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Aradigm receives FDA IND approval for inhaled liposomal ciprofloxacin

Aradigm Corporation today announced it received clearance from the U.S. Food and Drug Administration (FDA) for its inhaled liposomal ciprofloxacin Investigational New Drug (IND) application. The first trial planned under this IND is a Phase 1/2a, multicenter study designed to evaluate the pharmacokinetics, safety, and tolerability of once-daily administration of 150 mg (3 mL) of Ciprofloxacin for Inhalation (CFI, ARD-3100) in pediatric patients with cystic fibrosis (CF) who have a history of chronic Pseudomonas aeruginosa lung infection.

5 May 2010

New data on Surfaxin LS presented at 2010 PAS Annual Meeting

Discovery Laboratories, Inc., announced that new data regarding Surfaxin LS (its novel, lyophilized KL4 surfactant dosage form) were presented at the 2010 Pediatric Academic Societies Annual Meeting. The two studies presented demonstrate that Surfaxin LS improves lung function and oxygenation while attenuating lung inflammation in the preterm lamb model of respiratory distress syndrome.

5 May 2010

AMRI first-quarter total revenue down 9% to $49.3 million

AMRI today reported financial and operating results for the first quarter ended March 31, 2010.

5 May 2010

Mylan-Nifedipine Extended Release tablets launched in Canada

Mylan Pharmaceuticals ULC today announces it has launched Mylan-Nifedipine Extended Release tablets in 30 mg strength. Mylan is the only company in Canada to offer this generic alternative to Adalat XL. Previously available in 60 mg tablets, the addition of the 30 mg is another example of how generic manufacturers offer patients greater access to high quality products.

5 May 2010

Older men who receive pneumococcal vaccine not less likely to have heart attack, stroke: JAMA

Men 45 years or older who received pneumococcal vaccine were not less likely to have a heart attack or stroke compared to men who did not receive the vaccine, according to a study in the May 5 issue of JAMA.

5 May 2010

Merck acquires development, commercialization rights of ridaforolimus

Merck today announced that it has restructured its co-development and co-commercialization agreement with ARIAD Pharmaceuticals, Inc. for ridaforolimus, an investigational orally available mTOR inhibitor currently being evaluated for the treatment of multiple cancer types, to an exclusive license agreement.

5 May 2010

ARIAD restructures collaboration with Merck for ridaforolimus mTOR inhibitor

ARIAD Pharmaceuticals, Inc. today announced that it has restructured its July 2007 collaboration with Merck, Sharpe & Dohme Corp. for the development, manufacture, and commercialization of ridaforolimus - ARIAD's investigational mTOR inhibitor.

5 May 2010

Archivel Farma to start phase II clinical trials of RUTI vaccine for Latent Tuberculosis

Archivel Farma, S.L. has announced that its breakthrough treatment for tuberculosis (TB) will shortly start phase II clinical trials. The treatment uses the company's unique combination of its novel therapeutic vaccine called RUTI® in conjunction with an antibiotic. This cuts treatment time from nine months to one month, which reduces side effects and healthcare costs, by preventing re-infection during the eradication process. The company expects commercial availability in 2015.

5 May 2010

FDA's call for further review of pirfenidone disappointing for Pulmonary Fibrosis patients, says CPF

The Coalition for Pulmonary Fibrosis (CPF), representing tens of thousands of patients, is responding to the news that the FDA chose to ask for further study of Pirfenidone, which will delay potential approval of the first drug in the treatment of Pulmonary Fibrosis (PF), a lethal lung disease that is irreversible, progressive and deadly in an average of three years. On March 9, 2010, an FDA Advisory Committee recommended approval of the drug by the FDA.

5 May 2010

New treatments for intestinal failure, other intestinal absorption disorders

New treatments for intestinal failure and other intestinal absorption disorders are a step closer to the patients who need them after a discovery in Kelly Tappenden's University of Illinois laboratory.

5 May 2010

Targeted antibiotics provide safe, long-lasting improvement for IBS patients, says study

A targeted antibiotic provides effective and long-lasting relief of Irritable Bowel Syndrome symptoms, according to the results of two multisite Phase III clinical trials designed by Cedars-Sinai researchers. Rifaximin is the first drug treatment for IBS that relieves symptoms while it's being administered and continues to benefit patients after they stop taking the drug.

5 May 2010

Azithromycin does not improve lung function in children with cystic fibrosis

Children and adolescents with cystic fibrosis who received the antibiotic azithromycin did not experience improved lung function, compared to patients who received placebo, according to a study in the May 5 issue of JAMA.

