Clinical Trials (Phase III)
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With the positive results from this trial, as well as an earlier Phase III trial, Myovant Sciences plans to seek regulatory approval later this year.
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In the trial, 396 patients with moderate-to-severe psychotic symptoms related to adult schizophrenia received either Nuplazid or placebo added to their current antipsychotic treatment. The patients receiving Nuplazid showed a consistent trend in symptom improvement but did not hit statistical sig...
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At 96 weeks, 60% of the heavily pretreated HIV patients dosed with ViiV's experimental treatment achieved virologic suppression.
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While the trial did not hit its goals, Intec said data review has shown that certain subsets of patients saw a meaningful reduction in OFF time.
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Clinical Catch-up for July 15-19
7/22/2019
Here's a look at the top clinical trial news from last week, with updates from Neon, GSK, Biohaven, and more. -
Takeda will release complete Phase III data at a future scientific conference and is planning on seeking regulatory approval for the investigational formulation.
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IMFINZI® (durvalumab) US Label Updated With Overall Survival Data in Unresectable, Stage III Non-small Cell Lung Cancer
7/22/2019
AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved the inclusion of overall survival (OS) data from the Phase III PACIFIC trial in an update to the IMFINZI®
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ACADIA Pharmaceuticals Announces Top-line Results from Phase 3 ENHANCE Trial of Pimavanserin as Adjunctive Treatment for Patients with Schizophrenia
7/22/2019
ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD), today announced top-line results from its Phase 3 ENHANCE study, which evaluated pimavanserin as an adjunctive treatment in adult schizophrenia patients with persistent inadequate response to their current antipsychotic therapy.
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CytRx Corporation Highlights Arimoclomol Licensee Orphazyme A/S Completes Enrollment in its Phase 3 Clinical Trial of Arimoclomol in Amyotrophic Lateral Sclerosis
7/22/2019
Enrollment Completed Ahead of Schedule CytRx Eligible to Receive up to $120 Million in Future Milestones, Plus Royalties, From Arimoclomol Licensing Agreement
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Gilead Presents New Data on Biktarvy® for the Treatment of HIV in Women and in Virologically Suppressed Patients With Known Resistance
7/22/2019
Gilead Sciences, Inc. (NASDAQ: GILD) today presented findings from two Phase 3 trials – a trial demonstrating the effectiveness of switching to Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg tablets
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ViiV Healthcare presents positive 96-week data from phase III study of investigational fostemsavir in heavily treatment-experienced patients with HIV at IAS 2019
7/22/2019
ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced positive Week 96 results from the phase III BRIGHTE study of investigational fostemsavir in heavily treatment-experienced adults with HIV-1 infection.
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Intec Pharma Reports Top-Line Phase 3 Trial Results of Accordion Pill-Carbidopa/Levodopa in Advanced Parkinson's Disease Patients
7/22/2019
Intec Pharma Ltd. announces top-line data from the Company's pivotal Phase 3 trial evaluating the safety and efficacy of the Accordion Pill®-Carbidopa/Levodopa compared with immediate release CD/LD as a treatment for the symptoms of advanced Parkinson's disease.
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In its third installment of the Good Pharma Scorecard, Roche and Novo Nordisk scored perfect marks in overall trial transparency, while Johnson & Johnson slipped from the high spot on the previous ranking.
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With the latest major Phase 3 failure of Biogen and Eisai’s beta-amyloid-targeting antibody drug aducanumab, researchers are increasingly turning to other drug targets for Alzheimer’s disease.
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MyoKardia Announces HCM Program Updates: Accelerates Timing for Mavacamten Topline Phase 3 Data; Re-acquires U.S. Royalty Rights to HCM Programs from Sanofi
7/18/2019
MyoKardia, Inc. announced updates related to its hypertrophic cardiomyopathy treatment portfolio, including lead therapeutic candidate, mavacamten.
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Orphazyme Completes Enrollment In Phase 3 Trial Evaluating Arimoclomol In Amyotrophic Lateral Sclerosis
7/18/2019
Orphazyme A/S (ticker: ORPHA.CO), a biopharmaceutical company dedicated to developing treatments for patients living with rare diseases, today announces that it has completed enrollment in its phase 3 trial evaluating arimoclomol for the treatment of Amyotrophic Lateral Sclerosis (ALS) ahead of schedule.
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PMZ-1620, an Endothelin-B Agonist, enters Phase III Trial in Patients with Cerebral Ischemic Stroke
7/18/2019
Pharmazz, Inc., today announced that it has received permission to initiate a prospective, multicentric, randomized, double-blind, parallel, phase III clinical study to assess efficacy of PMZ-1620 along with standard treatment in patients of acute ischemic stroke in India.
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Lysogene Establishes Scientific Advisory Board with International Experts in CNS Gene Therapy
7/18/2019
Lysogene (Paris:LYS) (FR0013233475 – LYS), a leading, Phase 3, biopharmaceutical company pioneering gene therapy technologies to treat central nervous system (CNS) diseases, today announced the formation of a Scientific Advisory Board (SAB) comprised of world-leading experts in gene therapy discovery and development
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Polyphor closes the Phase III PRISM studies of murepavadin intravenous formulation and evaluates further product improvement options
7/17/2019
Polyphor announced that it has decided to close the Phase III PRISM MDR and UDR studies of murapavadin intravenous for hospital-acquired and ventilator-associated bacterial pneumonia which have been put on a voluntary temporary hold on May 9th, 2019.
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AM-Pharma Raises €116m [$133m] to Conduct Pivotal Phase III Trial of recAP in Acute Kidney Injury
7/16/2019
Financing co-led by new investors LSP and Andera Partners, with participation of existing investors Forbion, Ysios Capital, Kurma Partners, ID Invest Partners, BB Pureos Bioventures and Gilde Healthcare