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Stock Market & Financial Investment News

News Breaks
January 29, 2013
06:39 EDTAMGN, GSK, LLY, RHHBY, ACT, BMY, SNY, PFE, TEVA, MRK, JNJ, AZNBiotech companies pushing states to restrict generic drugs, NY Times says
Large biotech companies are lobbying state legislators around the country to pass laws that would limit the use of generic drugs, according to The New York Times. Amgen (AMGN) and Roche's (RHHBY) Genentech are proposing legislation that would restrict pharmacists' ability to substitute generic drugs for brand name products, the newspaper explained. Reference Link
News For RHHBY;AZN;PFE;LLY;JNJ;SNY;GSK;MRK;BMY;AMGN;TEVA;ACT From The Last 14 Days
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March 13, 2015
16:04 EDTMRKMerck provides update on investigational medicine sugammadex injection
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14:34 EDTJNJU.S. appeals court revives lawsuit over J&J's Benecol assertions
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11:19 EDTAZNBioMarin rallies amid positive call on DMD drug timeline, takeover rumor
The shares of drug maker BioMarin (BMRN) are climbing after research firm Jefferies quoted a regulatory expert as saying that the company's drisapersen drug has a good chance of being approved on an accelerated basis by the FDA. Drisapersen is a treatment for Duchenne Muscular Dystrophy, or DMD. WHAT'S NEW: "There is a strong possibility" that the FDA will grant accelerated approval to drisapersen because there is currently no approved drug for the treatment of DMD, Jefferies analyst Eun Yang quoted the expert as saying. The expert is also optimistic about the outlook for accelerated approval because she had a good experience working with BioMarin while she was with the FDA and because BioMarin has a favorable track record with the FDA, according to Yang. There is a 60% chance that drisapersen will be approved by the end of this year and the stock can rise to $155, versus its current level of about $121.50, if that does occur, the analyst stated. Yang's price target on the stock increased to $135 from $125 and the analyst kept a Buy rating on the shares. WHAT'S NOTABLE: Pharmaceutical giant AstraZeneca (AZN) has been rumored to be interested in buying BioMarin for $175 per share in cash, British newspaper Daily Mail reported. , Piper Jaffray analyst Joshua Schimmer wrote in a note to investors this morning that BioMarin, along with Vertex (VRTX) and Incyte (INCY), have a "clear path" to joining the group of companies with market caps of over $10B projected to deliver greater than 20% EPS CAGR, which the analyst identified as a set of criteria that has previously pointed to companies that make good potential takeover targets. PRICE ACTION: In mid-morning trading, BioMarin climbed nearly 4% to $120.
10:51 EDTTEVAOptions with increasing implied volatility
Options with increasing implied volatility: PVA BBEP SLXP ENDP MYL BBBY TEVA ZTS
10:37 EDTSNYSanofi says NHS England de-lists cabazitaxel, aflibercept
Sanofi announcd that NHS England has confirmed that it is de-listing both cabazitaxel and aflibercept from the Cancer Drugs Fund, so that neither of these medicines will be available to new patients in England on the NHS. It added, "However regarding cabazitaxel NHS England have agreed to engage in talks to explore immediate ways of maintaining access to patients until it is reviewed by NICE." Tarja Stenvall, General Manager for Sanofi in the UK, commented, "We are hugely disappointed that cabazitaxel and aflibercept have been cut from the CDF and that new patients in England will no longer have access to these crucial cancer treatments. However NHS England remains in dialogue with Sanofi to explore immediate ways of maintaining access to patients for cabazitaxel until the outcome of any NICE review. Our concern is for patients who should continue to have access to cabazitaxel until a longer term solution is reached and who may feel confused and uncertain until this happens."
08:07 EDTAZNAstraZeneca rumored to have BioMarin 'on shopping list,' Daily Mail says
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08:03 EDTACTActavis receives FDA approval SAPHRIS for pediatric patients
Actavis announced that the FDA has approved its supplemental new drug application for SAPHRIS as monotherapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder in pediatric patients. SAPHRIS is the only atypical antipsychotic treatment option with a sublingual formulation. The FDA approval of SAPHRIS is based on the results of a 3-week monotherapy trial in 403 pediatric patients, of which 302 pediatric patients received SAPHRIS twice daily in doses of either 2.5 mg, 5 mg or 10 mg. SAPHRIS was shown to demonstrate improvement in Young Mania Rating Scale total score and Clinical Global Impression-Bipolar Severity of Illness overall score versus placebo in a pediatric clinical trial.
