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Abbvie presents venetoclax Phase 1 results in patients with multiple myeloma at ASCO 2015

AbbVie, a global biopharmaceutical company, today announced that results from a Phase 1b trial of investigational venetoclax, a novel inhibitor of the B-cell lymphoma-2 (BCL-2) protein that is being developed in partnership with Genentech and Roche, in combination with bortezomib and dexamethasone, showed an 83 percent overall response rate (n=5/6) in bortezomib-naive patients with relapsed/refractory (R/R) multiple myeloma, including two patients who achieved complete responses.1 These data will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting on Sunday, May 31, in Chicago.

1 Jun 2015

Combination of Mekinist and Tafinlar drugs improves outcome in patients with metastatic melanoma

Novartis today announced data from the Phase III COMBI-d study showing a significant survival benefit for patients with BRAF V600E/K mutation-positive metastatic melanoma when treated with the combination of Tafinlar (dabrafenib) and Mekinist (trametinib) compared to Tafinlar monotherapy alone.

1 Jun 2015

FDA approves Humalog 200 units/mL KwikPen to improve glycemic control in diabetic patients

The U.S. Food and Drug Administration (FDA) has approved Humalog® 200 units/mL KwikPen® (insulin lispro 200 units/mL; U-200), a pre-filled pen containing a concentrated formulation of Lilly's rapid-acting insulin Humalog® (insulin lispro 100 units/mL) to improve glycemic control in people with type 1 and type 2 diabetes, Eli Lilly and Company announced today. Humalog U-200 KwikPen marks the first FDA approval of a concentrated mealtime insulin analog.

29 May 2015

Amgen to present clinical data on multiple blood cancer treatments at EHA 2015

Amgen today announced that it will present data from multiple Kyprolis (carfilzomib) for Injection, BLINCYTO (blinatumomab), oprozomib and Nplate (romiplostim)‎ studies at the 20th Congress of the European Hematology Association taking place in Vienna, June 11 - 14, 2015.

28 May 2015

Salix Pharmaceuticals receives FDA approval for Xifaxan 550 mg to treat IBS-D in adults

Valeant Pharmaceuticals International, Inc. announced that its wholly owned subsidiary, Salix Pharmaceuticals, Inc., has received approval from the U.S. Food and Drug Administration for Xifaxan 550 mg for the treatment of IBS-D in adults.

28 May 2015

AbbVie announces new results from Phase 3 GIFT-I study in GT1b HCV infected Japanese patients

AbbVie presented new results from the Phase 3 GIFT-I study of its investigational, all-oral, interferon (IFN)- and ribavirin (RBV)-free, two direct-acting antiviral treatment with ombitasvir/paritaprevir/ritonavir at the Annual Meeting of the Japan Society of Hepatology in Kumamoto, Japan.

27 May 2015

Lilly receives fourth FDA approval for CYRAMZA (ramucirumab)

Eli Lilly and Company has received its fourth U.S. Food and Drug Administration approval for CYRAMZA (ramucirumab). CYRAMZA (ramucirumab injection 10 mg/mL solution) is now also indicated in combination with FOLFIRI (irinotecan, folinic acid, and 5-fluorouracil) chemotherapy for the treatment of patients with metastatic colorectal cancer (mCRC) with disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine.

25 Apr 2015

Alnylam announces clinical data from patisiran Phase 2 OLE study for treatment of patients with FAP

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today initial 12-month clinical data from its ongoing Phase 2 open-label extension (OLE) study with patisiran, an investigational RNAi therapeutic in development for the treatment of transthyretin (TTR)-mediated amyloidosis (ATTR amyloidosis) in patients with familial amyloidotic polyneuropathy (FAP).

24 Apr 2015

Astellas Pharma, Medivation announce topline results from enzalutamide Phase 2 STRIVE trial

Astellas Pharma Inc. and Medivation, Inc. today announced topline results from the Phase 2 STRIVE trial comparing enzalutamide with bicalutamide in a study population of men with non-metastatic or metastatic castration-resistant prostate cancer.

2 Apr 2015

FDA approves Astellas' CRESEMBA for treatment of invasive aspergillosis, invasive mucormycosis

Astellas today announced that the U.S. Food and Drug Administration has approved its New Drug Application (NDA) for the use of CRESEMBA (isavuconazonium sulfate), the prodrug for isavuconazole, for patients 18 years of age and older in the treatment of invasive aspergillosis and invasive mucormycosis (also known as zygomycosis).

8 Mar 2015

Lilly receives FDA approval for CYRAMZA (ramucirumab)

Eli Lilly and Company has received its third U.S. Food and Drug Administration approval for CYRAMZA (ramucirumab).

16 Dec 2014

Pharmacyclics receives BayBio's 2014 Pantheon DiNA Award for Outstanding Company

Pharmacyclics, Inc. today announced that it has been awarded BayBio's 2014 Pantheon DiNA Award for Outstanding Company for its rapid development and commercialization of IMBRUVICA (ibrutinib). The award was presented at BayBio's 11th Annual Pantheon DiNA Awards ceremony in San Francisco.

