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July 1, 2014
11:16 EDTACT, PFE, AZNActavis represents good takeover alternative for Pfizer, says Leerink
Leerink believes Actavis (ACT), post its buyout of Forest Labs, represents a good takeover alternative to AstraZeneca (AZN) for Pfizer (PFE). The firm says Actavis is one of the few pharma companies that meets the financial criteria necessary for Pfizer to accomplish a tax inversion. Leerink believes such a combination would be compelling.
News For ACT;PFE;AZN From The Last 14 Days
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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."
July 23, 2014
10:02 EDTACTOn The Fly: Analyst Initiation Summary
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08:10 EDTACTDeutsche 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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16:09 EDTACTActavis initiated with a Buy at Deutsche Bank
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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 21, 2014
16:36 EDTACTActavis and Medicines360 announce FDA acceptance of Levosert NDA
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July 17, 2014
15:42 EDTACTDepomed says Actavis preliminarily enjoined from marketing generic Gralise
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08:08 EDTPFEBristol-Myers, Pfizer announce enrollment in Phase IV EMANATE trial for Eliquis
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July 16, 2014
11:28 EDTACTLeon Cooperman gives 12 stock picks at CNBC conference
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11:16 EDTACTCooperman lists Actavis, Citigroup, KKR among top-picks, CNBC says
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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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09:12 EDTACTLeerink healthcare analyst holds an analyst/industry conference call
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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.
July 11, 2014
16:31 EDTACTActavis confirms generic Diclegis patent challenge
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