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Stock Market & Financial Investment News

News Breaks
March 25, 2013
07:53 EDTSNY, TEVA, BIIB, NVSRuling on Sanofi MS drug may have implications for Teva, Biogen, Reuters says
Sanofi's (SNY) new multiple sclerosis pill Aubagio won an EU approval recommendation, but the European Medicines Agency refused to give it a "new active substance" designation because it is too similar to an older drug, meaning generic copies could be launched in Europe in as little as three years, reported Reuters, citing a Bernstein analyst. The analyst added that such generics could "wreak havoc" on the rest of the European MS market and could impact drugs from Teva (TEVA), Biogen Idec (BIIB) and Novartis (NVS). Reference Link
News For SNY;TEVA;BIIB;NVS From The Last 14 Days
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August 13, 2014
13:13 EDTSNYInterMune exploring sale after bids from Sanofi, Roche, Glaxo, Bloomberg says
InterMune (ITMN) is working with its financial advisers Goldman Sachs (GS) and Centerview Partners to evaluate takeover bids it has received from Sanofi (SNY), Roche (RHHBY), GlaxoSmithKline (GSK) and Actelion (ALIOF), said Bloomberg, citing people with knowledge of the matter. The report noted that one of the sources said Sanofi has so far shown the most interest in a deal for InterMune, whose shares are up more than 13% to $51.56 following the first headlines from the report. Reference Link
13:00 EDTSNYInterMune received takeover bids from Sanofi, Roche, Bloomberg says
August 12, 2014
08:52 EDTSNYSanofi launches authorized generic version of Eloxatin through Winthrop US
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August 11, 2014
15:51 EDTSNYMannKind price target raised to $10 from $6.50 at Piper Jaffray
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11:58 EDTSNYMannKind rallies after inking licensing agreement with Sanofi
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10:50 EDTBIIBBiogen weakness attributed to Forward Pharma IPO filing
Shares of Biogen Idec (BIIB) came off their earlier highs and moved into negative ground in early trading, with some attributing the move lower to another pharmaceutical company, Forward Pharma (FWP), filing its registration statement with the SEC relating to a proposed initial public offering and reporting that Joel Sendek has been appointed CFO. WHAT'S NOTABLE: Forward Pharma focuses on a proprietary formulation of dimethyl fumarate, or DMF, for the treatment of multiple sclerosis. DMF is the Active Pharmaceutical Ingredient, or API, found in Tecfidera, which Biogen Idec began selling for the treatment of RRMS following approval by the FDA in March 2013 and approval by the European Commission in February 2014, Forward Pharma indicated in its IPO filing. In addition to its filing, Forward Pharma announced this morning that it has hired Joel Sendek from Stifel Financial, where he served as Managing Director, Biotechnology and led the firm's healthcare equity research group. PRICE ACTION: Shares of Biogen are down fractionally in mid-morning trading after being up over 1% soon after today's opening bell.
09:06 EDTSNYOn The Fly: Pre-market Movers
HIGHER: PharmAthene (PIP), up 55% after announcing that a Delaware court awarded the company lump sum expectation damages for the value of its lost profits for SIGA Technologies' (SIGA) smallpox antiviral, Tecovirimat... MannKind (MNKD), up 19% after entering exclusive licensing agreement for development and commercialization of Afrezza inhaled insulin with Sanofi (SNY)... Kinder Morgan (KMI), up 19% after announcing it will acquire all of the outstanding equity securities of Kinder Morgan Energy Partners (KMP), Kinder Morgan Management (KMR) and El Paso Pipeline Partners (EPB)... Tesla (TSLA), up 2.7% following upgrade at Deutsche Bank... Achillion (ACHN), up 6% following upgrades at Wells Fargo and at Piper Jaffray... PepsiCo (PEP), up 0.9% following upgrade at UBS. LOWER: Dean Foods (DF), down 8.6% after reporting Q2 losses that were steeper than expected, saying balance of year "appears rocky," which makes it difficult to provide guidance beyond the immediate quarter... Priceline (PCLN), down 0.7% after reporting Q2 revenue that missed expectations, guiding Q3 EPS below consensus... SIGA Technologies, down 31% after ruling in suit with PharmAthene... 2U (TWOU), down 4.3% after downgraded at Goldman.
