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News Breaks
June 17, 2014
05:40 EDTENTA, ABBVAbbVie announces EMA validation of MMAs for GT1 HCV treatment
AbbVie (ABBV) and Entana Pharmaceuticals (ENTA) announced that the Marketing Authorization Applications, or MAAs, for its investigational, all-oral, interferon-free regimen for the treatment of adult patients with chronic genotype 1, or GT1, hepatitis C virus, or HCV, infection have been validated and are under accelerated assessment by the European Medicines Agency, or EMA. Accelerated assessment, which is designated to new medicines of major public health interest, was granted by the EMA for AbbVie's investigational HCV regimen in May. Validation of the MAAs confirms that the submissions are complete and starts the EMA's centralized review process. If approved, AbbVie's regimen could be available for marketing in the European Union in 1Q15. The MAAs were submitted on May 8 and are supported by data from a large clinical program including six Phase III studies of more than 2,300 GT1 patients in over 25 countries. Review of the MAAs will be conducted under the centralized licensing procedure, which, when finalized, provides marketing authorizations in all 28 member states of the EU. On June 13, AbbVie announced that the New Drug Application for AbbVie's regimen was accepted and granted priority review by the FDA.
News For ABBV;ENTA From The Last 14 Days
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May 26, 2015
19:16 EDTENTA, ABBVEnanta says may receive $30M milestone payment from AbbVie upon Japan approval
In reference to the release of GIFT-1 study data, Enanta (ENTA) stated that upon commercialization regulatory approval [sic] in Japan of AbbVie's (ABBV) treatment regimen related to GIFT-1, Enanta will be entitled to a $30M milestone payment from AbbVie. In addition, Enanta will be eligible to receive annually tiered royalties, ranging from the low double digits up to 20%, on AbbVies aggregate net sales of all paritaprevir-containing regimens, including 45% of AbbVies worldwide net sales of any two direct-acting antivirals regimen.
19:07 EDTENTA, ABBVAbbVie presents phase 3 GIFT-I data, says achieved primary endpoint
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10:46 EDTABBVAnthem sued for denying coverage for Gilead's Harvoni, WSJ says
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08:32 EDTABBVAbbVie completes acquisition of Pharmacyclics
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08:03 EDTABBVInfinity Pharmaceuticals reports preclinical data for duvelisib
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May 22, 2015
08:00 EDTABBVAbbVie announces expiration of HSR waiting period for Pharmacyclics acquisition
AbbVie (ABBV) announced that the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 for AbbVie's purchase of Pharmacyclics (PCYC) has expired today. The expiration satisfies the exchange offer condition with respect to the approvals and clearances required under antitrust laws. Assuming that the other customary exchange offer conditions are satisfied, including a minimum tender of at least a majority of outstanding Pharmacyclics shares, it is expected that the exchange offer to acquire all of the outstanding shares of common stock of Pharmacyclics will expire today at 5:00 p.m., New York City time, without any further extension.
May 21, 2015
08:04 EDTABBVAbbVie announces offer consideration for acquisition of Pharmacyclics
AbbVie (ABBV) announced the per share offer consideration amounts pursuant to its previously announced offer to acquire each outstanding share of common stock of Pharmacyclics (PCYC) for a mix of cash and AbbVie common stock, as described in the Registration Statement on Form S-4 filed with the SEC by AbbVie on March 23, 2015, as amended. The mixed consideration will consist of $152.25 in cash and 1.6639 shares of AbbVie common stock and, subject to proration, the all-stock consideration will consist of 3.9879 shares of AbbVie common stock.
07:58 EDTABBVDeutsche sees AbbVie shares getting to $80 over summer
Deutsche Bank sees pipeline readouts over the summer pushing shares of AbbVie to $80. The firm keeps a Buy rating on the stock with an $80 price target after meting with management.
07:37 EDTABBVPfizer replaces AbbVie as top global pharma pick at Jefferies
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May 20, 2015
09:07 EDTABBVJohnson & Johnson says exploring eight new indications for Imbruvica
Imbruvica is jointly developed and commercialized by Pharmacyclics (PCYC) and Johnson & Johnson (JNJ) subsidiary Janssen Biotech. AbbVie (ABBV) is in the process of acquiring Pharmacyclics.
07:21 EDTABBVUBS to hold a conference
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May 19, 2015
08:57 EDTABBVLeerink biotech analyst holds an analyst/industry conference call
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May 18, 2015
15:07 EDTENTAEnanta management to meet with JPMorgan
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May 15, 2015
16:46 EDTABBVAbbVie extends exchange offer to acquire Pharmacyclics
AbbVie (ABBV) announced that it has extended the expiration of its exchange offer to acquire all of the outstanding shares of common stock of Pharmacyclics (PCYC) to 5 p.m., New York City time, on May 22. The depositary of the exchange offer has advised that, as of 4:00 p.m., New York City time, on May 15, a total of approximately 42,822,941 shares of Pharmacyclics common stock were validly tendered and not properly withdrawn in the exchange offer. All other terms and conditions of the exchange offer remain unchanged.
10:29 EDTABBVAmerican Urological Association to hold an annual meeting
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09:45 EDTABBVAbbVie reports FDA orphan designation for Humira in treatment of HS
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May 14, 2015
13:12 EDTABBVAbbVie granted orphan status for Humira
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10:41 EDTABBVAnalysts upbeat on Amgen's Kyprolis after ASCO abstracts
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09:09 EDTABBVBristol-Myers down 1.3% after release of ASCO abstracts
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May 13, 2015
13:12 EDTABBVSen. Sanders urges VA to break patents on Gilead hepatitis C drugs
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