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News Breaks
April 28, 2014
05:42 EDTAZN, PFEAstraZeneca says Pfizer offer 'significantly undervalued' prospects
The board of AstraZeneca (AZN) notes the announcement by Pfizer (PFE) earlier today. The company said, "On 26 April 2014, Ian Read, Chairman and CEO of Pfizer, contacted Leif Johansson, the Chairman of AstraZeneca for the first time since January 2014. In this discussion, the Chairman of Pfizer did not make a specific proposal regarding an offer to acquire AstraZeneca, but nevertheless Pfizer requested that both companies issue a joint statement, prior to the market open on 28 April 2014, announcing that they had entered into discussions regarding a combination. The Board of AstraZeneca considered this request and concluded that, absent a specific and attractive proposal, it was not appropriate to engage in discussions with Pfizer." On November 25, 2013, AstraZeneca said it received an initial contact from Ian Read on behalf of Pfizer, in which he proposed that the two companies discuss a combination. AstraZeneca said its Chairman "expressed confidence in AstraZeneca's prospects as an independent business." However, the company said it agreed to an exploratory meeting and subsequently met with Pfizer on January 5 in New York. At the meeting, Pfizer made a "preliminary and conditional proposal" regarding a possible offer for AstraZeneca. The proposal comprised GBP13.98 in cash and 1.758 Pfizer shares per AstraZeneca share, representing a value of GBP46.61 per AstraZeneca share, based on the closing price of Pfizer shares of $30.52 on January 3. The board of AstraZeneca concluded that the "Proposal very significantly undervalued AstraZeneca and its prospects." AstraZeneca said its board remains committed to executing the strategy announced in March 2013.
News For AZN;PFE From The Last 14 Days
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July 28, 2014
06:36 EDTPFEPfizer downgraded to Market Perform from Outperform at BMO Capital
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05:55 EDTPFEStocks with implied volatility movement; IGT PFE
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05:36 EDTAZNQIAGEN, AstraZeneca announce collaboration
QIAGEN (QGEN) announced a collaboration agreement with AstraZeneca (AZN) for the co-development and commercialization of a liquid biopsy-based companion diagnostic to be paired with IRESSA, AstraZeneca's targeted therapy for non-small cell lung cancer, or NSCLC. The project builds on a master framework agreement signed by both companies in 2013 and aims to develop and market a novel QIAGEN companion diagnostic that analyzes plasma samples to assess EGFR mutation status in NSCLC patients. The assay will be designed to guide the treatment of NSCLC patients with Astra Zeneca's oral monotherapy anti-cancer treatment when tumor tissue is not available. QIAGEN already offers the therascreen EGFR RGQ PCR Kit as a tissue-based companion diagnostic for lung cancer patients, which was approved in the U.S. by the FDA in July 2013 and in China in May 2014. The companies will collaborate to create a new companion diagnostic for IRESSA based on liquid biopsy samples from NSCLC patients, rather than requiring invasive surgical collection of tissue samples. Data from several studies, including the IFUM Study presented at the "World Lung 2013" conference, provided evidence of the ability to assess the EGFR status of advanced lung cancer patients using blood / plasma samples. This breakthrough provides hope for patients for whom surgical biopsy is not an option by enabling them to have their EGFR mutation status assessed using a less invasive method.
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."
July 22, 2014
16:18 EDTPFEPuma Biotech now responsible for R&D expenses associated with legacy trials
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05:25 EDTAZNAdams Express, MedImmune announce clinical trial partnership
Advaxis (ADXS) has entered into a clinical trial collaboration with MedImmune, the global biologics research and development arm of AstraZeneca (AZN). The Phase I/II immunotherapy study will evaluate the safety and efficacy of MedImmune's investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736, in combination with Advaxis' lead cancer immunotherapy vaccine, ADXS-HPV, as a treatment for patients with advanced, recurrent or refractory human papillomavirus, or HPV,-associated cervical cancer and HPV-associated head and neck cancer. Both MEDI4736 and ADXS-HPV are cancer immunotherapies, a new class of treatments that use the body's own immune system to help fight cancer. Under the terms of the agreement, MedImmune and Advaxis will evaluate the combination as a treatment for HPV-associated cervical cancer and squamous cell carcinoma of the head and neck. The Phase I part of the trial is expected to establish a recommended dose regimen of MEDI4736 with ADXS-HPV, and the Phase II portion will assess the safety and efficacy of the combination. The study will be funded and conducted by Advaxis. Results from the study will be used to determine whether further clinical development of this combination is warranted. Under the terms of the deal, MedImmune has a non-exclusive relationship with respect to HPV-driven tumour types. MedImmune has first right of negotiation for future development of combinations involving MEDI4736 and ADXS-HPV.
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 EDTAZN, PFETreasury 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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08:01 EDTAZNAlexion names former AstraZeneca CEO David Brennan to board
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07:59 EDTPFE, AZNTreasury 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.

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