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February 1, 2014
16:51 EDTABBV, LLYFDA probes risk of cardiovascular events from testosterone product use
FDA is investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products. The FDA said, "We have been monitoring this risk and decided to reassess this safety issue based on the recent publication of two separate studies that each suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy. FDA is providing this alert while it continues to evaluate the information from these studies and other available data. FDA will communicate final conclusions and recommendations when the evaluation is complete." The Fly notes that products in this category include AndroGel from AbbVie (ABBV) and Axiron from Eli Lilly (LLY). Reference Link
News For ABBV;LLY From The Last 14 Days
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October 15, 2014
09:20 EDTABBVOn The Fly: Pre-market Movers
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07:30 EDTABBVAbbVie review of Shire deal an 'unwelcome surprise,' says Jefferies
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06:58 EDTABBVAbbVie volatility elevated into reconsidering Shire merger
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06:55 EDTABBVShire volatility elevated into AbbVie reconsidering merger recommendation
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05:34 EDTABBVShire says AbbVie should proceed with recommended offer
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October 14, 2014
19:59 EDTABBVAbbVie down nearly 2% after board reconsiders Shire merger
19:48 EDTABBVAbbVie board reconsidering recommendation to holders to accept Shire merger
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19:46 EDTABBVAbbVie board reconsidering recommendation to holders to accept Shire merger
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12:41 EDTABBVGilead retreats following Johnson & Johnson comments on HCV drug
Shares of Gilead (GILD), which has developed a hepatitis C treatment, are retreating after Johnson & Johnson (JNJ) said it would seek to make its own hepatitis C treatment accessible and competitive. Some investors believe that Johnson & Johnson's comments suggest that it will cut the price of its hepatitis C drug. WHAT'S NEW: Johnson & Johnson said on its earnings conference call today that it was "committed" to its treatment for hepatitis C virus, or HCV. The company added that it intends to remain competitive in the space and would look to make its HCV treatment, Olysio, accessible. In a separate development today, The Wall Street Journal reported that Abbvie (ABBV), which also has an HCV treatment, may have to consider pricing its HCV drug more aggressively after Gilead received FDA approval for Harvoni, the first combination pill approved to treat chronic HCV genotype 1 infection. One analyst quoted by The Journal, Roger Longman, said that AbbVie should consider pricing its drug at $76,000 for a 12 week regimen, representing a 20% discount to Harvoni, which will be priced at $94,500 for a full 12 week regimen. ANALYST REACTION: In a note to investors earlier today, RBC Capital analyst Michael Yee wrote that the weakness in Gilead's stock today has created a buying opportunity. Johnson & Johnson probably can't reduce the price of its Olysio drug much, since it is often used in combination with Gilead's Sovaldi, which costs $84,000 for 12 weeks, RBC Capital analyst Michael Yee wrote in a note to investors today. The price of AbbVie's treatment is unlikely to be much below Sovaldi's price, the analyst stated. WHAT'S NOTABLE: Gilead, along with a number of other drug companies, may also be under pressure because Ireland is reportedly closing its "Irish Double" tax loophole. Gilead is one of the companies that currently benefits from the "Irish Double," but Yee says that closing the loophole should only have a "minimal" impact on Gilead. PRICE ACTION: In early afternoon trading, Gilead fell 3.3% to $98.10, AbbVie gained 1.7% to $54.53 and Johnson & Johnson lost 0.6% to $98.52.
10:51 EDTABBVGilead weakness a buying opportunity, says RBC Capital
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10:05 EDTABBVAbbVie could cause Hep C price tipping point with aggressive pricing, WSJ says
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07:15 EDTLLYBiotech Industry Organization to hold a summit
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October 13, 2014
09:23 EDTABBVAbbVie's Humira for hidradenitis suppurativa meets Phase 3 trial endpoint
AbbVie announced new results from PIONEER II, a pivotal Phase 3 study, demonstrating the effect of Humira in reducing common clinical signs and symptoms in moderate-to-severe hidradenitis suppurativa, specifically the number of abscesses and inflammatory nodules. The results of this study, in combination with previously presented results from PIONEER I, will contribute to worldwide regulatory filings for an expanded use of Humira, which is not currently approved by regulatory authorities for the treatment of HS.
07:39 EDTABBVPharmaceutical Care Management Association to hold annual meeting
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07:37 EDTABBVAmerican Society of Anesthesiologists to hold annual meeting
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October 10, 2014
10:03 EDTLLYEli Lilly olaratumab granted orphan designation as soft tissue sarcoma treatment
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October 9, 2014
08:28 EDTABBVGilead to be challenged by AbbVie in HCV near-term, says Bernstein
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October 8, 2014
10:55 EDTLLYLeerink pharmaceuticals analyst holds an analyst/industry conference call
Analysts discuss prospects for drugs that raise HDL cholesterol, effects of CETP mechanism, expectations for REVEAL data and the potential place for CETP inhibitors in a crowded hypersholesterolemia landscape on an Analyst/Industry conference call to be held on October 9 at 11 am.
07:18 EDTABBVInfectious Diseases Society of America to hold a conference
ID Week 2014 is being held in Philadelphia on October 8-12.
06:11 EDTLLYNovartis says expects three executive committee members to leave
Novartis (NVS) confirmed that following completion of the transactions with GlaxoSmithKline (GSK) and Eli Lilly and Company (LLY) in the coming months, that the three business leaders of the Novartis divisions at the center of the transaction will leave the Executive Committee of Novartis. The expected changes to the ECN are subject to the closing of the transactions announced on April 22 - Novartis expects the transaction with GSK to be completed in the first half of 2015, and the transaction with Eli Lilly for its Animal Health Business to close in the first quarter of 2015. George Gunn, currently Division Head, Novartis Animal Health, will reach his contractual retirement age in July 2015 and will retire from Novartis. Upon closing of the Animal Health transaction with Lilly he will leave the ECN. Brian McNamara, currently Division Head, Novartis OTC, will transition to GSK as Head of Americas and Europe for the consumer health businesses, reporting to the President of GSK Consumer Healthcare, effective at closing of the transaction. Andrin Oswald, currently Division Head, Novartis Vaccines, will be leaving Novartis to pursue other opportunities following closing of the transaction with GSK.
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