Peripheral Edema News and Research

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CHMP adopts positive opinion for ABRAXANE with gemcitabine for treatment of metastatic pancreas

Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation, today announced that the European Medicines Agency's: Committee for Medicinal Products for Human Use has adopted a positive opinion for ABRAXANE (paclitaxel formulated as albumin bound nanoparticles, or nab-paclitaxel) in combination with gemcitabine for first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas.

25 Nov 2013

European Commission grants marketing authorization for Bayer HealthCare's Xofigo injection

Bayer HealthCare announced today that the European Commission has granted marketing authorization for Xofigo (radium Ra 223 dichloride) solution for injection for the treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases. This decision follows a positive recommendation from the European Committee for Medicinal Products for Human Use in September of this year.

15 Nov 2013

Once-daily prescription medicine for COPD now available throughout the U.S.

GlaxoSmithKline plc and Theravance, Inc. today announced that BREO ELLIPTA, a once-daily prescription medicine for chronic obstructive pulmonary disease, is now available to pharmacies throughout the U.S.

30 Oct 2013

New England publishes results of phase III clinical trial of ABRAXANE for metastatic pancreatic cancer

Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation , today announced the results of the MPACT phase III clinical trial of ABRAXANE® in combination with gemcitabine were published online in the October 16th edition of the New England Journal of Medicine.

17 Oct 2013

Adempas drug gets FDA approval for treatment of pulmonary hypertension

The U.S. Food and Drug Administration today approved Adempas (riociguat) to treat adults with two forms of pulmonary hypertension. Pulmonary hypertension is caused by abnormally high blood pressure in the arteries of the lungs.

10 Oct 2013

Bayer HealthCare receives FDA approval for Adempas tablets

Bayer HealthCare announced today that the United States Food and Drug Administration has approved Adempas (riociguat) tablets for: (i) the treatment of adults with persistent/recurrent chronic thromboembolic pulmonary hypertension (WHO Group 4) after surgical treatment or inoperable CTEPH to improve exercise capacity and WHO functional class; and (ii) the treatment of adults with pulmonary arterial hypertension (WHO Group 1) to improve exercise capacity, improve WHO functional class and delay clinical worsening.

9 Oct 2013

CHMP recommends approval of Xofigo for CRPC, symptomatic bone and visceral metastases

Bayer HealthCare announced today that the the European Committee for Medicinal Products for Human Use recommended Xofigo (radium Ra 223 dichloride) for approval with a proposed indication for the treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases.

20 Sep 2013

Avanir Pharmaceuticals, Wockhardt settle patent litigation related to NUEDEXTA capsules

Avanir Pharmaceuticals, Inc. today announced that it has entered into a settlement agreement with Wockhardt USA, LLC and Wockhardt Ltd. (collectively, "Wockhardt") to resolve pending patent litigation in response to Wockhardt's abbreviated new drug application (ANDA) seeking approval to market generic versions of Avanir's NUEDEXTA® (dextromethorphan hydrobromide/quinidine sulfate) capsules.

7 Sep 2013

FDA approves use of abraxane to treat patients with late-stage pancreatic cancer

The U.S. Food and Drug Administration today expanded the approved uses of Abraxane (paclitaxel protein-bound particles for injectable suspension, ablumin-bound) to treat patients with late-stage (metastatic) pancreatic cancer.

7 Sep 2013

Avanir Pharmaceuticals enters into patent settlement agreement with Actavis

Avanir Pharmaceuticals, Inc. today announced that it has entered into a settlement agreement with Actavis South Atlantic LLC and Actavis, Inc. (collectively, "Actavis") to resolve pending patent litigation in response to Actavis' abbreviated new drug application seeking approval to market generic versions of Avanir's NUEDEXTA (dextromethorphan hydrobromide/quinidine sulfate) capsules.

4 Sep 2013

Celgene to discontinue treatment with REVLIMID in phase III ORIGIN trial

Celgene Corporation today announced that after consultation with the U.S. Food and Drug Administration Celgene will discontinue treatment with REVLIMID (lenalidomide) in the open-label, phase III ORIGIN trial, which enrolled 450 patients in over 100 sites in 26 countries.

18 Jul 2013

Phase III study: REVLIMID meets primary endpoint in patients newly diagnosed with multiple myeloma

Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation, today announced that its phase III study (MM-020/IFM 07-01) of REVLIMID (lenalidomide) in combination with dexamethasone in patients newly diagnosed with multiple myeloma met its primary endpoint of progression-free survival.

11 Jul 2013

Ibrutinib monotherapy shows efficacy in patients with MCL or DLBCL

Pharmacyclics, Inc. today announced the results of two separate Phase 2 studies suggesting that ibrutinib, an investigational oral Bruton's tyrosine kinase inhibitor, showed efficacy when used as a monotherapy in patients with relapsed/refractory mantle cell lymphoma or diffuse large B-cell lymphoma.

17 Jun 2013

Tafinlar, Mekinist get FDA approval to treat patients with advanced melanoma

The U.S. Food and Drug Administration today approved two new drugs, Tafinlar (dabrafenib) and Mekinist (trametinib), for patients with advanced (metastatic) or unresectable (cannot be removed by surgery) melanoma, the most dangerous type of skin cancer.

30 May 2013

Bayer announces data from riociguat Phase III trial on CTEPH

Bayer HealthCare today announced data from the Phase III CHEST-1 trial evaluating its investigational drug riociguat in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) or with persistent or recurrent pulmonary hypertension (PH) after surgery.

24 Oct 2012

Bayer announces data from riociguat Phase III pulmonary arterial hypertension trial

Bayer HealthCare today announced data from the Phase III PATENT-1 pulmonary arterial hypertension (PAH) trial evaluating its investigational drug riociguat in both treatment-naive patients and those pre-treated with an endothelin receptor antagonist or an oral, inhaled or subcutaneous prostanoid.

22 Oct 2012

Navigating the Labyrinth of Traumatic Brain Injury to Discover a Secondary Neurological Condition

Working with individuals with traumatic brain injury (TBI) every day, I see the debilitating effects and long-term struggles firsthand.

9 Oct 2012

Children with negative TB skin test at high risk for mortality

Children with clinical signs of tuberculosis but with a negative tuberculin skin test result should not have treatment delayed, suggest study findings showing that false-negatives are common and associated with high mortality.

7 Aug 2012

Once-daily Gralise significantly reduces pain intensity in PHN patients

Depomed, Inc. today announced that a report of Phase 3 data published online this month, ahead of the print edition, in the Clinical Journal of Pain showed that once-daily Gralise (gabapentin) tablets (1,800 mg) formulation significantly reduces intensity of pain in patients with postherpetic neuralgia (PHN).

23 Jul 2012

UCB’s Neupro now available in U.S. pharmacies

UCB announced today that Neupro (Rotigotine Transdermal System) is now available in U.S. pharmacies. Neupro was approved by the U.S Food and Drug Administration in April to treat the signs and symptoms of early and advanced stage idiopathic Parkinson's disease and moderate-to-severe primary Restless Legs Syndrome.

16 Jul 2012