Report: Patients facing growing challenges accessing orphan drugs
- Since 1983, 7% more orphan drugs have been approved in the United States than in Europe, and 17% more were approved first in the United States than were approved first in Europe;
- There are fewer denials of orphan drug coverage by U.S. payers than by European payers; and
- While U.S. payers often require prior authorization as a condition of reimbursement, European health authorities employ more stringent conditions, such as on-label indication restrictions, step edits and coverage with evidence development.
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P&G rumored to be preparing a re-entry into the incontinence market
P&G's entry into this category confirms the growing need for these personal hygiene products. It also echoes the past decade of peer reviewed studies showing both urinary and bowel leakage as real, everyday health and wellness issues for tens of millions of women and men as young as 40. My company recently launched a product for the single largest unaddressed consumer need in the category: accidental bowel leakage (ABL). While there have been pads for urinary leakage and disposable briefs for heavier bowel leakage, there haven’t been any products for light ABL.This is surprising since numerous studies confirm ABL is the single biggest unmet need in the category globally. To learn more, visit: www.ABLinfo.org. Butterfly Body Liners are the first patented product to offer discreet protection for ABL. They are the only personal hygiene product which adheres gently to the skin. Many women tell us the launch of Butterfly is as important as the invention of tampons. Men tell us they are grateful to have not been left out of the conversation. Butterfly’s innovation was recently recognized with the nonwovens industry 2014 INDA Vision Award, as well as an Edison Award. Increased conversation, education and innovative product solutions will lead to increased care and better wellness.
Teva’s NDA for albuterol MDPI accepted by FDA
JERUSALEM — Teva Pharmaceuticals on Monday announced that the Food and Drug Administration has accepted the company's new drug application for albuterol multi-dose dry-powder inhaler, a breath-actuated dry-powder inhaler for the treatment or prevention of bronchospasm in patients 12 years of age and older with reversible obstructive airway disease. The inhaler also is indicated for the prevention of exercise-induced bronchospasm in patients 12 years of age and older, according to the company.
“We are extremely pleased the FDA has accepted for review the NDA for albuterol MDPI. If approved, albuterol MDPI would become the first breath-actuated dry-powder symptomatic and rescue inhaler available to asthma patients,” said Tushar Shah, M.D., SVP Teva global respiratory research and development. “As the current market-leader in asthma rescue inhalers, it is our hope that the new dry-powder innovation utilized with albuterol MDPI will help fill an unmet need in the existing asthma market.”
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