Tris seeks FDA OK for allergy treatment for kids
MONMOUTH JUNCTION, N.J. — The Food and Drug Administration has accepted a regulatory approval application from Tris Pharma for a drug to treat allergies in children ages 2 years and older, Tris said Wednesday.
Tris said that if approved, its carbinoxamine extended-release oral suspension would provide an alternative to currently available immediate-release formulations.
Carbinoxamine is a mildly sedating antihistamine. Before 2006, it was widely used, with more than 100 products containing the drug, but nearly all were older drugs that hadn’t undergone the FDA’s approval process. The agency removed all of them except two immediate-release formulations.
DiabetesMine launches 2011 design challenge
SAN FRANCISCO — An informational and community website for people with diabetes has kicked off its fourth annual design challenge, a Web-based competition that calls for fresh ideas for new devices, Web applications or other instruments designed to help people live better with the disease.
DiabetesMine, which is part of the Alliance Health Networks family of sites, said the 2011 design challenge fosters innovation. For the second year in a row, open community voting on the website will determine the top 10 finalists for this competition. Final winner selections will be made by a group of expert judges with expertise in diabetes care, medical technologies, design and venture capital funding. Three winners will be announced this year, with the grand prize winner awarded a cash prize and the opportunity to attend an industry event, as well as meet with experts.
"We’re very excited to expand the reach of the contest this year," said Amy Tenderich, DiabetesMine founder and Type 1 diabetic. "Not only do we look forward to another bounty of creative submissions, but we’re also planning a Diabetes Innovation Summit event that will bring together patient advocates, medical device designers, investors and other experts. It’s all about making ‘patient-centered care’ a truly meaningful term."
For DiabetesMine 2011 design challenge information, visit DiabetesMine.com.
Lilly head continues call for medical innovation
TOKYO — Eli Lilly leader John Lechleiter has become something of an evangelist for medical innovation lately.
On Wednesday, the Lilly chairman, president and CEO spoke to the U.S./Japan Business Council in Tokyo to call for changes and policies in the biopharmaceutical industry that encourage innovation, or “reinventing invention,” as he called it.
“We believe that wise investments in healthcare innovation will be among society’s most productive investments in the years ahead, and that medicines represent the most cost-effective approach to preventing and treating disease,” he said.
Japan has among the world’s fastest-aging societies, with almost 45,000 centenarians, a number expected to jump to 272,000 by 2050, with 40% of the population 65 years or older by then, according to a United Nations survey.
Lechleiter made similar remarks last month at The Economist magazine’s 2011 Pharma Summit in London, when he called for new approaches to research on diabetes, cancer and Alzheimer’s disease.
His promotion of innovation is notable, considering that it’s what big drug companies, such as Lilly, will need to stay afloat as a boatload of blockbuster drugs go off patent and face generic competition over the next few years.
The companies most vulnerable to generic competition, like Pfizer and Merck, sought to reinvigorate their pipelines with biotech drugs by buying out Wyeth and Schering-Plough, respectively, while French drug maker Sanofi-Aventis is spending $20.1 billion to acquire biotech giant Genzyme, and Bristol-Myers Squibb has transitioned from a traditional pharmaceutical company into a biotech company.
Lilly has avoided big-ticket acquisitions and sought instead to invest in its research and development pipeline, which already included a significant biotech segment.