13 Dec 2014

$IMBRUVICA-rituximab combination well tolerated in patients with relapsed or refractory MCL$

IMBRUVICA-rituximab combination well tolerated in patients with relapsed or refractory MCL

New IMBRUVICA (ibrutinib) Phase II data announced by Pharmacyclics, Inc. today demonstrates its potential utility as a combination therapy when used with rituximab. Data suggest that the overall efficacy and safety profile of IMBRUVICA is well tolerated when combined with rituximab in patients with relapsed or refractory mantle cell lymphoma (MCL).

9 Dec 2014

Amgen announces new data from BLINCYTO Phase 2 study for treatment of patients with ALL

Amgen today announced that new data from a pivotal Phase 2 study evaluating BLINCYTO (blinatumomab) for the treatment of adult patients with relapsed/refractory B-cell precursor acute lymphoblastic leukemia (ALL) was presented at the 56th American Society of Hematology Annual Meeting and Exposition.

9 Dec 2014

Phase 2 RESONATE-17 study: IMBRUVICA (ibrutinib) improves survival in CLL patients with del 17p

Results from the Phase 2 RESONATE-17 (PCYC-1117) study show IMBRUVICA (ibrutinib) was associated with an 82.6 percent investigator-assessed overall response rate (ORR; the primary endpoint) and a 79 percent progression-free survival (PFS) rate at 12 months in people living with relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have a genetic mutation known as deletion 17p (del 17p).

9 Dec 2014

Amgen's XGEVA (denosumab) receives FDA approval for treatment of hypercalcemia of malignancy

Amgen today announced that the U.S. Food and Drug Administration has approved a new indication for XGEVA (denosumab) for the treatment of hypercalcemia of malignancy (HCM) refractory to bisphosphonate therapy.

8 Dec 2014

IMBRUVICA demonstrates anti-tumor activity against multiple myeloma in Phase II study

New IMBRUVICA (ibrutinib) Phase II data announced here today by Pharmacyclics, Inc) during the 56th American Society of Hematology Annual Meeting suggests that IMBRUVICA demonstrates anti-tumor activity both as a single-agent and as combination therapy in heavily pre-treated patients with relapsed or relapsed/refractory multiple myeloma (MM).

7 Dec 2014

Orexo announces positive results from ISTART/006 study

Orexo US, Inc. announced results from the ISTART/006 study, being presented today at the 25th Annual Meeting and Symposium of the American Academy of Addiction Psychiatry in Aventura, Florida, USA.

7 Dec 2014

Pharmacyclics launches informCLL registry to explore natural history of CLL patients

Pharmacyclics, Inc. today announced the launch of informCLL, a large, observational, prospective registry that will explore the natural history of chronic lymphocytic leukemia (CLL), examine how IMBRUVICA (ibrutinib) and other approved targeted therapies are being used to treat patients with CLL, and provide a comparison to treatments using conventional chemoimmunotherapy (CIT).

5 Dec 2014

Pharmacyclics wins 2014 Society for Medicines Research Award for Drug Discovery

Pharmacyclics, Inc. today announced that it has won the prestigious 2014 Society for Medicines Research Award for Drug Discovery for its discovery of ibrutinib (IMBRUVICA). The award was presented by The Society of Medicines Research at its biennial award lecture in Kensington, London.

4 Dec 2014

Peripheral Edema News and Research

Abbvie presents venetoclax Phase 1 results in patients with multiple myeloma at ASCO 2015

Combination of Mekinist and Tafinlar drugs improves outcome in patients with metastatic melanoma

FDA approves Humalog 200 units/mL KwikPen to improve glycemic control in diabetic patients

Amgen to present clinical data on multiple blood cancer treatments at EHA 2015

Salix Pharmaceuticals receives FDA approval for Xifaxan 550 mg to treat IBS-D in adults

AbbVie announces new results from Phase 3 GIFT-I study in GT1b HCV infected Japanese patients

Lilly receives fourth FDA approval for CYRAMZA (ramucirumab)

Alnylam announces clinical data from patisiran Phase 2 OLE study for treatment of patients with FAP

Astellas Pharma, Medivation announce topline results from enzalutamide Phase 2 STRIVE trial

FDA approves Astellas' CRESEMBA for treatment of invasive aspergillosis, invasive mucormycosis

Lilly receives FDA approval for CYRAMZA (ramucirumab)

Pharmacyclics receives BayBio's 2014 Pantheon DiNA Award for Outstanding Company

IMBRUVICA-rituximab combination well tolerated in patients with relapsed or refractory MCL

Amgen announces new data from BLINCYTO Phase 2 study for treatment of patients with ALL

Phase 2 RESONATE-17 study: IMBRUVICA (ibrutinib) improves survival in CLL patients with del 17p

Amgen's XGEVA (denosumab) receives FDA approval for treatment of hypercalcemia of malignancy

IMBRUVICA demonstrates anti-tumor activity against multiple myeloma in Phase II study

Orexo announces positive results from ISTART/006 study

Pharmacyclics launches informCLL registry to explore natural history of CLL patients

Pharmacyclics wins 2014 Society for Medicines Research Award for Drug Discovery

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

From Puberty to Menopause: Clue’s CEO, Audrey Tsang on the Power of Femtech

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