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Genmab/GSK receive FDA sBLA approval for Arzerra in combination with chlorambucil for treatment of CLL

Genmab/GSK receive FDA sBLA approval for Arzerra in combination with chlorambucil for treatment of CLL

GlaxoSmithKline plc and Genmab A/S announced today that the U.S. Food and Drug Administration (FDA) has approved a Supplemental Biologic License Application (sBLA) for the use of Arzerra® (ofatumumab), a CD20-directed cytolytic monoclonal antibody, in combination with chlorambucil for the treatment of previously untreated patients with chronic lymphocytic leukaemia (CLL) for whom fludarabine-based therapy is considered inappropriate. [More]
Pradaxa receives FDA approval for treatment and reduction of risk of recurrence of DVT and PE

Pradaxa receives FDA approval for treatment and reduction of risk of recurrence of DVT and PE

Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Pradaxa® (dabigatran etexilate mesylate) for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have been treated with a parenteral anticoagulant for five to 10 days, and to reduce the risk of recurrent DVT and PE in patients who have been previously treated. DVT and PE are collectively referred to as venous thromboembolism (VTE). [More]
Clonidine increases hypotension and non-fatal cardiac arrest after noncardiac surgery

Clonidine increases hypotension and non-fatal cardiac arrest after noncardiac surgery

Clonidine - a drug that reduces blood pressure and heart rate - increased rates of clinically concerning hypotension and non-fatal cardiac arrest after noncardiac surgery, according to the POISE-2 trial presented at the American College of Cardiology's 63rd Annual Scientific Session. [More]

rEVO Biologics commences ATryn Phase 3 clinical program for treatment of preeclampsia in pregnant women

rEVO Biologics Inc., a subsidiary of LFB SA, today announced the initiation of the Phase 3 clinical program for ATryn for the treatment of preeclampsia in pregnant women during the 24th to 28th week of pregnancy. [More]

SEATTLE II study confirms safety and efficacy of thrombolytic therapy for acute PE

EKOS Corporation, a BTG International group company, notes the presentation of the results of the SEATTLE II trial this afternoon at ACC.14, the 63rd Annual Scientific Session and Exposition of the American College of Cardiology in Washington, DC in the United States. [More]

Study of astronauts show heart becomes more spherical when exposed to microgravity in space

New findings from a study of 12 astronauts show the heart becomes more spherical when exposed to long periods of microgravity in space, a change that could lead to cardiac problems, according to research to be presented at the American College of Cardiology's 63rd Annual Scientific Session. [More]
Biogen Idec's ALPROLIX receives FDA approval for hemophilia B treatment

Biogen Idec's ALPROLIX receives FDA approval for hemophilia B treatment

Today Biogen Idec announced that the U.S. Food and Drug Administration has approved ALPROLIX [Coagulation Factor IX (Recombinant), Fc Fusion Protein], the first recombinant, DNA derived hemophilia B therapy with prolonged circulation in the body. [More]
Kessler Foundation receives grant to supports variety of rehabilitation research projects in spinal cord injury

Kessler Foundation receives grant to supports variety of rehabilitation research projects in spinal cord injury

Kessler Foundation has received more than $718,000 in grant funding from the Craig Neilsen Foundation. The funding, comprised of five grants, supports a variety of rehabilitation research projects in spinal cord injury (SCI), including pain management, functional outcomes, quality of life, and factors affecting cognitive function. [More]
Pierre Fabre Dermatologie receives FDA marketing authorization for pediatric drug Hemangeol

Pierre Fabre Dermatologie receives FDA marketing authorization for pediatric drug Hemangeol

Pierre Fabre Dermatologie has obtained marketing authorization from the FDA for the pediatric drug Hemangeol (propranolol hydrochloride), which is the first and only approved treatment for "proliferating infantile hemangioma requiring systemic therapy". [More]
CSI's new Diamondback Peripheral 60cm systems receive FDA clearance for PAD treatment

CSI's new Diamondback Peripheral 60cm systems receive FDA clearance for PAD treatment

