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Tolerability
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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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Patients with Advanced Renal Cell Carcinoma Are on and off Treatment
Feb 27, 2014By Sara Freeman, medwireNews Reporter mewireNews: Shortening the time that patients with advanced renal cell carcinoma are on and off treatment with sunitinib improves the drug’s overall tolerability without affecting its efficacy, ...
Tags: ORR, Tolerability, PFS, Sunitinib
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Purified Cannabinoid Is Effective in Treating Severe Forms of Childhood Epilepsy
Feb 25, 2014A new international multi-center study led by researchers from UCSF Benioff Children's Hospital is the first to evaluate whether purified cannabinoid is effective in treating severe forms of childhood epilepsy that do not respond to ...
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A Study Is The First to Evaluate Whether Purified Purified Cannabinoid Is Effective
Feb 14, 2014A new international multi-center study led by researchers from UCSF Benioff Children's Hospital is the first to evaluate whether purified cannabinoid is effective in treating severe forms of childhood epilepsy that do not respond to ...
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Teva and Active Biotech Have Announced That Both Companies Remain
Feb 10, 2014Teva Pharmaceutical Industries and Active Biotech have announced that both companies remain committed to the Nerventra(laquinimod)clinical development program for multiple sclerosis(MS)following the announcement of a negative opinion for ...
Tags: Medicine, clinical studies, Nerventra
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Omeros Corporation Announced Positive Results From a Phase 2A Clinical Trial of OMS824
Feb 7, 2014Omeros Corporation (NASDAQ: OMER) today announced positive results from a Phase 2a clinical trial of OMS824, the company's phosphodiesterase 10 (PDE10) inhibitor, in which the drug was well tolerated and demonstrated comparable systemic ...
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Medac Pharma Has Reported FDA Acceptance of a NDA for Its Lead Product Candidate
Feb 7, 2014US-based Medac Pharma has reported the US Food and Drug Administration (FDA) acceptance of a new drug application (NDA) for its lead product candidate, MPI-2505, a subcutaneous injectable methotrexate (MTX) in a ready-to-use injection ...
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Teva Pharmaceuticals Received Approval for sNDA for Three-Times-a-Week COPAXONE 40mg/mL
Feb 7, 2014Teva Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for its supplemental new drug application (sNDA) for three-times-a-week COPAXONE 40mg/mL, a new dose of COPAXONE. COPAXONE (glatiramer acetate ...
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The Drug Inosine May Be a Safe and Effective Way to Raise Levels of Urate
Dec 31, 2013The drug inosine may be a safe and effective way to raise levels of urate -- a metabolism byproduct -- in patients with early Parkinson's, U.S. researchers say. Lead investigator Dr. Michael Schwarzschild of Massachusetts General Hospital ...
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United Therapeutics Obtained an Approval From FDA for Orenitram Extended-Release Tablets
Dec 24, 2013US-based biotechnology company United Therapeutics has obtained an approval from the US Food and Drug Administration (FDA) for the Orenitram (treprostinil) extended-release tablets, indicted for the treatment of pulmonary arterial ...
Tags: Extended-Release Tablets, Medicine
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Sanofi Has Released Results of a 24-Week Phase Iiib Clinical Trial
Dec 9, 2013Sanofi has released results of a 24-week Phase IIIb clinical trial showing that Lyxumia (lixisenatide) met the primary endpoint of non-inferiority in blood sugar lowering (HbA1c) when administered to patients either before breakfast or the ...
Tags: Diabetes Drug, Medicine
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Baxter Filed an Amended BLA to Re-Start Review Process to Treat Adult Patients with PI
Dec 5, 2013Baxter International has filed an amended biologics license application (BLA) to the US Food and Drug Administration (FDA) to re-start the review process for approval of HyQvia facilitated subcutaneous infusion to treat adult patients with ...
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The US FDA Has Approved Vifor Pharma's Hyperphosphatemia Drug Velphoro
Dec 3, 2013The US Food and Drug Administration (FDA) has approved Vifor Pharma's hyperphosphatemia drug Velphoro for the control of serum phosphorus levels in patients with Chronic Kidney Disease (CKD) on dialysis. Approval of Velphor, which is an ...
Tags: Drug, phosphate binder
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VBL Therapeutics Has Secured Fast Track Status From The US FDA
Nov 29, 2013VBL Therapeutics has secured fast track status from the US Food and Drug Administration (FDA) for its lead oncology drug VB-111, for prolongation of survival in patients with Recurrent Glioblastoma Multiforme (rGBM). VB-111 was already ...
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FDA Has Approved Merck's Noxafil 100 Mg Delayed-Release Tablets.
Nov 29, 2013The US Food and Drug Administration (FDA) has approved Merck's Noxafil (posaconazole) 100 mg delayed-release tablets. The tablets are a new formulation with a loading dose of 300mg (three 100mg delayed-release tablets) twice daily on the ...