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News Breaks
February 9, 2013
14:51 EDTAZN, NVS, ARRYArray expects to make progress on generating data on hematology programs
In a press release Array BioPharma said : During 2013, Array (ARRY) expects to make substantial progress in generating data to inform registration study decisions for our wholly-owned hematology programs, ARRY-520 and ARRY-614. Array-invented MEK162 will be tested in a Phase 3 trial in NRAS melanoma which is scheduled to start in April 2013, as well as BRAF mutant melanoma later in 2013 (with Novartis (NVS)). Also, AstraZeneca (AZN) recently announced a potential start of a Phase 3 trial with Array-invented selumetinib in non-small cell lung cancer during the second half of 2013.
News For ARRY;NVS;AZN From The Last 14 Days
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March 26, 2015
10:18 EDTNVSHigh option volume stocks
High option volume stocks: BTX ALL FIVE SGYP SWFT RHT IDCC NVS WGO XBI
March 24, 2015
11:05 EDTNVSNovartis granted orphan status for medulloblastoma treatment
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March 23, 2015
09:45 EDTNVS, AZNUBS to hold a field trip
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09:06 EDTAZNInsmed appoints Eugene Sullivan as Chief Medical and Scientific Officer
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09:03 EDTNVS, AZNLeerink analysts hold a meeting with a conference call hookup
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07:36 EDTAZNPfizer should rise 'significantly' over next two years, says Jefferies
Jefferies analyst Jeffrey Holford told investors this morning that he expects shares of Pfizer (PFE) to appreciate "significantly" over the next two years. A survey of U.S. oncologists indicated the company's Ibrance drug will be used in 50% of first line hormonal therapy within one year, with off-label use in all lines of therapy including adjuvant, Holford noted. He thinks peak sales of the drug could top $13B, which is well above consensus. In addition, the analyst views Pfizer's Global Established Pharmaceutical business as being underappreciated by the market. Potential value creating options for the pharmaceutical giant include spinning off its GEP unit by 2017 and accretive acquisitions, with possible takeover targets being Shire (SHPG), Actavis (ACT), AstraZeneca (AZN) and GlaxoSmithKline (GSK), in the eyes of Holford. He added the stock to the firm's Franchise Picks list, which encompasses its best ideas. He also raised his price target for Pfizer to $45 from $42. The stock closed Friday up 10c to $34.25.
March 20, 2015
12:33 EDTNVSNovartis says CLEAR Phase IIb study met primary endpoint
Novartis announced results from the CLEAR study demonstrating that Cosentyx is significantly superior to Stelara, a widely used biologic, in achieving clear or almost clear skin for psoriasis patients. The detailed findings were presented in a late-breaking research session at the 73rd Annual Meeting of the American Academy of Dermatology in San Francisco, USA. Cosentyx -- at a dose of 300 mg -- is the first and only interleukin-17A inhibitor approved to treat adult patients with moderate-to-severe plaque psoriasis. In this Phase IIIb study, Cosentyx met the primary endpoint of showing superiority to Stelara as assessed by the Psoriasis Area Severity Index 90 response, known as clear to almost clear skin at Week 16. PASI 90 is considered an important measure of treatment success by the European Medicines Agency and an optimal treatment goal for patients. In addition, completely clear skin at Week 16 was achieved by significantly more patients treated with Cosentyx than those receiving Stelara. In addition, Cosentyx demonstrated rapid onset of action and greater efficacy at all time points in the study up to Week 16, with 50% of Cosentyx patients achieving PASI 75 as early as Week 4 compared to Stelara. The CLEAR study follows the pivotal Phase III FIXTURE study, which showed Cosentyx was superior to Enbrel.
07:55 EDTAZNAstraZeneca seen as potential target again if oncology drugs lag, Bloomberg says
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07:41 EDTNVSAmerican Academy of Dermatology to hold annual meeting
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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
08:37 EDTAZNNektar and Daiichi Sankyo to commercialize Movantik in the U.S.
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March 17, 2015
14:10 EDTAZNIGI Laboratories recent sell-off a buying opportunity, says Craig-Hallum
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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
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
07:30 EDTAZNAmerican College of Cardiology to hold an expo
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March 13, 2015
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.
08:07 EDTAZNAstraZeneca rumored to have BioMarin 'on shopping list,' Daily Mail says
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05:40 EDTNVSNovartis to present Cosentyx data at AAD 2015
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