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Vertex gets European CHMP positive opinion for KALYDECO to treat patients with cystic fibrosis

Vertex Pharmaceuticals (Europe) Limited today announces that the European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion for KALYDECO (ivacaftor) to include the treatment of people with cystic fibrosis (CF) aged 12 to <24 months who have at least one of the following nine mutations in their cystic fibrosis transmembrane conductance regulator gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R.

22 Oct 2018

Immunotherapy increases survival in some patients with metastatic triple negative breast cancer

Immunotherapy improves survival in some patients with metastatic triple negative breast cancer, according to late-breaking results from the IMpassion130 trial reported at the ESMO 2018 Congress in Munich.

22 Oct 2018

Deciphera presents Phase 1 clinical results of DCC-2618 in patients with gastrointestinal stromal tumors

Deciphera Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company focused on addressing key mechanisms of tumor drug resistance, announced the presentation today of updated preliminary results from its ongoing Phase 1 clinical study of DCC-2618, the company's broad-spectrum KIT and PDGFRα inhibitor, in patients with gastrointestinal stromal tumors as a proffered paper presentation at the European Society of Medical Oncology 2018 Congress in Munich, Germany.

22 Oct 2018

Phase III trial reports positive results with HDAC inhibitor in advanced breast cancer patients

Epigenetic therapy with histone deacetylase inhibitors is worth pursuing in hormone receptor positive advanced breast cancer, suggests a phase III trial reported today at the ESMO 2018 Congress in Munich.

22 Oct 2018

Zoledronic acid increases disease-free survival in premenopausal women with HR+ early breast cancer

Adjuvant treatment with the bone sparing drug zoledronic acid plus hormonal therapy with the aromatase inhibitor letrozole significantly increases disease-free survival compared to tamoxifen in premenopausal women with hormone receptor positive (HR+) early breast cancer, according to results reported at ESMO 2018 Congress in Munich.

22 Oct 2018

Multi-strain probiotic helps reduce chemotherapy-induced diarrhea in cancer patients

A high concentration of multi-strain probiotic helps to reduce mild to moderate episodes of chemotherapy-induced diarrhea in cancer patients, according to results of a phase II/III study in India.

22 Oct 2018

Immunotherapy trial offers new hope for people with aggressive breast cancer

There is new hope for people with an aggressive type of breast cancer, as an immunotherapy trial shows for the first time that lives can be extended in people with triple-negative breast cancer.

22 Oct 2018

Study highlights existence of barriers to early clinical trial access for adolescents and young adults

Young cancer patients at the crossroads of childhood and adulthood seem to be stuck in a treatment impasse. A study to be presented at the ESMO 2018 Congress in Munich, has highlighted the existence of barriers to the inclusion of 12 to 25-year-olds in both adult and pediatric early phase clinical trials, suggesting a need for more tailored approaches to give this patient population better access to therapeutic innovation.

22 Oct 2018

Incyte announces Phase 2 FIGHT-202 trial data in patients with cholangiocarcinoma

Incyte Corporation announces updated data from its ongoing Phase 2 FIGHT-202 trial evaluating pemigatinib (INCB54828), its selective fibroblast growth factor receptor (FGFR) inhibitor, in patients with advanced/metastatic or surgically unresectable cholangiocarcinoma (bile duct cancer) who failed at least one previous treatment.

22 Oct 2018

Immune therapy may be potential treatment option for patients with hard-to-treat ankylosing spondylitis

Results from a phase 3 clinical trial indicate that patients who have not benefited from standard therapy for ankylosing spondylitis, a chronic inflammatory disease characterized by back pain and sacroiliac-joint damage, may have another treatment option in the biologic drug ixekizumab.

22 Oct 2018

Exelixis presents CABOSUN and METEOR trial results in patients with advanced renal cell carcinoma

Exelixis, Inc. today announced results from two analyses evaluating the effect of PD-L1 expression or prior treatment with immune checkpoint inhibitors on the efficacy of cabozantinib in patients with advanced renal cell carcinoma (RCC). The findings are being presented this week at the European Society for Medical Oncology 2018 Congress being held October 19-23 in Munich, Germany.

22 Oct 2018

Takeda announces positive Phase 3 ALTA-1L data in first-line therapy for advanced ALK+ NSCLC

Takeda Pharmaceutical Company Limited today announced that intracranial efficacy data from the Phase 3 ALTA-1L (ALK in Lung Cancer Trial of BrigAtinib in 1st Line) trial showed improved intracranial progression-free survival (PFS) and intracranial objective response rate (ORR) with ALUNBRIG (brigatinib) compared to crizotinib among anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC) patients.

22 Oct 2018

Gilead Sciences presents Phase 3 results of filgotinib in biologic-experienced rheumatoid arthritis at 2018 ACR/ARHP Annual Meeting

Gilead Sciences, Inc. and Galapagos NV today announced detailed results from the Phase 3 FINCH 2 clinical trial of filgotinib, an investigational, selective JAK1 inhibitor, in adults with moderately-to-severely active rheumatoid arthritis and prior inadequate response or intolerance to biologic agents.

