Inhalation in Medical Technology

Schering-Plough Announces U.S. Filing of Mometasone Furoate/Formoterol Fumarate Combination for the Maintenance Treatment of Asthma

... corticosteroid, ASMANEX((R) )(mometasone furoate inhalation powder), with the long-acting beta2-agonist, FORADIL((R)) (formoterol fumarate inhalation powder), administered via a single metered-dose ... ASMANEX((R)) TWISTHALER((R)) (mometasone furoate inhalation powder) is for the maintenance treatment of ...

Studies Show AFRESA(R) Controls Post-Meal Sugar Levels With Less Weight Gain and Hypoglycemia Risk for Diabetes Patients

... insulin AFRESA(R) (insulin human [rDNA origin]) inhalation Powder combined with basal insulin is comparable ... (FDA) requesting approval to market AFRESA inhalation Powder and the AFRESA Inhaler for use in adult ... combination product, consisting of AFRESA inhalation Powder pre-metered into single use dose ...

AFRESA(R) Phase 3 Pulmonary Function Safety Data in Patients with Diabetes Presented at ADA

... -- AFRESA(R) (insulin human [rDNA origin]) inhalation Powder is a well-tolerated, ultra rapid acting ... (FDA) requesting approval to market AFRESA inhalation Powder and the AFRESA Inhaler for use in adult ... combination product, consisting of AFRESA inhalation Powder pre-metered into single use dose ...

PARI Pharma Reports Successful Phase Ib Clinical Results for Inhaled Liposomal Cyclosporine A and Gains FDA Orphan Drug Designation for the Prevention and Treatment of Bronchiolitis Obliterans

... liposomal formulation of 10mg CsA/2.5mL for inhalation delivery via a customized Investigational eFlow ... lung diseases such as collagen vascular diseases, inhalation of toxic fumes, and respiratory tract infections. ... PARI Pharma provides comprehensive inhalation drug development, including nebulizer formulation ...

PharmAthene Submits Proposal to BARDA in Response to Broad Agency Announcement for Advanced Research and Development for Valortim(R)

... exposure. The serious forms of human anthrax are inhalation anthrax, cutaneous anthrax, and intestinal anthrax. Initial symptoms of inhalation anthrax infection may resemble a common cold. ... progress to severe breathing problems and shock. inhalation anthrax is often fatal, even if treated by ...

Human Genome Sciences Submits Biologics License Application to FDA for ABthrax(TM)

... - First-in-class treatment for inhalation anthrax - ROCKVILLE, Md., May 21 ... ABthrax(TM) (raxibacumab) for the treatment of inhalation anthrax. (Logo: ... potential to be an important new treatment for inhalation anthrax," said Sally D. Bolmer, Ph.D., R.A.C, ...

Novel Valortim(R) Mechanism of Action Data Presented at the Keystone Symposia on Molecular and Cellular Biology

... exposure. The serious forms of human anthrax are inhalation anthrax, cutaneous anthrax, and intestinal anthrax. Initial symptoms of inhalation anthrax infection may resemble a common cold. ... progress to severe breathing problems and shock. inhalation anthrax is often fatal, even if treated by ...

Human Genome Sciences Announces Fourth-Quarter and Full-Year 2008 Financial Results and Key Developments

... Stockpile for emergency use in the treatment of inhalation anthrax. The Company expects to receive at least ... includes novel drugs to treat hepatitis C, lupus, inhalation anthrax and cancer. The Company's primary ... in the event of an emergency for the treatment of inhalation anthrax. The Company also has several drugs in ...

Human Genome Sciences Begins Delivery of First-in-Class Anthrax Treatment to U.S. Strategic National Stockpile

... National Stockpile for use in the treatment of inhalation anthrax. (Photo: ... a significant step forward in the treatment of inhalation anthrax and could play an important role in ... by the bacteria into the blood and tissues. In an inhalation anthrax attack, people may not know they are ...

Human Genome Sciences Reports Substantial Progress Toward Commercialization and Announces 2009 Goals at JPMorgan Healthcare Conference

... C, LymphoStat-B(R) for lupus and ABthrax(R) for inhalation anthrax all progressing rapidly toward ... National Stockpile for emergency use in treating inhalation anthrax. The Company has completed the animal ... a significant step forward in the treatment of inhalation anthrax and could play an important role in ...

