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News Breaks
April 10, 2014
06:17 EDTPFE, ACURAcura Pharma announces return of product rights from Pfizer
Acura Pharmaceuticals (ACUR) announced a letter agreement with Pfizer (PFE) providing for the termination of Pfizer's license to Acura's AVERSION Technology and the return to Acura of the FDA approved Oxecta product. The letter agreement provides that Acura will make a one-time payment of $2M to Pfizer. The license termination is effective April 9. The AVERSION Technology utilizes a proprietary mixture of inactive ingredients to discourage tampering of a product for abusive purposes.
News For ACUR;PFE From The Last 14 Days
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March 3, 2015
12:06 EDTPFEPfizer receives orphan status for lung cancer drug
The FDA granted Pfizer orphan status for its treatment of non-small cell lung cancer with EGFR, HER2, HER4, or DDR2 mutations, dacomitinib.
08:37 EDTPFEPfizer says EC approves expanded indication for Prevenar 13
Pfizer announced that the European Commission approved an expanded indication for the use of Prevenar 13 -- pneumococcal polysaccharide conjugate vaccine 13-valent, adsorbed -- for the prevention of pneumonia caused by the 13 pneumococcal serotypes in the vaccine in adults aged 18 years and older. The Summary of Product Characteristics has also been updated to include efficacy data from Pfizer’s Community-Acquired Pneumonia Immunization Trial in Adults, which demonstrated statistically significant reductions in first episodes of vaccine-type pneumococcal community-acquired pneumonia, including non-invasive/non-bacteremic CAP, and invasive pneumococcal disease in adults aged 65 and older.
March 2, 2015
16:32 EDTACURAcura Pharma reports Q4 EPS (6c), consensus (9c)
For the twelve months ended December 31, Acura recorded $0.5M in license fee revenue and $0.2M in net product sales from NEXAFED as compared with $0.1M in net product sales from NEXAFED in the same period in 2013. In the fourth quarter of 2014, the Company shipped $0.2M of NEXAFED but has recognized only a portion of those shipments to customers until the right of return no longer exists or adequate history and information becomes available to estimate product returns. At December 31, the company has deferred the recognition of $0.4M in NEXAFED revenue and $0.2M in related cost of sales.
16:31 EDTPFEPfizer files automatic mixed securities shelf
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09:02 EDTPFEAstraZeneca mulls linking bonuses to Pfizer defense pledges, Sunday Times says
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February 27, 2015
09:58 EDTACUROn The Fly: Analyst Upgrade Summary
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06:27 EDTACURAcura Pharma upgraded to Buy from Hold at MLV & Co.
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February 26, 2015
12:31 EDTPFEPfizer says CDC recommends serogroup B meningococcal vaccine for those at risk
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February 24, 2015
08:07 EDTPFEPfizer announces Trumenba studies met primary objectives
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February 20, 2015
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 EDTPFEAbbVie replaces Pfizer as top global pharma pick at Jefferies
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February 19, 2015
18:25 EDTPFEPiper 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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07:12 EDTPFEWharton Health Care Club to hold a conference
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