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News Breaks
May 29, 2014
07:24 EDTRHHBY, PFE, NVSItaly pursues drug firms for anti-trust compensation, Reuters says
Italy said it was seeking over EUR1B in compensation from multinational drug firms after a ruling by the country's antitrust authority that their policies had been damaging to Italy's national health service, according to Reuters, citing a company statement from the country's health ministry. The health ministry requested EUR1.2B total from Novartis (NVS) and Roche (RHHBY) and EUR14M from Pfizer (PFE). Reference Link
News For RHHBY;NVS;PFE From The Last 14 Days
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February 23, 2015
07:14 EDTNVSSpectrum says plans to appeal patent suit loss to Novartis unit
Spectrum Pharmaceuticals (SPPI) confirmed in a regulatory filing that on February 20, the U.S. District Court for the District of Nevada ordered that judgment be entered in favor of defendant Sandoz in the matter entitled Spectrum Pharmaceuticals, Inc. et al v. Sandoz Inc. "Spectrum Pharmaceuticals Inc. intends to appeal this decision and the ultimate outcome of this litigation remains uncertain," the company stated. Sandoz is the generic pharmaceuticals division of Novartis (NVS).
06:21 EDTRHHBYFacebook's shuttle drivers approve new union contract, WSJ reports
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February 20, 2015
16:48 EDTRHHBYDow, S&P 500 finish week at record highs after Greek deal reached
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10:33 EDTPFEBattleground update: AbbVie named top global pick at Jefferies
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10:31 EDTPFEPfizer announces FDA acceptance of NDA for Rapamune
Pfizer announced that the FDA has accepted for priority review a supplemental New Drug Application for RAPAMUNE for the treatment of lymphangioleiomyomatosis, a rare, progressive lung disease in women of childbearing age that is often fatal. With the Priority Review designation for the sNDA, Pfizer anticipates a decision in June of 2015 based on the anticipated Prescription Drug User Fee Act action date. The sNDA is based on results from the Multicenter International Lymphangioleiomyomatosis Efficacy and Safety of Sirolimus Trial. The MILES Trial included 89 LAM patients with moderate lung impairment who were randomized to receive RAPAMUNE or placebo for 12 months, followed by a 12 month observation period. In the trial, those treated with RAPAMUNE for one year experienced stabilization of lung function as measured by forced expiratory volume in one second.
07:23 EDTRHHBY, PFEAbbVie replaces Pfizer as top global pharma pick at Jefferies
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07:08 EDTNVSAmerican Academy of Allergy, Asthma and Immunology to hold annual meeting
2015 Annual Meeting of AAAAI is being held in Houston, Texas on February 20-24.
February 19, 2015
18:25 EDTPFE, RHHBYPiper Jaffray biotech analyst to hold analyst/industry conference call
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14:49 EDTPFEWalgreens selected by Pfizer as one of pharmacies to dispense Ibrance
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09:09 EDTRHHBYLeerink's life science tools analyst holds an analyst/industry conference call
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07:12 EDTPFE, NVSWharton Health Care Club to hold a conference
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06:45 EDTRHHBYStudy shows Roche's treatments equal to Eylea in most cases, NY Times says
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05:31 EDTRHHBYExelixis announces acceptance of NDA for Genentech cobimetinib
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05:26 EDTRHHBYFDA grants Genentech cobimetinib priority review for combination use
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February 17, 2015
15:36 EDTPFETianyin JCM plans for FDA certification process
Tianyin Pharmaceutical (TPI) updated on the business and development at its Jiangchuan Macrolide Facility, or JCM, active pharmaceutical ingredients operation. In addition to JCM's certification at India, along with other international clients located at Bangladesh, Philippines and Iran on import status, TPI plans for FDA certification process at its JCM facility in order to service international clients such as Pfizer's (PFE) and their subsidiaries in China, the company said. "This is expected to translate to further demand for JCM's macrolide API business in both the domestic and international markets," Tianyin stated.
10:01 EDTPFECVS says PCSK9 inhibitors could cost system $150B annually
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February 13, 2015
11:31 EDTNVSNovartis says heart failure medicine LCZ696 granted FDA piority review
Novartis announced that the U.S. FDA has granted priority review designation to LCZ696, an investigational medicine for the treatment of heart failure with reduced ejection fraction. The designation accelerates the review of therapies that offer a significant improvement in the safety or effectiveness of the treatment, prevention or diagnosis of a serious condition[4]. For LCZ696 this reduces the total review time from 12 to 8 months, meaning the FDA could make a decision on approval in August 2015. The New Drug Application was submitted under the agency's Fast Track program and is based on results from the landmark PARADIGM-HF study, the largest ever conducted in heart failure, which showed LCZ696 was superior to ACE-inhibitor enalapril on key endpoints, including significantly reducing the risk of CV death or heart failure hospitalization. Patients' reports of how well they felt were significantly better with LCZ696 than enalapril, whilst maintaining an acceptable safety profile. In the EU the Committee for Medicinal Products for Human Use has granted accelerated assessment to LCZ696.
10:28 EDTPFEPfizer announces FDA acceptance for review of NDA for ALO-02
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08:23 EDTNVSPiper Jaffray biotech/healthcare analysts hold analyst/industry conference call
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08:19 EDTPFEAckman noncommittal on McDonald's rumors, Bloomberg reports
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