Cardiovascular Systems, Inc., announced today it has received FDA clearance of its new Diamondback 360 60cm Peripheral Orbital Atherectomy Systems (OAS) for the treatment of peripheral arterial disease (PAD). [More]
Cedars-Sinai neurosurgeon successfully performs CSF repair surgery on patient

Cedars-Sinai neurosurgeon successfully performs CSF repair surgery on patient

When Elizabeth "Beth" Johnson stood up from working at her computer Oct. 28, she noticed "a kind of funny feeling" in the back of her neck. By Nov. 2, the sensation had become an excruciating headache that came on whenever she tried to stand or sit upright. [More]
FDA grants accelerated approval to NORTHERA (droxidopa) for patients with symptomatic NOH

FDA grants accelerated approval to NORTHERA (droxidopa) for patients with symptomatic NOH

Chelsea Therapeutics International, Ltd. today announced that the U.S. Food and Drug Administration granted accelerated approval of NORTHERA (droxidopa) for the treatment of symptomatic neurogenic orthostatic hypotension (NOH). NORTHERA is the first and only therapy approved by the FDA which demonstrates symptomatic benefit in patients with NOH. [More]
Jazz Pharmaceuticals' Versacloz now commercially available in the U.S. for schizophrenia

Jazz Pharmaceuticals' Versacloz now commercially available in the U.S. for schizophrenia

Jazz Pharmaceuticals plc today announced U.S. commercial availability of Versacloz (clozapine, USP) oral suspension, the first and only oral suspension clozapine for severely ill treatment-resistant schizophrenia patients or those at risk of recurrent suicidal behavior with schizophrenia or schizoaffective disorder. [More]
KKH doctors develop novel DIVA System for blood pressure management

KKH doctors develop novel DIVA System for blood pressure management

New trial results1 have shown that the world's first Double Intravenous Vasopressor Automated (DIVA) System affords superior control of maternal blood pressure in women undergoing caesarean section under spinal anaesthesia, when compared with manually-administered medication to manage reduced blood pressure (vasopressor). [More]

Clonidine before surgery may control post-surgical pain and child's anxiety

Managing a child's pain and distress after surgery is an essential part of recovery. However, using strong painkilling medications post-surgery can put kids at risk for side effects and other complications. [More]
FDA approves Farxiga tablets to improve glycemic control in adults with type 2 diabetes mellitus

FDA approves Farxiga tablets to improve glycemic control in adults with type 2 diabetes mellitus

AstraZeneca and Bristol-Myers Squibb Company announced the U.S. Food and Drug Administration approved Farxiga™ [far-SEE-ga] (dapagliflozin), a once-daily oral treatment indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. [More]

GSK receives FDA approval for combination of Mekinist with Tafinlar for treatment of melanoma

GlaxoSmithKline plc announced today that the U.S. Food and Drug Administration (FDA) has approved Mekinist® (trametinib) for use in combination with Tafinlar® (dabrafenib) for the treatment of patients with unresectable melanoma (melanoma that cannot be removed by surgery) or metastatic melanoma (melanoma which has spread to other parts of the body) with BRAF V600E or V600K mutations. [More]
Sleep disorder linked to poor nonmotor status in Parkinson’s disease

Sleep disorder linked to poor nonmotor status in Parkinson’s disease

The presence of rapid eye movement sleep behavior disorder is associated with more severe nonmotor symptoms in patients with early-stage Parkinson’s disease, a study shows. [More]

Orenitram Extended-Release Tablets get FDA approval for pulmonary arterial hypertension treatment

United Therapeutics Corporation announced today that the United States Food and Drug Administration has approved Orenitram (treprostinil) Extended-Release Tablets for the treatment of pulmonary arterial hypertension in WHO Group I patients to improve exercise capacity. [More]

FDA approves Baxter's FEIBA for prophylactic treatment of hemophilia patients with inhibitors

Baxter International Inc. today announced that the United States Food and Drug Administration granted approval of Baxter's FEIBA [Anti-Inhibitor Coagulant Complex], the first and only FDA-approved treatment for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with hemophilia A or B who have developed inhibitors. [More]