FDA approves Novartis antibacterial treatment for cystic fibrosis
EAST HANOVER, N.J. — The Food and Drug Administration has approved a treatment for managing a type of bacterial infection in patients with cystic fibrosis.
Swiss drug maker Novartis announced the approval of Tobi Podhaler (tobramycin inhalation powder) for managing cystic fibrosis patients with Pseudomonas aeruginosa, or Pa bacteria, in the lungs.
Novartis called the product the only FDA-approved dry-powder inhaled antibacterial for Pa in the United States, and the company said it shortened the time needed to administer the drug by 70% in clinical trials. In other treatments, tobramycin is administered using a nebulizer.
"This is good news for the CF community," Cystic Fibrosis Foundation president Robert Beall said. "Managing daily CF treatments is a challenge for people with CF."
Actavis can launch generic version of Crestor in 2016, under deal with AstraZeneca
PARSIPPANY, N.J. — Generic drug maker Actavis has reached a deal with AstraZeneca that will allow it to launch a version of a drug used to treat cholesterol in three years, Actavis said Monday.
Under a deal to settle a patent-infringement lawsuit, Actavis will be allowed to launch its generic version of Crestor (rosuvastatin calcium) tablets in the 5-mg, 10-mg, 20-mg and 40-mg strengths 67 days before July 8, 2016, when the drug’s market exclusivity for use in children expires, at a fee of 39% of net sales to AstraZeneca.
Actavis also can launch rosuvastatin zinc alternate salt starting on May 2, 2016, but the company said it had made no decision regarding a potential launch.
"This agreement ensures that consumers will benefit from an earlier launch of a rosuvastatin calcium product and eliminates ongoing litigation and uncertainty of marketplace acceptance of a non-generically substitutable product if Actavis had proceeded to launch the alternative product," Actavis president and CEO Paul Bisaro said.
Crestor had sales of $4.4 billion in 2011, according to IMS Health.
Drug makers ramp up treatments for chronic conditions in the elderly, PhRMA report finds
WASHINGTON — More than 400 drugs are under development for the 10 most common chronic health conditions affecting elderly people, according to a new report by a drug industry trade group.
The Pharmaceutical Research and Manufacturers of America listed 465 drugs under various stages of development, adding that the aging of the population made chronic diseases a principal threat to the health and productivity of older Americans, as well as contribution to growing healthcare costs.
"Our ability to prevent, manage and treat chronic diseases has progressed dramatically in recent years, due in large part to the discovery and availability of new innovative medicines," PhRMA president and CEO John Castellani said. "But we can’t rest on our laurels. The more than 400 medicines in the pipeline for diseases prevalent among older Americans have tremendous potential to improve and extend the lives of seniors, and reduce costly emergency room visits, hospitalizations and surgical procedures."
The drugs include 142 for diabetes; 92 for rheumatoid arthritis and osteoarthritis; 82 for Alzheimer’s disease; 48 for heart failure; and 40 for chronic obstructive pulmonary disease. All of these conditions affect millions of elderly people in the United States, and Alzheimer’s could affect nearly 8 million people by 2030 unless a treatment or preventative measure is found.