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Alnylam announces positive results from Phase 3 Study of givosiran for treating acute hepatic porphyria

Alnylam Pharmaceuticals, Inc., the leading RNAi therapeutics company, announced today positive topline results from the interim analysis of the ENVISION Phase 3 Study of givosiran, an investigational RNAi therapeutic targeting aminolevulinic acid synthase 1 for the treatment of acute hepatic porphyria.

27 Sep 2018

Decibel obtains exclusive license to commercialize ORC-13661 for preventing hearing, balance disorders

Decibel Therapeutics and Oricula Therapeutics today announced that Decibel has obtained an exclusive, worldwide license to the development and commercialization of ORC-13661, an oral medication developed by Oricula Therapeutics for the prevention of hearing loss and balance disorders that can occur following treatment of severe infections with aminoglycoside antibiotics.

27 Sep 2018

Brigatinib drug may offer first-line treatment option for ALK-positive NSCLC

Results of a 275-patient, multi-national phase III clinical trial known as ALTA-1L published today in the New England Journal of Medicine and presented concurrently in the press program at the International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer 2018 argue for brigatinib as a first-line treatment option for advanced ALK-positive non-small cell lung cancer.

26 Sep 2018

New TB vaccine effective in half of the population in phase II trials

GlaxoSmithKline has come up with an experimental vaccine against tuberculosis (TB) that has shown effective prevention of the infection in half of the population it has been administered to. This could be a breakthrough in preventing the killer disease say researchers since most of the recent vaccines developed against the disease have failed to show efficacy.

26 Sep 2018

Cerevance starts dosing in Phase I clinical trial of CVN424 for treatment of Parkinson's disease

Cerevance, a clinical-stage drug discovery and development company focused on brain diseases, today announced the start of dosing in a Phase I first-in-human clinical trial of CVN424, an oral compound being developed for symptomatic treatment of Parkinson's disease.

25 Sep 2018

Phase 1 and 2 clinical trials of entrectinib drug in ROS1-positive NSCLC show promising results

Results of phase 1 and phase 2 clinical trials of the drug entrectinib in ROS1-positive non-small cell lung cancer presented on the press program of the International Association for the Study of Lung Cancer 19th World Conference on Lung Cancer show a response rate of 77.4 percent for 53 patients evaluable for response, with median duration of response of 24.6 months.

25 Sep 2018

Clinical trial investigators found non-compliant with requirement to report results on EU register

According to EU legislation, clinical trials must be prospectively registered in the European Union Clinical Trials Register and the main results must be reported there one year after completion of the trial. This information is thus publicly available.

25 Sep 2018

Lumos acquires license for LUM-201 drug that promotes secretion of growth hormone

Lumos Pharma, Inc., a clinical stage biopharmaceutical company focused on development and commercialization of therapeutics for rare and neglected diseases, today announced that it has acquired the license for LUM-201, an investigational orally administered small molecule that promotes secretion of growth hormone from the pituitary gland, from Ammonett Pharma LLC.

24 Sep 2018

Alexion announces positive results from Phase 3 PREVENT study of Soliris in patients with NMOSD

Alexion Pharmaceuticals, Inc. today announced positive topline results from the Phase 3 PREVENT study of Soliris in patients with anti-aquaporin-4 auto antibody-positive neuromyelitis optica spectrum disorder.

24 Sep 2018

FDA lifts partial clinical hold that paused enrollment of new patients in tazemetosta clinical trials

Epizyme, Inc., a clinical-stage company developing novel epigenetic therapies, today announced the U.S. Food and Drug Administration has lifted the partial clinical hold that had paused U.S.-based enrollment of new patients in its tazemetostat clinical trials.

24 Sep 2018

FARXIGA receives positive results in Phase III DECLARE-TIMI 58 cardiovascular outcomes trial

AstraZeneca today announced positive results from the Phase III DECLARE-TIMI 58 cardiovascular outcomes trial for FARXIGA, the broadest SGLT-2 inhibitor CVOT conducted to date.

24 Sep 2018

Biogen and Eisai announce results of LTE Phase 1b study of aducanumab for treating MCI

Biogen and Eisai Co., Ltd. announced results from a recent analysis of the ongoing long-term extension Phase 1b study of aducanumab, an investigational treatment for mild cognitive impairment due to Alzheimer's disease and mild AD dementia.

