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March 14, 2012
06:55 EDTCRTX, CRTX, CRTX, ACOR, ACOR, ACOR, JNJ, JNJ, JNJ, DNA, DNA, DNA, LLY, LLY, LLY, MYL, MYL, MYL, IPXL, IPXL, IPXL, VRTX, VRTX, VRTX, NVS, NVS, NVS, AMLN, AMLN, AMLNInstitute for International Research to host a summit
4th Annual Government Programs Summit is being held in Baltimore on March 14-16.
News For AMLN;NVS;VRTX;IPXL;MYL;LLY;DNA;JNJ;ACOR;CRTX From The Last 14 Days
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March 19, 2015
15:55 EDTNVSAmgen injunction bid for Neupogen biosimilar denied, Reuters reports
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15:13 EDTNVSAmgen denied preliminary injunction for biologics against Novartis, Reuters says
08:08 EDTLLYEli Lilly and Hanmi sign license and collaboration agreement
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March 18, 2015
12:48 EDTLLYFly Watch: Biogen predicted to report strong Alzheimer's data this Friday
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07:46 EDTLLYLilly Roche would have upbeat read through from strong BIIB data, says Bernstein
Bernstein notes that the data for Biogen's (BIIB) Alzheimer's treatment, due to be released on Friday, is widely expected to be positive. The firm thinks that positive data would boost the outlook for similar Alzheimer's drugs being developed by Eli Lilly (LLY) and Roche (RHHBY), since consensus estimates for those drugs are low. The firm keeps Outperform ratings on Eli Lilly and Roche.
March 17, 2015
12:51 EDTNVSNovartis hit with $100M gender discrimination lawsuit, Reuters reports
A proposed class action lawsuit against Novartis claims the drug maker routinely denied female employees equal pay and promotional opportunities, reports Reuters. The $110M lawsuit filed on Tuesday says Novartis' Alcon Laboratories maintains a "boy's club atmosphere" that is hostile to women and bars them from leadership positions. Reference Link
08:34 EDTMYLInSite Vision announces settlement of lawsuit against Mylan
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05:35 EDTJNJJohnson & Johnson to invest $10M in UK government fund to fight dementia
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05:32 EDTNVSIncyte announces Novartis receives EC approval for Jakavi
Incyte (INCY) announced that Novartis (NVS) received approval from the European Commission for Jakavi for the treatment of adult patients with polycythemia vera, or PV, who are resistant to or intolerant of hydroxyurea. Jakavi is the first targeted treatment approved by the European Commission for these patients. Under the Incyte-Novartis Collaboration and License Agreement signed in 2009, Novartis received exclusive development and commercialization rights to ruxolitinib outside of the United States for all hematologic and oncologic indications, and sells ruxolitinib under the name Jakavi. Ruxolitinib is marketed by Incyte in the United States as Jakafi. Jakafi is approved by the FDA for treatment of people with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea. Jakafi is also indicated for treatment of people with intermediate or high-risk myelofibrosis, or MF, including primary MF, post–polycythemia vera MF, and post–essential thrombocythemia MF.
05:30 EDTNVSNovartis receives EU approval for Jakavi in polycythemia vera
Novartis announced that the European Commission has approved Jakavi for the treatment of adult patients with polycythemia vera, or PV, who are resistant to or intolerant of hydroxyurea. Jakavi is the first targeted treatment approved by the European Commission for these patients. Jakavi is the only JAK 1/2 inhibitor available to treat PV and is also currently approved in more than 80 countries to treat myelofibrosis.
March 16, 2015
15:04 EDTJNJPharmacyclics says committee recommends unblinding after primary endpoint met
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10:28 EDTMYLOptions with increasing implied volatility
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09:01 EDTACORFlex Pharma names Thomas Wessel as Chief Medical Officer
Flex Pharma (FLKS) announced the appointment of Thomas Wessel, M.D., Ph.D., as its Chief Medical Officer, reporting to Christoph Westphal M.D., Ph.D., Flex Pharma’s President, CEO and Chair. Flex Pharma also announced that Elizabeth Woo, M.B.A., has been promoted to Senior VP, Investor Relations and Corporate Communications. Previously, Dr. Wessel has been the Chief Medical Officer of Acorda Therapeutics (ACOR).
07:27 EDTLLYBiodel BIOD-961 Phase 1 clinical trial meets primary efficacy endpoint
Biodel (BIOD) announced positive preliminary results from Study 6-101, a Phase 1 clinical trial comparing Biodel's lyophilized glucagon formulation BIOD-961, designed for use in a proprietary Glucagon Emergency Management, or GEM, auto-reconstitution device, to Eli Lilly's (LLY) Glucagon Emergency Rescue Kit and Novo Nordisk's GlucaGen HypoKit, which are marketed for the treatment of severe hypoglycemia. Study 6-101 was a randomized, single-center, double blind, six-period cross over study in 15 healthy volunteers who received each glucagon administered subcutaneously, or SC, and intramuscularly, or IM, in a randomized treatment sequence. The objectives of the study were to compare the pharmacokinetic, or PK, profiles, the pharmacodynamic, or PD, glucose, responses, and the PK/PD relationships of IM and SC dosing, as well as to assess safety profiles of the three test glucagons. Study 6-101 was a Phase 1 randomized, single-center, double blind, six-period cross over study designed to evaluate the PK and PD profiles of BIOD-961 compared to marketed glucagon formulations manufactured by Eli Lilly and Novo Nordisk. BIOD-961 is a lyophilized glucagon formulation designed for use in the GEM auto-reconstitution device. On six separate dosing days, each subject received 1 mg of one of the test glucagons delivered either SC or IM. Fifteen normal, healthy subjects were randomized into the study and ten completed all dosings. The objectives of the study were to compare the PK profiles, the PD responses, and the PK/PD relationships of IM and SC dosing, as well as to assess safety profiles of the three test glucagons. These data will facilitate selection of an appropriate marketed glucagon to use as a comparator in the planned pivotal study, in which the primary efficacy endpoint for approval is to demonstrate PK and PD bioequivalence of BIOD-961 to one of the marketed comparators.
March 13, 2015
14:34 EDTJNJU.S. appeals court revives lawsuit over J&J's Benecol assertions
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11:19 EDTVRTXBioMarin 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 EDTMYLOptions with increasing implied volatility
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07:23 EDTJNJJohnson & Johnson has a conference call hosted by JPMorgan
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05:56 EDTMYLStocks with implied volatility movement; MYL PBR
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05:40 EDTNVSNovartis to present Cosentyx data at AAD 2015
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