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News Breaks
May 3, 2013
08:00 EDTAMGN, AMGN, SNY, SNY, GENZ, GENZ, TEVA, TEVAFDA to hold a joint committee meeting
Joint Meeting of the Medical Imaging Drugs Advisory Committee and Oncologic Drugs Advisory Committee is being held to discuss the safety and efficacy of currently approved leukocyte growth factors (LGFs) as potential treatments for radiation-induced myelosuppression associated with a radiological/nuclear incident. The meeting will be held at FDA Silver Spring, Maryland offices on May 3 at 8 am. Webcast Link
News For AMGN;SNY;GENZ;TEVA From The Last 14 Days
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August 31, 2014
14:22 EDTSNYSanofi, Regeneron announce results from four Phase 3 ODYSSEY trials
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12:50 EDTSNY, AMGNEuropean Society of Cardiology to hold a conference
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August 29, 2014
12:23 EDTSNYNovartis drug data to be presented this weekend
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10:06 EDTSNYSanofi unit treatment of Fabry's disease granted orphan status
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08:18 EDTSNYPerrigo among companies showing interest in Omega Pharma, Bloomberg says
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August 28, 2014
11:22 EDTTEVAMylan ANDA for three times per week generic Copaxone accepted by FDA for filing
Mylan (MYL) announced that its abbreviated new drug application for a three times per week Glatiramer Acetate Injection 40 mg/mL has been accepted for filing by the U.S. Food and Drug Administration. This product is the generic version of Teva's (TEVA) Copaxone 40 mg/mL, which is indicated for the treatment of patients with relapsing forms of multiple sclerosis. Mylan believes it is one of the first companies to have filed a substantially complete ANDA containing a Paragraph IV certification for this product and expects to be eligible for 180 days of marketing exclusivity in the U.S. upon final FDA approval. Copaxone 40 mg/mL had U.S. sales of approximately $411.5M for the 12 months ending June 30, 2014, according to IMS Health.
09:18 EDTAMGNAmgen anounces Evolocumab YUKAWA-2 study meets co-primary endpoints
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09:04 EDTAMGNAmgen submits evolocumab BLA to FDA
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07:21 EDTTEVATeva recalls batch of generic Parkinson's drug in U.S., Globes reports
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August 27, 2014
09:20 EDTAMGNFDA grants Amgen priority review designation for ivabradine
Amgen announced the U.S. Food and Drug Administration has granted priority review designation for ivabradine for the treatment of chronic heart failure. Ivabradine is an oral drug that inhibits the If current in the sinoatrial node, the body's cardiac pacemaker. The New Drug Application is based on global clinical trial data from the Phase 3 SHIFT, or Systolic Heart failure treatment with the If inhibitor ivabradine Trial), study. The SHIFT study compared ivabradine to placebo on top of standard-of-care therapies, including beta-blockers, in more than 6,500 patients in sinus rhythm with reduced left ventricular function and heart rate greater than 70 beats per minute.
August 26, 2014
11:21 EDTAMGNAmgen added to short term buy list at Deutsche Bank
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August 25, 2014
16:17 EDTAMGNWestern Digital CFO Leyden to retire, Olivier Leonetti to succeed
Western Digital (WDC) announced that CFO Tim Leyden is retiring. He is being succeeded by Olivier Leonetti, who has served as vice president, finance at Amgen (AMGN) from 2011. Leyden will remain with the company through January 2015 in a transition role and advisory capacity to president and chief executive officer Steve Milligan and to Leonetti for an interim period to ensure a smooth transition. The changes are effective as of September 8.
12:19 EDTSNYOn The Fly: Midday Wrap
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11:48 EDTSNYSanofi and Regeneron co-host a conference call
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10:40 EDTSNYBiotechs rise after InterMune acquired by Roche
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August 22, 2014
12:39 EDTSNYThese five companies will benefit from increased ALS awareness, MarketWatch says
A recent surge in funding for Lou Gehrig's disease, or ALS, caused by the Ice Bucket challenge that is widespread on social media outlets, will benefit five pharmaceutical companies that are involved in the development of a cure for ALS, according to MarketWatch. The companies that are or have been involved in developing a treatment for ALS include Biogen Idec (BIIB), Avanir Pharmaceuticals (AVNR), Isis Pharmaceuticals (ISIS), Sanofi (SNY), and Bristol-Myers Squibb (BMY), MarketWatch added. Reference Link
August 21, 2014
15:16 EDTTEVADEA restricts painkiller drug prescriptions to curb abuse, WSJ reports
The Drug Enforcement Agency, or DEA, will reclassify hydrocodone combination painkiller drugs and place them in the category of medical substances that have the highest potential for harm in an attempt to curb the widespread abuse of the drugs, according to The Wall Street Journal. The rescheduling of the drugs will take effect in 45 days and result in people being able to obtain the drug for only 90 days without obtaining a new prescription. Major manufacturers of these drugs include Teva Pharmaceutical (TEVA), Mallinckrodt (MNK), AbbVie (ABBV), and Actavis (ACT). Reference Link
05:42 EDTSNYIllumina announces strategic partnership with AstraZeneca, Sanofi, Janssen
Illumina (ILMN) announced it has formed collaborative partnerships with leading pharmaceutical companies to develop a universal next-generation sequencing, or NGS,-based oncology test system. The system will be used for clinical trials of targeted cancer therapies with a goal of developing and commercializing a multi-gene panel for therapeutic selection, resulting in a more comprehensive tool for precision medicine. Initial strategic partners include AstraZeneca (AZN), Janssen Biotech, a Johnson & Johnson (JNJ) company, and Sanofi (SNY). Illumina is working with the strategic partners to develop assays that detect and measure multiple variants simultaneously to support partners’ clinical trials, with the objectives of securing regulatory agency approvals and test commercialization. In parallel, Illumina is working with key thought leaders to set standards for NGS-based assays in routine clinical oncology practice, as well as to define regulatory frameworks to enable this new testing paradigm. Together, Illumina and its strategic partners aim to transition from single-analyte companion diagnostics to panel-based assays that select for “companion therapeutics.”
August 19, 2014
16:46 EDTSNYFDA approves Genzyme Cerdelga capsules
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05:11 EDTTEVA, AMGNGamida Cell announces investment, option agreement with Novartis
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