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April 14, 2014
14:42 EDTNVS, ARWR, ALNY, TKMRAlnylam slips after Novartis reportedly cuts back RNAi development
Shares of Alnylam (ALNY) are lower in afternoon trading after a biotech focused newsletter reported that its partner, pharmaceutical giant Novartis (NVS), confirmed plans to "significantly reduce" its ribonucleic acid interface, or RNAi, research efforts. WHAT'S NEW: FierceBiotech reported earlier today that Novartis has decided to significantly cut back its once-ambitious RNAi research efforts, citing ongoing problems associated with delivering these therapies and the small number of relevant targets they could target. A total of 26 Novartis staffers were working full-time on the RNAi program full time, which grew out of a partnership with Alnylam, the report noted. OTHERS TO WATCH: Tekmira Pharmaceuticals (TKMR), like Alnylam, is focused on advancing ribonucleic acid interference therapeutics. Arrowhead Research (ARWR) is another biopharmaceutical company developing RNAi therapeutics. PRICE ACTION: In afternoon trading, Alnylam shares are down 4.5% to $52.58, Tekmira's stock is down nearly 16% to $15.49, and Arrowhead shares are off 3% to $12.71. Shares of Novartis are up about 1% to $83.48.
News For ALNY;NVS;TKMR;ARWR From The Last 14 Days
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November 25, 2015
11:29 EDTNVSStudy says Valeant, others exploding dermatology drug prices, WSJ reports
The JAMA Dermatology journal published a new study that found that retail prices of 19 dermatologic prescription drugs increased fivefold on average between 2009 and 2015, reported The Wall Street Journal. Targretin, marketed by Valeant (VRX), jumped to $30,320 this year from $15,708 last year and $1,687 in 2009, the study found, but "It's not just Valeant," said lead author Miranda Rosenberg. Prices for drugs made by GlaxoSmithKline (GSK) and Novartis (NVS) at least doubled or tripled over the same time frame, the report noted. Reference Link
November 24, 2015
17:51 EDTNVSFDA approves first seasonal influenza vaccine containing an adjuvant
The U.S. FDA approved Fluad, the first seasonal influenza vaccine containing an adjuvant. Fluad, a trivalent vaccine produced from three influenza virus strains (two subtype A and one type B), is approved for the prevention of seasonal influenza in people 65 years of age and older. Fluad and Agriflu are manufactured by Novartis Vaccines and Diagnostics Limited, an affiliate of Novartis Vaccines and Diagnostics, based in Cambridge, Massachusetts. Reference Link
10:06 EDTNVSHigh option volume stocks
High option volume stocks: BDBD UNXL NVS SEDG BLOX GPRE SIG BPL TIF DY
05:25 EDTNVSNovartis receives EU approval for Entresto
Novartis announced that the European Commission has approved Entresto for the treatment of adult patients with symptomatic chronic heart failure with reduced ejection fraction. Entresto is a twice a day tablet and has a unique mode of action which is thought to reduce the strain on the failing heart.
November 23, 2015
05:37 EDTNVSNovartis receives two EU approvals for Cosentyx
Novartis announced today that the European Commission has approved Cosentyx for the treatment of people living with ankylosing spondylitis, or AS, and psoriatic arthritis, or PsA. For AS, this is the first new treatment advance in 16 years since the development of the current standard of care, anti-tumor necrosis factor, or anti-TNF, therapy. Cosentyx is the first in a new class of medicines called interleukin-17A, or IL-17A, inhibitors to be made available in Europe for AS and PsA. These approvals follow on from the earlier EC approval of Cosentyx for the first-line treatment of patients with moderate-to-severe plaque psoriasis. AS and PsA are common inflammatory joint conditions affecting approximately five million people in Europe, yet they remain significantly under-diagnosed and under-treated. If not treated effectively, they can lead to irreversible damage to the spine and joints, causing life-long pain and disability. New treatments are urgently needed for both conditions as many patients do not respond well to existing treatments, with up to 40% not responding sufficiently to anti-TNFs.
