Articles From: FDA Approves Genzyme’s Cerdelga™ (eliglustat) Capsules to Federal Appeals Court Confirms That Acacia's Device Profiling Patent is Invalid


Genzyme , a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today that the U.S. Food and Drug Administration (FDA) has approved Cerdelga™ (eliglustat) capsules, the only first-line oral therapy for certain adult Gaucher disease type 1 patients.
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Third product from the BI-Lilly Diabetes alliance to be approved by FDA RIDGEFIELD, Conn.
Sign-up for FDA approves Jardiance® (empagliflozin) tablets for adults with type 2 diabetes investment picks
NPS Pharmaceuticals, Inc. (NASDAQ:NPSP), a global biopharmaceutical company pioneering and delivering therapies that transform the lives of patients with rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved updated labeling for Gattex® (teduglutide [rDNA origin]) for injection to include long-term data from the STEPS 2 study of adult patients with Short Bowel Syndrome (SBS). The data demonstrate that patients who continued Gattex treatment beyond two years achieved clinically meaningful reductions in parenteral support requirements, including volume and days off, with 13 out of 88 patients across all groups achieving complete independence.
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Approval aligns with Centers for Disease Control and Prevention's recommendations for meningococcal vaccination SWIFTWATER, Pa.
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NeuroMetrix, Inc. (Nasdaq: NURO) today announced that its wearable technology for treatment of chronic pain received 510(k) clearance (K140333) from the U.S. Food and Drug Administration (FDA) for over-the-counter use.
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Schedule for study completion remains unaffected Company anticipates submission of NDA by year end 2014 THE WOODLANDS, Texas, July 16, 2014 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc. ® (Nasdaq:RPRX) today announced it has received additional guidance from the FDA regarding primary endpoints for the two studies, ZA-304 and ZA-305, that it is currently conducting comparing Androxal ® to the leading approved testosterone gel and placebo.
Sign-up for FDA Confirms Sperm and Testosterone Endpoints as Key Parameters for Assessment of Androxal(R) Versus Approved Topical Gel and Placebo investment picks
http://at.marketwire.com/accesstracking/AccessTrackingLogServlet?PrId=1142090&ProfileId=051205&sourceType=1 AMES, IA --
Sign-up for FDA Gives NewLink Genetics Approval to Proceed to Phase 1 Clinical Studies of Their Ebola Vaccine investment picks
Aradigm Corporation (Nasdaq:ARDM) (the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its lead product candidate, Pulmaquin®, for treatment of non-cystic fibrosis bronchiectasis (non-CF BE) patients with chronic lung infections with Pseudomonas aeruginosa .
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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental Biologics License Application (sBLA) and granted Priority Review for Avastin ® (bevacizumab) plus chemotherapy for the treatment of women with persistent, recurrent or metastatic cervical cancer.
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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental Biologics License Application (sBLA) and granted Priority Review for Avastin ® (bevacizumab) plus chemotherapy for the treatment of women with recurrent platinum-resistant ovarian cancer.
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Alexion Pharmaceuticals (Nasdaq:ALXN) today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to Soliris® (eculizumab) for the treatment of patients with Myasthenia Gravis (MG), a rare, debilitating neurologic disorder caused by uncontrolled complement activation.
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Starpharma Holdings Ltd (ASX:SPL) (OTCQX:SPHRY) today announced that the US Food and Drug Administration (FDA) has granted Special Protocol Assessment (SPA) agreement on the design and planned analyses of the phase 3 clinical studies of the VivaGel ® bacterial vaginosis (BV) product for the prevention of recurrent BV.
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Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, announced today that the U.S. Food and Drug Administration (FDA) has granted Accelerated Approval of Beleodaq™ for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on Tumor Response Rate and Duration of Response .
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INDIANAPOLIS and RIDGEFIELD, Conn.
Sign-up for FDA Grants Tentative Approval for Lilly and Boehringer Ingelheim's Basaglar™ (insulin glargine injection) investment picks
VANCOUVER, British Columbia, Aug.
Sign-up for FDA Modifies Tekmira's TKM-Ebola Clinical Hold to Partial Hold investment picks
HAYWARD, Calif.
Sign-up for FDA Performs Inspection of Impax's Hayward Facility investment picks
HAYWARD, Calif.
Sign-up for FDA Performs Inspection of Impax's Taiwan Facility investment picks
NPS Pharmaceuticals, Inc. (NASDAQ:NPSP), a global biopharmaceutical company pioneering and delivering therapies that transform the lives of patients with rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has posted briefing materials for the September 12 Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) meeting to review the company’s Biologics License Application (BLA) for Natpara® (rhPTH[1-84]). Natpara is a bioengineered replacement therapy for endogenous parathyroid hormone (PTH) that NPS Pharma has developed for the treatment of Hypoparathyroidism, a rare endocrine disorder characterized by insufficient levels of PTH.
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REDWOOD CITY, Calif., Sept.
Sign-up for FDA Removes Partial Clinical Hold on OncoMed's Ipafricept investment picks
2014/7/9
Febreze® has teamed up with actor and comedian Jane Lynch to shed light on a naturally occurring condition that affects many but is rarely discussed in polite company: noseblindness.
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2014/6/24
WASHINGTON (MarketWatch) -- The Federal Reserve on Tuesday announced that it has given Citigroup Inc. six more months to resubmit a revised capital plan.
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WASHINGTON (MarketWatch) -- The Federal Reserve said Wednesday it has no objections to the stree-test capital plan submitted by Bank of America Corp.
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2014/8/28
By Michael S.
Sign-up for Fed Presidents Lockhart And Fisher Were Active Personal Asset Traders In 2013 investment picks
2014/6/25
WASHINGTON (MarketWatch) -- Some U.S. banks still seem to be in the dark about the riskiness of their businesses, said Federal Reserve Governor Daniel Tarullo on Wednesday.
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FREMONT, Calif., July 15, 2014 (GLOBE NEWSWIRE) -- Electronics For Imaging, Inc. (Nasdaq:EFII) , a world leader in customer-focused digital printing innovation, announced another key victory in a patent troll case filed against the company.
Sign-up for Federal Appeals Court Confirms That Acacia's Device Profiling Patent is Invalid investment picks
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Articles From: FDA Approves Genzyme’s Cerdelga™ (eliglustat) Capsules to Federal Appeals Court Confirms That Acacia's Device Profiling Patent is Invalid
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