5 May 2010

ZEGERID OTC capsules offer more rapid acid reduction than Prevacid- 24HR delayed-release capsules

Merck Consumer Care today announced results of a head-to-head clinical study showing that ZEGERID OTC- offers greater and faster acid control than Prevacid- 24HR. While acid control is an industry standard measure for acid-reducing drugs, greater and faster acid control does not imply greater and faster heartburn symptom relief.

5 May 2010

Non-compliance, NSAIDs use inhibit clinical benefit of aspirin

Charles H. Hennekens, M.D., the first Sir Richard Doll Research Professor in the Charles E. Schmidt College of Biomedical Science at Florida Atlantic University, was the first to demonstrate that aspirin prevents a first heart attack based on his landmark Physicians Health Study (PHS).

5 May 2010

Medication used to treat heart arrhythmias also reduces myotonic dystrophy: Researchers

A medication most often used to treat heart arrhythmias also reduces a central symptom of myotonic dystrophy, the most common type of muscular dystrophy in adults.

5 May 2010

Increase in spending for AIDS drugs validates price cuts offered to ADAPs

On the heels of a report released by the National Alliance of State and Territorial AIDS Directors (NASTAD) yesterday regarding the AIDS Drug Assistance Program (ADAP), AIDS Healthcare Foundation (AHF) noted that new data contained in the report validates recent drug company price cuts offered to the program.

5 May 2010

Osiris Therapeutics' Prochymal granted FDA Orphan Drug Designation

Osiris Therapeutics, Inc. today announced that it has been granted Orphan Drug designation from the U.S. Food and Drug Administration (FDA) for Prochymal as a treatment for type 1 diabetes mellitus. The FDA instituted the Orphan Drug Act to promote the development of treatments for underserved patient populations. To be eligible for Orphan Drug designation, the treatment must target a disease that affects fewer than 200,000 new patients per year in the United States.

5 May 2010

Fifth Community Pharmacy Agreement planned by the Pharmacy Guild of Australia

According to an Australian Financial Review report the major pharmaceutical companies have agreed to reduce the Australian government’s medicine bill by AUD $2 billion over the next four years only if they are assured of price modifications in future. The details of the agreement are to be revealed next week and experts believe it will reduce the burden on the federal budget which is still considering the source of funds to pay for its health reform package.

4 May 2010

Derma Sciences adds XTRASORB Foam dressing to advanced wound care product portfolio

Derma Sciences, Inc., a medical device and pharmaceutical company focused on advanced wound care, announced the launch of its new XTRASORB™ Foam dressing. The dressing is the company's first novel entry in the $300 million foam wound dressing market. First sales are expected during the second quarter of 2010.

4 May 2010

Widespread support for a full flu vaccine side effects enquiry

After nearly 250 children suffered from serious side effects of the seasonal flu shots including one death the Western Australian Government’s step to suspend further vaccinations and investigate the issue has received widespread support. The enquiry will look into the Health Department's handling of the flu vaccination program as well.

4 May 2010

Pharmaceutical News

Aradigm receives FDA IND approval for inhaled liposomal ciprofloxacin

New data on Surfaxin LS presented at 2010 PAS Annual Meeting

AMRI first-quarter total revenue down 9% to $49.3 million

Mylan-Nifedipine Extended Release tablets launched in Canada

Older men who receive pneumococcal vaccine not less likely to have heart attack, stroke: JAMA

Merck acquires development, commercialization rights of ridaforolimus

ARIAD restructures collaboration with Merck for ridaforolimus mTOR inhibitor

Archivel Farma to start phase II clinical trials of RUTI vaccine for Latent Tuberculosis

FDA's call for further review of pirfenidone disappointing for Pulmonary Fibrosis patients, says CPF

New treatments for intestinal failure, other intestinal absorption disorders

Targeted antibiotics provide safe, long-lasting improvement for IBS patients, says study

Azithromycin does not improve lung function in children with cystic fibrosis

ZEGERID OTC capsules offer more rapid acid reduction than Prevacid- 24HR delayed-release capsules

Non-compliance, NSAIDs use inhibit clinical benefit of aspirin

Medication used to treat heart arrhythmias also reduces myotonic dystrophy: Researchers

Increase in spending for AIDS drugs validates price cuts offered to ADAPs

Osiris Therapeutics' Prochymal granted FDA Orphan Drug Designation

Fifth Community Pharmacy Agreement planned by the Pharmacy Guild of Australia

Derma Sciences adds XTRASORB Foam dressing to advanced wound care product portfolio

Widespread support for a full flu vaccine side effects enquiry

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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