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Rwanda, QIAGEN and Merck launch comprehensive national cervical cancer prevention program

The Government of Rwanda, together with QIAGEN N.V. and Merck, known as MSD outside the United States and Canada, today announced the launch, in Kigali, Rwanda, of a comprehensive national cervical cancer prevention program that includes vaccination with GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] for appropriate girls 12 to 15 years of age and modern molecular diagnostic screening for women between the ages of 35 and 45.

From QIAGEN Manchester Limited 25 Apr 2011

POET-COPD study looks at controlling 'lung attacks' which can lead to increased ER visits

Chronic Obstructive Pulmonary Disease (COPD) is a major cause for hospital stays and emergency room visits across Canada and researchers say minimizing exacerbations or flare-ups of the disease can go a long way to reducing hospitalizations.

25 Mar 2011

FDA approves Forest Labs' Daliresp to treat COPD

Forest Laboratories, Inc. announced today that Daliresp was approved by the U.S. Food and Drug Administration as a treatment to reduce the risk of chronic obstructive pulmonary disease exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.

1 Mar 2011

Certain uses of terbutaline could lead to maternal heart problems and death, FDA warns

The U.S. Food and Drug Administration is warning that terbutaline administered by injection or through an infusion pump should not be used in pregnant women for prevention or prolonged (beyond 48-72 hours) treatment of preterm labor due to the potential for serious maternal heart problems and death. In addition, oral terbutaline tablets should not be used for prevention or treatment of preterm labor.

18 Feb 2011

Merck announces publication of GARDASIL pivotal Phase III study data in NEJM

Merck announced today that data from the pivotal Phase III study with GARDASIL in males were published in the February 3 issue of the New England Journal of Medicine.

3 Feb 2011

Alexza completes FDA review for AZ-004 NDA

Alexza Pharmaceuticals, Inc. announced today that it completed an End-of-Review meeting with the U.S. Food and Drug Administration (FDA or Agency) for the AZ-004 New Drug Application (NDA), and has received the official FDA minutes from the meeting. In December 2010, Alexza held the End-of-Review meeting in response to a Complete Response Letter (CRL) received in October 2010.

18 Jan 2011

FDA approves Cumberland's Acetadote Injection

Cumberland Pharmaceuticals today announced that it has received approval from the U.S. Food and Drug Administration for a new formulation of Acetadote Injection, the Company's product used to treat acetaminophen poisoning.

13 Jan 2011

Dendreon provides U.S. commercialization and European strategy updates for PROVENGE

Dendreon Corporation today announced several updates regarding the U.S. commercialization of PROVENGE® (sipuleucel-T), the European strategy for PROVENGE, and progress on its pipeline.

7 Jan 2011

Merck announces FDA approval for GARDASIL against HPV-related anal cancer

Merck, known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] for the prevention of anal cancer caused by human papillomavirus (HPV) types 16 and 18 and for the prevention of anal intraepithelial neoplasia (AIN) grades 1, 2 and 3 (anal dysplasias and precancerous lesions) caused by HPV types 6, 11, 16 and 18, in males and females 9 through 26 years of age.

23 Dec 2010

FDA issues CRL to Cumberland's Acetadote sNDA for non-acetaminophen acute liver failure

Cumberland Pharmaceuticals Inc. announced today that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) regarding its supplemental new drug application (sNDA) for Acetadote® (acetylcysteine) Injection to treat patients with non-acetaminophen induced acute liver failure.

22 Dec 2010

Merck announces FDA Advisory Committee approval of GARDASIL for anal cancer and AIN treatment

Merck announced today that the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee has advised that the data presented support an indication for GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] for the prevention of anal cancer and anal intraepithelial neoplasia (AIN) in both males and females 9 through 26 years of age.

18 Nov 2010

Teva presents QNAZE Phase III study results for SAR at ACAAI Meeting

Teva Pharmaceutical Industries Ltd. today announced results from a Phase III study of QNAZE (beclomethasone dipropionate [BDP]) HFA, a nasal aerosol corticosteroid in development for the treatment of seasonal allergic rhinitis (SAR), that demonstrated significantly greater symptom relief compared with placebo.

15 Nov 2010

Pharmaxis to present ARIDOL Bronchial Challenge Test Kit at 2010 ACAAI

Pharmaxis, a global specialty pharmaceutical company focused on therapeutic products for respiratory and immune disorders, will present ARIDOL™ (mannitol inhalation powder) Bronchial Challenge Test Kit, at the 2010 Annual Meeting of the American College of Allergy, Asthma and Immunology (ACAAI), November 11-16 in Phoenix, AZ.

11 Nov 2010

Acton submits Manufacturing Supplement to FDA for AEROSPAN Inhalation Aerosol

Acton Pharmaceuticals, Inc. today announced that it has submitted to the U.S. Food and Drug Administration (FDA), a Manufacturing Supplement to the previously approved AEROSPAN Inhalation Aerosol NDA.

4 Nov 2010

SYMBICORT improves lung function in African American asthma patients compared to budesonide alone

AstraZeneca announced today that results from TITAN, a 12-week study of SYMBICORT® (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol in African American patients with moderate to severe persistent asthma, showed significant improvement in lung function for patients taking SYMBICORT compared with those using budesonide alone.

3 Nov 2010

Gilead announces results from Phase III clinical trial of Cayston, TIS in cystic fibrosis patients

Gilead Sciences, Inc. today announced that its head-to-head Phase III clinical trial of Cayston (aztreonam for inhalation solution) versus tobramycin inhalation solution (TIS) in cystic fibrosis (CF) patients with Pseudomonas aeruginosa (P. aeruginosa) achieved its co-primary endpoint of superiority of Cayston for mean actual change in forced expiratory volume in one second (FEV1, a measure of lung function) percent predicted across three treatment cycles (six months).

22 Oct 2010

Acetadote Injection is now commercially available in Australia

Cumberland Pharmaceuticals Inc. and Phebra Pty Ltd. today announced that Acetadote (acetylcysteine) Injection, an injectable product used to treat acetaminophen (paracetamol) overdose, is now commercially available in the Australian market. Phebra Pty Ltd., an Australian-based specialty pharmaceutical company, has an exclusive license from U.S.-based Cumberland Pharmaceuticals to market and distribute the product in Australia.

15 Oct 2010

Pharmaxis receives FDA approval to market ARIDOL Test Kit

Pharmaxis, a global specialty pharmaceutical company focused on therapeutic products for chronic respiratory and immune disorders, announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to market ARIDOL™ (mannitol inhalation powder) Bronchial Challenge Test Kit, the first new bronchial challenge test in more than two decades.

7 Oct 2010

FDA extends review on Acetadote for non-acetaminophen acute liver failure

Cumberland Pharmaceuticals Inc. today announced the U.S. Food and Drug Administration (FDA) has extended its review of the supplemental new drug application (sNDA) for the use of Acetadote® (acetylcysteine) Injection in patients with non-acetaminophen acute liver failure.

21 Aug 2010

Cumberland Pharmaceuticals reports 9% increase in second quarter 2010 net revenue

Cumberland Pharmaceuticals Inc. ,a specialty pharmaceutical company focused on the hospital acute care and gastroenterology markets, today announces financial results for the second quarter ending June 30, 2010, and provides revenue guidance for full year 2010.

17 Aug 2010