Nebulized Perforomist(TM) Inhalation Solution Provided Prolonged Bronchodilation and Increased Patient Satisfaction Compared to Albuterol/Ipratropium MDI

... twice-daily treatment with Perforomist(TM) inhalation Solution nebulized formoterol fumarate over ... and efficacy of twice-daily Perforomist(TM) inhalation Solution, nebulized FFIS, compared to ... of treatment with either Perforomist(TM) inhalation Solution or albuterol/ipratropium MDI provided ...

Inhaled Nitric Oxide Data Presented at European Academy of Pediatrics Meeting

... III clinical trial -- INOT27, nitric oxide for inhalation for the treatment of bronchopulmonary disease ... of BPD in premature infants. Nitric oxide for inhalation should not be used routinely as a preventive ... of INOmax, Covox(R) (carbon monoxide) for inhalation and hydrogen sulfide. Ikaria is headquartered ...

New Drug Application for Inhaled Treprostinil Submitted to the U.S. Food and Drug Administration

... About TRIUMPH-1 TRIUMPH-1 (TReprostinil Sodium inhalation Used in the Management of Pulmonary Arterial ... once per day and administered in four daily inhalation sessions using the NEBU-TEC Optineb(TM) ultrasonic nebulizer, with each inhalation session taking approximately 1-2 minutes. The ...

Transave Announces Positive Phase II Results for Once-Daily Arikace(TM) in the Treatment of Cystic Fibrosis Patients Who Have Pseudomonas Lung Infections

... days at 280 mg and 560 mg dosages, using a novel inhalation device, the eFlow(R) Electronic Nebulizer (PARI ... Nebulizer Arikace is delivered by a novel inhalation device, the eFlow(R) Electronic Nebulizer, ... aerosols, PARI Pharma is dedicated to advancing inhalation therapies by developing innovative delivery ...

Human Genome Sciences Reports Progress With Late-Stage Products and New Initiatives

... potential launch in 2010 - - ABthrax(TM) for inhalation anthrax on track to begin delivery fall 2008 - ... symptoms of anthrax disease as a result of inhalation exposure to massively lethal doses of anthrax ... includes novel drugs to treat hepatitis C, lupus, inhalation anthrax, cancer and other ...

Treprostinil Data Presented at American Thoracic Society Conference Demonstrates Significant Clinical Progress in All Four Routes of Administration

... which is administered via four one-minute inhalation sessions per day. The TRIUMPH-1 (TReprostinil Sodium inhalation Used in the Management of Pulmonary Arterial ... inhaled treprostinil or placebo in four daily inhalation sessions with a maximum dose of 54 micrograms per ...

Concomitant Treatment With Nebulized Formoterol Fumarate and Tiotropium Provides Clinically Significant Improvements for COPD Patients

... a combination of nebulized formoterol fumarate inhalation solution (Perforomist(TM) inhalation Solution) and tiotropium (TIO), compared ... trial of Perforomist(TM) (formoterol fumarate) inhalation Solution, the first and only FDA-approved ...

Concomitant Use of Nebulized Formoterol Fumarate and Tiotropium Provides Significant Improvement in Dyspnea, COPD Symptoms and Rescue Medication Use over Tiotropium Alone

... data for Perforomist(TM) (Formoterol Fumarate) inhalation Solution presented at International ATS ... concomitant therapy with Perforomist(TM) inhalation Solution (formoterol fumarate inhalation solution; FFIS), delivered by nebulization, and ...

PARI's eFlow Included in Gilead's NDA Submission for Aztreonam Lysine for Inhalation

... for marketing approval of aztreonam lysine for inhalation (75 mg three times daily). Aztreonam lysine for ... lysine for inhalation. Aztreonam lysine for inhalation was administered over a two to three minute ... aerosol treatment times, as currently available inhalation therapies can average 20 to 25 minutes. PARI ...

