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Stock Market & Financial Investment News

News Breaks
March 28, 2014
05:46 EDTSHPG, ARIA, GSK, LLY, JAZZRumors suggest Jazz looking to buy ARIAD, Daily Mail reports
Rumors suggest that Jazz Pharmaceuticals (JAZZ) is willing to pay $20-plus per share to acquire ARIAD (ARIA), Daily Mail says in its Market Report. GlaxoSmithKline (GSK), Shire (SHPG) and Eli Lilly (LLY) are rumored to have lost out on the auction for ARIAD, the paper adds. Reference Link
News For ARIA;JAZZ;GSK;SHPG;LLY From The Last 14 Days
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April 16, 2015
09:14 EDTGSKAdamis says albuterol HFA product study met clinical FEV1 primary endpoint
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08:15 EDTGSKGlaxoSmithKline and Theravance announce launch of Anoro in Spain
In a regulatory filing, GlaxoSmithKline (GSK) and Theravance (THRX) announced the launch of Anoro in Spain following the approval in Europe in May 2014. Anoro Ellipta is indicated as a once-daily maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease. Anoro Ellipta is a combination of two bronchodilators, umeclidinium, a long-acting muscarinic antagonist and vilanterol, a long-acting beta2 agonist, in a single dry powder inhaler, the Ellipta. The approved dose of UMEC/VI is 55/22mcg. UMEC/VI has been developed under the 2002 LABA collaboration agreement between Glaxo Group Limited and Theravance.
April 15, 2015
11:53 EDTGSKGlaxoSmithKline initiated with a Sell at Societe Generale
07:41 EDTLLYEBD Group to hold a forum
ChinaBio Partnering Forum 2015 is being held in Shanghai, China on April 15-16.
April 13, 2015
14:20 EDTARIANHS Scotland accepts ARIAD's Iclusig for use
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07:20 EDTSHPGShire price target raised to $288 from $267 at JPMorgan
JPMorgan raised its price target for Shire to $288 after lifting its estimates for Lifitegrast in dry eye following the FDA's Priority Review designation. The firm believes the FDA is very likely to approve the application in October of this year, without waiting for the third Phase III study late 2015. It upped its 2020 Lifitegrast forecasts by $600M to $900M and reiterates an Overweight rating on Shire.
April 10, 2015
11:03 EDTLLYEli Lilly granted orphan status for anal cancer treatment
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April 9, 2015
13:27 EDTSHPGShire announces FDA Priority Review designation for lifitegrast
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10:48 EDTSHPGDeutsche compares PTC Therapeutics to Vertex, boosts target by $40
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09:25 EDTLLYPiper Jaffray pharmaceuticals analysts hold an analyst/industry conference call
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05:27 EDTSHPGShire reports results from three placebo-controlled Phase 2 studies of SHP625
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April 7, 2015
10:10 EDTJAZZ, SHPGJazz patent on Xyrem latest to be challenged by Kyle Bass
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08:10 EDTSHPGShire shares pricing in worst case scenario for patents, says Citigroup
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07:14 EDTGSK, LLYEyeforpharma to hold a summit
Philadelphia 2015 Commercial Pharma Summit is being held in Philadelphia on April 7-8.
07:13 EDTSHPGShire patent challenges only modest threat, says Jefferies
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05:23 EDTSHPGShire reaches agreement with FDA on clear regulatory path for SHP465
Shire announces that it has reached an agreement with the FDA on a clear regulatory path for SHP465, an investigational oral stimulant medication being evaluated as a potential treatment for Attention-Deficit/Hyperactivity Disorder, or ADHD, in adults. Shire has agreed with the FDA to conduct a short-term efficacy and safety study in pediatric patients with ADHD. While Shire intends to pursue an adult indication, the FDA is requesting this additional pediatric data to better understand the potential effects of SHP465 on children with ADHD in the event of use in this population. The company anticipates the clinical trial's first patient, first visit to take place in August 2015, with study completion targeted by the last quarter of 2016. Shire then expects to submit to the FDA by 2Q17 a Class 2 resubmission for approval of SHP465 as a treatment for ADHD in adults, which typically entails a 6-month review. Pending FDA approval, Shire anticipates launching the medicine in the second half of 2017. This update follows Shire's announcement on October 9, 2014, that it was engaging the FDA to determine the parameters of clinical data requirements in order to submit the Class 2 resubmission.
April 6, 2015
09:22 EDTARIAOn The Fly: Pre-market Movers
HIGHER: Uniqure (QURE), up 44.2% following strategic collaboration with Bristol-Myers (BMY)... Cytori Therapeutics (CYTX), up 22.4% after Lorem Vascular receives regulatory clearance in China... Curis (CRIS), up 8.5% after FDA grants orphan drug designation to CUDC-907 for the treatment of Diffuse Large B-Cell Lymphoma... Capnia (CAPN), up 5.9% after being awarded a $220,000 NIH grant... Tesla (TSLA), up 3.8% after reporting first quarter deliveries up 55% to 10,030 cars... Ariad (ARIA), up 3.4% following approval of Iclusig in Canada... Lumber Liquidators (LL), up 3.1% after being upgraded to Outperform from Market Perform at Raymond James. LOWER: Magnum Hunter (MHR), down 8.9% after being downgraded to Hold from Buy at Wunderlich... Herbalife (HLF), down following CNBC report that federal law enforcement agencies contacted the company regarding its business practices... Qualcomm (QCOM), down 2.2% following a Wall Street Journal report that the Samsung (SSNLF) Galaxy S6 did not have a Qualcomm LTE modem... Skyworks (SWKS), down 2.1% after being downgraded to Equal Weight from Overweight at Stephens.
09:09 EDTSHPGShire says will defend patents 'vigorously' after Hayman petitions
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07:36 EDTARIAARIAD announces approval of Iclusig in Canada
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07:14 EDTLLYBiodel GEM device demonstrates 'superior' usability
Biodel (BIOD) announced results from a formative human factors study of its Glucagon Emergency Management, or GEM, device, which is in development for the treatment of diabetes patients experiencing severe hypoglycemia. In the study, the GEM device demonstrated a substantial improvement in ease-of-use and successful delivery of the full dose, as well as a reduction in dosing errors, when compared to commercially available glucagon kits; Eli Lilly's (LLY) Glucagon Emergency Rescue Kit and Novo Nordisk's GlucaGen HypoKit. Furthermore, while training and previous experience increased the success rate with the Eli Lilly and Novo Nordisk glucagon kits, it did not further impact the already high success rate with the GEM device when compared to non-experienced, untrained participants.
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