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March 5, 2014
34th Annual Global Healthcare Conference is being held in Boston on March 3-5 with webcasted company presentations to begin on March 5 at 8:00 am; not all company presentations may be webcasted. Webcast Link
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January 14, 2015
12:49 EDTJAZZOn The Fly: Midday Wrap
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12:25 EDTABBVAbbVie says pipeline is 'most robust it's ever been'
12:09 EDTABBVAbbVie says 'strongly' committed to dividend, returning cash to shareholders
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12:09 EDTJAZZFlamel Technologies plunges after Jazz gets favorable patent ruling
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12:00 EDTABBVAbbVie says guidance to be further refined as HCV launch progresses
11:59 EDTABBVAbbVie repeats FY15 adjusted EPS view $4.25-$4.45, consensus $4.30
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07:37 EDTBDXJPMorgan to hold a conference
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January 13, 2015
13:23 EDTNKTRNektar says year ending cash, investments totaled $262.8M
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12:15 EDTABBVExpress Scripts CEO says Gilead relationship 'important' going forward
Express Scripts (ESRX) CEO George Paz at the J.P. Morgan Healthcare Conference said his company's relationship with Gilead (GILD) is "important" going forward. Paz said his company's goal is not to exclude drugs. He continues to discuss Express Scripts's deal with AbbVie (ABBV) and the company's goal of saving clients money with regards to healthcare costs.
09:07 EDTATRSOn The Fly: Pre-market Movers
HIGHER: Apple (AAPL), up 1.4% after Credit Suisse upgraded Apple to Outperform and raised its iPhone volume estimates again... Best Buy (BBY), up 2.8% after being upgraded to Buy from Neutral at Goldman... SunPower (SPWR), up 2.6% after being upgraded to Outperform at Credit Suisse... Alcoa (AA), up 2% after Q4 results beat expectations. RISING AFTER GUIDANCE: Pharmacyclics (PCYC), up 17.5%... CTI BioPharma (CTIC), up 8.3%... Emulex (ELX), up 15.5%... ARIAD (ARIA), up 2.6%. LOWER: ChannelAdvisor (ECOM), down 42% following preliminary fourth quarter revenue guidance and after receiving multiple analyst downgrades... Antares Pharma (ATRS), down 7.7% after the FDA recommended that the company create a larger safety database for its clinical development program for QuickShot Testosterone.
07:08 EDTATRSAntares Pharma receives written recommendations from FDA on QuickShot
Antares Pharma announced that it has received written recommendations from the FDA related to its clinical development program for QuickShot Testosterone, or QS T. The recommendations received were in response to various clinical, Chemistry, Manufacturing and Controls and user study submissions made by the company through November 2014. The company believes that it has already factored many of the recommendations cited in the advice letter into the protocol of the ongoing phase 3 study and into the protocols for planned human use studies as a result of guidance provided by FDA at the May 2014 Type C meeting. Based on a single reported occurrence of hives in the company’s phase 2 study, which the FDA characterized as an apparent allergic reaction, as well as the known safety experience with other parenteral testosterone products, the FDA is recommending that the company create a larger safety database, including approximately 350 subjects exposed to QS T with 200 subjects exposed for six months and 100 subjects exposed for a year. The company does not believe that the adverse event of hives reported in the phase 2 study was related to study drug. Based on the number of subjects in previous studies and in the current phase 3 study, the company anticipates that it may need approximately 70 additional subjects exposed to QS T for six months. The company is assessing the FDA’s comments in the advice letter and their impact on the timing of the filing of a New Drug Application for QS T with the FDA. The timing, cost and design of the study to obtain the additional 70 subjects and data required will be determined based on further discussion with the FDA. The company continues to expect to release top-line pharmacokinetic data from the current phase 3 study in the second quarter of 2015.
January 12, 2015
13:21 EDTJAZZJazz Pharmaceuticals says 2015 will include top, bottom line growth
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13:17 EDTJAZZJazz sees 2014 Erwinaze sales at upper end of range
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10:00 EDTARAYOn The Fly: Analyst Initiation Summary
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08:14 EDTINFIInfinity Pharmaceuticals sees reporting Dynamo data in 2H15
Infinity (INFI) anticipates that it will report top line data from DYNAMO, a Phase 2 study of duvelisib in patients with refractory indolent non-Hodgkin lymphoma, in the second half of 2015 following the completion of patient enrollment in the first half of the year. Infinity also expects to complete enrollment of DUO, a Phase 3 study of duvelisib in patients with relapsed/refractory chronic lymphocytic leukemia, in the second half of 2015. During the year, Infinity expects three company-sponsored clinical studies of duvelisib to be initiated, including the first clinical study of duvelisib in combination with venetoclax . Duvelisib is an investigational oral inhibitor of phosphoinositide-3-kinase -delta and PI3K-gamma being developed jointly with AbbVie (ABBV) in oncology.
08:13 EDTINFIInfinity Pharmaceuticals sees FY15 revenue $105M-$125M, consensus $96.45M
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08:01 EDTABBVAbbVie announces FDA approval of DUOPA enteral suspension
The FDA has approved AbbVie's DUOPA enteral suspension for the treatment of motor fluctuations for people with advanced Parkinson's disease. DUOPA is administered using a small, portable infusion pump that delivers carbidopa and levodopa directly into the small intestine for 16 continuous hours via a procedurally-placed tube. DUOPA was approved by the FDA as an orphan drug, a designation granted to products intended for the treatment of rare diseases or conditions affecting fewer than 200,000 patients in the U.S.
07:17 EDTABBVJPMorgan to hold a conference
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07:03 EDTARAYAccuray initiated with an Outperform at Northland
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05:33 EDTSSHSunshine Heart provides update on Counter HF and European OPTIONS HF studies
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