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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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September 1, 2015
07:31 EDTABBVBristol-Myers, AbbVie say FDA accepts BLA for Empliciti for priority review
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August 31, 2015
14:00 EDTABBVAbbVie September calls active
AbbVie September 65 and 67.5 calls are active on total call volume of 37K contracts (9K puts). September weekly call option implied volatility is at 37, September is at 36, October is at 31; compared to its 52-week range of 18 to 36. Active call volume suggests traders taking positions for price movement.
August 25, 2015
19:34 EDTABBVExperts tell White House to expand use of Hepatitis C drugs, NYT says
Health care experts from the Public Health Service and the Advisory Council on H.I.V./AIDS have recommended that Medicaid officials expand the use of costly Hepatitis C drugs including AbbVie's (ABBV) Viekira Pak and Gilead's (GILD) Sovaldi and Harvoni, reports the New York Times, citing correspondence sent to the White House. The advisory council said current usage limitations on the drugs are "unreasonable," but it also suggested that manufacturers disclose drug development costs in the face of the significant price tags on modern Hepatitis C treatments. Reference Link
09:03 EDTABBVAcorda has major overhang removed by IPR denials, says Leerink
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August 19, 2015
06:09 EDTABBVUnited Therapeutics agrees to sell PPRV to AbbVie for $350M
United Therapeutics (UTHR) announced that it has entered into an agreement to sell its Rare Pediatric Disease Priority Review Voucher, or PPRV, to a subsidiary of AbbVie (ABBV). United Therapeutics received the PPRV when Unituxin was approved by the FDA for the treatment of neuroblastoma, a rare pediatric disease. Upon closing of the transaction, United Therapeutics will receive $350M in cash in exchange for the PPRV. The voucher was awarded by the FDA under a provision that encourages development of new drugs and biologics for the prevention and treatment of rare pediatric diseases.
05:57 EDTABBVAbbVie implied volatility of 20 at lower end of index mean range

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