Bronchospasm News and Research

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Pivotal Phase 3 IMPACT study results of PROVENGE published in New England Journal of Medicine

Dendreon Corporation announced today the publication of data from the pivotal Phase 3 IMPACT study in the New England Journal of Medicine, showing that PROVENGE (sipuleucel-T) demonstrated a statistically significant improvement in overall survival compared to control in men with asymptomatic or minimally symptomatic metastatic castration resistant prostate cancer. The manuscript is published in the July 29, 2010 issue of the journal.

29 Jul 2010

Teva Respiratory reports positive results from BDP HFA Nasal Aerosol Phase III trial in seasonal allergic rhinitis

Teva Respiratory today announced positive results from a Phase III trial evaluating the efficacy and safety of beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) Nasal Aerosol in the treatment of seasonal allergic rhinitis (SAR). The study met all efficacy endpoints, demonstrating a statistically significant benefit as compared to placebo. Furthermore, the safety profile of BDP HFA Nasal Aerosol was similar to placebo.

29 Jul 2010

GE Healthcare Medical Diagnostics reintroduces Optison ultrasound contrast agent for echocardiograms

GE Healthcare Medical Diagnostics today announced the market reintroduction of Optison™ (Perflutren Protein-Type A Microspheres Injectable Suspension, USP), a diagnostic ultrasound contrast agent for use in select echocardiograms. Optison is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricle and to improve the delineation of the left ventricular endocardial borders. The safety and efficacy of Optison with exercise stress or pharmacologic stress testing have not been established.

12 Jul 2010

Merck's DULERA Inhalation Aerosol for asthma receives FDA approval

Merck today announced that the U.S. Food and Drug Administration (FDA) has approved DULERA® (mometasone furoate and formoterol fumarate dihydrate) Inhalation Aerosol, a new fixed-dose combination asthma treatment for patients 12 years of age and older. DULERA is not indicated for the relief of acute bronchospasm. DULERA combines an inhaled corticosteroid (mometasone furoate) with a long-acting beta2-agonist (formoterol fumarate).

24 Jun 2010

Phase III clinical trial data of Cayston versus TIS in CF patients with P. aeruginosa presented at ECFC 2010

Gilead Sciences, Inc. today announced that its head-to-head Phase III clinical trial of Cayston (aztreonam for inhalation solution) versus tobramycin inhalation solution in cystic fibrosis patients with Pseudomonas aeruginosa achieved one of its co-primary endpoints of non-inferiority for mean percent change in forced expiratory volume in one second (FEV1) percent predicted after 28 days of treatment.

19 Jun 2010

Beta-blocker medications provide new hope for patients with COPD: Study

Patients with chronic obstructive pulmonary disease may have fewer respiratory flare-ups and longer survival if they take beta-blocker medications, according to a report in the May 24 issue of Archives of Internal Medicine, one of the JAMA/Archives journals.

25 May 2010

Data from Phase 3 clinical trials of PROVENGE in advanced prostate cancer to be presented at ASCO 2010

Dendreon Corporation today announced the upcoming presentation of data from integrated analyses of three Phase 3 PROVENGE (sipuleucel-T) clinical trials of an autologous cellular immunotherapy in advanced prostate cancer, to be presented at the annual meeting of the American Society of Clinical Oncology in Chicago on Monday, June 7 at 8:00 a.m. CT.

21 May 2010

Study: EIB may affect lives and health of public if not addressed properly

For the vast majority of the general public, respiratory symptoms such as shortness of breath, wheezing or coughing are a common part of the exercise experience. However, together with chest tightness, noisy breathing and trouble taking a deep breath, these six symptoms make up the phenomenon known as exercise-induced bronchospasm (EIB), which has physical, emotional and psychological consequences if not addressed properly.

2 Mar 2010

FDA's warning over LABA medications for asthma: AANMA offers guidance

Today Allergy & Asthma Network Mothers of Asthmatics (AANMA) offered guidance to help patients understand recent Food and Drug Administration (FDA) warnings about Advair ® (fluticasone and salmeterol), Foradil ® (formoterol), Severent ® (salmeterol) and Symbicort ® (budesonide and formoterol), daily inhaled medications containing a long-acting beta agonist (LABA, a 12-hour bronchodilator).

