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April 23, 2014
06:16 EDTAZN, RHHBY, SNY, BMY, NVS, MRK, LLY, PFE, JNJ, GSKPharmaceutical companies narrowing focus, WSJ reports
After decades of broadening their drug portfolios through acquisitions, the Wall Street Journal reports that pharmaceutical companies are reversing course to focus more narrowly on what they think they can do best. Publicly traded companies in the space include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY). Reference Link
News For AZN;JNJ;PFE;LLY;MRK;NVS;BMY;SNY;RHHBY;GSK From The Last 14 Days
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October 8, 2014
08:03 EDTBMYBristol-Myers resolves outstanding U.S. litigation on efavirenz
Bristol-Myers Squibb Company says it has "successfully resolved all outstanding U.S. patent litigation relating to efavirenz, an active ingredient contained in our Sustiva -- efavirenz -- and Atripla products. Accordingly, we believe that loss of exclusivity in the U.S. for efavirenz should not occur until December 2017. Bristol-Myers Squibb remains committed to delivering our medicines and to developing new and innovative treatments to help patients prevail over serious disease. Atripla is currently the #1 prescribed U.S. regimen in its category, with over 8 million prescriptions written since its launch in 2006. Earlier this year the company submitted a new drug application to the U.S. Food and Drug Administration for a fixed-dose combination of atazanavir sulfate and cobicistat, an investigational pharmacokinetic enhancer. In addition, studies are ongoing for new treatments including an HIV-1 attachment inhibitor, an HIV-1 maturation inhibitor and an anti-PD-L1. The establishment of intellectual property rights allows Bristol-Myers Squibb to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. We will continue to defend our intellectual property rights against infringement as we remain focused on providing a deep and broad portfolio of innovative medicines to patients around the world."
07:19 EDTNVS, PFE, RHHBYCBI to hold a conference
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07:18 EDTMRK, PFE, SNY, BMYInfectious Diseases Society of America to hold a conference
ID Week 2014 is being held in Philadelphia on October 8-12.
06:11 EDTGSK, NVS, LLYNovartis says expects three executive committee members to leave
Novartis (NVS) confirmed that following completion of the transactions with GlaxoSmithKline (GSK) and Eli Lilly and Company (LLY) in the coming months, that the three business leaders of the Novartis divisions at the center of the transaction will leave the Executive Committee of Novartis. The expected changes to the ECN are subject to the closing of the transactions announced on April 22 - Novartis expects the transaction with GSK to be completed in the first half of 2015, and the transaction with Eli Lilly for its Animal Health Business to close in the first quarter of 2015. George Gunn, currently Division Head, Novartis Animal Health, will reach his contractual retirement age in July 2015 and will retire from Novartis. Upon closing of the Animal Health transaction with Lilly he will leave the ECN. Brian McNamara, currently Division Head, Novartis OTC, will transition to GSK as Head of Americas and Europe for the consumer health businesses, reporting to the President of GSK Consumer Healthcare, effective at closing of the transaction. Andrin Oswald, currently Division Head, Novartis Vaccines, will be leaving Novartis to pursue other opportunities following closing of the transaction with GSK.
October 7, 2014
12:57 EDTJNJJohnson & Johnson October volatility increases into Q3 and outlook
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08:39 EDTNVSImmunoGen says Novartis exercises rights to take licenses under agreement
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08:34 EDTBMYBristol-Myers withdrawing NDA for asunaprevir
Given the rapidly evolving hepatitis C treatment landscape in the U.S., Bristol-Myers Squibb has decided that it will not pursue U.S. Food and Drug Administration approval of the dual regimen of daclatasvir and asunaprevir for the treatment of HCV genotype 1b patients in the United States and has therefore withdrawn its new drug application for asunaprevir, an NS3/4A protease inhibitor. The company will continue to pursue FDA approval of daclatasvir, a potent, pan-genotypic NS5A complex inhibitor, which is currently being investigated globally in multiple treatment regimens for HCV patients with high unmet need. Bristol-Myers says "The dual regimen was developed to meet the distinct need of the Japanese patient population, and we believe this treatment has the potential to play a major role in curing HCV patients in Japan, as well as in other markets where the HCV patient population is similar to Japan. In the EU, daclatasvir was recently approved for use in combination with other medicinal products across genotypes 1, 2, 3 and 4 for the treatment of HCV infection in adults. Similarly, we believe that daclatasvir-based regimens have the potential to fill continued unmet medical need in the U.S. and elsewhere in the world. We plan to submit additional data for daclatasvir to the FDA from our ongoing clinical trial program focused on difficult-to-treat patients, including patients with HCV genotype 3, patients who are pre- and post-liver transplant, and patients co-infected with HIV. Next month at the annual meeting of The American Association for the Study of Liver Diseases, we will present new data from several daclatasvir-based regimens. We look forward to bringing daclatasvir to patients in the U.S. and will continue to work closely with the FDA to advance our regulatory application, with the aim of bringing the investigational product to market as quickly as possible."
