Bradycardia News and Research

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Bradycardia, ("heart slowness"), as applied to adult medicine, is defined as a resting heart rate of under 60 beats per minute, though it is seldom symptomatic until the rate drops below 50 beat/min.

FDA approves new drug application for NEXTERONE Premixed Injection

Prism Pharmaceuticals, Inc. announced today that the U.S. Food & Drug Administration has approved the supplemental new drug application for NEXTERONE (amiodarone HCl) Premixed Injection, the first and only premixed intravenous (IV) bag formulation of the antiarrhythmic agent amiodarone IV.

19 Nov 2010

Coadministration of INTUNIV tablets with stimulant reduces ADHD symptoms

Shire plc the global specialty biopharmaceutical company, today presented research results of once-daily INTUNIV (guanfacine) Extended-Release Tablets, coadministered with stimulants in children and adolescents diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) who had suboptimal response to treatment with a long-acting stimulant alone.

29 Oct 2010

Astellas Pharma announces Phase IV study results of Lexiscan injection at ASNC session

Today Astellas Pharma US, Inc. announced results of a Phase IV study showing Lexiscan(regadenoson) Injection was comparable to placebo in causing a >15% decrease in forced expiratory volume in one second (FEV1) in subjects with asthma or chronic obstructive pulmonary disease (COPD) who are likely candidates for myocardial perfusion imaging (MPI) studies.

27 Sep 2010

BRINAVESS IV granted marketing approval in EU for conversion of recent onset AF to sinus rhythm

MSD and Cardiome Pharma Corp. today announced that the intravenous (IV) formulation of BRINAVESS™ (vernakalant) has been granted marketing approval in the European Union (EU), Iceland and Norway for the conversion of recent onset atrial fibrillation (AF) to sinus rhythm in adults.

2 Sep 2010

Hospira Japan receives approval for long term use of Precedex IV sedative

Hospira Japan Co., Ltd. today announced it has received an approval for the long-term (greater than 24 hour) use of the sedative "Precedex IV™200ug" (generic name: dexmedetomidine hydrochloride). This approval follows Hospira's first launches earlier this year of Precedex in Canada and in South Korea, important milestones for Hospira as the company continues to build the molecule's global presence.

23 Aug 2010

OraVerse MAA accepted for review in five key European countries

Sanofi-Aventis Deutschland GmbH and Novalar Pharmaceuticals, Inc. today announced that the Marketing Authorization Application (MAA) for OraVerse has been accepted for review by the regulatory agencies of the United Kingdom (UK), Germany, Italy, France and Spain. OraVerse is the first and only local anesthesia reversal agent that accelerates the return of normal sensation and function following routine dental procedures. OraVerse is approved for use in the U.S. by the Food and Drug Administration and sold by Novalar direct to U.S. dentists.

14 Jul 2010

EMA CHMP recommends marketing approval of BRINAVESS for conversion of recent onset AF to sinus rhythm

Merck and Cardiome Pharma Corp. today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing approval for BRINAVESS® (vernakalant), an investigational intravenous (IV) formulation for the conversion of recent onset atrial fibrillation (AF) to sinus rhythm in adults.

28 Jun 2010

CHMP adopts positive opinion on pending MAA for SYCREST sublingual tablets

Merck announced that the Committee for Medicinal Products for Human Use adopted a positive opinion on the pending Marketing Authorization Application for SYCREST (asenapine) sublingual tablets. The CHMP has recommended that the European Commission grant a marketing authorization for SYCREST for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults. The CHMP did not support an indication for the treatment of schizophrenia.

25 Jun 2010

BIOTRONIK announces commercial availability of new ProMRI Pacing Systems

BIOTRONIK SE & Co. KG, a leading manufacturer of high-quality implantable cardiac devices and pioneer of wireless remote monitoring technologies, announced today the commercial availability of its new ProMRI Pacing Systems — Evia pacemaker series and Safio pacing leads — providing European patients the first portfolio of bradycardia systems that are compatible with Magnetic Resonance Imaging scans under specific conditions.

15 Jun 2010

Discovery Labs reports preliminary results from Surfaxin Phase 2 trial in children with Acute Respiratory Failure

Discovery Laboratories, Inc., reports preliminary results from its Phase 2 clinical trial of Surfaxin® in children with Acute Respiratory Failure (ARF), a critical condition often caused in children by severe respiratory infections. The objective of the study was to evaluate the safety and tolerability of intratracheal administration of Surfaxin and to assess whether Surfaxin treatment could decrease the duration of mechanical ventilation in children with ARF.

