New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
June 17, 2014
05:40 EDTABBV, ENTAAbbVie 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
Sign up for a free trial to see the rest of the stories you've been missing.
December 21, 2014
12:42 EDTENTA, ABBVEnanta says FDA approval of AbbVie's VIEKIRA PAK triggers $75M milestone payment
Subscribe for More Information
December 19, 2014
17:46 EDTABBVAbbVie confirms FDA approval of VIEKIRA PAK
Subscribe for More Information
14:40 EDTENTA, ABBVFDA approves Viekira Pak to treat hepatitis C
Subscribe for More Information
11:02 EDTABBVAbbVie receives orphan status for brain metastases treatment
The FDA granted AbbVie orphan status for veliparib, its treatment of brain metastases when used in combination with DNA-damaging agents.
December 11, 2014
10:13 EDTABBVOn The Fly: Analyst Downgrade Summary
Today's noteworthy downgrades include: ARIAD (ARIA) downgraded at Credit Suisse... AbbVie (ABBV) downgraded to Equal Weight from Overweight at Morgan Stanley... Aimco (AIV) downgraded to Hold from Buy at KeyBanc... Anglo American (AAUKY) downgraded to Underperform from Neutral at Exane BNP Paribas... Approach Resources (AREX) downgraded at Sterne Agee... CommVault (CVLT) downgraded to Neutral from Outperform at Macquarie... Fifth Street Senior (FSFR) downgraded to Perform from Outperform at Oppenheimer... Harmonic (HLIT) downgraded to Neutral from Buy at Sidoti... Macerich (MAC) downgraded to Hold from Buy at Deutsche Bank... Newell Rubbermaid (NWL) downgraded to Outperform from Strong Buy at Raymond James... Olin Corp. (OLN) downgraded at Longbow... Penn West (PWE) downgraded to Underperform from Neutral at BofA/Merrill... Prudential plc (PUK) downgraded to Neutral from Buy at Nomura... Semiconductor Manufacturing (SMI) downgraded to Hold from Buy at Jefferies... Suncor (SU) downgraded to Neutral from Buy at BofA/Merrill... Talisman Energy (TLM) downgraded to Underperform from Neutral at BofA/Merrill... Thompson Creek (TC) downgraded to Hold from Buy at Deutsche Bank... Toll Brothers (TOL) downgraded to Underperform from Sector Perform at RBC Capital... Travelers (TRV) downgraded to Neutral from Buy at UBS... United Therapeutics (UTHR) downgraded at Credit Suisse... Vera Bradley (VRA) downgraded to Underperform from Neutral at Sterne Agee.
08:34 EDTABBVAbbVie downgraded at Morgan Stanley
Subscribe for More Information
07:54 EDTABBVGilead shares poised to continue to advance, says RBC Capital
Subscribe for More Information
06:29 EDTABBVShire CEO sees no immediate need to spend break-up fee, Reuters reports
Subscribe for More Information
06:20 EDTABBVAbbVie downgraded to Equal Weight from Overweight at Morgan Stanley
December 9, 2014
07:44 EDTABBVAmerican Association for Cancer Research to hold a symposium
Subscribe for More Information

Sign up for a free trial to see the rest of the stories you've been missing.

I agree to the theflyonthewall.com disclaimer & terms of use