PHARMACY

Study: Asthma medication sales to gradually decline

BY Drew Buono

WALTHAM, Mass. The pharmaceutical and healthcare research and advisory firm Decision Resources has found that increased competition, generic price erosion and cost consciousness will control growth in the asthma drug market as sales will decline from $10.9 billion in 2007 to $10.1 billion in 2017 in the world’s major pharmaceutical markets.

The new Pharmacor report, titled Asthma, finds that although sales will decline over the next decade in the United States, France, Germany, Italy, Spain, United Kingdom and Japan, the launch of several new long-acting beta-agonist/inhaled corticosteroid combinations will drive growth in this class. However, none of these new therapies, which are set to launch by 2017, will overtake the current market leader in this class, GlaxoSmithKline’s Advair.

The report also finds that although the asthma market is filled with many safe and effective drugs, pharmaceutical companies continue to develop new therapies to maximize their earning potential in this lucrative market.

“Asthma therapies that are emerging over the next 10 years in the U.S., European, and/or Japanese markets that offer improved convenience will capture market share but will still not surpass sales of Advair,” said Amy Whiting, analyst at Decision Resources. “Other key players will rely on competitive pricing, incremental gains in safety or improved efficacy to differentiate themselves from competitors.”

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Scientific Labs shut down by the FDA

BY Drew Buono

WASHINGTON The Food and Drug Administration announced that Scientific Laboratories and its president, Rajeshwari Patel, and chief executive officer, Amit Roy, have signed a Consent Decree of Permanent Injunction that bars the company from manufacturing and distributing drug products until they bring their manufacturing operations into compliance with law and obtain approval for their products.

Scientific Labs is a contract manufacturer and distributor of various prescription cough and cold products. The government’s complaint, filed by the U.S. Department of Justice, alleged violations of the Federal Food, Drug and Cosmetic Act. The company failed to seek required FDA approval for some of its products and failed to comply with current good manufacturing practice requirements.

The unapproved new drugs manufactured and marketed as prescription cough and cold products include: B-Vex Suspension, Ben-Tann Suspension, D-Tann Suspension, D-Tann AT Suspension, D-Tann CT Suspension, D-Tann DM Suspension, D-Tann HC Suspension, Dur-Tann DM Suspension, Duratan DM Suspension, L-All 12 Suspension, Nazarin Liquid, and Nazarin HC Liquid. Because these drugs have not undergone FDA review nor received approval, their safety and effectiveness have not been established. Additionally, the FDA has not reviewed the adequacy and accuracy of the directions and warnings in their labeling.

The FDA had warned Scientific Labs against violating the FD&C Act and about the risk of enforcement action if it failed to take corrective measures.

“The FDA will not allow a company to put the public’s health at risk,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “These unapproved new drugs have not undergone FDA review for safety and efficacy and may pose potential health risks.”

The consent decree bars the defendants from manufacturing and distributing any drug until they obtain required FDA approval and fully comply with CGMP requirements. The defendants must destroy their illegal drugs. The consent decree also allows the FDA to order the defendants to shut down in the event of future violations.

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Amgen cancer drug trials show significantly reduced fracture risk

BY Alaric DeArment

THOUSAND OAKS, Calif. Amgen’s cancer drug denosumab cuts fracture risk in cancer patients and women with postmenopausal osteoporosis, tests have shown.

According to early results released by the American Society of Clinical Oncology, the experimental cancer drug reduced fracture risk in 64 percent of the 111 patients tested, most of whom had breast and prostate tumors. Breast and prostate cancer are two types of cancer likely to spread to bones.

Results of Phase III testing of the drug released last month showed increases in bone mineral density among women with postmenopausal osteoporosis. Those tests examined 332 patients over a two-year period in which subjects received injections of denosumab twice a year.

Denosumab is a genetically engineered antibody that inhibits RANK Ligand, a protein that contributes to bone loss.

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