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FDA's PADAC supports approval of BREO ELLIPTA as once-daily inhaled treatment for COPD

GlaxoSmithKline plc and Theravance, Inc. today announced that the Pulmonary-Allergy Drugs Advisory Committee to the US Food and Drug Administration voted that the efficacy and safety data provide substantial evidence to support approval of BREO ELLIPTA as a once-daily inhaled treatment for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (9 for, 4 against) and also for the reduction of COPD exacerbations in patients with a history of exacerbations (9 for, 4 against).

18 Apr 2013

Mylan gets final approval from FDA for generic Xopenex Inhalation Solution

Mylan Inc. today announced that its subsidiary Mylan Specialty L.P. has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Levalbuterol Inhalation Solution USP, 0.31 mg/3 mL (0.0103%), 0.63 mg/3 mL (0.021%), and 1.25 mg/3 mL (0.042%), (Concentrate).

19 Mar 2013

Baxter files FEIBA NF BLA with FDA for prophylactic treatment of hemophilia A or B

Baxter International Inc. today announced that the company has submitted a biologics license application (BLA) supplement to the U.S. Food and Drug Administration (FDA) for the approval of prophylaxis treatment of FEIBA NF [Anti-Inhibitor Coagulant Complex], Nanofiltered and Vapor Heated, in patients with hemophilia A or B and inhibitors.

From Baxter International Inc. 26 Feb 2013

Almirall, Forest Laboratories' Tudorza Pressair now available in the U.S. pharmacies

Forest Laboratories, Inc. and Almirall, S.A. announced today that Tudorza Pressair (aclidinium bromide inhalation powder) 400mcg is now available in pharmacies throughout the United States.

11 Dec 2012

Chronic respiratory disease treatments: an interview with Dr Sven Jan-Anders Karlsson, CEO of Verona Pharma

There are many different chronic respiratory diseases. Verona Pharma is mainly focused on two diseases: asthma and COPD. Asthma is a very common disease and unfortunately it has been increasing in prevalence in developed countries. This is the same with COPD; however, there may be different reasons for this.

25 Sep 2012

FDA approves Acton’s AEROSPAN sNDA to treat asthma

Acton Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved the sNDA (Supplemental New Drug Application) for AEROSPAN (flunisolide HFA, 80 mcg) Inhalation Aerosol, a hydrofluoroalkane (HFA) orally inhaled corticosteroid indicated for the maintenance treatment of asthma as a prophylactic therapy in adult and pediatric patients 6 years of age and older.

21 Sep 2012

FDA approves Forest Laboratories’ Tudorza Pressair to treat COPD

Forest Laboratories, Inc. and Almirall, S.A. announced today that the U.S. Food and Drug Administration (FDA) has approved Tudorza Pressair (aclidinium bromide inhalation powder) for the long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

24 Jul 2012

Forest Pharmaceuticals receives FDA approval for Tudorza Pressair to treat COPD

The U.S. Food and Drug Administration today approved Tudorza Pressair (aclidinium bromide) for the long-term maintenance treatment of bronchospasm (narrowing of the airways in the lung) associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

24 Jul 2012

Merck welcomes launch of ROTATEQ in Rwanda of Africa’s rotavirus vaccination program

Merck, known as MSD outside the United States and Canada, welcomes today's launch in Rwanda of Africa's first national rotavirus vaccination program with ROTATEQ (rotavirus vaccine, live, oral, pentavalent), Merck's vaccine for the prevention of rotavirus disease.

25 May 2012

Novartis' Arcapta Neohaler now available in the U.S. for COPD treatment

Novartis Pharmaceuticals Corporation today announced that once-daily Arcapta Neohaler (indacaterol inhalation powder) 75 mcg is now available in the US and in pharmacies nationwide.

20 Mar 2012

FDA approves Teva's ProAir HFA with dose counter for asthma, COPD and EIB

Teva Respiratory announced today that the U.S. Food and Drug Administration (FDA) has approved ProAir HFA with a dose counter for use in patients 4 years of age and older for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.

8 Mar 2012

CMS assigns J-code for Pharmaxis ARIDOL Bronchial Challenge Test Kit

Pharmaxis, Inc. today announced that the Centers for Medicare and Medicaid Services (CMS) has assigned a product-specific billing code, or J-code, for ARIDOL (mannitol inhalation powder) Bronchial Challenge Test Kit.

4 Jan 2012

Teva reports data from QNASL studies on seasonal and perennial allergic rhinitis

Teva Pharmaceutical Industries Ltd. today announced that data from four late-stage studies examining QNASL (beclomethasone dipropionate [BDP]) HFA, a nasal aerosol corticosteroid in development for the treatment of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR) symptoms, will be presented at the 2011 Annual Meeting of the American College of Allergy, Asthma and Immunology (ACAAI) in Boston, Mass., November 3-8, 2011.

1 Nov 2011

Aspirin desensitization procedure can benefit patients with sinusitis, asthma and AERD

Beth Moore can now keep up with her children. The suburban Philadelphia mother of two had suffered from allergies and chronic sinusitis since her teens. With age her symptoms became more severe, turning into bronchitis and eventually asthma, diminishing her ability to breathe and sapping her of her energy. The only complete relief came from aspirin; and the aspirin desensitization that allowed her to overcome her aspirin allergy and end her decades-long battle with sinusitis.

11 Oct 2011

Boehringer Ingelheim receives FDA approval for COMBIVENT RESPIMAT to treat COPD

Boehringer Ingelheim Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved COMBIVENT RESPIMAT, a new, propellant-free inhaler product that uses a slow-moving mist to deliver the same active ingredients of COMBIVENT Inhalation Aerosol in a metered dose inhaler.

10 Oct 2011

The US Oncology Network affiliate treats advanced prostate cancer patients with PROVENGE

David, a 67-year-old father of three and soon to be first-time grandfather, felt too young to be diagnosed with prostate cancer. "I felt great," he said. "I had no symptoms." David, under the advisement of his oncologist, decided to be treated with PROVENGE (sipuleucel-T), the first in a new therapeutic class known as autologous cellular immunotherapies.

1 Oct 2011

FDA accepts Teva's NDA for BDP Nasal HFA to treat allergic rhinitis

Teva Pharmaceutical Industries Ltd. today announced that the U.S. Food and Drug Administration has accepted for filing Teva's New Drug Application (NDA) for beclomethasone dipropionate hydrofluoroalkane (BDP Nasal HFA), a nasal aerosol corticosteroid in development for the treatment of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR).

8 Aug 2011

Dendreon receives FDA approval for Los Angeles cancer immunotherapy manufacturing facility

Dendreon Corporation today announced that the U.S. Food and Drug Administration approved its Los Angeles cancer immunotherapy manufacturing facility, allowing the company to continue to increase the availability of PROVENGE across the U.S. to help meet the needs of patients with asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer.

30 Jun 2011

GE Healthcare announces results of Optison heart ultrasound contrast agent presented at ASE

Today, GE Healthcare Medical Diagnostics announced results of a study that evaluated the cardiopulmonary safety of Optison- (Perflutren Protein-Type A Microspheres Injectable Suspension, USP), a diagnostic ultrasound contrast agent for use in improving suboptimal echocardiograms.

14 Jun 2011

SYMBICORT long-term comparative study data in African American asthma patients presented at ATS 2011

AstraZeneca today announced results from a long-term study comparing SYMBICORT Inhalation Aerosol 160/4.5 mcg with budesonide pressurized metered-dose inhaler 160 mcg in self-reported African American patients with moderate to severe persistent asthma.

17 May 2011