08:33 EDTBMYBristol-Myers withdrawing NDA for asunaprevir
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07:54 EDTSNYSanofi says alerted U.S. authorities about allegations of impropriety, WSJ says
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07:48 EDTAZNSalix reinstated with a Buy at Jefferies
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07:48 EDTPFEU.S. Chamber of Commerce to hold a discussion
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07:24 EDTJNJAlliance for Regenerative Medicine
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06:08 EDTJNJJohnson & Johnson Remicade competition could come in 2016, says Wells Fargo
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October 6, 2014
09:25 EDTSNYOn The Fly: Pre-market Movers
HIGHER: HP (HPQ), up 5% after confirming plans to separate into two companies... CareFusion (CFN), up 24% after Becton Dickinson (BDX) agreed to acquire the company for $58 per share in $12.2B deal. Becton Dickinson shares are up 7% following the news... Chimerix (CMRX), up 7% after announcing announced that brincidofovir has been provided for potential use in patients with Ebola Virus Disease... Conn's (CONN), up 6.5% after announcing that it is exploring strategic alternatives... TASER (TASR), up 5% after announces multiple orders of TASER Smart Weapons... Tableau (DATA), up 3.5% after upgraded at Morgan Stanley... Splunk (SPLK), up 3.9% after upgraded at Morgan Stanley... Unilife (UNIS), up 52% after signing a 15-year commercial supply agreement with Sanofi (SNY). LOWER: RadioShack (RSH), down 5% after confirming definitive agreements to restructure debt... Alcobra (ADHD), down 43% after announcing results from Phase III study of MDX in adult ADHD... Sunesis (SNSS), down 71% after announcing Phase 3 VALOR trial did not meet primary endpoint... H&R Block Bank (HRB), down 5% after deal with BofI (BOFI) not expected to get regulatory approval this year. Tekmira (TKMR), down 8% after downgraded at Leerink.
08:04 EDTNVS, BMYBristol-Myers announces Opdivo clinical trial with Novartis therapies
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08:02 EDTSNYUnilife signs 15-year commercial supply agreement with Sanofi
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08:02 EDTBMYBristol-Myers announces research collaboration to evaluate Opdivo
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07:32 EDTAZNAstraZeneca confirms AHA, ACC updated guideline
AstraZeneca confirmed that the American Heart Association and American College of Cardiology have updated the guideline for the management of patients with non–ST-elevation acute coronary syndromes. The guideline supports differentiation among currently available P2Y12 inhibitors, including ticagrelor, clopidogrel, and prasugrel, for these patients. BRILINTA is now preferred over clopidogrel for the management of NSTE-ACS patients who undergo an early invasive or ischemia-guided strategy or those who receive a coronary stent. This is the first time the AHA and ACC have recommended one P2Y12 over another in the treatment of acute coronary syndrome. The approved Prescribing Information for BRILINTA includes information about the approved uses for BRILINTA. BRILINTA has two Boxed WARNINGS, one for bleeding risk and the other for aspirin dose and reduced BRILINTA effectiveness. The Boxed WARNING on BLEEDING RISK states, like other antiplatelet agents, BRILINTA can cause significant, sometimes fatal, bleeding.
07:19 EDTSNYLeerink healthcare analysts hold an analyst/industry conference call
Healthcare Analysts discuss PCSK9 antibodies and evaluate the commercial potential and unmet need on an Analyst/Industry conference call. Relevant companies Amgen, Sanofi and Regeneron may be discussed on the Analyst/Industry conference call being held on October 6 at 11 am.
05:14 EDTBMY, NVSNovartis announce clinical collaboration with Bristol-Myers
Novartis (NVS) announced that it has entered into a clinical collaboration with Bristol-Myers Squibb (BMY) to evaluate the safety, tolerability and preliminary efficacy of three molecularly targeted compounds in combination with Bristol-Myers Squibb's investigational PD-1 immune checkpoint inhibitor, Opdivo, in Phase I/II trials of patients with non-small cell lung cancer, or NSCLC. Both studies will be conducted by Novartis. One trial will evaluate the combination of Opdivo with Zykadia, an FDA-approved treatment for patients with anaplastic lymphoma kinase-positive metastatic NSCLC who have progressed on or are intolerant to crizotinib. A second study will investigate Opdivo with INC280, a potent and highly selective inhibitor of c-MET receptor tyrosine kinase, and separately with EGF816, a potent, third-generation EGFR tyrosine kinase inhibitor that is active against T790 mutations. INC280 and EGF816 are currently being investigated in various Phase I/II NSCLC trials. Additional details of the collaboration were not disclosed.
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