November 20, 2015
17:16 EDTNVSNovartis announces FDA approval of Tafinlar + Mekinist
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14:41 EDTNVSNY AG leads team of states in $390M settlement with Novartis over kickbacks
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14:00 EDTNVSNY AG leads team of states in $390M settlement with Novartis over kickbacks
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10:52 EDTNVSFDA approves new oral medication to treat multiple myeloma
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November 18, 2015
08:11 EDTNVSIMS Health forecasts global drug spending to increase 30% by 2020 to $1.4T
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07:43 EDTNVSJefferies to hold a conference
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November 17, 2015
16:38 EDTNVSAduro Biotech to delay filing 10-Q
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07:34 EDTNVSOphthotech to hold a conference call
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06:08 EDTNVSRoche subsidiary to participate in Ophthotech and Novartis agreement
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05:24 EDTNVSNovartis announces Phase III FLAME head-to-head trial met primary endpoint
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November 16, 2015
11:09 EDTARWRArrowhead says data shows ARC-520 can produce reductions of HBV antigens
Arrowhead Research Corporation presented data from a Phase 2a clinical study at The AASLD Liver Meeting 2015 demonstrating that ARC-520, its lead drug candidate against chronic hepatitis B infection, effectively reduced HBV viral antigens derived from cccDNA. HBV surface antigen was reduced substantially with a maximum reduction of 1.9 logs and a mean maximum reduction of 1.5 logs in treatment naive e-antigen-positive patients. This direct antiviral effect was still evident 57 days after a single dose. These data strongly support advancement of ARC-520, and Arrowhead has initiated multiple studies aimed at producing a functional cure of HBV. In this presentation, Dr. Yuen and co-authors show that in the Heparc-2001 clinical study, ARC-520 in combination with entecavir achieved maximum reductions of HBsAg, HBV DNA, HBeAg, and core-related antigen of 1.9 logs, 4.3 logs, 1.7 logs, and 1.2 logs, respectively. Consistent with findings from Arrowhead's chimpanzee study, also presented at AASLD, variations in viral antigen reduction indicated that patients previously treated with chronic entecavir and patients that were treatment-naive and negative for HBeAg likely had lower levels of cccDNA derived mRNA transcripts. As such, HBeAg-positive treatment naive patients experienced a greater relative reduction in HBsAg than patients that were HBeAg-negative or treatment experienced. One transitional patient in cohort 7 was HBeAg-positive at baseline and became HBeAg-negative at days 3 to 43. This patient experienced an intermediate response initially, however HBsAg continued to trend downward through day 57, the last time-point available. ARC-520 was well tolerated with no serious adverse events, no dose limiting toxicities, no discontinuations due to medication AEs, and a modest occurrence rate of AEs that were all deemed unrelated to study drug by the principal investigator. No AE occurred more than once. There were no AEs amongst 10 patients receiving placebo. There was a low occurrence rate of abnormal laboratory tests, with no observed relationship to timing or dose.
08:27 EDTARWRArrowhead to hold an analyst and investor reception
Management hosts an Analyst and Investor Reception to discuss ARC-520 and key data presented at the 66th Annual Meeting of AASLD in San Francisco on November 16 at 9:30 pm. Webcast Link
November 15, 2015
18:28 EDTARWRArrowhead reports data on anti-hepatitis B effects of ARC-520 in chimpanzees
Arrowhead announced the presentation of data demonstrating that ARC-520, its drug candidate against chronic hepatitis B infection, leads to "robust, sustained anti-viral effects in chimpanzees with chronic HBV," according to the company. Arrowhead also reported a new discovery that HBV DNA integrated into the host genome is "likely an important source of HBV surface antigen production, particularly in chimps that are negative for hepatitis B e-antigen." ARC-520 led to a drop in circulating HBsAg, with the degree of HBsAg reduction correlating with HBeAg status. HBeAg-positive and negative chimps demonstrated HBsAg reductions of 96.8%-99.8% and 68.4%-87.4%, respectively, with an intermediate response in a chimp transitioning from HBeAg positive to negative. In addition, one chimp seroconverted for HBeAg during ARC-520 therapy and had a sustained virologic response with respect to HBeAg, HBV DNA, and HBsAg. This persisted off therapy and through at least 32 weeks after ARC-520 and NUC therapy was removed. A second chimp demonstrated effects consistent with immunologic reactivation. Arrowhead also found that the predominant form of liver HBV DNA differed in HBeAg-negative versus HBeAg-positive chimps. Most HBV DNA in HBeAg-positive chimps was cccDNA, while less than 5% of HBV DNA in HBeAg-negative chimps was cccDNA. In addition, HBV RNA profiles in HBeAg-negative chimps were consistent with transcripts arising from integrated DNA. "These data and others, strongly suggest that integrated DNA is likely an important source of HBsAg production in HBeAg-negative chimps," claimed the company. "Direct confirmatory data" was obtained by treating HBeAg negative chimps with a siRNA designed to target transcripts originating from integrated HBV DNA. Up to an additional 99% of HBsAg knockdown was achieved, resulting in overall relative knockdown levels similar to those observed using ARC-520 in HBeAg-positive chimps. Arrowhead said it has incorporated one of these RNAi triggers and one targeting predominantly cccDNA derived transcripts into a new complementary drug candidate, ARC-521, that is planned to be in clinical trials in 2016. The company noted it plans to present additional data at the Hep Dart conference in December demonstrating that two of four HBeAg-positive chimps exhibited signs of immune reactivation, "which is believed to be a necessary step toward achieving a functional cure of HBV."
November 13, 2015
08:28 EDTARWRAmerican Association for Study of Liver Diseases to hold annual meeting
The Liver Meeting 2015 is being held in San Francisco on November 13-17.

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