07:23 EDTJNJJohnson & Johnson has a conference call hosted by JPMorgan
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05:47 EDTTEVAStocks with implied volatility movement; SLXP MNKD
Stocks with implied volatility movement; Salix (SLXP) 20, Teva (TEVA) 27 according to iVolatility.
March 12, 2015
17:08 EDTAZNActavis: Court grants injunction pending appeal relating to Pulmicort RESPULES
Actavis (ACT) confirmed that the United States Court of Appeals for the Federal Circuit has granted AstraZeneca's (AZN) request for an injunction pending appeal preventing Actavis from further distribution of its generic version of Pulmicort RESPULES. Under the ruling, Actavis' sales of generic Pulmicort have been enjoined pending the resolution of AstraZeneca's appeal before the Court. The Court has set an expedited briefing schedule for the appeal, with expedited briefing to be concluded within 33 days. The injunction does not address product shipped prior to its issuance. Actavis' sales of generic Pulmicort had previously been enjoined under a temporary injunction granted by the Appeals Court on February 16. The Appeals Court ruling followed the Feb. 13 launch of Actavis' product after the United States District Court for the District of New Jersey (i) found United States Patent No. 7,524,834 invalid, and (ii) denied AstraZeneca's request for a permanent injunction. Pulmicort RESPULES is a maintenance medicine used to control and prevent asthma symptoms in children ages 12 months to 8 years. For the 12 months ended June 30, 2014, total U.S. brand and generic sales of Pulmicort RESPULES were approximately $1.1B.
16:39 EDTPFEPfizer says primary endpoint not achieved in Phase 4 study of Lyrica
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16:01 EDTTEVAOptions Update; March 12, 2015
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15:02 EDTBMYBristol-Myers announces FDA acceptance of NDA for daclatasvir
Bristol-Myers Squibb Company announced that the resubmitted new drug application, or NDA, for daclatasvir, an investigational NS5A replication complex inhibitor, has been accepted for review by the FDA for use in combination with sofosbuvir for the treatment of chronic hepatitis C, or HCV, genotype 3. The original NDA has been amended to include data from the Phase III ALLY-3 trial, which showed high cure rates for the combination, with sustained virologic response 12 weeks after treatment in 90% of treatment-na´ve and 86% of treatment-experienced genotype 3 HCV patients. SVR12 rates were higher in non-cirrhotic genotype 3 patients, regardless of treatment history. The FDA will now review the submission within a six-month timeframe.
13:01 EDTLLYEli Lilly management to meet with SunTrust
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12:49 EDTBMY, TEVAWHO recommends tenofovir or entecavir for hepatitis B treatment
The World Health Organization issued its first-ever guidance for the treatment of chronic hepatitis B. Its recommended medicines consist of Gilead's (GILD) tenofovir or Bristol-Myers' (BMY) entecavir. Teva (TEVA) has FDA approval for generic entecavir.
11:38 EDTTEVATeva volatility increases on share price rally
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11:21 EDTGSKGlaxoSmithKline to sell half of Aspen Pharmacare stake
GlaxoSmithKline announces that it intends to sell approximately half of its 12.4% stake in Aspen Pharmacare. The disposal will be through a placing of ordinary shares in Aspen to institutional investors. The offering is expected to comprise 28.2M Aspen ordinary shares. After the proposed transaction, GSK would remain a 6.2% shareholder in Aspen and has undertaken not to dispose of any shares in Aspen for a period of 180 days following completion, subject to certain limited exceptions. GSK has entered into a placing agreement with Citigroup Global Markets Limited and UBS Limited to act as the Joint Bookrunners in relation to the Offering. Proceeds from the transaction will be used for general corporate purposes, GSK said. The net profit on disposal will not be included in core operating profit and core EPS in 2015 and it is expected that GSK will no longer account for Aspen as an associate going forward.
11:14 EDTTEVA, MRKPiper Jaffray biopharm analyst analyst/industry conference call at 12 pm
***TIME CHANGED TO 12pm from 11am on March 12***Biopharmaceuticals Analyst Schimmer, along with Dr. Bianca Weinstock-Guttman, discuss the current and future treatment paradigm and practice dynamics in MS on an Analyst/Industry conference call to be held on March 12.
08:09 EDTTEVATeva Mylan combination problematic for now, says Bernstein
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05:55 EDTTEVAStocks with implied volatility movement; TEVA VRX
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