24 Sep 2018

CHMP recommends approval of Gilenya for treatment of multiple sclerosis in children, adolescents

Novartis today announced the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended approval of Gilenya (fingolimod) for the treatment of children and adolescents 10 to 17 years of age with relapsing remitting forms of multiple sclerosis.

24 Sep 2018

CHMP adopts positive opinion of Takeda’s ALUNBRIG for treatment of ALK+ non-small cell lung cancer

Takeda Pharmaceutical Company Limited today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion, recommending the full approval of ALUNBRIG® as a monotherapy for the treatment of adult patients with anaplastic lymphoma kinase-positive advanced non-small cell lung cancer previously treated with crizotinib.

24 Sep 2018

First-in-human phase 0 study shows clinically-relevant activity of new drug in glioblastoma

Combating glioblastoma remains a major challenge due the complex nature of these tumors, the inability of drugs to penetrate the brain tissue, and lack of correlation between animal models and the human condition.

21 Sep 2018

NIH launches clinical trial to test infusions of combination antibodies in people with HIV

A clinical trial testing infusions of combination antibodies in people living with HIV has begun at the National Institutes of Health.

20 Sep 2018

Sesen Bio to present its three-month Phase 3 VISTA Trial data at Global Congress

Sesen Bio, Inc., a late-stage clinical company developing fusion protein therapies for the treatment of cancer, today announced that the company will present its three-month Phase 3 VISTA Trial data during a poster session at the Global Congress on Bladder Cancer 2018.

20 Sep 2018

Emergex signs MoU with Brazil’s Fiocruz for development of viral vaccines

Emergex Vaccines Holding Limited, a biotechnology company pioneering a new approach to synthetic vaccine development in the field of infectious diseases, today announces that it has signed a Memorandum of Understanding with Brazil-based Oswaldo Cruz Foundation 'Fiocruz' for the development of viral vaccines.

20 Sep 2018

Cell Medica successfully doses first patient with CMD-501 targeting pediatric neuroblastoma

Cell Medica announces the treatment of the first patient world-wide to receive CMD-501, an autologous CAR-NKT therapy targeting pediatric neuroblastoma

20 Sep 2018

Addition of CTLA4 targeted therapy to PD-1 targeted therapy may benefit patients with ovarian cancer

An analysis of the NRG Oncology clinical trial NRG-GY003 suggests that adding ipilimumab, a monoclonal antibody that targets the protein receptor CTLA-4, to a regimen with the checkpoint inhibitor nivolumab could improve the proportion with tumor response and progression-free survival hazard rates for women with recurrent epithelial ovarian cancer.

19 Sep 2018

Drug Trial News

Alnylam announces positive results from Phase 3 Study of givosiran for treating acute hepatic porphyria

Decibel obtains exclusive license to commercialize ORC-13661 for preventing hearing, balance disorders

Brigatinib drug may offer first-line treatment option for ALK-positive NSCLC

New TB vaccine effective in half of the population in phase II trials

Cerevance starts dosing in Phase I clinical trial of CVN424 for treatment of Parkinson's disease

Phase 1 and 2 clinical trials of entrectinib drug in ROS1-positive NSCLC show promising results

Clinical trial investigators found non-compliant with requirement to report results on EU register

Lumos acquires license for LUM-201 drug that promotes secretion of growth hormone

Alexion announces positive results from Phase 3 PREVENT study of Soliris in patients with NMOSD

FDA lifts partial clinical hold that paused enrollment of new patients in tazemetosta clinical trials

FARXIGA receives positive results in Phase III DECLARE-TIMI 58 cardiovascular outcomes trial

Biogen and Eisai announce results of LTE Phase 1b study of aducanumab for treating MCI

CHMP recommends approval of Gilenya for treatment of multiple sclerosis in children, adolescents

CHMP adopts positive opinion of Takeda’s ALUNBRIG for treatment of ALK+ non-small cell lung cancer

First-in-human phase 0 study shows clinically-relevant activity of new drug in glioblastoma

NIH launches clinical trial to test infusions of combination antibodies in people with HIV

Sesen Bio to present its three-month Phase 3 VISTA Trial data at Global Congress

Emergex signs MoU with Brazil’s Fiocruz for development of viral vaccines

Cell Medica successfully doses first patient with CMD-501 targeting pediatric neuroblastoma

Addition of CTLA4 targeted therapy to PD-1 targeted therapy may benefit patients with ovarian cancer

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