Kosher Certifications, Biologic License Applications, Positive Study Results, Development Programs, and Product Acquisitions - Analyst Notes on Pfizer, Novartis, Sanofi, Zogenix and Impax
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NEW YORK, July 7, 2014 /PRNewswire/ --
Today, Analysts Review released its analysts' notes regarding Pfizer Inc. (NYSE: PFE), Novartis AG (NYSE: NVS), Sanofi (NYSE: SNY), Zogenix, Inc. (NASDAQ: ZGNX) and Impax Laboratories Inc. (NASDAQ: IPXL). Private wealth members receive these notes ahead of publication. To reserve complementary membership, limited openings are available at: http://www.analystsreview.com/4487-100free.
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Pfizer Inc. Analyst Notes
On July 1, 2014, Pfizer Inc. (Pfizer) announced that it has received kosher certification to ELELYSO ™ (taliglucerase alfa) by the Orthodox Union (OU). Pfizer informed that ELELYSO is an enzyme replacement therapy (ERT) for the long-term treatment of adults with a confirmed diagnosis of Type 1 Gaucher disease. According to the Company, ELELYSO is the first prescription medication to be certified kosher by the OU. "Type 1 Gaucher disease is a rare disease, most frequently found among individuals of Ashkenazi Jewish descent, which has a significant impact on patients and their families," said Rory O'Connor, Pfizer's Senior Vice President, Head of Global Medical Affairs, Innovative Pharma Business. "This certification reflects Pfizer's commitment to all patients suffering from Type 1 Gaucher disease." The full analyst notes on Pfizer are available to download free of charge at:
http://www.analystsreview.com/Jul-07-2014/PFE/report.pdf
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Novartis AG Analyst Notes
On June 17, 2014, Novartis AG (Novartis) announced that it has submitted a Biologic License Application (BLA) to the US Food and Drug Administration (FDA) for marketing approval for the use of Bexsero® that helps protect adolescents and young adults from 10 years through 25 years of age against invasive meningococcal disease caused by serogroup B (meningitis B). "Bexsero is the result of 20 years of groundbreaking research and a testament to our leadership in preventing rare but devastating diseases," said Andrin Oswald, Division Head, Novartis Vaccines. "With today's submission, we are one step closer to ensuring that no family in the US has to endure the loss of a loved one from vaccine-preventable meningitis." The Company's submission initiates a rolling submission process for Bexsero to the FDA, following the receipt of a Breakthrough Therapy designation in April 2014. The full analyst notes on Novartis are available to download free of charge at:
http://www.analystsreview.com/Jul-07-2014/NVS/report.pdf
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Sanofi Analyst Notes
On June 14, 2014, Sanofi announced positive phase 3 results for Toujeo ® (insulin glargine [rDNA origin] injection, 300 U/mL). The study results consistently showed significantly fewer low blood sugar events (hypoglycemia) at any time of day, including night-time events, compared with Lantus® (insulin glargine [rDNA origin] injection, 100 U/mL). "Toujeo has been recently accepted for review by EMA and this important milestone is another step forward in expanding our insulin portfolio," said Pierre Chancel, Senior Vice President, Global Diabetes Division, Sanofi. "We continue to be encouraged by the positive Phase 3 results from EDITION, which demonstrated the potential of Toujeo to help meet unmet needs of people living with diabetes." Toujeo is the intended trade name for insulin glargine [rDNA origin] injection, 300 U/mL; formerly abbreviated as "U300". According to the Company, U300 is not currently approved or licensed anywhere in the world. The full analyst notes on Sanofi are available to download free of charge at:
http://www.analystsreview.com/Jul-07-2014/SNY/report.pdf
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Zogenix, Inc. Analyst Notes
On July 2, 2014, Zogenix, Inc. (Zogenix) announced updates on its development programs focused on the introduction of abuse deterrent formulations of Zohydro® ER (hydrocodone bitartrate) Extended-Release Capsules, CII. The Company stated that Zohydro ER is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Zogenix plans to file a supplemental new drug application (sNDA) by October 2014 for a next-generation formulation of Zohydro ER Extended-Release Capsules designed to make it more difficult to abuse by injection or nasal administration. Zogenix added that if approved, this new formulation could be available to prescribers in early 2015. The full analyst notes on Zogenix are available to download free of charge at:
http://www.analystsreview.com/Jul-07-2014/ZGNX/report.pdf
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Impax Laboratories Inc. Analyst Notes
On July 2, 2014, Impax Laboratories, Inc. (Impax) announced that it has acquired two generic products from Actavis plc for cash consideration pursuant to a Purchase Agreement and a Supply Agreement. The acquisition includes Ursodiol tablet, which is marketed under an Abbreviated New Drug Application (ANDA), and Lamotrigine orally disintegrating tablet (ODT), which is approved ANDA that is not yet marketed. "The acquisition of these products from Actavis is just one example of our ongoing strategy of expanding our product offerings and portfolio with strategic business development projects," said Fred Wilkinson, President and CEO of Impax, "Successful implementation of our M&A and business development activities should complement our internal development programs and provide further long term growth for the Company." The full analyst notes on Impax are available to download free of charge at:
http://www.analystsreview.com/Jul-07-2014/IPXL/report.pdf
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