Tag: Clinical Trials

Clinical trials are experiments or observations done in clinical research. Such prospective biomedical or behavioral research studies on human participants are designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. Clinical trials generate data on safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial – their approval does not mean that the therapy is ‘safe’ or effective, only that the trial may be conducted.

Novartis’ MS Treatment Met Endpoints in Two Studies

Novartis’ ofatumumab (OMB157) has achieved the primary endpoints in two phase III trials of relapsing multiple sclerosis (MS). The data from ASCLEPIOS I and II studies has demonstrated that ofatumu...

Roche OCREVUS Study Show Reduction of Disability Progression in Multiple Sclerosis

Roche announced longer-term data from the Phase III open-label extension studies of OPERA I, OPERA II and ORATORIO showed that patients who were treated with OCREVUS® (ocrelizumab) continuously for si...

Celgene Announces Results from Phase 3 Study of Investigational Therapy CC-486

celgene
Celgene Corporation announced top-line results from the international phase 3, randomized, double-blind, placebo-controlled study, QUAZAR AML-001. The study evaluated the efficacy and safety of inv...

Roche Presented Pivotal Phase III Study Results for Satralizumab

Roche presented full pivotal phase III study results for satralizumab as a monotherapy for neuromyelitis optica spectrum disorder (NMOSD), a rare, debilitating central nervous system disease. Resul...

BMS Announced Opdivo’s Long-Term Pooled Efficacy and Safety

bms
Bristol-Myers Squibb Company announced long-term pooled efficacy and safety results from the Phase 3 CheckMate -017 and CheckMate -057 studies in patients with previously treated advanced non-small ce...

Daiichi Sankyo Announced Results from Edoxaban Plus P2Y12 Inhibitor Study

Daiichi Sankyo Company, Limited announced results from ENTRUST-AF PCI, the first large randomised study to evaluate the efficacy and safety of once-daily edoxaban (brand name as LIXIANA®) plus a P2Y12...

AZ Announced Pozitive Results from Brilinta Trials

AstraZeneca announced detailed results from the positive Phase III THEMIS trial which showed Brilinta (ticagrelor) plus aspirin reduced the relative risk for the composite of cardiovascular (CV) death...

Roche’s Xofluza Reduce Risk of Flu after Contact with Infected Person

influenza vaccine
Roche announced that the phase III BLOCKSTONE study showed preventive treatment with XofluzaTM (baloxavir marboxil) after exposure to an infected household member significantly reduced the risk of peo...

Draft ICH Guideline on Clinical Trials Discussed at EMA

clinical-trials
The global guidance for the conduct of clinical trials is currently undergoing a major revision. As part of the worldwide consultation process, the International Council for Harmonisation of Technical...

Novartis Announced Positive Results for Ofatumumab Clinical Trials

Novartis, a global leader in neuroscience, announced positive results for ofatumumab (OMB157) from the Phase III ASCLEPIOS I and II studies. In both head-to-head studies, ofatumumab demonstrated su...

AstraZeneca Announced Positive Results from Phase III ETHOS Trial of Breztri Aerosphere

AstraZeneca announced positive results from the Phase III ETHOS trialfor triple-combination therapy Breztri Aerosphere, formerly PT010, in patients with moderate to very severe chronic obstructive pul...

FDA Encourages Drugmakers to Enroll Male Patients in Breast Cancer Clinical Trials

clinical trials
The US Food and Drug Administration (FDA) issued new draft guidance encouraging drugmakers to enroll male patients in breast cancer clinical trials. While men account for less than one percent of b...

GSK Announce Primary Objective in Belantamab Mafodotin Multiple Myeloma Trial

gsk
GlaxoSmithKline’s (GSK) immuno-conjugate belantamab mafodotin (GSK2857916) has achieved its primary objective in the multiple myeloma trial. The company has reported positive headline results f...

AstraZeneca Announced Final Results from Global Trial of Imfinzi

astrazeneca
AstraZeneca announced final overall survival (OS) results from the Phase III NEPTUNE trial, a randomised, open-label, multi-centre, global trial of Imfinzi (durvalumab) in combination with tremelimuma...

AstraZeneca Announced Positive Results from Phase III DAPA-HF Trial of Farxiga

astrazeneca
AstraZeneca announced positive results from the landmark Phase III DAPA-HF trial which showed that Farxiga (dapagliflozin) met the primary composite endpoint with a statistically-significant and clini...

Regeneron Pharmaceuticals Announced Positive Pivotal Phase 3 Results for Evinacumab

regeneron
Regeneron Pharmaceuticals, Inc. announced positive pivotal Phase 3 results for evinacumab, an investigational angiopoietin-like 3 (ANGPTL3) antibody, in patients with homozygous familial hypercholeste...