07:45 EDTSNYMannKind partnership likely to be viewed favorably, says Piper Jaffray
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07:07 EDTSNYIgnyta names Adrian Senderowicz as Chief Medical Officer
Ignyta (RXDX) announced that Adrian Senderowicz, M.D., has been appointed as Chief Medical Officer and SVP, Clinical Development and Regulatory Affairs. Senderowicz was most recently Vice President, Global Regulatory Oncology at Sanofi (SNY).
06:31 EDTSNYMannKind to host conference call
Conference call to discuss the collaboration with Sanofi about global licensing agreement for development and commercialization of Afrezza will be held on August 11 at 8:30 am. Webcast Link
05:18 EDTNVSNovartis reports LCZ696 significantly reduced cardiovascular deaths
New data revealing the reduction in cardiovascular, or CV, deaths with Novartis' LCZ696 in patients with heart failure with reduced ejection fraction, or HF-REF, will be presented at the European Society of Cardiology, or ESC, Congress 2014. The 8,442 patient study, PARADIGM-HF, was specifically designed to see if LCZ696 could increase survival over and above what can be achieved with ACE-inhibitor enalapril in addition to current best treatment in HF-REF patients. In March the Data Monitoring Committee overseeing the study confirmed those given LCZ696 were significantly less likely to die from CV causes, leading to the trial being closed early. LCZ696 significantly reduced cardiovascular deaths in head to head study against enalapril, in addition to current best treatment, in patients with HF-REF. PARADIGM-HF is the largest heart failure study ever conducted and was stopped early in March due to compelling efficacy. LCZ696 was recently granted FDA Fast Track status and rolling submission expected to be complete by end of year.
05:13 EDTSNYSanofi, MannKind announce global licensing agreement for Afrezza
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August 8, 2014
06:51 EDTNVSJudge rules DOJ can pursue Novartis kickback suit, Reuters says
U.S. District Judge Colleen McMahon ruled that the U.S. Department of Justice is allowed to continue its False Claims Act lawsuit versus Novartis regarding allegations that the company used kickbacks to increase sales of medications covered by Medicare and Medicaid, according to Reuters, citing comments from McMahon. Reference Link
August 7, 2014
13:55 EDTTEVATeva won't be meaningfully hurt soon by new Copaxone filing, says BMO Capital
After Teva (TEVA) confirmed that it received the first paragraph IV notice for the 3x per week version of its Copaxone drug from Dr. Reddy's (RDY), BMO Capital said it had expected companies to seek to market a generic version of the latest Copaxone formulation, but was surprised that Dr. Reddy's took this action. The firm notes that Teva's decision to file a lawsuit against Dr. Reddy over the application will trigger a 30 month stay of approval of the generic version,. BMIO Capital says that investors should keep this issue on their radar, but the firm does not expect Teva to be meaningfully hurt in the near-term by this development. It keeps an Outperform rating on Teva.
12:06 EDTTEVATeva will continue to defend COPAXONE intellectual property rights
Teva (TEVA) confirmed that it has received the first paragraph IV notice for its three-times-a-week COPAXONE 40 mg/mL product from Dr. Reddy’s Laboratories (RDY). Teva will continue to vigorously defend its COPAXONE intellectual property rights against infringement wherever they are challenged. Teva intends to file a lawsuit for patent infringement against Dr. Reddy’s within the 45 day period provided under the Hatch-Waxman Act. The filing of the lawsuit will trigger a 30 month stay of FDA approval of Dr. Reddy’s ANDA. COPAXONE 40 mg/mL is protected by two Orange Book patents that expire in 2030.
10:51 EDTBIIBOptions with increasing implied volatility
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10:20 EDTTEVAMylan says litigation ins ongoing in India regarding Teva
Mylan (MYL) said that it expects Teva's (TEVA) efforts to seek an injunction will "as ineffective as it was in U.S. courts." The company said it will not provide further comment on the matter. Mylan said it will also postpone its 2014 Investor Day due to the ongoing nature of the Abbott (ABT) transaction. It expects its fully realized savings and profit from new products will not be realized till 2015. Comments taken from Q2 earnings conference call.
08:40 EDTSNYSanofi and Immune Design enters licensing agreement for use of GLASStm
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08:38 EDTNVSEnanta's HCV NS5A inhibitor EDP-239 advances into combination studies
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07:42 EDTSNYPOZEN plans to make future employee reductions
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