HEALTH

PharmaLink gets orphan drug designation for Nefecon

BY Alaric DeArment

STOCKHOLM The Food and Drug Administration has given orphan drug designation to a treatment for a rare kidney disease under mid-stage clinical development by privately owned Swedish drug maker PharmaLink, the company said.

 

The FDA granted the designation to Nefecon (PL-56), a treatment for IgA nephropathy, also known as Berger’s disease, a disorder that leads to end-stage kidney disease. The FDA gives orphan drug designation to incentivize development of treatments for rare and serious disorders.

 

 

“Today’s news marks a significant milestone for PharmaLink and increases the commercial value of Nefecon as it moves toward the marketplace,” PharmaLink managing director Johan Haggblad said. “We believe this product candidate has great potential in treating IgA nephropathy.”

 

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CVS/pharmacy reaches mobile customers with iPhone app

BY Allison Cerra

WOONSOCKET, R.I. CVS/pharmacy has developed a free, downloadable application for mobile customers that seek to manage their prescriptions and shopping lists on the go.

The drug store chain said that its app is available for the iPhone, can be downloaded from iTunes or the Apple app store and allows customers to take advantage of the following features:

  • Find nearby CVS/pharmacy locations using the GPS-based store locator with integrated driving directions and maps;
  • Refill prescriptions from a personalized prescription history for pickup at any CVS/pharmacy;
  • Transfer prescriptions from another pharmacy to CVS/pharmacy;
  • Access the Drug Information Center to retrieve critical details about medication management, including instructions for use, dosing information, side effects and relevant safety warnings;
  • View and manage sales circular to create a custom shopping list and identify money-saving deals each week; and
  • Schedule a flu shot at any local CVS/pharmacy location.

“We have introduced the CVS/pharmacy mobile application to give customers the ability to manage prescriptions and access important health information from any location,” said Rob Price, SVP marketing and chief marketing officer for CVS/pharmacy. “In addition to managing prescriptions, the mobile application will provide instant access to our flu shot scheduler, and even allow customers to plan shopping trips in advance using our mobile circular. With more than 7,000 locations and the addition of this mobile application, CVS/pharmacy continues to be the most convenient destination for our customers’ healthcare needs.”

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FDA targets dietary supplements maker for selling unapproved, misbranded drugs

BY Michael Johnsen

SILVER SPRING, Md. The Food and Drug Administration on Wednesday announced that Toby McAdam and Greta Armstrong, doing business at Rising Sun Health and The Center for Complementary and Alternative Health of Livingston, Mont., have signed a consent decree that prohibits them from manufacturing and selling unapproved new drugs and adulterated or misbranded dietary supplements in violation of the law.

Prior to entry of the consent decree, Rising Sun manufactured and distributed a variety of unapproved new drugs under such names as Black Salve, Cansema and Can-Support. These products included topical salves purported to treat skin cancer, as well as oils and capsules claimed to be therapies for other serious diseases, such as breast cancer, asthma, anemia and epilepsy. Rising Sun misbranded many of these unapproved new drugs as dietary supplements.

“The FDA will not tolerate unsubstantiated health or disease claims that may mislead customers,” stated Deborah Autor, director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research. “The FDA is committed to ensuring that consumers do not become victims of false cures.” 

Under the consent decree, Rising Sun agreed to stop making and selling unapproved new drugs and products with unauthorized health claims. Rising Sun also agreed to hire an independent expert to review the claims made for future products and to certify that all violative claims have been omitted. The FDA can order Rising Sun to stop manufacturing and distributing any product that fails to comply with the consent decree or the Federal Food, Drug, and Cosmetic Act. The consent decree also provides for damages to be assessed against Rising Sun in the event of such violations.

The consent decree was filed in the U.S. District Court for the District of Montana and is subject to court approval.

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