Clinical Trial Data on the Safety and Efficacy of Concomitant Formoterol Fumarate/ Tiotropium Treatment for COPD

... CHEST 2007 on concomitant use of Perforomist(TM) inhalation Solution with tiotropium for COPD ... nebulized formoterol fumarate is Perforomist(TM) inhalation Solution, which is indicated for ... tiotropium alone. For physicians, Perforomist(TM) inhalation Solution and commonly prescribed ...

Data from Three Clinical Trials for Perforomist(TM) Inhalation Solution to be Presented at CHEST 2007 on October 24, 2007

... study of the concomitant use of Perforomist(TM) inhalation Solution with tiotropium for the treatment of COPD. Perforomist(TM) inhalation Solution is the first and only ... Solution. About Perforomist(TM) inhalation Solution Indication ...

MicroDose Announces Positive Results From the QDose Inhaled Insulin Glucose Clamp Study

... published values for the currently marketed inhalation product -- Administration of the same total dose ... an advantage over the currently marketed inhalation product The study was a randomized, crossover, ... a broad range of compounds independent of inhalation effort. Partnered programs for the inhaler ...

Human Genome Sciences and GlaxoSmithKline Announce Positive Phase 3 Study Results for BENLYSTA(TM) in Systemic Lupus Erythematosus

... development pipeline includes novel drugs to treat hepatitis C, lupus, inhalation anthrax and cancer. The Company's primary focus is rapid ... late-stage development is raxibacumab (ABthrax(TM)) for the treatment of inhalation anthrax (Biologics License Application currently pending with the U.S. ...

Advanced Life Sciences Announces Outcome of FDA's Anti-Infective Drugs Advisory Committee Review of Restanza(TM) (cethromycin)

... CAP, Restanza is also being investigated for the prophylactic treatment of inhalation anthrax post-exposure. The FDA has designated Restanza as an orphan drug for the prophylactic treatment of inhalation anthrax post exposure, but the drug is not yet approved for this or any ...

PARI Pharma's Nebulized DSCG Shows Results Similar to Inhaled Steroids in Asthma Studies Presented at ATS

... to attract water molecules] of DSCG, and its tendency to grow in size upon inhalation when administered via a dry powder or metered dose inhaler (DPI or MDI). ... patients among other indications. PARI Pharma provides comprehensive inhalation drug development, including nebulizer formulation development and ...

Human Genome Sciences Reports Positive Late-Breaker Results at EASL from ACHIEVE Phase 3 Trials of Albuferon(R) in Patients with Chronic Hepatitis C

... development pipeline includes novel drugs to treat hepatitis C, lupus, inhalation anthrax and cancer. The Company's primary focus is rapid progress ... Stockpile for use in the event of an emergency for the treatment of inhalation anthrax; completion of delivery is expected in the second quarter. The ...

Human Genome Sciences Announces Positive Results in Second of Two Phase 3 Trials of Albuferon(R) in Chronic Hepatitis C

... development pipeline includes novel drugs to treat hepatitis C, lupus, inhalation anthrax and cancer. The Company's primary focus is rapid progress ... Stockpile for use in the event of an emergency for the treatment of inhalation anthrax. The Company also has several drugs in earlier stages of clinical ...

MannKind Reports Successful Completion of Device Bioequivalence Trial

... Scale Inhalers Study 138 compared the bioequivalence of MannKind's inhalation device, which underwent some design changes after the initiation of Phase ... costly to manufacture. Clinical trial subjects were administered AFRESA inhalation Powder from the same bulk lot, according to a randomized two-way crossover ...

Study Found That Long Term Use of Advair Diskus(R) 250/50 Did Not Adversely Affect Bone Loss in Patients with COPD

... hip between Advair Diskus 250/50 (fluticasone propionate and salmeterol inhalation powder) and salmeterol - Study provides support for long term use of ... Diskus 250/50 has not been demonstrated. Patients should only take one inhalation of Advair twice a day. People with COPD taking Advair may have a higher ...

Data Show Aerovance's Aerovant(TM) Inhalation Powder is Well Tolerated in Asthma Patients

... with no evidence of local irritancy following asthma patients' inhalation of a single 10 mg dose. This 10 mg dose will be the highest of three ... in the study and were administered a single 10 mg dose of Aerovant inhalation powder via the EZ Aer(TM) Inhaler. Serial measurements of PK and lung ...