22 Oct 2018

ImmunoGen announces study results of platinum-resistant ovarian cancer therapy at ESMO 2018 Congress

ImmunoGen, Inc., a leader in the expanding field of antibody-drug conjugates for the treatment of cancer, today announced initial safety and preliminary anti-tumor activity from the FORWARD II expansion cohort assessing mirvetuximab soravtansine in combination with Merck's anti-PD-1 therapy, KEYTRUDA (pembrolizumab).

22 Oct 2018

X4 Pharmaceuticals announces clinical data of X4P-001-IO and Opdivo in patients with clear cell renal cell carcinoma

X4 Pharmaceuticals, a clinical stage biotechnology company developing novel CXCR4 antagonists to improve immune cell trafficking to treat cancer and rare disease, today announced results from a pilot study of X4P-001-IO in combination with Opdivo (nivolumab) in patients with clear cell renal cell carcinoma who are non-responsive to the anti-PD-1 checkpoint inhibitor Opdivo alone.

22 Oct 2018

Shorter course of trastuzumab could be an option for women with HER2+ early breast cancer

Women with HER2-positive early breast cancer with small tumours have similar disease-free survival and lower risk of cardiac toxicity with a nine-week course of adjuvant trastuzumab compared to those treated for one year, according to a subgroup analysis of the Short-HER trial reported at ESMO 2018 Congress in Munich.

22 Oct 2018

Ultromics expands multiple clinical trials for coronary heart disease to the U.S.

Ultromics is currently supporting multiple ongoing clinical trials including “Rainier”, based in the U.S., and “EVAREST”, in the UK.

19 Oct 2018

FDA grants Rare Pediatric Disease Designation for Immusoft’s Iduronicrin genleukocel-T

Immusoft Corporation, a Seattle-Wash.-based cell therapy company, announced today that the U.S. Food and Drug Administration (FDA) has granted it Rare Pediatric Disease Designation (RPDD) for Iduronicrin genleukocel-T, Immusoft's Sleeping Beauty transposon-engineered autologous plasmablasts for the expression and delivery of alpha-L-iduronidase (IDUA) to treat Mucopolysaccharidosis type I (MPS I).

17 Oct 2018

Purdue Pharma, Eisai announce positive topline results from Phase 3 study of lemborexant

Eisai Co., Ltd. and Purdue Pharma L.P. announced positive topline results from SUNRISE 2, a long-term Phase 3 efficacy and safety evaluation of lemborexant, an investigational agent for sleep-wake regulation currently being studied for the potential treatment of multiple sleep-wake disorders.

17 Oct 2018

WRAIR clinical study evaluates safety and immunogenicity of Marburg vaccine

The Walter Reed Army Institute of Research this week administered the first vaccine in a Phase 1 clinical trial to evaluate the safety and immunogenicity of a Marburg vaccine candidate in healthy adult volunteers.

15 Oct 2018

Drug Trial News

Vertex gets European CHMP positive opinion for KALYDECO to treat patients with cystic fibrosis

Immunotherapy increases survival in some patients with metastatic triple negative breast cancer

Deciphera presents Phase 1 clinical results of DCC-2618 in patients with gastrointestinal stromal tumors

Phase III trial reports positive results with HDAC inhibitor in advanced breast cancer patients

Zoledronic acid increases disease-free survival in premenopausal women with HR+ early breast cancer

Multi-strain probiotic helps reduce chemotherapy-induced diarrhea in cancer patients

Immunotherapy trial offers new hope for people with aggressive breast cancer

Study highlights existence of barriers to early clinical trial access for adolescents and young adults

Incyte announces Phase 2 FIGHT-202 trial data in patients with cholangiocarcinoma

Immune therapy may be potential treatment option for patients with hard-to-treat ankylosing spondylitis

Exelixis presents CABOSUN and METEOR trial results in patients with advanced renal cell carcinoma

Takeda announces positive Phase 3 ALTA-1L data in first-line therapy for advanced ALK+ NSCLC

Gilead Sciences presents Phase 3 results of filgotinib in biologic-experienced rheumatoid arthritis at 2018 ACR/ARHP Annual Meeting

ImmunoGen announces study results of platinum-resistant ovarian cancer therapy at ESMO 2018 Congress

X4 Pharmaceuticals announces clinical data of X4P-001-IO and Opdivo in patients with clear cell renal cell carcinoma

Shorter course of trastuzumab could be an option for women with HER2+ early breast cancer

Ultromics expands multiple clinical trials for coronary heart disease to the U.S.

FDA grants Rare Pediatric Disease Designation for Immusoft’s Iduronicrin genleukocel-T

Purdue Pharma, Eisai announce positive topline results from Phase 3 study of lemborexant

WRAIR clinical study evaluates safety and immunogenicity of Marburg vaccine

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