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X4P-001-RD demonstrates promising activity in WHIM syndrome patients
By PBR Staff Writer
X4 Pharmaceuticals said that its X4P-001-RD has demonstrated promising activity in the ongoing open-label phase 2 portion of a phase 2/3 study in patients with WHIM syndrome.
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BMS’ elotuzumab / pomalidomide improves progression-free survival in cancer trial
Bristol-Myers Squibb (BMS) has announced that the ELOQUENT-3 trial, an international Phase 2 study evaluating the addition of Empliciti (elotuzumab) to pomalidomide and low-dose dexamethasone (EPd) in patients with relapsed/refractory multiple myeloma (RRMM), achieved its primary endpoint.
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Futility forces Teva to halt fremanezumab’s chronic cluster headache study
By PBR Staff Writer
Israel-based Teva Pharmaceutical Industries said that it will stop an ongoing phase 3 trial of its migraine drug fremanezumab for the treatment of chronic cluster headache due to futility.
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Faron Pharmaceuticals reports inconsistent Traumakine biomarker results
Faron Pharmaceuticals has announced preliminary biomarker data from its Phase III INTEREST trial of Traumakine for the treatment of Acute Respiratory Distress Syndrome (ARDS).
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ViiV’s dolutegravir/lamivudine regimen succeeds in two phase 3 HIV-1 trials
By PBR Staff Writer
ViiV Healthcare reported that two phase 3 trials evaluating the two-drug regimen (2DR) of dolutegravir (Tivicay) and lamivudine (Epivir) in treatment naïve HIV-1 infected adults demonstrated the ability to control HIV.
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Flex Pharma to stop two neuromuscular disease trials over safety concerns
By PBR Staff Writer
Flex Pharma said that it is scrapping two ongoing phase 2 neuromuscular disease trials, evaluating its lead drug candidate FLX-787, due to safety concerns.
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Grünenthal begins phase III trials in Complex Regional Pain Syndrome
Grünenthal has recruited first patients in two trials of pivotal phase III program to investigate neridronate for the treatment of Complex Regional Pain Syndrome (CRPS).
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AstraZeneca, Eli Lilly terminate clinical trials of Alzheimer's disease treatment lanabecestat
By PBR Staff Writer
AstraZeneca and Eli Lilly have announced the termination of global phase 3 clinical trials of Alzheimer's disease treatment, lanabecestat, which is an oral beta secretase cleaving enzyme (BACE) inhibitor.
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Advaxis doses first patient with ADXS-NEO cancer immunotherapy
Advaxis has started a phase 1 trial with the dosing of the first patient with ADXS-NEO, an investigational personalized immunotherapy candidate targeting personal neoantigens found by sequencing a patient’s own cancer cells.
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FDA accepts Cellenkos’ IND to begin clinical trial of CK0801 for bone marrow failure syndromes
The US Food and Drug Administration (FDA) has cleared Cellenkos’ investigational new drug (IND) application to proceed with a phase I clinical trial of CK0801, third party cord blood derived regulatory T cells, in patients with bone marrow failure syndrome including aplastic anemia, myelodysplastic syndrome and myelofibrosis.
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Alnylam's Lumasiran yields positive results in phase 1/2 Hyperoxaluria study
Alnylam Pharmaceuticals said that lumasiran, its investigational RNAi therapeutic targeting glycolate oxidase (GO) has yielded positive results from a phase 1/2 study in patients with Primary Hyperoxaluria Type 1 (PH1).
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AbbVie’s upadacitinib succeeds in phase 3 trial in rheumatoid arthritis
AbbVie said that the phase 3 SELECT-EARLY trial evaluating two doses of upadacitinib (15 mg and 30 mg) as monotherapy in the treatment of rheumatoid arthritis met the primary endpoints of ACR50a at week 12 and clinical remissionb at week 24 versus methotrexate (MTX).
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AstraZeneca says Lynparza/abiraterone combo delayed disease progression in mCRPC
By PBR Staff Writer
AstraZeneca has reported that Lynparza (olaparib) in combination with abiraterone succeeded in a phase II trial by delaying disease progression in metastatic castration-resistant prostate cancer (mCRPC) patients.
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Novartis phase III trial shows Kisqali combo therapy improves PFS in HR+/HER2- advanced breast cancer
Novartis has reported positive results from the third Phase III trial of Kisqali (ribociclib) in advanced or metastatic breast cancer.
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Merck’s Keytruda shows improved ORR in phase 2 renal cell carcinoma study
By PBR Staff Writer
A phase 2 trial assessing Merck’s Keytruda (pembrolizumab) demonstrated overall response rate (ORR) of about 40% as first-line therapy in patients with advanced clear cell renal cell carcinoma (RCC).
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