PharmAthene Presents Data for Protexia(R) and Valortim(R) at 2008 BARDA Industry Conference / PHEMCE Stakeholders Workshop

... Valortim(R), an Anti-toxin Monoclonal Antibody, in the Treatment of inhalation Anthrax in the African Green Monkey Model," investigators at USAMRIID ... agents, such as sarin gas, soman, tabun or VX, enter the blood stream via inhalation or absorption through the skin. The nerve agents travel in the circulatory ...

Human Genome Sciences Reports Initial Results of Randomized Phase 2 Trial of HGS-ETR1 in Combination With Bortezomib in Advanced Multiple Myeloma

... development pipeline includes novel drugs to treat hepatitis C, lupus, inhalation anthrax, cancer and other immune-mediated diseases. The Company's primary ... (raxibacumab) is in late-stage development for the treatment of inhalation anthrax, and the Company is on track to begin the delivery in fall 2008 of ...

Human Genome Sciences Completes Enrollment in Second Phase 3 LymphoStat-B(R) Trial

... development pipeline includes novel drugs to treat hepatitis C, lupus, inhalation anthrax, cancer and other immune-mediated diseases. The Company's primary ... (raxibacumab) is in late-stage development for the treatment of inhalation anthrax, and the Company is on track to begin the delivery in fall 2008 of ...

Human Genome Sciences Completes Enrollment in Randomized Phase 2 Trial of HGS-ETR1 in Non-Small Cell Lung Cancer

... development pipeline includes novel drugs to treat hepatitis C, lupus, inhalation anthrax, cancer and other immune-mediated diseases. The Company's primary ... (raxibacumab) is in late-stage development for the treatment of inhalation anthrax, and the Company is on track to begin the delivery in fall 2008 of ...

MAP Pharmaceuticals Reports Positive Pharmacological Response Data for Migraine Product Candidate at the American Headache Society Annual Meeting

... Sustained Relief and Freedom Over 24 and 48 Hours Post Dosing -- Chronic inhalation Toxicological Assessment of Dihydroergotamine in Dogs -- Assessment of ... by currently available medicines. The Company applies its proprietary inhalation technologies to enhance the therapeutic benefits and commercial ...

Inspire's Phase 3 CF Trial, Using PARI's Nebulizer & Compressor, Shows Positive Top-Line Results

... top-line results of the first Phase 3 trial with denufosol tetrasodium inhalation solution delivered via PARI's LC STAR nebulizer and PRONEB Ultra ... positive top-line results and hope that Inspire's denufosol tetrasodium inhalation solution delivered via PARI's LC STAR and PRONEB Ultra compressor will ...

Human Genome Sciences Reports Positive Long-Term Data for LymphoStat-B in Patients With Active Systemic Lupus Erythematosus

... development pipeline includes novel drugs to treat hepatitis C, lupus, inhalation anthrax, cancer and other immune-mediated diseases. The Company's primary ... (raxibacumab) is in late-stage development for the treatment of inhalation anthrax, and the Company is on track to begin the delivery in fall 2008 of ...

Results From One-Year Study Suggest Advair(R) Provides Important Benefits for African American Patients With Asthma

... received treatment with the ICS Flovent Diskus(R) (fluticasone propionate inhalation powder) alone, although the difference was not statistically significant. ... twice-daily Advair Diskus 100/50 (fluticasone propionate and salmeterol inhalation powder) or twice-daily Flovent Diskus 100mcg for a year, was the first ...

Human Genome Sciences Initiates First Clinical Trial of Lead IAP Inhibitor HGS1029 in Advanced Solid Tumors

... development pipeline includes novel drugs to treat hepatitis C, lupus, inhalation anthrax, cancer and other immune-mediated diseases. The Company's primary ... (raxibacumab) is in late-stage development for the treatment of inhalation anthrax, and the Company is on track to begin the delivery in fall 2008 of ...

Advanced Life Sciences Announces Successful Thorough QT Study of Cethromycin

... cethromycin is also being investigated for the prophylactic treatment of inhalation anthrax post-exposure. The FDA has designated cethromycin as an orphan drug for the prophylactic treatment of inhalation anthrax post-exposure, but the drug is not yet approved for this or any ...