArray says binimetinib-encorafenib combo shows differentiated tolerability
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07:58 EDTNVSNovartis to hold a conference call
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07:31 EDTMYLMylan launches generic Invega tablets
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07:27 EDTMYLFDA and the Parental Drug Association to co-host a conference
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September 27, 2015
18:48 EDTNVSNovartis reports updated Phase 3 data on Tafinlar-Mekinist for melanoma
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16:16 EDTNVSNovartis reports Phase 3 reults on Afinitor for neuroendocrine tumors
Novartis announced results of a Phase 3 pivotal study showing Afinitor, or everolimus, tablets reduced the risk of progression by 52% versus placebo in patients with advanced, progressive, nonfunctional neuroendocrine tumors of gastrointestinal or lung origin. Additionally, the data show everolimus, a mammalian target of rapamycin inhibitor, extended median progression free survival by 7.1 months. Median PFS by central review was 11 months in the everolimus arm and 3.9 months in the placebo arm. Overall survival was a key secondary endpoint of the trial. While the OS data are not mature, the first interim analysis showed a trend favoring the everolimus arm, according to Novartis. Additional analyses are planned. Another secondary endpoint was best overall response rate. The study found that 64% of patients receiving everolimus experienced at least some degree of tumor shrinkage compared to 26% of those on placebo. Adverse events were consistent with the known safety profile of everolimus. The results of the RADIANT-4 study will serve as the basis of worldwide regulatory submissions for Afinitor for the treatment of advanced, progressive, nonfunctional GI and lung NET, Novartis said.
September 25, 2015
13:51 EDTMYLBMO's pharma predictions for rest of year include take on Mylan, Perrigo
BMO Capital analyst David Maris rolled out his rest of year predictions for the Specialty Pharmaceuticals space. Among them is his belief that Mylan (MYL) will be unsuccessful in acquiring Perrigo (PRGO). Perrigo will either be acquired by another company or make an acquisition itself, Maris tells investors in a research note. His other predictions include Jazz Pharmaceuticals (JAZZ) proving to be a good buying opportunity amidst the current negative sentiment and ZS Pharma (ZSPH) offering upside following the recent pullback given the potential for a near-term buyout and prospects for its "best in class drug for hyperkalemia" winning approval in 2016.
07:22 EDTNVSEuropean Society for Medical Oncology to hold a conference
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05:15 EDTNVSNovartis announces CHMP adopted positive opinion for Entresto
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