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Phase 3 study
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NASDAQ: ISIS Provided an Update on Its Ongoing Open Label, Multiple Dose Phase 2 Study
Feb 27, 2014Isis Pharmaceuticals, Inc. (NASDAQ: ISIS) today provided an update on its ongoing open label, multiple dose Phase 2 study of ISIS-SMNRx in infants with spinal muscular atrophy (SMA). To date, all four infants in the 6 mg cohort have been ...
Tags: ISIS, SMA, Infant, respiratory assistance
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Mannkind Has Completed The Phase 3 Clinical Study of Afrezza
Jun 4, 2013MannKind has completed the Phase 3 clinical study of Afrezza (insulin human [rDNA origin]) in patients with type 1 diabetes and expects to release the data in the summer of 2013. Administered using MannKind's next-generation inhaler, the ...
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Basilea Pharmaceutica Has Obtained FDA Orphan Drug Status to isavuconazole
May 29, 2013Basilea Pharmaceutica has obtained FDA orphan drug status to isavuconazole, an investigational intravenous and oral broad-spectrum antifungal, for the treatment of invasive aspergillosis. Isavuconazole is being investigated in phase 3 ...
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Pfizer Has Received Breakthrough Therapy Designation From The U.S FDA
Apr 15, 2013Pfizer has received breakthrough therapy designation from the United States Food and Drug Administration (FDA) for its investigational compound Palbociclib, a potential treatment for patients with breast cancer. The breakthrough therapy ...
Tags: Cancer Drug, Pfizer, Therapy Designation
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Nymox Has Reported New Positive Data From Phase 3 Study for Benign Prostatic Hyperplasia
Jan 25, 2013Nymox Pharmaceutical has reported new positive data from Phase 3 study, designed to evaluate the safety and efficacy of the reinjection of NX-1207 for benign prostatic hyperplasia (BPH). The NX02-0020 study participants included 192 ...
Tags: Nymox Pharmaceutical, BPH, Phase 3 study
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The USFDA Has Accepted for Filing Astellas Pharma's Supplemental New Drug Application
Jan 18, 2013The USFDA has accepted for filing Astellas Pharma's supplemental new drug application (sNDA) for Tarceva (erlotinib) tablets for a genetically distinct form of advanced lung cancer. Astellas is seeking approval to use Tarceva as the ...
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Japan Tobacco Has Filed a New Drug Application for The Marketing Approval
Jan 9, 2013Japan Tobacco (JT), Keryx Biopharmaceuticals' Japanese partner, has filed a new drug application (NDA) for the marketing approval of Ferric Citrate (Zerenex) in Japan for the treatment of hyperphosphatemia in chronic kidney disease (CKD) ...
Tags: Ferric Citrate, Tobacco, CKD, Pharmaceutical
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mCRPC Has Won FDA Approval for Use in Patients Who Have Not Received Chemotherapy
Dec 11, 2012Janssen's Zytiga indicated for metastatic castration-resistant prostate cancer(mCRPC),has won FDA approval for use in patients who have not received chemotherapy. The oral,once-daily medication was previously used in combination with ...
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Janssen Research & Development Has Submitted Supplemental New Drug Applications
Dec 5, 2012Janssen Research & Development has submitted supplemental New Drug Applications (sNDAs) to the US Food and Drug Administration (FDA) for the use of Xarelto (rivaroxaban), an oral anticoagulant. Janssen said the drug is used to treat ...
Tags: Xarelto, rivaroxaban, DVT, pulmonary embolism, VTE
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Keryx Biopharmaceuticals Has Reported a Net Loss of $5.47m for The Third Quarter
Nov 29, 2012Keryx Biopharmaceuticals has reported a net loss of $5.47m, or $0.08 per share, for the third quarter ended 30 September 2012 compared to a net loss of $10.25m, or $0.15 per share, for the third quarter ended 30 September 2011. Operating ...
Tags: Net Loss, Biopharmaceuticals, top-line data
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Insmed Has Dosed First Cystic Fibrosis (CF) Patient in The Clinical Evaluation
Nov 28, 2012Insmed has dosed first Cystic Fibrosis (CF) patient in the Clinical Evaluation of ARIKACE (CLEAR-108) phase 3 study of Arikace (liposomal amikacin for inhalation) in Europe. CLEAR-108 is a 300-patient randomized phase 3 trial comparing ...
Tags: Study of Arikace, pulmonary function, open-label safety study
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InSite Vision Has Started The Patient Enrollment for ISV-303
Nov 28, 2012Ophthalmologic products provider, InSite Vision has started the patient enrollment for the first Phase 3 clinical trial of BromSite (ISV-303), which is used to reduce pain and inflammation post cataract surgery. The study will enroll ...
Tags: Insite Vision, BromSite Phase 3 Study, Ophthalmologic products
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FDA Accepted to Review Ferring Pharmaceuticals' NDA for Review
Oct 24, 2012The US Food and Drug Administration (FDA) has accepted to review Ferring Pharmaceuticals' new drug application (NDA) of controlled release misoprostol vaginal insert (MVI) for decreasing time to vaginal delivery in women with an unfavorable ...
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Ziopharm Oncology's Palifosfamide (ZIO-201) Recieves Patent No. 8,232,262 From USPTO
Aug 3, 2012The US Patent and Trademark Office (USPTO) has granted patent No. 8,232,262 to Ziopharm Oncology's palifosfamide (ZIO-201). The patent covers palifosfamide compositions, formulations, methods of use and methods of manufacture, which now ...
Tags: USPTO, patent, Palifosfamide, cancer treatment drug
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