24 Feb 2010

FDA issues approval for Gileads's Cayston for respiratory symptoms in cystic fibrosis

Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Cayston® (aztreonam for inhalation solution) as a treatment to improve respiratory symptoms in cystic fibrosis patients with Pseudomonas aeruginosa. Cayston’s safety and efficacy have not been established in pediatric patients below the age of 7, patients with forced expiratory volume in one second of less than 25 percent or greater than 75 percent predicted, or patients colonized with Burkholderia cepacia.

23 Feb 2010

Survey reveals need for better access to levalbuterol for asthma patients

A recent electronic survey of US asthma experts demonstrated the need for better access to levalbuterol, the fast-acting medicine used to treat the narrowing of airways (bronchospasm) caused by asthma, for selected patients.

9 Feb 2010

Sepracor to be acquired by Dainippon Sumitomo Pharma for $2.6 billion

Dainippon Sumitomo Pharma Co., Ltd. (“DSP”, TSE: 4506) and Sepracor Inc. (“Sepracor”, Nasdaq: SEPR) today announced that they have entered into a definitive agreement pursuant to which DSP will acquire Sepracor for approximately $2.6 billion through a cash tender offer of $23.00 per share, followed by a merger to acquire all remaining outstanding Sepracor shares at the same price paid in the tender offer.

3 Sep 2009

Mylan's subsidiary launches levalbuterol inhalation solution used for treating bronchospasm

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has launched levalbuterol inhalation solution USP (Concentrate), 0.25%, (1.25 mg/0.5 mL). Mylan, which has already launched the product, will market this product with 180 days of exclusivity.

2 Sep 2009

FDA approves Extavia for multiple sclerosis

The US Food and Drug Administration (FDA) has approved Extavia(R) (interferon beta-1b), the first in a new planned portfolio of multiple sclerosis (MS) medicines from Novartis to help patients manage this devastating disease.

17 Aug 2009

Athletes with asthma need more help from their team trainers

Very few athletic trainers associated with National Collegiate Athletic Association (NCAA) programs said that they were following best practice standards for managing asthma among their athletes, according to a new study.

30 Apr 2009

GlaxoSmithKline ready to supply Biota's Relenza to meet CDC recommendations

GlaxoSmithKline (GSK) is prepared to respond to public health needs for Relenza (zanamivir) Inhalation Powder this flu season following a Health Alert Advisory issued by the Centers for Disease Control and Prevention (CDC).

21 Dec 2008

AstraZeneca responds to FDA advisory committees' recommendation on SYMBICORT

On December 11, 2008, the Joint Advisory Committees of the U.S. Food and Drug Administration (FDA) - including the Drug Safety & Risk Management Advisory Committee, the Pediatric Advisory Committee, and the Pulmonary-Allergy Drugs Advisory Committee - completed a review of the benefits and risks of asthma medications containing long-acting beta-agonists (LABAs).

12 Dec 2008

Popular COPD treatment increases risk for cardiac events, cardiac death

New research out of Wake Forest University School of Medicine shows that use of the most commonly prescribed once-a-day treatment for chronic obstructive pulmonary disease (COPD) for longer than one month increases the risk of cardiovascular death, heart attack or stroke by more than 50 percent

24 Sep 2008

CFC-propelled inhalers no longer available as of Dec. 31 2008

The U.S. Food and Drug Administration today issued a public health advisory to alert patients, caregivers and health care professionals to switch to hydrofluoroalkane (HFA)-propelled albuterol inhalers because chlorofluorocarbon (CFC)-propelled inhalers will not be available in the United States after Dec. 31, 2008.

30 May 2008

AstraZeneca submits sNDA for SYMBICORT in chronic obstructive pulmonary disease

AstraZeneca today announced that it submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for approval of a new indication for SYMBICORT (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol for the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD). SYMBICORT is currently approved for the long-term maintenance treatment of asthma in patients 12 years and older.

30 Apr 2008