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July 11, 2014
11:54 EDTAGN, ABBV, SHPGAbbVie, Shire in active takeover talks, Bloomberg reports
AbbVie (ABBV) and Shire (SHPG) are in active talks about a potential merger after AbbVie raised its takeover offer for a fourth time, Bloomberg reports, citing people with knowledge of the matter. The talks are in the early stage and may not lead to an agreement, sources told Bloomberg. Shares of Shire are up 5%, or $12.04, to $250.65 following the report.
News For SHPG;ABBV;AGN From The Last 14 Days
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April 26, 2015
15:15 EDTABBVAbbVie announces 'promising' data for Viekirax plus Exviera regimen
AbbVie announced new, preliminary safety and efficacy data from the first cohort of its ongoing, phase 3b Ruby-I study. Ruby-I is evaluating Viekirax tablets, or ombitasvir/paritaprevir/ritonavir, plus Exviera tablets, or dasabuvir, with or without ribavirin in treatment-nave, non-cirrhotic, genotype 1 chronic hepatitis C patients with severe renal impairment at stage 4 or 5, including those on hemodialysis. The primary endpoint of the study is the percentage of patients achieving sustained virologic response at 12 weeks post-treatment. Patients who reached post-treatment week four to date -- 10 of 20 patients enrolled -- achieved 100% SVR4. Ruby-I was presented as a late-breaker at the International Liver Congress 2015. "The preliminary results seen in Ruby-I show promising initial SVR rates with the Viekirax plus Exviera regimen," said AbbVie. Ruby-I data showed no virologic failures to date. Preliminary safety analyses reported that patients experienced mainly mild or moderate adverse events. To date, eight of 13 genotype 1a patients had a RBV dose interruption.
April 24, 2015
07:23 EDTABBVAbbVie price target raised to $81 from $76 at UBS
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05:32 EDTABBVAbbVie announces priority review from FDA for OBV/PTV/r
AbbVie has announced that the FDA has accepted its New Drug Application, or NDA, and granted priority review for the company's, all-oral, interferon-free, two direct-acting antiviral treatment of ombitasvir, paritaprevir, ritonavir, or OBV/PTV/r, with ribavirin, or RBV. The NDA is for the treatment of adults with chronic genotype 4, or GT4, hepatitis C virus, or HCV, infection. AbbVie's regimen is the first all-oral, interferon-free therapy being evaluated by the FDA for patients in the United States with chronic GT4 HCV infection. This submission affirms the company's commitment to seeking access to curative therapy for patients living with chronic HCV infection. The FDA granted priority review to AbbVie for the regimen based in part on data from the PEARL-I study, which was recently published online in The Lancet. The FDA grants priority review designation to investigational therapies that treat a serious condition and, if approved, would provide a significant improvement in safety or effectiveness. This designation shortens the regulatory review period for non-new chemical entity NDAs from the normal 10 months to six months. AbbVie's regimen was also granted a Breakthrough Therapy designation by the FDA on June 30, 2014, a status given to investigational treatments for serious or life-threatening conditions with preliminary clinical evidence that may demonstrate substantial improvement on at least one clinically significant endpoint compared to available therapy.
April 23, 2015
10:02 EDTABBVAbbVie says communication with Johnson & Johnson has been 'very positive'
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09:38 EDTABBVAbbVie says cutting Humira spending 'not a prudent strategy'
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09:29 EDTABBVAbbVie sees Q2 EPS $1.04-$1.06, consensus $1.05
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09:26 EDTABBVAbbVie says not completly immune to forex, but hedges protect bottom line impact
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09:20 EDTSHPGCelgene patent latest to be challenged by Hayman Capital's Bass
The Coalition For Affordable Drugs, a group linked to Hayman Capital's Kyle Bass, has requested an Inter Partes Review of Claims 110 of U.S. Patent No. 6,045,501 held by Celgene (CELG), according to a USPTO filing. The 501 patent claims methods for delivering a drug, including a teratogenic drug, to a patient while preventing the exposure of a fetus or other contraindicated individuals to the drug. The patent is related to the company's Revlimid drug. BACKGROUND: Previously, the same coalition requested an Inter Partes Review of patents held by Pharmacyclics (PCYC), Acorda Therapeutics (ACOR), Shire (SHPG) and Jazz Pharmaceuticals (JAZZ). On January 7, Reuters reported that Bass planned to take "around 15 pharmaceutical companies with a combined market capitalization of $450B" into an Inter Partes Review for extending patents in questionable ways, citing a presentation made by Bass in Oslo. PRICE ACTION: Shares of Celgene are down 0.5% to $114.92 in pre-market trading.
09:16 EDTABBVAbbVie says intends to enforce IP if Humira challenged by biosimilar applicant
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09:07 EDTABBVAbbVie says remains on track to complete Pharmacyclics acquisition in Q2
09:04 EDTABBVAbbVie says continues to see strong underlying demand for Humira
Comment from earnings conference call.
08:19 EDTABBVEnanta announces FDA grants priority review for AbbVie treatment regimen
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07:52 EDTABBVAbbVie expects Pharmacyclics transaction to close in Q2
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07:51 EDTABBVAbbVie raises FY15 adjusted EPS to $4.10-$4.30 from $4.05-$4.25, consensus $4.19
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07:51 EDTABBVAbbVie reports Q1 HUMIRA sales up 26% to $3.11B
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07:49 EDTABBVAbbVie reports Q1 adjusted EPS 94c, consensus 85c
Reports Q1 revenue $5.04B, consensus $4.98B
April 22, 2015
15:50 EDTABBVNotable companies reporting before tomorrow's open
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14:08 EDTABBVEarnings Watch: AbbVie's Humira sales will be focus for Q1
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08:55 EDTABBVDeutsche Bank biotech analyst holds an analyst/industry conference call
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07:07 EDTSHPG, ABBVEuropean Association for the Study of the Liver to hold annual meeting
50th Annual Meeting of EASL will be held in Vienna, Austria on April 22-26.
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