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Stock Market & Financial Investment News

News Breaks
May 12, 2014
04:55 EDTCMRX, CMRX, CMRX, CMRX, CMRX, CMRX, PFE, PFE, PFE, PFE, PFE, PFE, GILD, GILD, GILD, GILD, GILD, GILD, GSK, GSK, GSK, GSK, GSK, GSK, BMY, BMY, BMY, BMY, BMY, BMY, RHHBY, RHHBY, RHHBY, RHHBY, RHHBY, RHHBY, AZN, AZN, AZN, AZN, AZN, AZN, SRPT, SRPT, SRPT, SRPT, SRPT, SRPTInternational Society for Antiviral Research to hold a conference
27th International Conference on Antiviral Research to be held in Raleigh, North Carolina on May 12-17.
News For CMRX;PFE;GILD;GSK;BMY;RHHBY;AZN;SRPT From The Last 14 Days
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August 24, 2015
08:01 EDTPFEPfizer receives clearance from FTC for Hospira acquisition
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07:08 EDTBMYBristol-Myers upgraded to Neutral from Underweight at Piper Jaffray
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06:50 EDTSRPTSarepta upgraded to Overweight from Neutral at Piper Jaffray
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05:13 EDTAZNAstraZeneca to collaborate with Peregrine on cancer immunotherapy clinical trial
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August 23, 2015
12:35 EDTPFE, RHHBY, BMY, AZNBiotech firms could see 'billions' in sales from new cancer drugs, Barron's says
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August 21, 2015
10:36 EDTSRPTOptions with increasing implied volatility
Options with increasing implied volatility: PTCT UVXY VIX VXX SVXXY SRPT TZA UPRO VNR SPXU
09:38 EDTRHHBYUBS global healthcare analysts hold an analyst/industry conference call
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08:32 EDTSRPTSarepta says FDA grants rare pediatric disease designation for Eteplirsen
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08:01 EDTPFEPfizer says two Phase 3 Trumenba studies met primary endpoints
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05:25 EDTGSKNovartis acquires all remaining rights to Ofatumumab from GSK
Novartis (NVS) announced that it has entered into an agreement to acquire all remaining rights to Ofatumumab from GlaxoSmithKline (GSK). Ofatumumab, a fully human monoclonal antibody which targets CD20, is being developed for relapsing remitting multiple sclerosis, or RRMS, and other autoimmune indications. Novartis previously acquired the rights to Ofatumumab for oncology indications and it is marketed under the brand name Arzerra. Novartis will be responsible for the worldwide development, regulatory and commercialization activities for Ofatumumab. Under the terms of the agreement, Novartis will make an initial upfront payment of $300M to GSK for the acquisition of the compound and a further payment of $200M payable following the start of a phase III study in MS by Novartis. Upon completion of pre-determined milestones, contingent payments of up to $534M may be made. Novartis will also pay royalties of up to 12% to GSK on any future net sales of Ofatumumab in autoimmune conditions.
August 20, 2015
16:34 EDTGILDGilead MAA for HIV regimen has been fully validated by EMA
Gilead Sciences announced that the company's Marketing Authorization Application, MAA, for an investigational, once-daily single tablet regimen that combines emtricitabine 200 mg, tenofovir alafenamide 25 mg and rilpivirine 25 mg has been fully validated and is now under evaluation by the European Medicines Agency, EMA. Emtricitabine and tenofovir alafenamide are marketed by Gilead Sciences and rilpivirine is marketed by Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson. The data included in the application support the use of R/F/TAF for the treatment of HIV-1 infection in adults and pediatric patients 12 years and older. "With this validation, R/F/TAF is now the third TAF-based filing under review by the EMA as we advance a portfolio of new treatment options that may offer high efficacy and favorable safety profiles," said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. "The R/F/TAF filing also represents the next step in our collaboration with Janssen to develop HIV treatments that potentially meet the diverse needs of people living with HIV."
11:49 EDTSRPTOptions with increasing implied volatility
Options with increasing implied volatility: SRPT ACHN VIAV ZG RAD DIS ORCL SPY XLF OEX
11:33 EDTAZNLeerink major pharmaceuticals analyst holds an analyst/industry conference call
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11:24 EDTPFEPfizer says Ibrance application validated by EMA
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09:23 EDTAZNAdvaxis, MedImmune begin enrollment in axalimogene filolisbac Phase I/II study
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06:01 EDTBMYBristol-Myers announces Canadian approval of Daklinza
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August 19, 2015
13:25 EDTCMRXPatient with Ebola-like symptoms rushed to NYC hospital, NY Post reports
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09:17 EDTSRPT'Female Viagra' approval seen as positive for Sarepta, BioMarin
The FDA's approval of the world's first drug designed to boost a woman's sexual desire is seen as boding well for companies awaiting critical decisions by the agency. FEMALE VIAGRA: The Food and Drug Administration yesterday approved flibanserin to treat acquired, generalized hypoactive sexual desire disorder in premenopausal women. The drug, which will be sold under the name "Addyi" and is commonly referred to as the "female Viagra," is the first FDA-approved treatment for sexual desire disorders in men or women, the agency prominently stated in its press release. HSDD is characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to a co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance, the FDA explained. Addyi was approved with a risk evaluation and mitigation strategy as well as a Boxed Warning given the risk of severe hypotension and syncope in patients who drink alcohol during treatment. The drug is made by privately held Sprout Pharmaceuticals. ANALYST REACTION: Addyi's approval is "another sign of flexibility" by the FDA, especially for first-in-class therapies, Roth Capital analyst Debjit Chattopadhyay writes this morning in a note to investors. This bodes well for the approval of eteplirsen, drisapersen and Translarna, the analyst contends. Eteplirsen, designed by Sarepta Therapeutics (SRPT), and drisapersen, designed by BioMarin (BMRN), are experimental drugs being developed to treat Duchenne muscular dystrophy. Translarna, designed by PTC Therapeutics (PTCT), is already being sold in Europe as a treatment for DMD and is awaiting approval from the FDA. Duchenne muscular dystrophy is a form of muscular dystrophy affecting around 1 in 3,600 boys, which results in muscle degeneration and premature death. SAVING LIVES: While female sexual dysfunction is a clinical problem, eteplirsen is designed to save lives, Chattopadhyay points out. He has a Buy rating on Sarepta and noted his price target of $45 assumes accelerated approval for eteplirsen in the first quarter of 2016. Shares of the Massachusetts-based biopharmaceutical company closed yesterday at $35.69.
08:29 EDTSRPTFlibanserin approval bodes well for Sarepta, others, says Roth Capital
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05:46 EDTBMYStocks with implied volatility movement; ESRX BMY
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