NDA Submission, Results Release Schedules, FDA Grants and Approvals, and Agreements - Analyst Notes on Gilead, Biogen Idec, Amgen, Illumina and MannKind - WBOY.com: Clarksburg, Morgantown: News, Sports, Weather

NDA Submission, Results Release Schedules, FDA Grants and Approvals, and Agreements - Analyst Notes on Gilead, Biogen Idec, Amgen, Illumina and MannKind

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NEW YORK, July 4, 2014 /PRNewswire/ --

Today, Analysts Review released its analysts' notes regarding Gilead Sciences, Inc. (NASDAQ: GILD), Biogen Idec Inc. (NASDAQ: BIIB), Amgen, Inc. (NASDAQ: AMGN), Illumina, Inc. (NASDAQ: ILMN) and MannKind Corporation (NASDAQ: MNKD). Private wealth members receive these notes ahead of publication. To reserve complementary membership, limited openings are available at: http://www.analystsreview.com/4444-100free.

Gilead Sciences, Inc. Analyst Notes
On June 27, 2014, Gilead Sciences, Inc. (Gilead) announced that it has submitted a New Drug Application (NDA) to Japan's Pharmaceutical and Medical Devices Agency (PMDA) for approval of sofosbuvir, a once-daily nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C virus (HCV) infection. The data in the NDA support the use of sofosbuvir with ribavirin (RBV) for 12 weeks in patients with genotype 2 HCV infection. "There is an urgent need in Japan for new HCV treatment options that are more effective, well-tolerated and simpler for patients," said Norbert Bischofberger, PhD, Executive Vice President of Research and Development and Chief Scientific Officer at Gilead. "Based on Phase 3 studies, we believe that sofosbuvir has the potential to provide high cure rates among genotype 2 patients in just 12 weeks of interferon-free therapy." The full analyst notes on Gilead are available to download free of charge at:


Biogen Idec Inc. Analyst Notes
On June 30, 2014, Biogen Idec Inc. (Biogen Idec) announced that it intends to report its Q2 2014 financial results on July 23, 2014, before the financial markets open. Following the results release, the Company will also host a conference call at 9:00 am ET to discuss its performance. The full analyst notes on Biogen Idec are available to download free of charge at:


Amgen, Inc. Analyst Notes
On July 1, 2014, Amgen, Inc. (Amgen) announced that the FDA has granted Breakthrough Therapy Designation to the Company's investigational bispecific T cell engager (BiTE) antibody blinatumomab. The Company informed that FDA's Breakthrough Therapy Designation was based on the results of a Phase 2 trial of 189 adult patients with Philadelphia-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL) treated with blinatumomab. "There is a high unmet need for new medicines to treat relapsed and refractory ALL patients, who have very few treatment options," said Sean E. Harper, M.D., Executive Vice President of Research and Development at Amgen. "The results from the Phase 2 trial evaluating blinatumomab in adult patients with relapsed or refractory ALL are encouraging and provide a strong basis for a regulatory filing later this year and potential approval in this serious disease." The full analyst notes on Amgen are available to download free of charge at:


Illumina, Inc. Analyst Notes
On June 30, 2014, Illumina, Inc. (Illumina) announced that it has entered into separate agreements with Biomnis, Genoma, and the Center for Human Genetics and Laboratory Diagnostics Martinsried, under which they will use the HiSeq 2500 and consumables from Illumina to develop and perform non-invasive prenatal testing (NIPT). "These agreements are another step in establishing Illumina as a global leader in reproductive and genetic health solutions and as a valued partner for NGS-based testing across a broad range of clinical applications," said Tristan Orpin, Senior Vice President and General Manager of Reproductive and Genetic Health at Illumina. The full analyst notes on Illumina are available to download free of charge at:


MannKind Corporation Analyst Notes
On June 27, 2014, MannKind Corporation (MannKind) announced that it has received FDA approval for AFREZZA (insulin human) Inhalation Powder to improve glycemic control in adult patients with diabetes mellitus. "We are excited for patients, as we believe that AFREZZA's distinct profile and non-injectable administration will address many of their unmet needs for mealtime insulin therapy, and has the potential to change the way that diabetes is treated. We thank the more than 6,500 adult patients and healthy volunteers who participated in the AFREZZA clinical program," said Alfred Mann, CEO of MannKind. The full analyst notes on MannKind are available to download free of charge at:


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