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News Breaks
April 17, 2014
08:38 EDTTEVA, PFETeva settles patent ligitigation with Pfizer on Celebrex
Teva (TEVA) announced that its subsidiary Teva Pharmaceuticals USA, Inc. has entered into a settlement with Pfizer (PFE) related to Teva’s generic version of Celebrex 50, 100, 200 and 400 mg capsules in the United States. Under the terms of the settlement, Teva may launch its generic versions in December 2014 or earlier under certain circumstances. Teva has received tentative approval from the U.S. Food and Drug Administration for all strengths and believes that it is first-to-file on at least the 100, 200 and 400 mg capsules. Sales of Celebrex were $2.2B in the U.S. according to IMS data as of December, 2013.
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July 28, 2014
05:55 EDTPFEStocks with implied volatility movement; IGT PFE
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July 25, 2014
07:29 EDTPFEEMA recommends indication for Ecalta to treat invasive candidiasis
The Committee for Medicinal Products for Human Use adopted a positive opinion recommending a variation to the terms of the marketing authorization for the medicinal product Ecalta, offered by Pfizer. The CHMP adopted a change to an indication as follows: "Treatment of invasive candidiasis in adult patients."
07:14 EDTTEVATeva August weekly volatility elevated into Q2 and outlook
Teva August weekly call option implied volatility is at 34, August is at 25, September and January is at 22; compared to its 26-week average of 27 according to Track Data, suggesting large near term price movement into the expected release of Q2 results on July 31.
July 24, 2014
07:27 EDTTEVASome of Teva's biggest investors to vote against re-electing directors, WSJ says
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06:45 EDTTEVATeva price target raised to $70 from $65 at Barclays
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July 23, 2014
10:02 EDTTEVAOn The Fly: Analyst Initiation Summary
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08:10 EDTTEVADeutsche Bank hosts an analyst Specialty Pharma/Industry conference call
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July 22, 2014
16:18 EDTPFEPuma Biotech now responsible for R&D expenses associated with legacy trials
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16:08 EDTTEVATeva initiated with a Buy at Deutsche Bank
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July 21, 2014
08:11 EDTTEVAArena Pharma' subsidiary enters into agreement for Belviq with Teva subsidiary
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08:01 EDTTEVATeva completes acquisition of Labrys
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July 17, 2014
08:08 EDTPFEBristol-Myers, Pfizer announce enrollment in Phase IV EMANATE trial for Eliquis
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July 16, 2014
10:36 EDTPFETreasury calls on Congress to halt inversion deals
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09:27 EDTPFEPfizer to acquire InnoPharma for upfront cash payment of $225M
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08:48 EDTTEVATeva says ISS supports company's nominees, shareholders' meeting proposals
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07:59 EDTPFETreasury Secretary urges Congress to take action on tax inversions
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07:04 EDTPFEPfizer says primary endpoint met in Phase 3 study of BeneFIX
Pfizer announced the positive results of a Phase 3 study comparing a prophylaxis regimen of BeneFIX Coagulation Factor IX 100 IU/kg once-weekly to on-demand treatment in people with moderately severe to severe hemophilia B. The top-line results of the study showed that the primary study endpoint was met and hemophilia B patients taking once-weekly BeneFIX showed a statistically significant reduction in the annualized bleeding rate relative to on-demand treatment with BeneFIX. In the study, the median ABR value, a commonly used measure of efficacy for prophylaxis regimens in hemophilia, was 2.0 for the prophylaxis regimen, compared to 33.6 for the on-demand regimen, representing a 94% decrease in bleeding rates. The mean ABR value was 3.6 for the prophylaxis period, compared to 32.9 for the on-demand treatment, which represents a reduction of 89%. Study results also showed that prophylaxis treatment significantly reduced both spontaneous and traumatic ABR compared to on-demand treatment with BeneFIX. In addition to meeting the primary endpoint, the secondary study endpoints showed that none of the 1,254 prophylaxis infusions administered during the study were associated with a less than expected therapeutic effect occurrence, which was defined as a spontaneous bleed occurring within 48 hours of a prophylaxis infusion. These results are preliminary, top-line data and are subject to additional analyses. Complete results from this study will be submitted for presentation at upcoming medical congresses and submitted for publication in a peer-reviewed journal.
July 15, 2014
11:13 EDTTEVAPerrigo retreats after analyst sees limited potential buyers
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06:28 EDTTEVAActivist shareholder says Teva to appoint new chairman, Reuters says
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July 14, 2014
08:04 EDTTEVATeva announces FDA acceptance of NDA filing for albuterol MDPI
Teva Pharmaceuticals Industries announced that the U.S. Food and Drug Administration has accepted for review the company’s new drug application for albuterol multi-dose dry-powder inhaler, an investigational breath-actuated dry-powder inhaler for the treatment or prevention of bronchospasm in patients 12 years of age and older with reversible obstructive airway disease; and for the prevention of exercise-induced bronchospasm in patients 12 years of age and older. The NDA filing includes data from eight clinical studies that evaluated the safety and efficacy of albuterol MDPI in adults and adolescents with asthma and exercise-induced bronchospasm. The NDA for albuterol MDPI has been accepted by the FDA for standard review, with a FDA Regulatory Action expected in March 2015.
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