9 Jun 2010

Arrhythmia Alliance launches 'Know Your Pulse' global awareness campaign on World Heart Rhythm Week

Arrhythmia Alliance, the Heart Rhythm Charity, announced today the results of a survey conducted in Europe that showed a large number of respondents ignore basic measures to check for potential cardiac arrhythmias, or heart rhythm disorders. To raise awareness of the importance of pulse checking and to inform people about how to take their pulse, the Arrhythmia Alliance will open 2010 World Heart Rhythm Week (7-13 June) with the launch of the global awareness campaign 'Know Your Pulse'.

7 Jun 2010

Antiemetic-regimen with fosaprepitant injection provides similar protection against CINV as oral EMEND

Merck announced today results from a new non-inferiority trial of an antiemetic regimen containing fosaprepitant dimeglumine administered as a single intravenous (IV) 150-mg dose in combination with a 5-HT3 antagonist and dexamethasone compared with a three-day regimen of aprepitant with a 5-HT3 antagonist and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving a first cycle of cisplatin-based chemotherapy.

4 Jun 2010

Genzyme's Lumizyme for Pompe disease receives FDA marketing approval

Genzyme Corporation announced today that the FDA has granted U.S. marketing approval for Lumizyme™ (alglucosidase alfa), produced at the 4000 liter (L) bioreactor scale at its manufacturing facility in Geel, Belgium. Lumizyme is the first treatment approved in the United States specifically to treat patients with late-onset Pompe disease.

25 May 2010

New findings on INTUNIV Extended Release Tablets presented at major psychiatric meeting

Shire plc, the global specialty biopharmaceutical company, today announced new findings on once-daily INTUNIV (guanfacine) Extended Release Tablets, the first selective alpha-2A agonist approved for the treatment of Attention Deficit Hyperactivity Disorder, at a major psychiatric meeting.

24 May 2010

FDA approves Evia pacemaker for distribution in the U.S.

BIOTRONIK today announced that the U.S. Food and Drug Administration has cleared the Evia pacemaker for distribution in the U.S., giving physicians and patients access to a unique Bradycardia system designed and manufactured with BIOTRONIK's unparalleled legacy of quality.

13 May 2010

Sanofi-aventis commences multinational Phase IIIb PALLAS trial of Multaq in permanent AF patients

Sanofi-aventis announced today the initiation of a multinational, randomized double-blind Phase IIIb trial, PALLAS, to assess the potential clinical benefit of Multaq(R) (dronedarone) in over 10, 000 patients with permanent atrial fibrillation (AF) to reduce major adverse cardiovascular events. The announcement was made during Heart Rhythm 2010, the Heart Rhythm Society's 31st Annual Scientific Sessions.

12 May 2010

Data from Phase IV study of Bystolic tablets in Hispanic patients with hypertension presented at ASH 2010

Forest Laboratories, Inc. today presented data from a Phase IV study evaluating the effects of Bystolic (nebivolol) tablets in Hispanic patients with hypertension at the 2010 annual scientific meeting of the American Society of Hypertension.

4 May 2010

BIOTRONIK receives European approval for new ProMRI Pacing Systems

BIOTRONIK, a leading manufacturer of implantable cardiac devices and pioneer of wireless remote monitoring technologies, announced today the European approval of its new ProMRI Pacing Systems — Evia pacemaker series and Safio S pacing leads — providing European patients the first portfolio of bradycardia systems that are compatible with Magnetic Resonance Imaging (MRI) scans under specific conditions.

8 Apr 2010

FDA approves TachoSil adjunctive hemostatic agent for use in cardiovascular surgery

Baxter International Inc. and Nycomed today announced the U.S. Food and Drug Administration (FDA) approval of TachoSil (Absorbable Fibrin Sealant Patch) for use as an adjunct to hemostasis in cardiovascular surgery. TachoSil is the first and only adjunctive hemostatic agent available in the U.S. that combines a collagen patch with a coating of human coagulation factors.

From Baxter International Inc. 7 Apr 2010

Aton Pharma introduces authorized generic version of Timoptic-XE

Aton Pharma, Inc., a diversified specialty pharmaceutical company, today announced that it has launched an authorized generic version of its Timoptic-XE® (timolol maleate ophthalmic gel forming solution). Timoptic-XE is a non-selective beta-adrenergic receptor blocking agent indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Aton also announced that it will continue to make available branded Timoptic-XE.

9 Mar 2010